inform advise reach educate april 2012 vol 4 • issue 2

Transcription

GLOBALforum gf
APRIL 2012
VOL 4 • ISSUE 2
INFORM
ADVISE
REACH
EDUCATE
gf
CONTENTS
INFORM
ADVISE
REACH
EDUCATE
Devised to
educate and
update you on
advances in a
specific area of
research, drugs,
diagnostics or
devices.
15
Time
management,
skill
development,
technology,
software topics
and more are
examined. 41
What we are
doing around
the globe and
how advances
in each region
can have a
worldwide
impact.
61
Keeps you
abreast of
the
association,
membership,
regulatory,
and legislative
news.
103
In Every Issue
Open Forum
6
Andrzej Czar necki
President’s Message
8
Yves Juillet
Executive Director’s Message
10
Paul Pomerantz
Co-Chairs Further Explain SLC SLCs Establish Global Community
12
Association News
DIA Student Day
Danny Benau120
Worldwide ED Named to NHC Board
Paul Pomerantz
121
2012 EuroMeeting Award W inners
122
Patient Perspective
Dwindling T ime and Lingering Hope
124
Book Review
The World’s Health Care Crisis:
From the laboratory bench to the
patient’s bedside
by Ibis Sanchez-Serrano
128
Members on the Move
130
3
gf
GLOBAL FORUM
The Global Forum (ISSN: 1944-1991) is a
publication of the Drug Information Association.
Editorial Office:
Drug Information Association (DIA),
800 Enterprise Road, Suite 200,
Horsham, PA 19044-3595,
PUBLISHING
I N F O R M AT I O N
USA; phone - 215.442.6100;
fax: 215.442.6199.
Copyright © 2012, Drug Information Association.
The Global Forum (ISSN: 1944-1991) is
published six times a year, in February,
April, June, August, October, and December.
Paul Pomerantz, Executive Director
Andrzej Czarnecki, MD, PhD, DSc,
Editor-in-Chief
ISSUE 2
Global Forum Staff
VOL 4
4
Periodical postage paid at Horsham,
Pennsylvania, and additional mailing offices.
Thirteen dollars of each member’s annual
membership fee is for a year’s subscription.
Prices include postage and are subject to
Judy Connors, Managing Editor
change without notice. Notify DIA eight weeks
Chris Slawecki, Senior Copywriter
in advance of address change with a copy
Joe Krasowski, Marketing Communications
of the mailing label. Back issues of most
Manager
previously published issues are available from DIA.
Freelance Writers
Pat Friia
Joyce Litwin Zimmerman
Mission
PUBLICATIONS MAIL
AGREEMENT NO. 41103506
RETURN UNDELIVERABLE CANADIAN
ADDRESSES TO CIRCULATION DEPARTMENT,
The Global Forum provides a multidisciplinary,
PO BOX 1051, FORT ERIE, ONTARIO L2A 6C7
neutral forum for communicating information
Postmaster: Send changes of address to
related to drug development and lifecycle
Global Forum, 800 Enterprise Road, Suite 200,
management on a global basis. The Global
Horsham, PA 19044-3595, USA.
Forum disseminates content that is relevant to
members’ professional experiences, including
Design: Imagevolution - 610.867.4460
international industry and regulatory updates
Cover Illustration: Copyright © BIGSTOCK.com
and news of the association and its programs.
The magazine is circulated six times a year as a
benefit of DIA membership.
Publishing and Subscription:
Drug Information Association (DIA),
800 Enterprise Road
Suite 200, Horsham, PA 19044-3595, USA.
Contact Information
for Advertising:
Worldwide Advertising Sales,
Frank Cassera - SAGE Publishing
frank.cassera@sagepub.com
Subscription Information,
Customer Service - 215.442.6100
Membership Services,
Mike McGovern - 215.442.6129
Senior Marketing Manager,
Mike Keller - 215.442.6173
DIA is a neutral organization that does not
advocate for or against any issue. The views
expressed by the individual authors or
interviewees in the Global Forum are theirs and
do not necessarily represent the views of the
Drug Information Association.
5
gf
GLOBAL FORUM
OPEN
FORUM
ISSUE 2
Bridging the gap
VOL 4
6
ANDRZEJ
CZ ARNECKI
Technology keeps progressing
and creating new developments
in a blink of an eye. It provides
us with new solutions for nearly
everything, and gradually without
use of computer-like hardware
(laptop, tablet, smart-phone) life
will become difficult to impossible.
Several years ago modern society
entered the era of Social Media
(SM), articles on Web 2.0 and
beyond, and the whole concept
was alien to the vast majority
of people over a certain age. I
believe that to a large extent, it
is still the case. Despite that, we
cannot deny the existence of a
different/parallel way of life and
communication being present
around us, and being used by
an increasing percentage of the
world’s population - estimated to
be in excess of 15% worldwide.
The INFORM section of this
month’s Global Forum is devoted
to some aspects of social media:
covering the regulatory guidelines
and everyday use, and some
advice on use in the current
environment, e.g., for work and
personal activities. It is very clear
that the younger part of society
exists, communicates, works,
does business and organizes
their private lives using social
media, predominantly with the
help of their smart phones on
which, in our profession, we are
encouraged to read new scientific
articles, receive, keep and send
patients records, and basically do
all of our everyday phone calls,
e-mails and transactions.
The take up of SM surpassed
all expectations, even those of
its creators. There are not many
businesses that would not be
present on Facebook and/or
Twitter, or would not use blogs.
These ways of communication
have established themselves
firmly in our everyday existence,
and also in our professional lives
in medicine/pharmaceuticals.
Interestingly, it appears that
professional social networks have
become the main source of job
searching and, for employers,
screening for appropriate
candidates, which they would
do on Facebook and, more likely
in our case, LinkedIn. It is worth
acknowledging that changes
in this respect have only just
happened a short while ago.
The changes in SM area occur
so swiftly and frequently that
any attempts to describe them
become outdated before they
may be ready to share as printed
material.
In this issue of the Global Forum,
Nancy Smith, the editor of our
INFORM section compiled a series
of overview articles on SM to keep
us up-to-date at least to some
degree. We thank Nancy for this
successful attempt. Due to the
extent of the topics, only some
of aspects of SM are covered.
Considering the content of the
section and the fact that most
social skills of our modern society
are developed via SM, we have
an opportunity to judge at which
stage our social skills are, and
decide how we want to progress
from there.
Social Media provides us with a
new way of delivering information
and communication to a wider
audience. This function is
becoming increasingly important
across the pharmaceutical sector.
It was always obvious that if a
patient does not understand
their diagnosis, therapeutic
procedure, and/or reason or
method of treatment, then the
chances of getting them healthy
again diminish, and everybody is
at loss: the patient, society, the
physician, the system, etc. The
use of social media has created
a new way of communicating
with the public and patients and,
most importantly, also between
patients. The ‘old and new’ ways
of intercommunicating raise an
issue of a fine balance between
the full transparency being broadly
advocated and required, and a
provision of information that would
be understandable, i.e., useful
to the patient/public. It is a big
challenge and has been reflected
upon in our profile this month,
very well delivered by Mary Baker
(see Profile), from the European
Brain Council representing
patients’ organizations. She stated
that, “What they (Pharmaceutical
industry) are nervous about is
that this information release
will contain data that is totally
unrecognizable to patients. It is
almost a different language...”
and they will be accused of“…
pretending to be transparent”
and failing the task again. These
words from a longstanding
patients’ representative confirm
that we need to recognize, and
appropriately deal with, a very fine
line between total transparency,
and understandable information.
It is a big challenge. The same
interview raises numerous issues
that our publication has continued
to raise over the years. It is good
to hear that patients praise DIA
for its openness, and the ability
to bring people together from a
wide range of backgrounds and
environments, and provide them
with an independent platform to
discuss any issue they feel may be
important. Last year, the Oxford
Debate at the beginning of the
Euromeeting in Geneva (Open
Forum, June 2011, Global Forum)
was clear about the fact that
everybody needs to come out of
their silos and work together to
achieve a better ‘end product’,
better and faster regulatory
process and better targeted
medicines for patients. Mary
provided some examples how
new quality could be born out
of such an approach. Based on
them and Mary’s overall message,
it is clear that the patients align
in full with the industry in support
of better cooperation between
all stakeholders- regulators,
academics, patients and industry.
Only then will we reach a full
understanding of what is needed,
and how to deliver the best
outcome, i.e., how the new quality
will emerge from the combined
approach and work of minds
thinking alike for the benefit of
patients. Social media might
just be able to help us in this
exchange of information, that
otherwise would take much longer
to reach interested parties.
Global Forum
Editorial Board
Andrzej Czarnecki, MD, PhD, DSc
Editor-in-Chief
Richard Chamberlain, PhD
ECS, Inc.
Ron Fitzmartin, PhD, MBA
FDA / CDER
Alberto Grignolo, PhD
PAREXEL
Betty R. Kuhnert, PhD, MBA
Sarah Powell
Thomson Reuters
Nancy D. Smith, PhD
Potomac, MD
Jean H. Soul-Lawton, DPhil
GlaxoSmithKline
J. Rick Turner, PhD
Quintiles
Qingshan Zheng, PhD
Shanghai University of
Chinese Medicine, China
7
gf
GLOBAL FORUM
PRESIDENT’S
MESSAGE
Reflections from Europe
ISSUE 2
As spring begins to thaw an
exceptionally brutal European
winter, it seems to provide an
opportune pause for reflection in
between our recently concluded
24th Annual EuroMeeting in
Denmark and our upcoming 48th
Annual Meeting, DIA 2012, in
the US. Having formerly served
as programme co-chair of the
2004 EuroMeeting in Prague, and
currently serving as the first DIA
Board President from Europe, it
is heartwarming to contemplate
from these perspectives how
the evolution of the EuroMeeting
reflects the evolution of DIA.
VOL 4
8
y v es
juillet
Serving as EuroMeeting co-chair
certainly taught me that organizing
a meeting of such size and scope
presents quite a challenging task.
To be truly effective, DIA programs
must provide timely content
that addresses important issues
and meets the needs of all our
participants. But because these
participants come from different
constituencies including regulatory
authorities, we must address
these issues with consistency and
diversity. These programs must
also address critical, emerging hot
topics, even though our planning
process often begins several
months before the program
actually takes place. We must
also identify and coordinate the
efforts of volunteer contributors
who simultaneously possess the
required topical expertise and
commitment to meeting program
schedules.
As you can see, we have much
gratitude to extend to those
who serve as Chairs and on the
Committees for all our educational
programs; especially, because
of their expansive scope, those
who help lead our regional annual
meetings such as our upcoming
4th Annual Meeting in China this
May in Beijing, and of course our
DIA 2012 48th Annual Meeting
coming to Philadelphia in June.
But it is also important to
remember that such meetings,
while standalone events, are
also just one point on a larger
development continuum.
Organizing and presenting a
meeting is an important step
but our efforts don’t end there.
Shared ideas help identify new
important issues, new emerging
hot topics, new training needs
and new volunteer contributors
who possess the expertise and
ambition to drive knowledge
forward in these areas.
Reviewing the development
of our EuroMeeting provides
several examples of how DIA
has incorporated new ideas and
contributors. DIA has increased
our efforts in the fields of
medical devices, diagnostics,
and combination products,
and in the fields of Health
Technology Assessments (HTA
in Europe) and Comparative
Effectiveness Research (CER in
the US). Looking back, devices
and diagnostics, and HTA and
clinical evidence, were featured
EuroMeeting themes; looking
forward, they will certainly be large
topics at our Annual Meeting.
In our shared environment of
global supply chains, multinational
clinical trials, and international
regulatory and scientific
harmonization, globalization
is another key component of
our refined strategic direction
and educational content. As
development and regulatory
activities grow more global, so do
our educational programs – and
so do our contributors, members,
and volunteers.
I tend to think of DIA as a
“natural stream” that flows
from participants who become
members and then contribute
as volunteers. Professionals
from nearly every background,
discipline, workplace,
management level, and nation
come together through DIA. Over
the past few years, we have
successfully introduced initiatives
for students at our EuroMeeting
and Annual Meeting. Many
students often take that critical
first step into active professional
life, and we have introduced
activities for new industry
professionals at these programs,
too. Further downstream, young
professionals often benefit from
the guidance of more experienced
and mature professionals, another
key DIA stakeholder group. DIA
manages to bring all these people
together for their mutual benefit.
DIA has also embraced patients
and patient advocates as
stakeholders, which is the
aim of our Patient Fellowship
program introduced six years
ago at the EuroMeeting and now
incorporated into our Annual
Meeting. But their presence at
these meetings has been only
the first step. They have already
started to follow up attending
by actively participating as
session speakers and chairs,
and as members of our planning
committees for these programs.
DIA regional advisory councils for
Europe and North America now
include patient representatives,
and we look forward to this trend
advancing into our other regions.
Your previous issue of the Global
Forum (Volume 4, Issue 1,
February 2012) was devoted to
patients with rare diseases and
orphan product development.
In my President’s Message for
that issue (“Acting on the Patient
Voice”), I explained how more
active participation by patients
and patient advocates within DIA
events provides a microcosm
of the new ways that patients
are helping to lead product
development, approval and
regulation, marketing and postmarketing activities, all around the
world.
Like no other organization or
association, DIA brings together
people working in different
professional activities and
disciplines, at different stages of
their education or career, from
different countries in different
regions of the world, for our
shared vision and purpose. DIA
works not only for everyone, but
for each and every one.
9
gf
GLOBAL FORUM
F rom t h e D es k of
Pau l P omerant z
Wo r l d w i d e E x e c u t i v e D i r e c t o r
Creating Global Community
ISSUE 2
In this issue, I’d like to present
the background and purpose of
a recent major transformation
within our Special Interest Area
Communities (SIACs) and SIAC
leadership, and also explain how
the concept of SIACs and the new
SIAC Leadership Council (SLC)
both embody and reinforce the
global and culture of quality aspects
of our refined strategic direction.
VOL 4
10
PAU L
POMERANTZ
Exe c u t ive Di rec t o r
The SIACs are undergoing an
exciting transformation. Today,
DIA has over 30 SIACs which
cover virtually every aspect of
biopharmaceutical and medical
product development. [All current
SIACs are listed in the sidebar.]
They are growing to cover
new topics, they are becoming
increasingly global, and they are
becoming increasingly connected
through the DIA ConneX social
networking tool. Increasingly, SIACs
are lending their expertise to create
enduring programs and resources
such as the Electronic Document
Management (EDM) Reference
Model and the Trial Master File.
SIACs are rapidly emerging to
become an essential value to
members and stakeholders,
a place where professionals
with shared interests can come
together, network, and solve
common problems. DIA’s SIAC
structure is ideally suited to help
address today’s challenges, which
require a mix of global and regional
approaches. In particular, a global
SIAC structure is suited to an
environment of multi-national firms,
multi-regional clinical trials, a global
supply train, and an increasingly
international regulatory framework.
First, some background. The first
SIACs were created more than a
decade ago when DIA was largely
a North American organization. As
such, they fell largely under the
purview of the Advisory Council
of North America. As DIA became
more global, extending into Europe,
Asia and Latin America, interest in
SIACs from members worldwide
grew. However, because SIACs
were viewed as largely North
American, this view limited their
growth and acceptance across DIA
regions.
In 2010, the Board began to
explore the best way to realign
the SIACs and the ACNA as part
of addressing two related if not
simultaneous issues: How can we
meet the tremendously increased
global interest in developing new
and existing SIACs? And, how can
we free North American leadership,
which had been spending a
tremendous amount of effort on
overseeing SIAC activities, to focus
on the programmatic needs of this
region?
In 2011, after careful consideration
by SIAC and regional North
American leadership, the Board
agreed to uncouple SIAC oversight
from the ACNA by creating the
SIAC Leadership Council (SLC).
Consisting of experienced DIA
volunteers who represent the
needs of all key regions, the SLC
is chartered to provide strategic
input to the Board through the
Member & Volunteer Engagement
Committee, to support and grow
the global nature of SIACs, and to
provide input and feedback to staff
on SIAC needs. The SLC is chaired
Deborah Dolan (Vice President,
Key Accounts, AmerisourceBergen
Corp.) and co-chaired by Dr.
Gesine Bejeuhr (Senior Manager,
Regulatory Affairs/Quality, vfa
Research-based Pharmaceutical
Companies, Germany). They share
their thoughts on what the SLC
will mean to DIA SIAC members
in the attached article, along with
Jennifer Riggins (Director, Global
Information Disclosure, Eli Lilly and
Company), who chairs the ACNA.
Built around knowledge of
specific scientific and professional
disciplines, SIACs are global
communities. But helping SIACs
to develop and disseminate this
knowledge (through our educational
programs and other offerings) is a
regional responsibility. For example,
professionals who work in the field
of pharmacovigilance generally
have the same responsibilities
and concerns. At the same
time, the practical conduct of
pharmacovigilance in London
may be significantly different
from performing that same job
in Tokyo. As a result, developing
and delivering educational content
of value to pharmacovigilance
professionals in London and/
or Tokyo requires collaboration
between our global and regional
leadership.
One of the things we’re emphasizing
as an organization is developing
knowledge to benefit our industry
stakeholders. I previously
mentioned the Electronic Document
Management Reference Model and
Trial Master File initiatives, both of
which were led by DIA SIACs. Our
SIACs also develop many annual,
discipline-specific programs that
deliver essential knowledge about
specific industry skills throughout
our global enterprise.
Developing knowledge is also a
priority behind the Digital Initiative,
one of our key strategic priorities.
One such tool is right on our own
website, our DIA ConneX secure
interactive professional collaboration
forum. Each SIAC operates in its
own ConneX community, which not
only allows for global collaboration
but can accommodate regional
subgroups within each global
discipline where, for example,
members can develop ideas and
content in their native language.
Just as importantly, DIA ConneX
can facilitate dissemination of
the discipline-specific content
developed by our SIACs to
make it more accessible to a
broader audience – to all DIA
stakeholders. SIACs will play a
lead role in not only identifying
and developing this knowledge
but in spreading it throughout our
global constituencies, and in further
identifying additional content needs
and new delivery systems, toward
this same purpose.
We’re confident that better support
will help to raise awareness of the
professional potential that SIACs,
one of the best benefits of DIA
membership, offer to DIA members.
If you’re not yet a SIAC member,
please allow me to personally invite
you to join. Now, more than ever,
promises to be a great time to jump
in and participate. Thank you for
reading, and for your continued
support.
DIA SIACs
Biotechnology and Innovative Preclinical
Sciences
Chemistry, Manufacturing and Controls and
Quality System
Clinical Data Management
Clinical Pharmacology
Clinical Research
Clinical Safety and Pharmacovigilance
Clinical Trial Disclosure
Devices and Diagnostics
Document and Records Management
eClinical
Electronic Regulatory Submissions
Emerging Professionals
Evidence Based Medicine
Global Sourcing
Good Clinical Practices and Quality
Assurance
Information Technology
Investigator and Investigative Sites
Legal Affairs
Marketing and Sales
Medical Communications
Medical Writing
Medical Science Liaison
Natural Health Products
Pediatrics
Professional Education, Training and
Development
Project Management
Quality Risk Management
Regulatory Affairs
Statistics
Study Endpoints
Validation
11
gf
GLOBAL FORUM
SLCs Establish
Global Community
ISSUE 2
Co-Chairs Further Explain SLC
Deb o r a h Do l a n
VOL 4
12
Je n n if er R i g g i n s
Ges in e Bej eu hr
“The SLC has two goals. One is to
help SIAC members more easily
communicate with each other so
that their SIAC experience is more
valuable for them personally and
for their professional interests. The
second is to encourage global
participation in SIACs,” explains
Deborah Dolan.
“The SLC looked at the global
metrics for SIAC membership,
which were significantly skewed
to the United States. This created
a feeling among members that
SIACs were North American driven
and not open to other areas of
the world. And, as you know,
perception is reality, and the DIA
Board concluded that we were not
going to be able to break through
this perception unless something
changed.”
“We want SIACs to reflect the
globalization that DIA has embraced
as an organization, and wish
to help steer this globalization
by supporting SIAC global
development and growth through
the SLC,” explains Gesine Bejeuhr.
“We have developed a slogan to
share at the SIAC luncheon at
our EuroMeeting in Copenhagen,
‘Reaching around the world to
create a global community,’ which
expresses this motivation.”
“Enabling SIACs to work globally
is too important to not get right
because the pharmaceutical
industry IS a global industry, and
one of the biggest advantages that
DIA provides to members is the
opportunity to interact with all the
industry’s key regions. This global
aspect is incredibly important,”
Deborah says. “We are already
seeing great interest in China, in
India, as well as in Japan and Latin
America, so we want to open SIACs
to truly global membership. We
want to make sure that we remove
barriers to participation to make
it easier for interested members
all over the world to be actively
involved.”
Gesine further explains a different
but no less important aspect
of SIACs “As an organization,
DIA presents a truly unique
opportunity: You can work both
locally and globally at the same
time,” she suggests. “This is
one of the core messages of our
SIACs: They create, on the one
hand, the opportunity for DIA
members to meet their fellows in
their specific region and, at the
same time, the opportunity to
communicate, through the global
SIAC organization, with their
fellows all over the world. One
feature of global SIACs is regional
communities; they present the
opportunity to create regional
communities that mirror on the
local level the structure of the
global SIAC. This also makes
DIA’s information technology
environment – more specifically,
DIA ConneX – a very important tool
because it provides a channel for
communication.”
“That’s really important,” Deborah
concurs. “If the global SIAC is
based in North America or Europe,
or has co-chairs based in the US
and in Europe, the basic barrier is
the time zone, the simple difference
in time. For example, a group
may be very active in China, but
time differences present a real
challenge for their participation
in a teleconference that is based
or starts in the US. Language is
another barrier that has gotten in
our way and so, as Gesine said,
local participation is critical. They
can share information in their own
language through teleconferences
or online through DIA ConneX. They
can even select a chair, if they wish,
of that regional subcommunity, and
designate that person to serve as
their regional liaison to their global
SIAC. Regional communities will be
grown over time according to the
level of interest in that region, within
each global SIAC interest area.”
“Even if they work regionally in
their local language, they should
always be open for interaction with
the global membership,” Gesine
concludes.
ACNA Chair Jennifer Riggins also
believes that the SLC will bring
great benefits to both individual
SIAC contributors and our entire
organization. “I am very excited
about the creation of the SLC. It’s
great for our members that there
will be a group truly focused on
ensuring the global nature of, and
participation in, our SIACs,” she
says. “The SLC ensures that SIACs
are global in nature and support
the needs of our membership and
organization as a whole, not just an
activity exclusive to North America.
De-coupling SIACs from the ACNA
also more fully aligns North America
with other DIA regional councils
around the world by allowing us to
function the same way that they
do: By focusing on the business
within our region. It’s a win-win
across the board for our entire
organization.”
13
INFORM now houses the Special Sections:
Devised to educate and update you on advances in a specific area of research, drugs,
diagnostics or devices.
SOCIAL MEDIA
Chair: Nancy Smith
gf
INFORM
LinkedIn
Profiles:
Perception
Matters
The
Challenges
of Social
Media Use
in the
Pharmaceutical
Industry
Social
Media and
Pharmacovigilance
Regulatory
Guidelines
and
Social
Media:
Proceed
with
Caution
Introduction16
Nancy Smith
LinkedIn Profiles: Perception Matters
Bridgid Nelson
The Challenges of Social Media Use
in the Pharmaceutical Industry
Elizabeth E. Garrard
Social Media and Pharmacovigilance
Dinesh Kasthuril
18
24
28
Regulatory Guidelines and
Social Media: Proceed with Caution
31
Jennifer Riggins, Kimberly Wu, and Genevieve Ness
Communicating Drug Information
in a Virtual World
Molly Fellin Spence
36
15
gf
GLOBAL FORUM | INFORM
ISSUE 2
An Introduction to Social Media
Chairperson: Nancy Smith
Nancy
Smith
VOL 4
16
I remember when people surfed
the breaking waves at the
seashore, when only little birds
tweeted, when girls twittered as
they exchanged secrets, and
when text referred to the main
document of an article or paper.
My ten- and twelve- year- old
grandchildren surf, tweet, twitter,
and text, and these words have
totally different meanings for them
than they do for me.
For the past decade and a half,
Social Media has invaded our
thoughts and conversations. In
less than one generation, it has
come to dominate worldwide
communication. The statistics are
amazing1:
• If Facebook was a country,
with its more than 800,000,000
users it would be the third
largest nation in the world; it is
expected to hit a billion users by
August of 2012
• One in every 7 minutes that
users spend online is spent on
Facebook
• Twitter has over 100,000,000
active users, and is adding
nearly 500,000 new users per
day
• There are more than
136,000,000 professionals on
the networking site LinkedIn.
• Over three billion videos are
viewed on YouTube every
day, and 48 hours of video is
uploaded to it every minute.
In a recent study to be published
in the journal Psychological
Science, researchers measured
the willpower of 205 people aged
18-85 in Wurzburg, Germany.
Assistant Professor Wilhelm
Hofmann and his colleagues at
the University of Chicago Booth
School of Business collected
over 10,000 responses in the
study, which suggests that email
and social media outlets, such
as Facebook and Twitter, are
more addictive than alcohol and
cigarettes.²
On the following pages, you will
read about the challenges facing
the health care industry as they
try to determine how to use social
media in their research, patient
care, professional interactions,
and pharmacovigilance, while
considering the FDA’s draft
guidance published late in 2011
on this subject.
An old Chinese proverb says,
“May you live in interesting times”.
Indeed, the introduction of social
media to our lives, both personal
and professional, requires a
vigilance about this ever-changing
and ever-growing medium that
certainly makes these interesting
times.
References:
1.“10 Mind-Blowing Social
Media Stats for 2012”; http://
www.activeendurance.com/
blog/2012/01/24/10-mindblowing-social-media-stats/
2. Meikle, James; “Twitter is
harder to resist than cigarettes
and alcohol, study finds”;
published in the Guardian
on February 3, 2012. http://
www.guardian.co.uk/
technology/2012/feb/03/
twitter-resist-cigarettes-alcoholstudy?newsfeed=true
17
gf
ISSUE 2
LinkedIn Profiles:
Perception Matters
VOL 4
18
Bridgid
Nelson i s
a Permanent
R e c r u i t e r wi t h
He a l t h c a re
IT Practice.
She can be
re a c h e d a t
Br i d g i d .
Ne l so n @
g re y t h o r n .c o m
As a professional Recruiter, I
am exposed to more people
on a monthly basis than
many people will interact
with in any given quarter,
or even in a year. I speak
with people in person, on
the phone, through email,
and online. As a result, I
see the good, the bad, and
the ugly of individuals more
than the average Joe (or
Jane). What I can tell you
is that first impressions are
critical, particularly in a
professional setting. In this
day and age, many of our
initial encounters are not in
person, but occur over the
phone or most often, online.
When we meet others online,
perceptions are formed based
on the information that is
readily accessible to anyone
with an Inter net connection.
Since your career can grow
or stagnate based on these
perceptions, shaping your
online presence is especially
crucial. The Inter net and
social media can be powerful
tools–positively or negatively
affecting your career.
While not everyone is looking
to ascend the corporat e
ladder at lightning speed, I
would challenge you to find
someone who truly wishes
to stay stagnant in their
career. Imagine the following
scenario: You get promoted
into a cushy Director role
with a cor ner office. However,
instead of looking to continue
growing your career, you
decide that you want to stay
in that exact role, with those
same responsibilities, at the
same company, in the same
office, at the same desk
for the next 20 years until
you retire. Sure, you might
get a gold watch and a pat
on the back – that is, if the
company doesn’t decide
on a layoff or corporate
restructuring. Meanwhile,
your colleagues have been
moving on to bigger and
better things, into new
and exciting d epartments.
And all this time, you have
simply put your career in
park; being passed over
for promotions, raises, and
new opportunities. I highly
doubt that this is a scenario
many of you envision as your
reality. And based on my
own empirical research, you
are not alone – most people
don’t want to remain stagnant
in their careers. Of my 900plus professional contacts
on LinkedIn, a lmost one-
third of them started a new
position in 2011. From my
experience, I’d imagine that
another one-third is actively
pursuing a new role in 2012,
and the remaining one-third
is currently enhancing their
experience and building their
resume in order to position
themselves to ‘take the next
step’ in their career in the
future.
Consider these facts: “Every
one of the Fortune 500 has
employees on LinkedIn;
499 have employees at the
director level or above.
The average LinkedIn user
is 41 years old and ear ns
more than $110,000 per
year. LinkedIn members are
64% male and 36% female.
LinkedIn has become a
must-have tool for ambitious
professionals, whether
they’re currently looking
for a job or not. In just a
few ye ars it’s grown into
the largest and strongest
business network in the
world.” 1 Additionally, LinkedIn
“can be an ideal way for
professionals to present an
online profile of themselves.
Unlike social networking
sites, [with] LinkedIn you’re
outlining all your credentials;
presenting the professional
rather than the personal
you. Considering the sheer
vastness of the digital space,
the potential for building
up a solid base of contacts
and fostering new business
relationships is boundless.” 2
Assuming that you, along
with pretty much every other
professional, are looking
to grow professionally, you
should be aware of what your
online presence is saying
about you. The picture it
paints, if not up to snuff,
can be detrimental to your
success, even if you are not
proactively searching for your
next role. Your goal should
be to create a powerful and
POSITIVE presence online,
through LinkedIn, Facebook,
other social media outlets,
as well as what can be found
through a simple search
engine, which will aggregate
any and all information about
you into one location with a
minimal amount of clicks and
effort to the chagrin of many
employees and the delight of
many employers.
When crafting your LinkedIn profile, consider the positives and negatives of your online profile in the chart below.
GOOD
BAD
Professional information that is current and up-to-date.
Inaccurate or misrepresented job history with incorrect dates.
Reasonable ways to be contacted – i.e., email address or LinkedIn profile
Out of date or inaccurate contact information.
address.
Articles published, awards won, and recognition gained.
Political or religious statements, information about drinking, drugs, arrests
or illegal activities.
Volunteer activities and causes that are close to your heart, i.e., Susan G.
Negative statements about your employer, trade secrets, or
Komen 3-day Walk for the Cure participant and fundraiser.
private company information.
A professional photo of yourself for business purposes.
Graphic photos, racist or insensitive statements, information or pictures
that can get you fired from your job or kicked out of school.
Objectives: career opportunities, consulting offers, new ventures, job Private medical information or private family moments, including freshinquiries, expertise requests, business deals, reference requests, and/
from-the-womb photos.
or getting back in touch.
19
ISSUE 2
gf
VOL 4
20
These potential employers
will use search engines
such as “Google” or “Bing”
to research prospective
candidates or to monitor
current employees. A useful
exercise to perform is to
search for yourself online –
you might be amazed at what
you find. “Your professional
life exists on t he Inter net,
whether you realize it or not.
Just do a Google search
for your name, and you’re
likely to find all types of
references you may or may
not have known even existed.
You can use LinkedIn as the
dashboard that drives your
Inter net presence. Carefully
cr afted, your LinkedIn profile
will be among their first
search results whenever
someone prowls Google
to find out more about
you. Since you create that
LinkedIn profile, and you can
link it to more of your own
good work, you gain control
over what people are most
likely to lear n about you from
searching the Web.” 3 As
such, there are certain ‘rules
of engagement’ or guidelines
that will assist you in putting
your best foot forward online.
Crafting your profile is a
crucial step in the process
of creating your online
presence – think of your
LinkedIn profile as your
online resume. Your career
progression should be clear
and concise, with thorough
details regarding your actual
responsibilities. Uploading
your resume is a simple way
to populate the fields initially,
and then take a step back
to reevaluate what you are
attempting to convey. It is
important to express your
ambition without seeming
aggressive – allow your
accomplishments to speak
for themselves. I suggest
taking your profile history
back approximately 15-20
years, if you have that kind
of work history under your
belt. Showing promotions
is a positive thing – you’ve
worked hard to get where you
are and there is no shame in
sharing that progress.
Once you’ve constructed
your profile, it’s time to think
about growing your network.
On LinkedIn, you are able to
contact directly anyone who
is up to 3 degrees removed
from you. You will see as you
add connections that your
extended network will grow
dramatically. You will see that
I do have a large personal
network of over 1000 direct
contacts, but what is amazing
is the exponential growth as
I step two and three degrees
away from myself. One step
removed from my immediate
contacts, I have access to
over 440,000 people. When
I go one step further, I can
directly contact almost ten
and a half MILLION people. If
you didn’t believe it be fore,
you can see how amazing
your network can be for you
professionally.
You will find that this network
is imperative to your career
growth. In tracking my own
recruiting efforts, I have
lear ned that the majority of
individuals have found their
current job through their
professional or personal
networks, whether those
networks were cultivated in
person or online. LinkedIn
and Facebook, along with
any other social media sites,
are communities – involving a
give and take; an interaction
that is mutually beneficial for
all members. The community
you create and nurture can
assist you, and in tur n, you
can support others. When
building your “community”,
your network should include
colleagues from your current
and previous jobs. You
should consider clients and
exter nal individuals as well as
alumni from your bachelor’s,
master’s, or doctorate
programs. Personal contacts
are acceptable as well – for
example, I am connected on
LinkedIn to my brother, my
husband, and my best college
friend. Their contacts and
connections have helped me
in my career more than once.
After expanding your
network, you should take
an opportunity to consider
requesting recommendations.
A great function of the
site is the ability to ask
a contact to write you a
recommendation for your
profile. One word of advice is
to ask for a re commendation
immediately after completing
a project. Strike while the
iron is hot – w hile your strong
performance is front-of-mind
is a perfect time to tap a
contact for assistance. Your
recommendations can come
from a superior, a colleague,
or an individual from
another company – I rarely
suggest asking someone
who reports into you for a
recommendation, since it can
be viewed as being coerced.
Also, when asking for a
reference, be sure to ask the
individual if they can provide
you with a positive reference,
since a negative reference
can be more damaging than
helpful. You will have the
option of proofreading any
recommendation before it
goes public, and you may
find that you have contacts
whom you think highly of, and
you’d like to repay the favor
for them.
As a professional who hires
individuals on a regular
basis, I look for a few key
things when I am reviewing
a LinkedIn profile. I look
for a completed profile
with comprehensive job
descriptions and at least a
few recommendations from
trusted professionals. I notice
if you have more than merely
a handful of contacts, and if
you have become a member
of relevant networking
groups. To know that you
have made an effort to utilize
the LinkedIn community
and to see that you have
“paid i t forward” to other
individuals shows me what
type of a person you are. I
also look to see if you and
I have any shared contacts.
The ability to do a “back
door reference” is critical
– if you and I both share
John Doe as a contact, I will
certainly call him to get the
inside scoop on you. Another
thing that any potential
hiring manager will notice
is grammar, punctuation,
and spelling. When you are
being considered by an
organization, they want to
know that you are capable of
representing yourself and the
company well. Text speak is
a massive strike against you,
even as we have moved to
more of an online interaction
in the past 5-10 years. These
are simply things to be aware
of as you are working within
social media sites.
In case you were wondering,
I would like to note that I am
not an employee of Facebook
or LinkedIn, and I receive no
compensation from any entity
to discuss these sites. In my
experience as a professional
Recruiter, I simply have found
them to be the most widely
used sites for personal and
professional networking,
respectively. “W ith
135 million users, LinkedIn
is ahead of its competitors
V iadeo (35 million) and
XING (10 million).” 4 Even
since the writing of that
article, LinkedIn has grown
dramatically. As of February
9, 2012, LinkedIn reached
a milestone and announced
150 million members. A book
that is a great resource and
I quote in this article “How
to Find a Job on LinkedIn,
Facebook, Twitter, MySpace,
and Other Social Networks,”
was written in 2009 and
references only 35 million
users on LinkedIn. You can
see the dramatic growth and
the exposure your profile will
have once it is completed.
Most importantly, please
note that I have always
been, and will always be,
a proponent of personal
connections as a preference
to online interactions. There
is NO substitute for face
to face contact - it should
remain your PRIMARY form of
networking. However, in our
global economy, you will find
that much of your contact
will also include a significant
amount of online interaction.
As such, I am an advocate
of LinkedIn for professional
networking and Facebook
21
ISSUE 2
gf
VOL 4
22
for personal networking. The
sites give each and every
one of us the ability to craft
an online presence that
represents us accurately.
However, keep in mind that
“as much as we enjoy and
admire LinkedIn, the site
is a tool that can greatly
enhance your job-hunting
experience, but it won’t
necessarily answer all your
career-building needs. Offline
strategies for communicating
with employers and job
hunting in general may seem
antiquated in view of your
newfound power, but they
still should take a vital place
in your job search.” 5 You
are your own best advocate
when you can look a contact
directly in the eyes, smile,
offer your hand, and say
“Nice to meet you,” and truly
mean it.
Action Steps:
SEARCH for yourself online
– make sure that you’re
aware of what potential
employers may find when
they search for you. You
want the primary search
items to be related to your
professional life.
COMPLETE your profile –
there is a function that allows
you to import your resume
and will parse it out (most
times accurately) to make the
completion process simpler.
Be clear about your title and
your responsibilities. Ensure
dates are accurate, and that
you are not misrepresenting
yourself in an effort to
look more accomplished.
Proofread your profile for
accuracy, grammar, spelling
and punctuation. Remember,
this is essentially your online
resume, and as such, it
should represent the caliber
of work of which you are
capable.
BUILD your network –
Start by connecting with
professional and personal
contacts you know and
trust. When you connect
with individuals (whether you
think they are valuable to
your future career or not) let
them know that you will be
sending them an invitation
to connect on LinkedIn and
that you’d appreciate the
connection. You never know
when someone can help you
in the future, so it’s better to
have their contact information
available to you. It is in
human nature to want to
help. Do not send invitations
out at random, or without
clarifying to the invitee why
you would like to connect
with them.
CONTRIBUTE to the
LinkedIn community – V isit
the site regularly. I am on the
site all day every day, but
I know that my situation is
unique. I’d suggest checking
the site at least weekly, if
not daily. Offer to provide
introductions for others,
share industry articles, pass
on job information to those in
your network, etc. Genuinely
think of this as a community.
Ask yourself what you can
do to help others in your
community, knowing that,
in tur n, you will be asking
for their assistance at some
point in the future.
KEEP it clean – The best
rule of thumb is this: Don’t
post anything you wouldn’t
want your mother, your
grandmother, your child,
or your boss to see. That
inappropriate picture from the
college frat party shouldn’t
be online; nor should the
video of your child’s home
birth. As beautiful as it may
be to you and your spouse,
things like this are meant to
be kept private. Additionally,
religious and political
statements, no matter how
benign, can offend others
unknowingly. Always ask
yourself – “Would I hire this
individual?” If the answer is
no, then clean it up.
UPDATE your profile – Do
this as needed when you take
a new job, get an award,
ear n a promotion, change
your email address or cell
phone number, etc. Current
information is necessary, or
you lose the opportunity to
network. If you took a new
job in 2007 and still haven’t
updated your profile, now is
the time to do it.
JOIN Groups – Facebook
and LinkedIn have special
interest groups that may
be relevant to you and your
career. By joining these
groups and becoming an
active member, you will have
insight into industry news and
connections with others who
have similar skill sets and
interests.
UTILIZE the tool – “LinkedIn
has been described by
online trade publication
TechRepublic as having
“become the de facto tool for
professional networking.” 6
When looking for a new job or
looking to hire for your own
te am – consider LinkedIn a
primary resource. Track down
an old colleague or mentor
with whom you’ve lost touch.
The tool is onl y as good as
those who use it. Over a
hundred million professionals
are taking advantage of the
opportunities it provides. Are
you? If not, you should be.
REFERENCES
1. Schepp, Debra (2009).
How to Find a Job on
LinkedIn, Facebook,
Twitter, MySpace, and
Other Social Networks.
2. O’Sullivan, James (2011),
“Make the most of the
networking tools that are
available”, Evening Echo,
09-May-11. Pg 32.
LinkedIn, Facebook,
Abbr.
4. “Facts and Figures”.
XING. September 1, 2010.
http://corporate.xing.com/
deutsch/investor-relations/
basisinformationen/faktenund-zahlen/.
LinkedIn, Facebook,
6. “Five Benefits of LinkedIn
for Organizations (and
IT Pros) | TechRepublic.”
Web. May 9, 2011.
23
gf
ISSUE 2
The Challenges of Social Media Use
in the Pharmaceutical Industry
VOL 4
24
Elizabeth
E. Garrard ,
PharmD, RPh,
i s t h e Ch i e f
S a f e t y Off i c e r,
Drug Safety
Alliance, Inc.
She can be
re a c h e d a t
e g a r r a rd @
drugsafetya l l i a n c e .c o m .
The use of social media by
the pharmaceutical industry
has been the subject of
much uncertainty and debate
for some time now, and the
discussion regarding this
subject seems unlikely to
end anytime soon. While
the use of sites such as
blogs, Facebook, Twitter
and LinkedIn has been
embraced by other industries
as a key to connecting with
customers, many in pharma
seem to be struggling with
this new technology, unsure
of the correct approach and
fearful of the ramifications
of adverse events that could
be reported via social media
platforms. As Web 2.0
has taken hold, numerous
questions have arisen
regarding the posting of
possible inaccurate content
and the legal responsibilities
of pharmaceutical companies
in monitoring interactive
sites.
A Current Look at
Social Media
Since the advent of blogs and
the first social network ing
sites of the early 2000s,
social media has experienced
explosive growth. Particularly
in recent years, the use of
Web 2.0, or interactive sites,
has become commonplace,
with people around the world
visiting these sites daily.
Facebook, the world’s most
popular social media site,
currently has more than 800
million active users – 11%
of the world’s population.
Others boast staggering
numbers as well. LinkedIn
has more than 100 million
active users, while Twitter
has approximately 175 million
users and sees 8,900 Tweets
per second. As of July 2011,
there are an estimated 164
million active blogs (up from
3 million in 2004), and the
popular video-sharing site
YouTube sees nearly 2 hours
of video uploaded each
second.
W ith more consumers
using social media, it is
not surprising that they are
tur ning to Web 2.0 for health
care purposes as well. A
2011 PwC Health Research
Institute Consumer Survey
found that nearly one-third
of consumers have used
social media for health care
purposes. In a similar survey
by the Pew Research Center
as part of their Inter net &
American Life Project, it was
found that of the 74% of
adults who use the Inter net,
80% have looked online for
information about health
topics such as specific
diseases or treatments –
that’s 59% of all adults.
Additionally, 1 in 4 users
consult online reviews of
drugs or treatments, while
one-fifth of ad ult users
search online to find others
with health concer ns similar
to their own. According to
the survey, however, only
4% have posted online their
experiences w ith a particular
drug or medical treatment.
Social Media and
the Pharmaceutical
Industry
The ever-growing presence
of social media has caused
much uneasiness in an
industry known for strict
regulations and carefully
controlled content. The
industry was comfortable with
the Web 1.0 format, which
allowe d for the presentation
of truthful, scientifically
accurate information but
did not allow for interaction
with consumers. The growth
of Web 2.0 has led to
much debate regarding the
monitoring of social media
sites and the correct handling
of adverse events that could
potentially be reported on
those sites.
Many in the industry are
uncomfortable with the
values embraced by social
media users – immediacy,
spontaneity and information
that’s “good enough” if
not 100% accurate. In an
industry gover ned by strict
rules regarding the accuracy
of information, the idea that
there may be user-generated
information on the web that
is not completely accurate is
a daunting one – if inaccurate
information or an adverse
event is posted, then who
responsible for reporting
on and correcting the
information?
There exists a perception
among those in pharma that
social media is safe only
when used for promotional
purposes, and that the
need for confidentiality and
proprietary transactions does
not lend itself to the free and
open format of social media
sites. The concer n about
the potential impact of not
responding appropriately to
an adverse event encountered
via Web 2.0 keeps many
companies frozen in place,
fearful of taking the steps
necessary to dive into the
social media realm.
There are some companies,
however, who have
determined that, although
the idea of entering this new
territory can be daunting, it
is a risk worth taking. Among
the worldwide pharmaceutical
industry, there are
approximately 100 Twitter
accounts, 120 Facebook
sites, 60 YouTube accounts,
37 brand-sponsored
communities and 30 blogs.
Pfizer has even developed
a Social Media response
flow chart to guide staff in
responding to mentions of its
products encountered online.
One major reason for the
industry’s lack of socia l
media presence is the elusive
guidance on the subject
by the US Food and Drug
Administration (FDA). The
FDA’s most recent draft
guidance on Responding
to Unsolicited Requests
for Off-Label Information
about Prescription Drugs
and Medical Devices,
released in late December
2011, includes a section on
requests encountered through
emerging electronic media,
yet stops short of providing
a framework for responding
25
gf
ISSUE 2
to adverse events reported
through social media.
VOL 4
26
It is worth noting that the
FDA has its own Facebook
page, although it is
mainly used to post press
releases and exter nal links.
Additionally, the page’s
comment policy states that
the organization cannot
respond directly to comments
and is unable to answer
questions about specific
health care situations. This
cautious, one-way approach
to social media mirrors
the stance taken by the
pharmaceutical industry.
Adverse Event Reporting
via Social Media
W ill an increased social
media presence by the
pharmaceutical industry
lead to an influx of adverse
events? While one can’t say
for certain, research has
indicated that AE reporting
via social media may not be
as overwhelming as some
might think.
In a recent study by V isible
Technologies, the social
media mentions of 224
over-the-counter (OTC)
and prescription brands
were tracked, collected
and analyzed over a 30-day
period. The study found that
only 3 out of every 1,000
mentions (less than 0.5%)
contained a report of an
adverse event, and only 1 in 7
posts with a reported adverse
event contained enough
information to meet the 4 AE
reporting criteria established
by the FDA – an identif iable
patient, identifiable reporter,
specific medication and an
adverse event. A random
survey of 500 messages
on health-related Google
and Yahoo! sites by Nielson
Online found similar results
– only one message of the
500 contained a report able
adverse event, a 0.2%
occurrence.
Best Practices
In November 2009, the FDA
held a public hearing on
the issue of social media.
Attendees came to the
following agreements:
1. Pharmaceutical companies
should only be held
responsible for content
they have originated or
sponsored.
2. Transparency is
paramount.
3. Companies are
responsible for making
reasonable efforts
to monitor product
references in social
media and respond where
appropriate, but should
not be expected to police
the entire Inter net.
Conclusions
A well-monitored social
media site can improve
health literacy and ease
the transmission of reliable
information. However,
clarity is still required in a
number of areas, including
specific guidelines on a
company’s responsibility for
monitoring online discussions
for adverse ev ents and
whether the company’s
online presence, for example
via advertising or posting
messages in a n online forum,
changes that responsibility.
Another question concer ns
the case of a broader safety
incident – in this case, should
a company proactively reach
out to monitor adverse
events that may be reported
online, and/or should it use
consumer-generated media
sources to post information
for consumers to report
adverse events directly
to the FDA? And finally, if
a message is discovered
weeks or months after it was
originally posted, does this
delay affect the company’s
responsibility for follow-up?
Although questions remain
regarding the use of social
media, it is not an excuse
for avoiding the medium
altogether. If we are truly
putting patients first, then
we must overcome the fear
of the unknown and welcome
the opportunity to engage in
two-way conversation with
the public. If the industry
doesn’t take on this challenge
and meet the expectations of
today’s consumers, it faces
a clear risk of being left
behind.
Elizabeth E. Garrard,
PharmD, RPh
Elizabeth Garrard has
more than 30 years of
clinical and regulatory
experience spanning
the pharmaceutical,
clinical, hospital and
retail industries. As
Chief Safety Officer for
Drug Safety Alliance,
Inc., Dr. Garrard
provides leadership
in strategic planning,
analysis, development,
implementation and
measurement of all
aspects of drug safety
medical services including
signal management
and risk evaluation and
mitigation strategy.
Prior to joining Drug
Safety Alliance, she
gained valuable
pharmacovigilance
experience with
GlaxoSmithKline, where
she focused her expertise
on both pre and post
marketing adverse
event reporting. Her
career also includes
the development of HIV,
oncology and infectious
disease pharmaceutical
care plans for Coram
Healthcare. Dr. Garrard
is a licensed pharmacist
and a member of the Drug
Information Association
(DIA) and the American
Society of Health System
Pharmacists.
27
gf
ISSUE 2
Social Media
and Pharmacovigilance
VOL 4
28
Dinesh
Kasthuril
i s a D i re c t o r,
Service Delive r y a t S c i f o rmi x Co r p o r a t i o n . I n h i s ro l e
h e i s re sp o n si b l e f o r g l o b a l
consultancy
a n d se r v i c e s
a c ro s s p h a rma c o v i g i l a n c e
and clinical
o p e r a t i o n s.
Dinesh has
overseen and
b e e n re sp o n s i b l e f o r
establishing
and operati n g p h a r ma covigilance
operations
a c ro s s mu l t i p l e p h a r ma c e u t i c a l c o m p a n i e s g l o b a l l y.
The use of social media
and the Inter net is an
increasingly prominent part
of the health care delivery
system. Health consumers
use the inter net for a variety
of reasons- to share health
information, to obtain drugrelated information and side
effects, to form a support
group for patients, and as a
virtual location to collectively
understand treatment
options and their availability.
Pharmaceutical companies,
on the other hand, use the
Inter net to provide product
information, such as product
websites.
An inter nal study of social
media content performed
by Sciformix suggested that
a substantial number of
health websites are used by
consumers for discussing
their experiences which
are “suspected” to be due
to a specific drug. Of the
websites reviewed over
a six-month period for 3
specified products, about
half the websites had at least
one reference to an adverse
patient experience. This
provides an indication of the
safety-related discussions
in which consumers are
engaging.
Consumers are certainly
discussing their
experiences related to using
pharmaceutical products in
Inter net chat rooms, blogs
and other social media
content. However, the
challenge of sifting through
this chatter to uncover and
identify hitherto unknown
effects of the product and
doing this is in a structured
and scientifically rigorous
manner poses challenges.
Social media is about the
open and free exchange
of ideas and engaging in
two-way communication in
an unstructured manner.
Pharmacovigilance is more
focused on patient privacy
and confidenti ality. And
therein lays the dichotomy
of using social media for
pharmacoviglance. The
approach of these two
areas and the way they are
practiced are very different.
Pharmacoviglance,
specifically individual case
processing, is based on
identifying and processing
data which meets the 4
minimum criteria, namely:
1.An identifiable patient
2.An identifiable reporter
3.A suspect drug or product
4.An adverse experience or
fatal outcome suspected to
be due to the suspect drug
or product
Using these criteria to
filter out valid adverse
drug experiences from the
remainder is something that
drug safety organizations
have been routinely
performing over the years.
However, applying these
criteria to data from the
social media sources raises
some interesting challenges.
One of the basic challenges
faced is a consistent and
widely accepted definition
of an “identifiable reporter”
and an “identifiable patient”
that can be applied to the
social media world. In the
absence of any applicable
regulatory guidelines in this
area, there is not a commonly
used yardstick that would be
applicable to the Inter net.
Most often the “user na me” or
“screen name” that a person
uses is the only identifiable
piece of information that is
available for a blog, chat
room transcript or a message
board query. However,
these most often do not
provide any indication of
routinely used identifiers
like name, gender, phone
number, address etc. Trying
to obtain this information
would involve approaching
the chat room administrator
or other organization and
has customer privacy
implications.
29
ISSUE 2
gf
VOL 4
30
Also, in the absence of
contact information there
is limited ability to get
additional information or
perform follow ups. This is
routine practice and involves
contacting the patient or
patient’s treating physician
and obtaining medical
records, etc. These are
used to assess the reported
adverse event in the light
of the patient’s current
condition or prior medical
history and to ascertain if
the condition that the patient
has experienced has since
resolved itself or is further
aggravated. The inability to
pursue this avenue, in most
cases, causes the social
media data results to be less
comprehensive or robust
than other pharmacovigilance
sources.
A suspect product and
an adverse experience
are most often available.
These are cod ed using
standard dictionaries like
WHODrug and MedDRA to
ensure that a consistent
nomenclature is being used
to assess the case. This
data can then be used to
determine the seriousness
and expectedness of the
reported event. However, it
is expected that sufficient
data to establish a causal
relationship between the drug
and the adverse event will
seldom be available.
In summary, despite the vast
quantity of data available
from social media, as a
reliable source there is not a
good measure of the quality
of the data available. The
challenges faced are multifold and can be broadly
categorized into:
Policy Challenges
Today there is a lack of
clarity on the ownership of
social media content and
responsibility for monitoring
social media sources. For
example, unlike company
product websites, which are
owned and operated by the
pharmaceutical company,
there is no requirement for
a pharmaceutical company
to monitor content on the
public Inter net since the
companies have no ownership
or accountability for this
content. Even if content is
being monitored, there is no
accepted standard on what
aspects need to be monitored
and how. Could a keywordbased search similar to that
used in routine literature
searches be used to try to
identify potential cases of
interest? And, once a case is
identified, how could it then
used to better understand or
improve the safety profile of
the product?
Operational Challenges
Though there is general
agreement that the volume
of data provided by social
media is significant, the
jury is still out on the
quality of the data and how
effectively this data can be
used to better understand
the product’s safety profile.
The use of technology and
tools can certainly ease a
very laborious process used
to sift through the data
and to automatically flag
social media conversat ions
of interest for further
analysis. However, all of
this will generate significant
additional work and, without
a regulatory mandate, it is
unlikely that pharmaceutical
companies will adopt
pharmacovigilance from
social media in a thorough
manner.
Regulatory Guidelines and
Social Media: Proceed with Caution
Jennifer
Riggins,
PharmD is
the Director, Global
Information
Disclosure at
Eli Lilly and
Company.
She can be
reached at
rig@lilly.com.
Kimberly
Wu
Genevieve
Ness
31
Introduction
The Inter net and social
media tools are increasingly
important for consumers and
health care professionals
seeking health-related
information, including
pharmaceutical product
information. Pharmaceutical
manufacturers are well
positioned to provide
accurate and reliable disease
state information, scientific
product information, and
related resources online.
However, due to a lack of
guidance from the U.S. Food
and Drug Administration
(FDA) and other regulatory
agencies, pharmaceutical
manufacturers are moving
cautiously and, consequently,
not maximizing the use of
the Inter net and social media
tools as a communication
channel to consumers and
healthcare professionals.
FDA Actions
In April 2009, the
FDA Division of Drug
Marketing, Advertising, and
Communications (DDMAC)
issued war ning letters top
14 major pharmaceutical
companies in regards to their
sponsored links on sea rch
engines for their products. 1
The sponsored links were
considered misleading as
they made representations
and/or suggestions about the
gf
ISSUE 2
efficacy of their products, but
failed to communicate any
risk information. Additionally,
many of the sponsored links
were considered to have
inadequately communicated
the products’ indication.
VOL 4
32
Then in July 2010, Novartis
received a war ning letter
for a share widget on their
branded consumer website
for Tasigna ® . 2 The widget,
located on the webpage,
enabled consumers to click
and “share” information
about the drug through social
sites such as Facebook and
Twitter. However, DDMAC
felt thi s was misleading as
it also made representations
regarding the efficacy of
Tasigna ® while failing to
communicate any risk
information associated with
the use of the product.
Finally in September 2011,
Pfizer received a war ning
letter regarding their
branded Lipitor ® website. 3
On the website, DDMAC
found language which
made representations and/
or suggestions about
the efficacy of 3 of their
products, but did not
communicate any risk
information regarding these
products. DDMAC noted
that for each product,
the webpage contained
a “Click to Continue” link
taking users to each of the
product’s individual websites
or prescribing information.
However, this was considered
insufficient to mitigate the
missing risk information from
the webpage.
These events beg the
question: “What do FDA and
other regulatory agencies
allow when using social
media tools?” As many are
aware, the expectant FDA
guidance is trickling out
and many would consider
it currently still unavailable.
However, if one investigates
the historical and current
developments surrounding
the issue, one will appreciate
both its depth and scope.
Additionally, one will realize
the need for both regulatory
agencies and pharmaceutical
companies to proceed with
caution regarding the release
of guidance on and the use of
social media tools.
FDA Regulatory
Guidance Development
Timeline
The FDA held a public hearing
in November of 2009 to
address the communication
and promotion of FDAregulated medical products
using the Inter net and social
media tools. 4 Representatives
from a variety of industries
including pharmaceutical
companies, Inter net vendors,
marketing agencies, as well
as consumers and health care
providers participated.
Three common themes
emerged from the public
hearing 4 :
1.The arena is paralyzed.
Both the regulated industry
and vendors would like the
opportunity to explore this
space but are apprehensive
to do so in the absence of
approved guidelines.
2.To what extent will
pharmaceutical
manufacturers be held
accountable? Questions
still remain such as will
industry be required
to monitor third party
postings? What about
adverse eve nts? And how
should companies address
off-label comments?
3.Participants also expressed
concer ns regarding the
regulations themselves and
the need for guidelines
robust enough to meet
their specific needs,
but flexible enough to
keep current with new
technology trends.
Written or electronic
comments from the public
were accepted until February
28, 2010. 4
Following the close of the
comment period, DDMAC
announced that a draft
guidance would be expected
by the end of 2010. 4
Nevertheless this deadline,
as well as others, was not
met. However, in the first
quarter of 2011, DDMAC did
release a number of topics
which the guidance would
be expected to address
including: responding to
unsolicited requests, fulfilling
post-marketing submissions,
when regulated bodies are
accountable d uring on-line
communications, fulfilling
regulatory requirements
when using tools with space
limitations, use of links on
the Inter net, a nd correcting
misinformation.
Follow ing the release of
potential guidance topics,
the FDA announced the
beginning of a research
series to investigate
direct to consumer (DTC)
advertising, the inter net, and
fair balance. 5 This series,
entitled the Examination
of Online Direct-toConsumer Prescription Drug
Promotion, would investigate
what, if any, effect the
followi ng would have on
consumer perceptions in
maintaining an accurate
understanding of the risks
and benefits of the product
on a branded drug website:
format and presentation of
risk information, addition
of special features such
as interactive visuals, and
having links to exter nal
organizations, such as
the American Diabetes
Association or an online
health community.
Randomized participants
diagnosed with a particular
medical condition will be
assigned to view one version
of a fictitious prescription
drug website. Upon
conclusion of the review,
subjects will participate in a
25-minute interview where
they will answer a series
of questions. Comments
concer ning the objective
and methodology for these
studies were accepted until
June 27, 2011.
Finally, at the conclusion
of 2011, the FDA released
the first draft guidance
entitled, Guidance for
Industry Responding to
Unsolicited Requests for
Off-Label Information
About Prescription Drugs
and Medical Devices. 6 The
guidance touches on the use
of the Inter net and soc ial
media tools in the context
of responding to a request
for information but primarily
focuses on the difference
between an unsolicited and
solicited request and the
recommended means to
respond to both privately
and publicly received offlabel requests. Comme nts
regarding the draft guidance
will be accepted until
March 29, 2012.
Global Regulatory
Developments
The lack of guidance is
consistent outside of the
United States as well.
The United Kingdom’s
Prescription Medicines Code
of Practice Authority (PMCPA)
issued an informal guidance
on digital communications
in April 2011. 7 The informal
guidance provided a list
of allowances and a list of
restrictions but stopped
short of providing any real
guidance.
Although little social
media guidance exists,
pharmaceutical manufacturers
in the United Kingdom must
still adhere to the Association
of the British Pharmaceutical
Industry (ABPI) Code of
Practice. In 2011 Bayer
Healthcare was cited for
breaching clauses 2, 9.1,
22.1, and 22.2 of the ABPI
Code of Practice when using
Twitter to announce the
launch of two prescription
33
ISSUE 2
gf
VOL 4
34
only medicines. 8 The panel
cited the guidance on digital
communications stating that
if a company were to promote
a prescription only product
using Twitter, it would need
to ensure that the audience
was limited to only health
professionals. At the time,
the Twitter account was
accessible to the public.
The panel also noted that
the tweets were taken
from headlines of certified
press releases; however,
the tweets themselves were
not certified. In December
2011, Allergan was also
found to be in breach of
the code (clauses 9.1 and
22.1) when an employee
tweeted about Botox ® and
stroke rehabilitation using a
personal Twitter account. 9
The tweet was intended to be
private but was accessible by
Twitter followers of a patient
organization.
Conclusion
Overall, current regulatory
guidelines gover ning
Promotional Advertising,
Promotional Labeling,
Responding to Requests
and Disease Awareness
are focused on defining
what content is subject to
regulation. However, due
to gray areas created by
ever-evolving technology,
the “manner” in which
manufacturers are expected
to achieve compliance with
traditional standards must
be more flexible, nimble, and
suitable to non-traditional,
dynamic environments.
Pharmaceutical manufacturers
are well positioned to provide
accurate and reliable disease
state information, scientific
product information, and
related resources online.
However, without good
guidance, which is slow
coming, it will be critical
to partner and collaborate
effectively and crossfunctionally to share lear ning,
evaluate risk, and ensure
compliance with existing
regulatory guidelines while
venturing into the use of new
media.
References:
1.Food and Drug Administration. War ning Letters 2009.
Available at: www.fda.gov/
Drugs/
GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/
War ningLettersandNoticeofV iolationLetterstoPharmaceuticalCompanies/
ucm055773.htm Accessed:
January 25, 2011.
2.Food and Drug Administration. DDMAC War ning Letter to Novartis.
Available at: www.fda.
gov/downloads/Drugs/
UCM221325.pdf. Accessed: January 25, 2011.
3.Food and Drug Administration. DDMAC War ning
Letter to Pfizer. Available at: http://www.fda.
gov/downloads/Drugs/
6.Food and Drug Administration. Draft Guidance
for Industry Responding
and Medical Devices.
Available at: www.fda.gov/
downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
4.Food and Drug Administration. Public Hearing on
Promotion of FDA-Regulated Medical Products
Using the Inter net and
Social Media Tools. Available at: http://www.fda.
gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/
ucm184250.htm. Accessed
January 26, 2012.
7.Prescription Medicines
Code of Practice Authority.
Advice on the Code: Digital
Communications. Available
at: http://www.pmcpa.org.
uk/?q=node/920. Accessed
January 20, 2012.
5.Federal Register. Agency
Information Collection
Activities; Proposed Collection; Comment Request;
Examination of Online
Direct-to-Consumer Prescription Drug Promotion.
Available at: https://www.
federalregister.gov/arti
cles/2011/04/28/201110253/agency-information-collection-activitiesproposed-collection-comment-request-examinationof-online#p-17. Accessed
January 26, 2012.
Annual Report for 2010.
Available at: www.pmcpa.
org.uk/files/August%20
2011%20Review.pdf. Accessed: January 27, 2012.
Completed Cases. Available at: www.pmcpa.org.
uk/files/2455%2020%20
Jan.pdf. Accessed February 2, 2012.
A c k n o wle dge me nt : Je nnife r Jul i a n f o r c re a t ion of t he ima ge .
35
gf
ISSUE 2
Communicating
Drug Information
in a Virtual World
VOL 4
36
Molly
Fellin
Spence
is a medical
a n d re g u l a t o r y wr i t e r f o r
I D R A C’s A d Co mm B u l l e t i n .
Photo courtesy of Thomson Reuters
The scenario happens every
day: A patient goes online,
seeking information about a
drug he takes or a disease
from which he suffers. He
posts a question on a public
forum: “Can Drug X be used
for Condition Y?”
This straightforward,
unsolicited, specific query
can be easily answered
by representatives of the
pharmaceutical company
that sponsors the drug in
question. Since the patient
was specific and the question
was unsolicited, that drug’s
sponsor would be legally
allowe d to respond to the
patient directly.
But, if the scenario changed
slightly, the sponsor could
stray into illegal territory.
If this question was posted
instead: “What drug could
be used for Condition Y?”
then no drug firm would be
allowed to respond to the
request, according to FDA
regulations.
Scenarios similar to this
are a reason that the FDA
held a two-day public
hearing in November 2009.
The FDA’s Center for Drug
Evaluation and Research
(CDER), in collaboration with
FDA’s Center for Biologics
Evaluation and Research
(CBER), Center for Veterinary
Medicine (CVM), and Center
for Devices and Radiological
Health (CDRH), sponsored
the public hea ring to
discuss issues related to the
promotion of FDA-regulated
medical products (including
prescription drugs for humans
and animals, prescription
biologics, and medical
devices) using the Inter net
and social media tools.
Presenters and participants in
the hearing aimed to address
the need for a social media
guidance authored by the
FDA to assist drug sponsors
in managing drug information
in a constantly changing
online world.
The hearing was focused
on industry accountability
regarding online
communications and industry
regulatory requirements
(i.e., fair balance, disclosure
or indication and risk
information, postmarketing
submission requirements),
and parameters applicable
to the posting of corrective
information on Inter net sites
controlled by third parties.
Another focus was adverse
event reporting via the
Inter net.
During the hearing, several
presenters stated that
accountability and disclosure
of material connections are
necessary, especially when a
formal or informal agreement
between a content provider
and a manufacturer exists.
One presenter cited the “3
Cs Rule” which notes that
if one of three connections
to an Inter net site exists—
Creation, Collaboration, or
Compensation—then the
manufacturer should be held
accountable for that site’s
information. A suggestion
that resulted from the hearing
was a call for a digital FDA
“seal of approval.” This
approach would identify FDAreview ed content in posts and
discussion threads online and
provide a hyperlink to pages
with FDA-approved content.
Follow ing the 2009 hearing,
interested parties waited
more than two years for
the FDA to respond with a
related guidance. A draft
of that guidance came in
late December 2011. The
“Guidance for Industry:
Responding to Unsolicited
Reque sts for Off-Label
Information Prescription
Drugs and Medical Devices,”
was limited in scope and
did not satisfy all of the
questions and concer ns
regarding pharmaceutical
companies’ use of social
media. Some say no guidance
ever could.
HISTORY OF PHARMA’S
INTERNET USE
More than ever before,
consumers are using the
Inter net to search for health
information and to gain
advice regarding specific
diseases or treatments. A
2011 survey titled “The Social
Life of Health Information,”
from Pew Inter net, a project
of The Pew Research
Center, found that 80% of
adult Inter net users have
sought information online
about diseases or medical
treatments. This translates
to 59% of all adults. The
survey also found that 34%
of Inter net users (or 25%
of all adults) have read
commentaries or exper iences
about health or medical
issues in an online news
group, website, or blog. (See
the chart below for more
Inter net habits related to
health/medical information.)
Pharmaceutical companies
are slowly attempting to
37
ISSUE 2
gf
VOL 4
38
ta ke advantage of this
vast interest in finding
information. Most have their
own websites, citing product
information. Many also host
pages on Facebook and
have dedicated channels on
YouTube to reach consumers.
In 2008, the p harmaceutical
industry spent $4 billion
on direct-to-consumer
advertising, but only 4% of
that went to the Inter net.
Most drug makers have been
holding back due to fear of
FDA retaliation if interactions
with consumers on the
Inter net are construed as offlabel marketing.
Absent a guidance giving
specific advice on social
media use from the FDA,
most manufacturers have
relied on culled-together
rules. On stati c websites,
the “one-click rule,” aims for
risk information about drugs
being advertised to be no
further than a single click
on a mouse from consumer
Inter net users. This rule is
not always followed properly,
and it is not always enough
to satisfy FDA regulations.
In April 2009, the FDA
issued war ning letters to
14 manufacturers who
sponsored search-engine
ads for prescription drugs in
which no obvious connection
was made to a statement of
risks.
When many of the regulations
for drug and device
promotion were created, most
of the technologies used
today did not exist. Section
502(n) of the Food, Drug and
Cosmetic Act of 1962 gives
FDA authority to regulate
prescription drug advertising
and promotion. It prohibits
false statements and requires
a summary of side effects,
contraindications, and
effectiveness to be accessible
to consumers. Since that
act was passed, several
other guidances related to
promotion and advertising
have been published. Some,
such as “Presenting Risk
Information in Prescription
Drug and Medical Device
Promotion,” from May 2009,
or “Guidance for Industry:
Consumer-Directed Broadcast
Advertisements,” from August
1999 contain information
that can be applied to social
media and Inter net use. But
until December 2011, no
specific Inter net or social
media guidance existed.
THE N EW GUIDANCE
In late December 2011, the
FDA responded to requests
for a guidance related to
Inter net and social media
use by releasing a draft
version of “Guidance for
Industry: Responding
and Medical Devices.” Its
purpose was to update and
clarify the FDA’s policies on
unsolicited requests for offlabel information, including
those that drug companies
encounter through emerging
electronic media.
In the guidance, the FDA
acknowledges that the rapid
growth of the Inter net, and
especially social media
tools, has encouraged
more interaction between
consumers, health care
professionals, and drug
firms. The availability of
public forums, chat rooms,
discussion boards, and other
forums allow consumers to
quickly seek information
about medical conditions
and treatments. This quick
and easy access also leads
to requests for off-label
information about products.
The Federal Food, Drug, and
Cosmetic Act (FD&C Act)
prohibits manufacturers and
distributors from introducing
new drugs or medical
devices into the market
for any intended use that
the FDA has not officia lly
determined to be safe and
effective. Firms may respond
to questions about FDAregulated medical products
by “providing truthful,
balanced, non-misleading,
and non-promotional
scientific or medical
information that is responsive
to a specific request,” even
if that requires the firm
to provide information on
unapproved indications.
According to the guidance,
information distributed
in response to an
unsolicited request should
be accompanied by the
following:
• A copy of the FDArequired labeling, if any,
for the product (e.g., FDAapproved package insert
and, if the response is for
a consumer, FDA-approved
patient labeling or, for
new animal drugs, FDAapproved client information
sheet)
• A prominent statement
notifying the recipient that
FDA has not approved or
cleared the product as safe
and effective for the use
addressed in the materials
provided
disclosing the indication(s)
for which FDA has
approved or cleared the
product
providing all important
safety information
including, if applicable,
any boxed war ning for the
product
• A complete list of
references for all of the
information disseminated
in the response (e.g., a
bibliography of publications
in peer-reviewed medical
jour nals or in medical or
scientific texts; citations
for data on file, for
summary documents, or for
abstracts)
Regardless of whether the
request was made in a
public or nonpublic forum,
the guidance states that
“a firm that chooses to
respond should provide the
final response containing
the requested off-label
information about its
product only to the specific
individual who requested the
information as a private, oneon-one communication.”
If those parameters are
followed, then the FDA
does not expect those
responses to meet regulatory
requirements for promotional
labeling or advertising, and
it would not be evidence of
intended use.
Regardless of the forum or
format, the guidance advises
pharmaceutical companies
to keep in mind the spirit of
the original FDA regulations
regarding product promotion.
Providing medical or scientific
information that is truthful,
balanced, non-misleading,
and non-promotional will
always be allowed and
encouraged.
39
ADVISE includes the “how to” articles you
have become accustomed to reading in the
former Best Practices section: Time management, skill development, technology, software
topics and more are examined for day-to-day
implementation in your own jobs and offices.
gf
ADVISE
Social
Media
Overview
for Life
Sciences
Project
Management in the
Pharmaceutical
Industry
Patient
Adherence:
Cross-Over
Insights
41
Social Media Overview for Life Sciences
V. (Bala) Balasubramanian, Yves Goulnik
42
Project Management in the Pharmaceutical Industry:
Competencies of the Future
50
Martin D. Hynes III
Patient Adherence: Cross-Over Insights for the
Commercial Arena from the Clinical Research Worl d 56
Carmen R. Gonzalez
gf
GLOBAL FORUM | ADVISE
ISSUE 2
Social Media Overview
for Life Sciences
VOL 4
42
V. (Bala)
Balasubramanian
is th e P res id e n t an d
Co - F ou n d e r
of C a b e u s , a
n ic h e s e r vic e s
an d s olu tion s
p ro v id e r in t h e
are a s of en t e rp ris e collab orat ion , c on te n t
ma n agem e n t
an d s oc ia l
me d ia .
Yves
Goulnik
i s a p h a rma c e u t i c a l
ma r k e t e r wi t h
extensive
k n o wl e d g e i n
d i g i t a l t a c t i c s,
mo b i l e p l a t f o r ms, so c i a l
me d i a t e c h n o l o g i e s a n d we b
d e v e l o p me n t .
Executive Summary
With Facebook being virtually the
third largest nation in the world,
there is exploding awareness
and use of Social Media across
all walks of life across the globe.
While a number of consumer
product companies are fully
leveraging this new media to reach
out to their customers, many
companies in the Life Sciences
sector, especially those dealing
with prescription pharmaceuticals,
are either at a loss or trying to
figure out how best to leverage
this media without exposing
themselves to the risks that are
associated with it. At the same
time, there is a general belief that
appropriate use of social media
can strengthen relationships with
patients and providers, and build
brand reputation, leading to better
business outcomes.
An overview of Social Media,
along with a systematic approach
on how best to think about the
various dimensions of Social
Media as they pertain to the
Life Sciences sector will be
discussed. This article is a result
of our own search to understand
the overall landscape of Social
Media and its impact on Life
Sciences. We strongly believe
that a comprehensive overview is
required to start off any strategic
discussions or initiatives around
the use of Social Media in Life
Sciences.
Social Media Overview
Social Media and Social
Networking refer to the building
of content, relationships and
communities based on common
interests or sharing of ideas using
a variety of online and interactive
tools.1 These tools are based on
Web 2.0 technologies and a lot
of us are familiar with popular
tools such as Facebook, LinkedIn,
Twitter, YouTube, and Flickr as
well as capabilities such as wikis,
blogs, and discussion threads.
We have seen the tremendous
uptake and exponential adoption
of social media by companies in
the consumer products business
as opposed to regulated industries
such as pharmaceuticals or
life sciences, primarily due to
insufficient regulatory guidelines
around their use. There are only
a few pharmaceutical companies
that are actively using some form
of social media to engage the
public, mostly for educational
or customer awareness
purposes and not for product
promotions. Some of these
include Johnson and Johnson
(JNJ), Roche, AstraZeneca, Eli
Lilly, GlaxoSmithKline, who use
a range of tools such as simple
blogs (LillyPad) to YouTube
videos (AstraZeneca) to more
complex product campaigns (JNJ
consumer products).
In order to develop a
comprehensive strategy around
the potential use of social
media, where do Life Sciences
companies start? In order to
facilitate this discussion, we
have developed a mind map to
consider various dimensions such
as the following:
• Business Drivers
• Stakeholders
• Governance and Regulations
• Use Cases
• Benefits
• Features
• People
• Processes
• Technologies
• Effectiveness
• Challenges and Issues
• Case Studies
43
gf
ISSUE 2
We will briefly explore some of
these major dimensions in the
rest of this section. Note that
this framework is preliminary and
evolving and we will be revising
it based on our own experiences
and other best practices.
However, we believe that for any
business purpose use, these
dimensions must be explored
in detail in order to define the
strategy and roadmaps for the
enterprise.
VOL 4
44
Business Drivers
The foremost consideration would
be to understand the primary
business drivers on why the
company needs to establish a
social media presence. Drivers
could be to further promote
brand loyalty, to engage patients
and customers to provide their
insights, to promote collaboration
with internal and external
stakeholders and partners, or to
acquire next-generation talent.
These business drivers must be
aligned with both the short-and
long-term goals and objectives of
the organization.
Stakeholders
Social Media has great
potential for both internal
and external stakeholders –
internal stakeholders could
be R&D business functions,
HR, legal, regulatory, technical
operations, commercialization,
sales and marketing. External
stakeholders could be patients,
researchers, caregivers,
healthcare professionals or
health communities. Based on
the business drivers, focus may
be directed towards increasing
innovation or efficiencies
Roche Social Media Principles in short:
7 Rules for PERSONAL
online activities
Speaking “about” Roche
7 Rules for PROFESSIONAL
online activities
Speaking “onbehalf of”
Roche
• Be conscious about
mixing your personal and
business lives.
• Follow the Roche Group
Code of Conduct and
Communications Policy.
• You are responsible for
your actions.
• Follow approval
processes for
publications and
communication.
• Follow the Roche Group
Code of Conduct.
• Mind the global
audience.
• Be careful if talking
about Roche. Only
share publicly available
information.
• Be transparent about
your affiliation with
Roche and that opinions
raised are your own.
• Be a “scout” for
sentiment and critical
issues.
within internal stakeholders or
establishing and strengthening
customer relationships.
Governance and
Regulations
The whole landscape around
social media regulations is a
green field, full of challenges
and opportunities. For example,
FDA’s DDMAC has postponed
issuing guidelines around the
use of Social Media for Life
Sciences several times over the
past two years. The UK’s Code
• Mind Copyrights and
give credit to the owners.
• Use special care if
talking about Roche
products or financial
data.
• Identify yourself as a
representative of Roche.
• Monitor your relevant
social media channels.
• Know and follow our
Record Management
Practices.
of Practice regulator, ABPI, has
issued guidance on social media
and other digital communications
tools, stating that all digital
communications fall under existing
regulations.2 Many organizations
are eager to move forward in
order to exploit the tremendous
potential of this media.
Regardless of new regulations,
Life Sciences companies still
have to comply with existing
product marketing and promotion
guidelines, which include not
promoting off-label use.
Some organizations have
established internal guidelines
around the use of social media,
while acknowledging that this
is an evolving area. One of the
examples often cited around
policies and guidelines is Roche’s
Social Media Principles.3 Here we
show an example set of principles,
taken from Roche’s Web site:
Source: http://www.roche.com/
social_media_guidelines.pdf
Similarly, AstraZeneca, as part of
its white paper on social media in
the pharmaceutical industry, has
outlined five principles or rules of
engagement.6
In addition to regulations, there
needs to be strong internal
governance – as powerful as
the media may be, it can also
enable the fast deterioration of the
brand or market presence if the
right controls are not in place or
messages are not controlled.
Benefits
Social Media enables individuals
to have an active dialog not only
with the companies but also with
other patients or customers,
making them heard with equal
voice as large businesses and
institutions. The sharing of
ideas enables the creation of
communities which have like
issues to be discussed across
the globe. This, in turn, increases
social intelligence or awareness
of issues, which so far may
be localized to certain small
populations. The technologies
allow these interactions to take
place across time and geographic
boundaries, thereby creating
opportunities that can
be leveraged by businesses,
to the extent that they do not
antagonize basic principles of
trust and openness, without
overdoing control over content
and/or messages.
Social Media plays a key role
by introducing a notion of
triangulation and trust, which
are key components to garner
solid engagement between
companies and customers.
Triangulation is the ability to
reconcile various sources of
information and enhance trust.
For example, people may refer
to ‘official’ product specifications
such as package inserts from
the manufacturer, then follow
up with thorough scientific
reviews from professional
journals or websites which is
subsequently cross-checked
with experiences from friends or
other individuals. Social media
enables individuals to perform
this cross-check and build trust.
Similarly, in a conventional setting,
companies build their customer
base by paying for messages
through TV commercials, print
advertisements, etc. Using social
media, companies can build their
customer base by earning their
trust through the creation of a
community of sharing. These
communities may become the
platform for the emergence
of independent Key Opinion
Influencers (similar to Key Opinion
Leaders) who are sitting between
the sponsors and patients or
providers, potentially exerting
strong influence through their
posts/articles.
Use Cases
Use cases depend on business
drivers and target stakeholders.
With respect to externalfacing use cases, social media
campaigns can help increase
customer awareness or educate
customers about certain
disease areas. For example,
AstraZeneca has established a
general awareness site called
AZ HealthConnections (http://
www.azhealthconnections.
com/). While this has not been
tried, due to lack of regulations,
another example could be patient
recruitment for clinical trials as
part of treatment of rare diseases.
Some companies, such as Eli
Lilly are actively using blogs to
have a dialog with the general
public about public health and
policy issues. Another news article
cites the use of Social Media by
MO BIO labs to directly engage
scientists in pharmaceutical
companies about their products
for nucleic acid isolation.7 There
is a huge potential to recruit next
generation workforce, who are
increasingly living in the era of
social media.
It is important to distinguish that
unlike in the US where Direct-toConsumer (DTC) advertising is
45
ISSUE 2
gf
VOL 4
46
permitted, most other markets
in the world do not permit this
approach, regardless of channel.
Social media opportunities include
disease awareness campaigns,
experience-sharing for patients
with chronic conditions, centered
around personal aspects of
disease management, comorbidities etc. Carefully planned
social media campaigns help
companies strengthen their
brands and also help establish a
continuous dialog with customers
and gather insights.
Similarly, there are a number
of use cases for internal use
within the organization. While
this has not been tried, social
media, along with the ability to
easily shoot videos can become
a powerful tool for scientists
to share best practices or
procedures around innovative
ways of setting up and conducting
experiments or assays. Similarly,
idea generation and voting/
ranking tools can be used for
internal efficiency and innovation
campaigns, encouraging everyone
to participate in the growth of the
company. While companies such
as Merck have implemented the
concept of expertise location, it
is still too early to measure the
adoption rate or success of such
initiatives. But, if the success of
networks such as LinkedIn is any
indication, similar efforts would
yield great benefits within the
walls of the organization as well
– the key is to encourage sharing
and change the culture towards
one of openness.
While there are significant benefits
with collaborative marketing and
social media, especially in the
consumer products sector, life
sciences organizations must tread
the landscape carefully since they
are subject to existing regulations
about product marketing and
promotions.
People
It is important to focus on the
people and organizational aspects
as organizations gear towards
social media. First, there needs
to be greater collaboration and
coordination across corporate
communications, marketing,
HR, legal and other functions
while developing a social media
strategy. Apart from building
organizational constructs, the
right resources need to be hired
and training provided to establish
a social media program. In
addition, organizational change
management programs need to
be put in place to encourage and
manage behavioral and cultural
change.
Processes
Key processes that need to be
considered as part of the social
media strategy include content
and records management. While
many organizations are struggling
with records management for
digital content such as email,
documents, etc., social media
adds a new dimension to the
whole issue. Life Sciences
companies should look into how
other regulated industries deal
with records management of
social media interactions. Also,
processes must be put in place for
social listening and monitoring of
social media sites and channels.
The processes should outline
broad categories of social media
channels available, their benefits,
their potential risks along with
mitigation strategies. In addition,
appropriate standard operating
procedures and work instructions
must be defined to support any
social media initiatives. Data
analytics processes need to
defined and implemented in order
to measure KPIs and metrics.
Technologies
Various tools and technologies
are available for life sciences
companies to establish Social
Media presence. Many
of companies have made
significant investments into
Microsoft SharePoint, Office and
Communicator which together
provide a rich array of Web 2.0
or social media capabilities.
There are also add-on products,
built on SharePoint, for crowdsourcing, idea generation, voting
and ranking. Facebook and Twitter
are two popular technologies.
Facebook also comes with
application programming
interfaces so applications can
leverage social media features.
Another capability that is emerging
fast is Yammer which is an
enterprise-class social networking
platform that allows enterprise
users to collaborate, communicate
and share information, locate
expertise and also connect
with remote workers more
easily than other means. Many
companies have started using
LinkedIn as a way to scout for
and recruit talent. Platforms
such as NewsGator, built on
SharePoint, facilitate enterprise
social networking “by providing
an integrated, behind-the-firewall,
social computing platform that
supports collaboration, facilitates
communication, and improves
worker knowledge.”
Effectiveness
Similar to any enterprise strategy,
it is important to define key
performance indicators and
metrics to measure effectiveness.
Any social media campaign
needs to take into account
social listening, which refers
to monitoring interactions
through social media channels
and analyzing data to obtain
customer or market insights. It is
also possible to gather insights
into customer searches, needs,
preferences and concerns without
compromising privacy regulations
or jeopardizing customer data.
Some of the metrics that would
be helpful to track effectiveness
of social media channels
include a) number of unique
and active customer postings
and interactions b) number of
issues identified and customer
sentiments – positive, negative
or neutral c) responses to issues,
resolutions and time-to-resolutions
d) number of brand loyalists and
e) overall cost/benefit ratio.
Challenges and Issues
PwC reports that intense
regulatory scrutiny of marketing
practices and stringent adverse
event (AE) reporting requirements
have made life sciences industry
wary of taking active steps
towards social media adoption.8
It is slowly emerging that AE
reporting is a non-issue as Social
Media typically lacks some
major criteria required for AE
reporting. Two-way sites such as
blogs can open up opportunities
for disgruntled employees or
dissatisfied customers to create
negative impressions that can
spread virally. Even if companies
decide to use blogs or Facebook
for non-product specific, brand
promotion activities, utmost care
needs to be taken so as to not
get carried away with postings
that may be misconstrued or
may cause damage to the brand.
Companies can address these
issues by working with their
respective regulatory and legal
functions and putting in a process
to review and approve any social
media approach or campaign.
One of the key challenges is that
the boundaries between personal
and professional engagement of
employees are increasingly blurred
in many ways, for example,
with employees using personal
devices to perform work-related
activities and vice versa. With this
comes the danger of individuals
losing their identity and perhaps
speaking out of turn in social
media outlets that may not
represent the official company
position but may be misconstrued
as such due to their professional
association.
Case Studies
We explore a few examples or
case studies with Life Sciences
companies having social media
presence. There is so much
activity going on that we can write
a separate white paper on Case
Studies alone.
LillyPad (http://lillypad.lilly.com/)
is the official blog of Eli Lilly,
which was launched to “focus on
public policy issues, corporate
responsibility initiatives, our
advocacy efforts and the work
our employees do every day to
make the world a healthier place
to live…we don’t want to simply
provide our perspective on the
issues. We want this to be a twoway conversation and encourage
you to join us and share your
thoughts.”
47
gf
1.0 Key Considerations
ISSUE 2
While some initial guidances are
emerging5, following are some key
considerations for life sciences
organizations as they enter the
world of Social Media:
VOL 4
48
AstraZeneca has perhaps the
most exhaustive social media
presence with channels on
YouTube, Twitter and Facebook.
AZ’s Twitter presence is actively
used for talking about public
health, their strategies around
presence in emerging markets,
public announcements on
collaborations and product
approvals etc. AZ’s YouTube
channel carries messages from
the CEO (http://www.youtube.
com/user/AstraZenecaPharma)
as well as already approved
promotions which appear
in traditional media such as
television, print etc.
Janssen Pharmaceuticals has
recently set up a Facebook site
called Psoriasis 360 (https://
www.facebook.com/home.php#!/
psoriasis360) outside the US
with moderated discussions,
talking about the disease, coping
mechanisms and treatment
approaches.
Roche has established social
media presence on multiple
channels such as Facebook and
Twitter (German) and YouTube
(Canadian - http://www.youtube.
com/user/accuchekcanada) for its
Accu-Check showcasing product
use information or carrying
interviews or stories with patients
about use of products.
GlaxoSmithKline has set up
presence on Facebook similar
to their primary company web
site (https://www.facebook.com/
GlaxoSmithKline). There are many
others who are joining the race to
establish social media presence.
• Similar to planning any
communications or media
strategy, start with a strategy
and plan to establish social
media presence. Bear in mind
that social media should be
part of your larger marketing
and consumer relationship
strategy.
• Define a strategy and
implementation roadmap
based on the business drivers
and needs of the organization.
• Be mindful of existing
regulations while developing
your strategy – so, focus
more on quick wins such
as developing a community
or increasing customer
awareness and do not venture
into dialogs on prescription
products or adverse event
monitoring.
• Focus on your strategy and
plans, not on the technologies
per se. Technologies are just
a means to an end, not the
end itself.
• Start small with a proofof-concept, define metrics
for success, and develop a
plan for social listening and
monitoring.
• If you are looking at testing
two-way interactions, start
with blogs to discuss public
policy issues or to understand
customers’ or providers’
perceptions of overall brand,
not any specific product.
the ability to increase their
reputation, brand loyalty and
market share. We believe that
there is tremendous potential
to be unearthed with Social
Media given the right strategy
and approach.
• Being engaged in Social
Media is a full-time effort.
Create a small, dedicated
team to understand the
Social Media landscape
and possibilities. This
needs a combination of
communications and media
professionals, IT professionals
proficient with emerging
social media tools, creative
and graphic design
professionals, infrastructure
professionals, organizational
change management
professionals, etc.
References
2.0 Conclusion
4 .M c K i nse y Q ua r t e r ly, “ The R ise
o f t h e Ne t w or k e d Ent e r pr ise :
We b 2 . 0 Finds it s Pa y da y ” ,
D e c e m be r 2010.
In this article, we introduced a
systematic approach to generate
ideas and facilitate discussions
around developing a strategy for
Social Media in Life Sciences.
We believe entering the world of
Social Media requires thoughtful
strategy and planning just like any
other media or communications
approach and cannot be taken
lightly in an enterprise setting.
At the same time, the power
of the media enables Life
Sciences companies to reach
out to partners, providers and
customers more readily with
easy-to-use capabilities and
technology solutions, creating a
true networked enterprise4 with
1 .R a wn Sha h, “ Soc ia l
Ne t wo rk ing for B usine ss” ,
Wh a r t o n Sc hool Publishing,
2010.
2 .I n P h a r m, “ UK ge t s Soc ia l
M e d i a G uida nc e ” , ht t p://w w w.
i n p h a r m.c om/ne w s/153270/
d i g i t a l -pha r ma - pmc pa - digit a lc o m m unic a t ions- guide line s
3 .R o c he , “ R oc he Soc ia l
M e d i a Pr inc iple s” ,
h t t p ://ww w.roc he .c om/soc ia l_
me d i a _ guide line s.pdf, 2010.
5 .D e l o i t t e , “ Soc ia l Me dia for
L i f e S c ie nc e s: Tr ic k or Tw e e t ?” ,
2010.
6 .A s t r aZe ne c a , “ Soc ia l Me dia in
t h e P h a r ma c e ut ic a l I ndust r y ” ,
2010.
7 .G e n e t ic Engine e r ing a nd
B i o t e c hnology Ne w s, “ R e le v a nc y
o f S o c i a l Me dia in Life
S c i e n c es” , Apr il 2010.
8 .P wC K now le dge Line , “ Life
S c i e n c es I ndust r y Ve nt ure s int o
S o c i a l Me dia De spit e R e gula t or y
Un c e r t aint y ” , June 2010.
About the Authors
V. (Bala) Balasubramanian
is the President and
Co-Founder of Cabeus
where he is responsible
for vision, strategy, reusable frameworks and
methodologies. Bala can
be contacted at balasubv@
cabeusinc.com.
Dr. Yves Goulnik is an
innovative lifesciences
marketer with extensive
knowledge in digital tactics,
mobile platforms, social
media technologies as
well as internet application
development. Yves can be
contacted at yves@goulnik.
com.
49
gf
ISSUE 2
Project Management in the
Pharmaceutical Industry:
Competencies of the Future
Martin D.
Hynes III
VOL 4
50
The pharmaceutical industry
has numerous issues it needs to
confront; these include long cycle
times, costs that have increased
exponentially, as well as low
probabilities of technical success.
These issues are so significant
that the viability of the industry
which provides patients in need
access to safe and effective new
medicine is in jeopardy.
There are numerous
countermeasures that have been
implemented by the industry
in response to the current
challenges. This includes mergers,
acquisitions, and reengineering of
the drug development process as
well as outsourcing. All of these
responses have had a profound
impact on the pharmaceutical
project manager. The following
discussion will look at some of
these responses and their impact
on the project manager.
The role of the project manager is
vitally important to the planning,
execution, and control of drug
development projects, i.e.,
bringing new drug to patients in
need. In most organizations these
project managers lead or co-lead
the teams charged with these
tasks throughout the development
life cycle.
The Project Management
Institute’s (PMI) Project
Management Body of Knowledge
(PMBOK) states that the
primary objective of the project
manager, as well as the project
management process, is to
make the most effective use of
resources.1 Those resources
include people, equipment,
facilities, materials and, most
importantly, dollars or financial
resources. With the average
cost of developing a new drug
in excess of 1.3 billion USD
and potentially as high as 11
billion USD, the appropriate
management of resources is an
important and challenging role.2
The goal of the project manager’s
activities is ensuring the project
goals are achieved within budget
and on schedule while meeting
the performance expectations of
the sponsor organization and the
requirements of global regulatory
authorities.
The job of the project manager
has not been an easy one as
they are on the front lines of drug
development, often experiencing
the changes in the environment
and the efforts to confront these
changes first hand. The project
manager and the teams they lead
are confronted with:
1. Changes to the drug
development process,
2. More sophisticated project
management tools,
3. The move from a FIPCO to a
FIPNET environment,
4. Tailored therapeutics,
5. A changing regulatory
environment,
6. New project management
techniques,
7. Industry consolidation.
A look at these will demonstrate
the significant impact each
of these changes has
on responsibilities of the
pharmaceutical project manager.
1.The Drug Devel opment
Process
The drug development process
has not changed significantly in a
number of decades. It is a “given”
that the process utilized to bring
new pharmaceuticals to patients
in need can have a profound
impact on the cost and time. Thus,
changing the process has the
potential to decrease the cycle time
and cost of developing a new drug.
Even if those changes were
incremental, these small
improvements when taken
together could have an
appreciable impact on decreasing
both cost and cycle time, while
even more radical changes might
also be expected to have an even
greater impact on the process.
The impact is manifested in two
important ways. One is that
project managers need to be
consulted and engaged as subject
matter experts in the efforts to
change the process, which can
be time consuming. Additionally,
they need to learn these process
changes, help others in the
organization learn them, as well
as implement them during the
conduct of their drug development
project.
2.N ew and More
Sophisticated Project
Management Tools
Given the cycle times and cost
involved, as well as the number
of projects and deliverables per
project, most project management
organizations have used some
type of software to help track
the key data elements within
their organization. These project
management software tools can
range from Microsoft Project™,
which runs on a single desktop or
lab computer, to larger enterprise
systems like SAP or OPX2. The
size and sophistication of the
software/hardware deployed
is directly linked to the size of
company and/or the portfolio
of drug development projects.
Most importantly, the project
manager has to utilize the data
collected from these project
management tools to manage
drug development projects more
effectively.
3.F IPCO to FIPNET
Transition
It was not all that many years
ago that major pharmaceutical
companies did all development
work within the walls of their
organization. That has changed
dramatically in the last five to ten
years. Many organizations have
moved from this fully integrated
pharmaceutical company (FIPCO)
model to the fully integrated
pharmaceutical network (FIPNET).3
This is supported by the fact that
some large firms now outsource a
significant amount of development
work, in some cases as much
as 50-60%, while some smaller
organizations have outsourced
51
ISSUE 2
gf
VOL 4
52
up to 100% of their activities.
This move to a FIPNET model
has brought profound change to
project managers who now need
to be involved in vendor selection
and management, as well as to
integrate their work with other
vendors and corporate functions.
This represents a profound
change from the days when a
fellow company employee was
managing the toxicology studies,
the production of clinical trial
materials, etc. Now the toxicology
studies or, for that matter, any
development activity may be
performed by external vendors
located in different countries,
time zones, and who work in
a different language as well as
culture context. This creates a
number of new challenges for
the project manager, such as
organizing teleconferences or
video conferences at an hour
that accommodates a global
development effort. The project
manager is also now responsible
for overseeing the quality, cost,
and timelines of work performed
by an external vendor – tasks for
which they historically have little
formal training and preparation.
therapy and stratifying their
response into groups of specific
patient populations. The goal
is to enhance and optimize the
risk/benefit ratio for the patient
populations. The benefits of
such a development paradigm
are clear. But it is not hard to
envision project managers and
their teams being charged with
developing drugs as well as their
companion diagnostics. This
requires the project manager and
their team not only to plan for
the new chemical entity (NCE)
but the companion diagnostic
as well. This would also increase
the burden of executing and
controlling an additional project
focusing on the companion
diagnostic. The project team
would also have to ensure that
the regulatory standards for that
diagnostic have been achieved
during development as well as
in the submission itself, thus
increasing the amount of project
work the project manager and
their project team must plan and
execute.
4.T ailored Therapeutics
The regulatory environment
in which the pharmaceutical
project manager works has
continued to evolve and change.
These changes impact all areas
of drug development, from
product development to clinical
development.
The vast majority of drugs
developed historically have been
designed to treat all patients
with a given disease process.
Literally, a one size fits all model
of drug development. Medicine
and pharmacology are radically
advancing to a targeted therapy
model. This would move in the
direction of assessing a spectrum
of patient responses to a given
5.Regulatory
Environment
The project manager is not
expected to be the regulatory
expert; that responsibility clearly
falls to the team’s regulatory
scientist. It is, however, important
for the pharmaceutical project
manager to be aware of the
regulatory landscape to ensure
that the project team’s plan
will meet all of the applicable
requirements at the time of
submission. A changing regulatory
environment can make this both
a challenging, time-consuming
endeavor, as well as a seemingly
never-ending task.
6.P roject M anagement
Techniques
Formal project management
functions in the pharmaceutical
industry have only existed for the
past three decades. Prior to that
time, drug development activities
were driven in many cases by
laboratory scientists. Today
many of the project managers
in the pharmaceutical/biotech
industry have extensive project
management training. Many go to
project management boot camps
to gain in-depth knowledge. A
number even go on to receive the
Project Management Professional
certification, a far cry from the
humble start just thirty years ago.
A number of pharmaceutical
companies have incorporated
critical chain project management
into their tool kit4,5,6. An extensive
review of these methods is outside
the scope of this article, but for
the purpose of this paper it should
be noted that it requires project
managers who are prepared to
implement this method and to
learn new tools and techniques,
including student syndromes,
buffers, as well as understanding
the critical chain as opposed to
the critical path methodology.
Not only does this require the
project manager to spend time
learning the new tools and
techniques, as well as its lexicon
of terms, it requires patience
and practice in implementation
as well as time and energy in
helping team members and their
home function to adapt to the
behavioral changes required, such
as focus on critical chain tasks
and elimination of multitasking
during these times. This is not an
insignificant change in behavior.
7. Industry
Consolidation and Down
Sizing
The pharmaceutical industry has
seen considerable change in
the last ten years. The hallmarks
of this change have been
consolidations with the resulting
downsizing. The pharmaceutical
industry trend towards
consolidation has resulted in the
combination of many companies
into existing entities or into new
ones. These consolidations
impact not only the organization
and its employees, but the drug
development process as well. This
type of change can complicate the
life of the pharmaceutical project
manager. They are not only trying
to figure out the new organization
and its drug development process
so that they can drive projects
forward, but in many cases they
are groping at a personal level
to understand the impact to
them as an individual. This can
be challenging for any person
undergoing such change, but it is
especially so for project managers
given their key role in driving new
molecules to patients in need.
53
gf
ISSUE 2
Conclusion
VOL 4
54
The role of a project manager
in the pharmaceutical industry
can be both challenging and
rewarding. The challenge has
only grown in recent years as
the industry tries to maintain its
viability. Any one of the changes
described here would take time
to understand and prepare for.
However, when all of these major
changes are taken in concert,
it represents a significant shift
for the project manager. These
already busy professionals have
to understand these changes
as well as make sure that they
are working with their drug
development teams to create
plans that reflect/adapt to this
changing environment. This
requires the project manager to
expand their already long list of
competencies into areas that they
have precious little time to spend
learning given the significant
amount of scientific and project
detail that they have to manage.
A competency model for
pharmaceutical project managers
has suggested scientific/technical,
process and leadership skills are
needed areas of competency.7,8
The details of this model are given
in Figure 1. A recent review of
the model by a DIA working group
confirmed that these in fact were
the correct skills9.
However, given the rapidly
changing environment, these
competencies will have to be
expanded. The “Know the
Business” area of competency,
for example, will need to
reflect the requirement to be
knowledgeable in the area of
changing regulatory requirements.
A new competency around the
Figure 1. Pharmaceutical Project Management:
Three Areas of Core Competency and Supporting Detail 7,8
Scientific /Technical Process
Leadership
Knows the Business
Communicates
Clearly
Develops People
Initiates Action
Pays Attention to
Details
Focuses on
Results
Thinks Critically
Structures the
Process
Builds a Team
Manages Risk
Manages
Complexity
Makes Tough
Decisions
Builds Strategic
Support
management and integration of
FIPNET activities will need to be
added into this list. As more of
these pharmaceutical project
managers’ core competencies are
modified, expanded, and added
to, the more important it will be
to keep up with these changes.
This will require drug development
organizations to provide adequate
time for their project managers
to train in the rapidly evolving
discipline of pharmaceutical
project management.
REFERENCES
1. A Guide to the Project
Management Body of
Knowledge. 4th ed.
Newtown Square, PA: Project
Management Institute; 2008.
2. Herper, M. The truly
staggering cost of inventing
new drugs. Forbes website.
http://www.forbes.com/sites/
matthewherper/2012/02/10/
the-truly-staggering-costof-inventing-new-drugs/.
Accessed February 10, 2012.
3. Kaitin KI. Deconstructing the
drug development process:
The new face of innovation.
Clin Pharm & Therapeutics.
2010;87(3):356-361.
4. Goldratt E. Critical Chain.
North River Press; 1997.
5. Goldratt EM. The Goal:
A Process of ongoing
Improvement. North River
Press; 1984.
6. Scherer A. Be Fast or Be
Gone: Racing the Clock
with Critical Chain Project
Management. Lake Ridge, VA:
ProChain Press; 2011.
7. Hynes MD, Susemichel
AD, Konechnik TJ, Phipps
CS, Winiarski K, Byers
LK. The development of a
core competency model
for pharmaceutical project
managers. Proceedings
of the 30th Annual Project
Management Institute
Seminars & Symposium.
Philadelphia, PA: 1999;20.
8. Kerzner H. Applied Project
Management: Best Practices
on Achieving Global
Excellence. New York:
John Wiley and Sons, Inc.;
2010:339.
9. DIA Project Management
Conference. Tomorrow’s
Project Manager:
Evolving Competencies
for Biopharmaceutical
Professionals. October 26-27,
2010. Baltimore, MD.
Martin D. Hynes III, PhD,
has authored or co-authored
over 130 scientific articles,
abstracts, book chapters, and
patents. He most recently
edited Preparing for FDA
Pre-Approval Inspections,
published by Marcel Dekker,
Inc. Dr. Hynes serves on
the DIA Project Management
Special Interest Area Core
Committee, as well as on
the Project Management
Special Interest Area Training
subcommittee. He serves
as instructor for the DIA
Project Management training
course. Dr. Hynes earned
his Bachelor’s degree in
Psychology from Providence
College and his PhD in
Pharmacology and Toxicology
from the University of Rhode
Island. Dr. Hynes currently
serves as Senior Director
of Product Research and
Development at Lilly Research
Laboratories, Eli Lilly and
Company. He can be reached
at (317) 276-4034 or hynes_
martin_d_iii@lilly.com.
55
gf
ISSUE 2
Patient Adherence: Cross-Over
Insights for the Commercial Arena
from the Clinical Research World
VOL 4
56
Carmen R.
Gonzalez
is the Manager of Strate g y & Co m mu n i c a t i o n s
a t He a l t h c a re
Co mmu n i c a t i o n s Gro u p
wh e re sh e
g u i d e s p h a rma c e u t i c a l
organization
c l i e n t s re g a rd i n g p a t i e n t re c r u i t me n t a n d
re t e n t i o n c o n cerning their
g l o b a l re se a rc h
st u d i e s .
Solving challenges related to
drug adherence have generally
been characterized as requiring
education and reminders. The
problem is much more complex.
All those who practice in the
clinical research arena have
to overcome drug compliance
hurdles with every study
undertaken. This essay reviews
the experiences that have crossover relevance to your peers in
the commercial area, and which
if adopted, can help ensure
improved adherence.
For a comprehensive approach
regarding medication adherence,
it is important to capture the
widest aperture of all factors
that undercut compliance. These
considerations should embrace
the patient’s life as a holistic
continuum, including the following
factors:
•Family dynamics
•Employment
•School
•Religion
•Literacy
While any single category listed
above can wreak havoc on drug
adherence, it is quite common
that multiple intrusions arise in a
patient’s life to upend their faithful
treatment regimen.
Family Dynamics
To view the patient as a single
actor often belies their everyday
life circumstances. The better
course is to consider the patient
as part of a family unit and to
anticipate recurrent themes
that often affect daily life. For
example, family vacations might
disrupt certain drug treatment
schedules. To guard against
such interruptions, it is advised
to equip doctors with portable
calendaring tools for distribution
among patients which allow them
to plan ahead and integrate their
medication requirements.
Likewise, there are circumstances
which are less predictable but
occur often enough to warrant
support. In today’s society,
divorce is more common than in
times past, representing a serious
familial rupture that can disrupt
faithful drug adherence. Providing
doctors with handy postcards on
how to inquire about family life to
help support their patients is one
way to address this phenomenon.
Offering physicians local resources
to share with patients regarding
family counseling and support
groups is another. The key here
is to support the doctor-to-patient
dialogue to help patients stay on
track with their medications.
Another common threat to
adherence is a patient’s grief
owing to a death in the family. As
with divorce, it is the emotional
loss that can distract a patient
from maintaining their drug
schedule. Once again, preparing
medical professionals to inquire
about family circumstances,
including loss of loved ones, is
important when safeguarding
adherence. Provision of grief
counseling resources assists
doctors with broaching such
conversations.
Exhibit 1: Comparative Poverty and Unemployment Percentage Rates (2011)
Employment
Ordinarily, in better economic
times the issue of job continuity
plays a minor role in upsetting
drug treatment adherence. The
world economy today is much
more fragile and has presented
a new class of individuals who
are experiencing long-term
unemployment in the US and in
many European countries. This
new era presents emotional
and psychological stressors
upon the jobless and creates
gaps and deficits in health care
access and insurance coverage
among patients facing these
challenges. Information relating to
drug subsidies and/or rebates is
important to advance in countries
where the economic shockwaves
are most severe.
57
Exhibit 2: Threats to Adherence Posed by Health Care Access Barriers
ISSUE 2
gf
VOL 4
58
School
Literacy
A central part of some patients’
lives is their school schedule
which can shift from year to year,
particularly if pediatric patients
become college bound. Changes
in school location can create new
environmental influences that may
disrupt adherence. Once again, by
arming physicians with calendar
tools that remind them to raise the
topic of school commitments with
patients and/or their caregivers,
medical providers can guard
against compliance lapses.
Offering portable diaries and even
mobile apps to disease support
groups for distribution among
patients/caregivers that assist with
drug adherence are helpful for
reinforcing treatment compliance.
Suggesting coping strategies for
likely scenarios in guide book form
are other examples of proactively
supporting adherence (eg, how
to keep final exam week from
cramping your health).
Messaging content is equally
important when it comes to
securing effective drug adherence.
While literacy rates vary among
countries, the general rule of
applying a Flesch-Kincaid 9th
grade level standard to written
text may not always achieve
the desired result. According
to a University of Utah Health
Sciences Center study, one in
5 US adults reflected a reading
level at 5th grade or below. This
issue is not confined to the US
either. In Europe, one in five
15-year olds, and many adults,
lack basic reading and writing
skills as cited by the European
Commission. According to
some estimates, literacy rates
range from 50% to 69% in India.
The upshot from these trends
is the need to present dosing
information in non-clinical terms at
reading levels closer to grammar
school standards. Apart from
packaging information on drug
labels, consider designing one
sheet provided to physicians that
heavily rely on graphics to help
in communicating information
(eg, the use of sun and moon
icons to indicate morning or night
medication ingestion).
Religion
Often overlooked, the role of
religion in a patient’s life can
pose frequent challenges to drug
compliance when holidays occur.
Many religions include fasting
practices as part of their rituals
thereby affecting some drug
regimens (eg, intake requirements
involving food ingestion). Likewise,
holiday feasting can also affect
adherence. In both cases,
creating educational materials for
doctor-to-patient conversations,
disease association affiliates,
and disease support groups can
assist the patient to remain on
target regarding their medication
schedule.
Considering a patient’s everyday
life and circumstances can go
a long way to crafting the right
strategy to support adherence.
While not every challenge can
be predicted, by tackling the
core issues many patients face,
pharmaceutical companies can
enhance their contribution to raise
compliance and patient health.
Endnotes
1. Income, Poverty and Health
Insurance Coverage in the
United States: 2010, U.S.
Census Bureau, September
13, 2011, http://www.census.
gov/newsroom/releases/archives/income_wealth/cb11157.html
2. United States Unemployment
Rate at 9.10 Percent, Trading
Economics, September 2011,
http://www.tradingeconomics.
com/united-states/unemployment-rate
3. Thousands Protest Economic
Crisis, High Unemployment
in Spain, CNN World, May
18, 2011, http://www.cnn.
com/2011/WORLD/europe/05/18/spain.protests/
index.html
4. Poverty Risk in Spain, The
Olive Press, May 24, 2011,
http://www.theolivepress.
es/spain-news/2011/05/24/
poverty-risk-spain/
5. U.K. Unemployment Increases to 8.1%, Highest in 15
Years, Bloomberg Business
Week, October 12, 2011,
http://www.businessweek.
com/news/2011-10-12/u-kunemployment-increases-to8-1-highest-in-15-years.html
6. UK Seeing ‘A Big Rise in Poverty’, BBC News, October 10,
2011, http://www.bbc.co.uk/
news/business-15238468
7. India Unemployment Rate,
Index Mundi, July 12, 2011,
http://www.indexmundi.com/
india/unemployment_rate.html
8. Fast-Growing India Facing Unemployment Bomb,
The Sydney Morning Herald,
February 6, 2011, http://
news.smh.com.au/breakingnews-world/fastgrowing-indiafacing-unemployment-bomb20110206-1ai52.html
9. India’s Medical Emergency, Time Magazine, May
2008, http://www.time.
com/time/magazine/article/0,9171,1736516,00.html
10.India’s Health Care Crisis, Time Magazine, May
2008, http://www.time.
com/time/photogallery/0,29307,1711814,00.html
11.India Makes Some Progress
on Poverty, IndiaRealTime,
Wall Street Journal, July 11,
2011, http://blogs.wsj.com/
indiarealtime/2011/07/11/
india-makes-some-progressin-reducing-poverty/
12.Y. Balarajan, et al, Healthcare
and Equity in India, The
Lancet, Vol.377, Issue
9764, pp.505-515, February
2011, http://www.thelancet.
com/journals/lancet/article/
PIIS0140-6736(10)61894-6/
abstract
13.NHS Fares Best on Free
Access to Healthcare, The
Guardian, November 18,
2010, http://www.guardian.
co.uk/society/2010/nov/18/
nhs-best-free-accesshealthcare
14. Flesch-Kincaid readability
test, Wikipedia, http://
en.wikipedia.org/wiki/
Flesch%E2%80%93Kincaid_
readability_test
15.Bailey, B., Ph.D., Readability
Formulas, UI Design
Newsletter – July 2002,
Human Factors International,
http://www.humanfactors.
com/downloads/jun02.asp
16.Commission Launches
High-Level Expert Group on
Literacy Chaired by Princess
Laurentien of the Netherlands,
European Commission Education & Training, February
1, 2011, http://ec.europa.eu/
education/news/news2773_
en.htm
17. Literacy, Wikipedia, http://
en.wikipedia.org/wiki/Literacy
59
REACH: Reflects the global nature of DIA and
exposes readers to what we are doing around
the globe and how advances in each region
can have a worldwide impact. This is where
Upcoming Events now resides, in an easyto-read sidebar box for each region outlining
their educational offerings.
gf
REACH
EUROPE
NORTH
AMERICA
LATIN
AMERICA
INDIA
JAPAN
CHINA
61
EUROPE
Ex ploring New Countries –
DIA Advisory Council of Europe (ACE)
Meets Colleagues in Their
Home Countri es
Tatyana Benisheva and Gesine Bejeuhr62
North America
FDA/DIA Statistics Forum 2012
72
RIM Conference Runs
on Two Tracks
Sarah Powell74
PCORI:
Its History Shapes its Future
75
Innovation: Engine Driving DIA 2012
Craig Lipset
Paul Pomerantz80
DIA 2012 Social Media & Rare Disease
Patient Communities
Julia Nable82
Content Partners Collaborate on
DIA 2012
84
DIA 2012 Spotlight on Social Media
& Patient Rec ruitment
85
Latin America
Dr. Diana Valencia pACLA Member
Colombia88
Dr. Daniel Mazzolenis pACLA
Member Argentina
90
INDIA
Comprehensive Program on Effective
Project Management
Dr. S. M. Sapatnekar92
CMC: Converting Science into
Regulatory Submission
Dr. Nandkumar Chodankar94
The Curtain Raiser
5th DIA Global Regulatory
Conference, Mumbai
97
JAPAN
Japan Hosts Clinical Data
Management Workshop
Makoto Yokobori99
CHINA
4th Annual China Meeting to be
Held in Shanghai
101
gf
GLOBAL FORUM | REACH
ISSUE 2
EUROPE
VOL 4
62
Tatyana
Benisheva
and
Gesine Bejeuhr
Exploring New Countries
– DIA Advisory Council of
Europe (ACE) Meets Colleagues
in Their Home Countries
DIA offers a neutral forum for
discussions between stakeholders
– this was the message conveyed
in free workshops held during
the last two years in European
countries new to DIA.
When the DIA Advisory Council of
Europe (ACE) was discussing the
needs of those countries that had
joined the European Union since
2004, the idea was put forward
that workshops might offer the
ideal platform for both DIA and the
professionals in those countries to
get to know each other. Instead
of the usual meetings in the
centre of Europe, the ACE met in
Budapest, Warsaw, Zagreb, Sofia
and Istanbul.
The workshops consisted of two
sessions. In the mornings the
ACE agenda was discussed and
in the afternoons, ACE members
volunteered to give presentations
on topics based on their expertise
to the representatives from the
industry and regulatory authorities.
These free workshops started
with an introduction to DIA by Dr.
Brigitte Franke-Bray, Director DIA
Europe, Global Training Officer.
These were complemented by
local speakers who gave their
views on current legislative
procedures and guidelines.
Tailored to the needs of the
respective host country, local and
EU-experts were invited to present
their thoughts about burning
issues. When we were planning
these workshops, no one knew
that we would sometimes face
snow and ice, hours of delay at
airports and speakers who literally
arrived as their presentation
went up on the screen. These
workshops proved to be great
experiences both of collaboration
and of hospitality.
Budapest, 27 November
2009
Faculty
•Peter Bachmann, European
Drug and International Affairs,
BfArM, Germany, (CMD(h)
Member; now chair)
•Gesine Bejeuhr, Regulatory
Affairs/ Quality, vfa – ResearchBased Pharmaceutical
Companies, Germany
•Gyula Fehér, Vice President
Hungarian Regulatory Affairs
Society (HURAS), Registration
Manager, KRKA, Hungary
The audience is very attentive as DIA President Yves Juillet opens the discussion
•Brigitte Franke-Bray, FFPM,
Director DIA Europe, Switzerland
•Anthony Humphreys, Head
of Sector, Regulatory Affairs
and Organisational Support,
European Medicines Agency
•Yves Juillet, Senior Advisor,
LEEM, France, current
President, DIA
•Sandor Kerpel-Fronius,
Professor, M.D. D.Sc.
Department of Pharmacology
and Pharmacotherapy,
Semmelweis University
Budapest, Hungary
•Henrik K. Nielsen, Corporate
Vice President Regulatory
Affairs, Marketed Products,
Novo Nordisk A/S, Denmark
•Tamás Paál, Professor, President
of the Operative Board to the
Director-General, National
Institute of Pharmacy, Hungary
•Lívia Stankovics,
Pharmacovigilance and
Regulatory Medical Affairs
Manager, Chinoin/SanofiAventis, Hungary
•Dagmar Stara, at this time Head
of the EU Affairs Coordination
Unit, State Institute for Drug
Control, Slovakia
The first workshop was held in
Budapest on a cold and wet
November day in 2009. The
participants received the latest
news about European Regulations
and discussed their practical
implementation in Hungary.
Regulatory priorities in Hungary
were presented by Gyula Fehér
and Sandor Kerpel-Fronius.
Then ACE-member Henrik K.
Nielsen chaired the session,
“Changing EU Requirements and
Their National Impact”. The fight
against counterfeit products was
described by ACE-member (now
DIA president) Yves Juillet in his
update on the EU Pharmaceutical
Package. This was complemented
by Tamás Paál with his
presentation on inspections of API
manufacturers. The improvement
in pharmacovigilance (Lívia
Stankovics and the technical
impact of the Readability
Guidelines [ACE-member Gesine
Bejeuhr]) were other aspects of
the changing environment that
63
gf
were covered. Regulatory Affairs’
work was further complicated by
the Variation Regulation.
ACE-member Anthony Humphreys
co-chaired this session and ACEmember Peter Bachmann asked,
‘Update on Implementation Status
- Are We Ready?’ ACE-member
Dagmar Stara presented her
practical experience with “National
Implementation Activities”.
ISSUE 2
Warsaw, 28 May 2010
VOL 4
64
Faculty
Member; now chair)
•Christer Backman, EU
Coordinator & Senior Expert,
Medical Products Agency (MPA),
Sweden (CMDh Member)
Companies, Germany
•Anna Dziag, Associate Director,
Site Start Up, Quintiles Poland
Sp. z o.o.
•Brigitte Franke-Bray FFPM,
President, DIA
•Marcin Kolakowski, VicePresident, Office for Registration
of Medicinal Products
•Wojciech Matusewicz, Head of
AOTM, Poland
•Elzbieta Mokwinska, Director
Clinical Operations, Quintiles
Poland Sp. z o.o.
•Lidia Retkowska-Mika, Head,
Legal Legal Unit, Office for
Registration of Medicinal
Products, Medical Devices
and Biocides, Poland (CMDh
Member)
•Pawel Sztwiertnia, Director
General, INFARMA, Poland
Warsaw greeted us with warm
sunshine in May 2010. Under
the heading, “Changing EU
Requirements and Their National
Impact”, ACE-members Yves
Juillet, Peter Bachmann and
Christer Backman presented an
update of regulations (Variations
and Pharmacovigilance). Marcin
Kolakowski and Lidia RetkowskaMika put this into context for the
Polish audience.
Pawel Sztwiertnia and Gesine
Bejeuhr chaired the discussion
on the “Pharmaceutical Package
– GMP Requirements and
Inspections, Falsified Medicines
in the Pharmaceutical Package
Proposal” where Ms. Lidia
Retkowska-Mika gave an overview
from the CMDh-viewpoint.
Particulars about clinical trials
in Poland were presented
by Anna Dziag and Elzbieta
Mokwinska. A speaker from
the Polish Pharmacoeconomic
Society together with Wojciech
Matusewicz explained the way
Pharmacoeconomics work in
Poland.
Zagreb, 30 November 2010
Faculty
Member; now chair)
•Ivana Ferber, Regulatory
Lead Croatia / Bosnia and
Herzegovina, Merck Sharp and
Dohme d.o.o., CARPC Member,
Croatia
•Angelika Joos, Head Regulatory
Policy, EU & Most of World,
Merck Sharp & Dohme (Europe)
Inc., Belgium
President, DIA
•Dagmar Stara, Teacher at
Faculty of Pharmacy, Comenius
University, Bratislava
•Ivana Starešinić-Šernhorst,
Regulatory Affairs, Assistant
Director, BELUPO Inc., Croatia
•Siniša Tomić, Head of Agency,
Agency for Medicinal Products
and Medical Devices, Croatia
Anu Tummavuori-Liemann,
Associate Director European
Regulatory Liaison, Celgene,
Switzerland
In Zagreb, Croatia in pouring
rain in November 2010, 100
people attended this workshop,
easily exceeding the number
of participants at the previous
Here follows a detailed impression of this workshop:
Influence of the EU Legislation on the
Bulgarian Drug Industry
In relation to the new Pharmacovigilance
provisions and HTA
Yves Juillet, DIA President and Brigitte Franke-Bray welcomed
all the participants, including those from the Bulgarian
regulatory authority and from industry.
On Behalf of the Republic of Bulgaria the Deputy Minister
of Health, Gergana Pavlova, sent a welcome address to the
participants of the workshop:
DEAR COLLEAGUES, ESTEEMED GUESTS,
I have exceptional pleasure extending my congratulations to
the participants and the organisers of today’s meeting and to
address my wishes for a successful work.
I believe that the actuality of the topic of the impact of the
European legislation to the Bulgarian pharmaceutical industry
will allow you to familiarise with what has been done to
date, to enrich your practical experience, and to realise new
professional contacts. I am assured that, in the course of
your discussions, you will find the answers to a lot of the
issues concerning your everyday professional practice.
Conducting a rational pharmaceutical policy and the
establishment of an effectively functioning system of
provision and distribution of medicinal products in Bulgaria is
one of the major priorities in the management program of the
Ministry of Health.
The introduction and implementation of the requirements of
united Europe relating to the trade in medicinal products,
their quality and safety, can only be achieved by joint efforts
of the state institutions, professional organizations, and the
whole professional community.
The Ministry of Health is conducting a policy of active and
correct dialogue with all participants in the process of
manufacturing, trade and distribution of medicinal products.
Our aim is to jointly find the most effective solutions to
protect and guarantee the interests of the whole society, of
all Bulgarian citizens.
I wish all participants in this working meeting fruitful work
and further success!”
workshops. Many ACE members
faced difficulties in getting to
Zagreb as snow had affected
nearly all other European regions
and flights were massively
delayed.
The local regulatory authority
was very supportive and active
in the preparation and conduct
of this workshop. Prof. Siniša
Tomić, Head of Agency, Agency
for Medicinal Products and
Medical Devices, Croatia, gave a
welcome address and presented
his vision for working within the
EU Regulators’ Network. He
chaired the session, “Preparing
for European Marketing
Authorisation”, where ACEmember Anthony Humphreys
spoke about “Accession Tools
& EU Requirements for CP
Products” and explained what
the EMA expected from New
Member States. Peter Bachmann
described how regulators
assisted regulators through
close collaboration and twinning
projects before the accession of
new member states in 2004. Anu
Tummavuori-Liemann presented
lessons learned from those earlier
accessions.
In a session, “Facilitating Smooth
Transition into the New Era,”
(Session Chairperson: Ivana
Ferber), Dagmar Stara shared
practical experiences from EU
Accession and how candidate
Agencies transitioned smoothly
into the EU Regulators Network.
Ivana Ferber and Ivana StarešinićŠernhorst presented the current
challenges and expectations
65
gf
the industry is facing. ACEmember Christer Backman – who
had literally just arrived at the
meeting - completed the picture
and showed how the Swedish
agency co-ordinated MR and DC
Procedures.
Sofia, 26 May 2011
ISSUE 2
Faculty
VOL 4
66
Member; now chair)
Companies, Germany
•Tatyana Benisheva, Assoc.
Prof. Drug Regulatory Affairs,
Bulgarian Medical University
Sofia
•Deyan Denev, Executive Director,
ARPharM, Bulgaria
•Luca De Nigro, Postmarketing
drug register coordinator, AIFAItalian Medicines Agency
ACE Members Beat Widler, Gesine Bejeuhr and
Peter Bachmann during one of the breaks
LEEM, France; current
President, DIA
•Birka Lehmann, Head of
Licensing Division 3, BfArM,
Germany
•Yavor Pomakov, Clinical Maniger
of PPD in Bulgaria
•Maria Popova, Head of
Medicines Use Control,
Department at the Bulgarian
Authority, Bulgarian Drug
Agency
On May 26, 2011 in Sofia, the
DIA Workshop focused on the
“Influence of the EU Legislation on
the Bulgarian Drug Industry”. Our
colleagues in Bulgaria rose to the
challenge and when we arrived
had registered more than 110
participants.
The audience is very attentive as
DIA President Yves Juillet opens
the discussion
The workshop was divided
into 3 sessions. The first
session was, “Clinical Trials
and Pharmacovigilance – New
Challenges”, Chaired by Beat
Widler, ACE Chair and DIA Board
Member
Birka Lehmann introduced
the legislators’ views with her
presentation, “Clinical Trials
- Report of the European
Commission and New Guidelines
on Adverse Event Reporting and
Publication in EUDRACT“. The
main objective for new legislation
in 2001 was the protection of both
subjects participating in clinical
trials and of trial data, the single
decision per member state by
competent authorities, and single
opinion by Ethics Committees,
and the principles of Good
Manufacturing Practice (GMP),
Good Clinical Practice (GCP).
Birka stated that on February
9, 2011, a Public Consultation
on a concept paper on the
revision of the ‘Clinical Trials
Directive ‘2001/20/EC had been
published. It was a medium/longterm project, aimed at structural
improvements.
In addition, the existing detailed
guidance of the Commission
on adverse reaction reporting,
including SUSAR reporting, should
be amended. These improvements
had, out of necessity, to be limited
to what was possible under the
current legal framework.
The EU Clinical Trials Register
website update launched on
March 22, 2011 enabled the
public to search for information in
the EudraCT database; such as
eg, the description of a phase II IV of adult clinical trials where the
investigator sites were in the EU
member states and the European
Economic Area (EEA). The
navigation and the web content
of the newly launched register
was in English only. The register
was limited to medicinal products
and did not cover the information
on clinical trials for surgical
procedures, medical devices or
psychotherapeutic procedures
and did not allow requests for
joining any clinical trial published
on the website.
Information on clinical trials which
were part of an agreed Paediatric
Investigation Plan (PIP) and were
conducted outside the European
Union and the EEA will be
published retrospectively on the
website by March 2012.
“New Pharmacovigilance
Legislation and Clinical Trials” was
presented by Yavor Pomakov. He
presented the pharmacovigilance
legislation changes which will
come into force in 2012, such as
changes in the terminology and
definitions essential for clinical
trials: Adverse Drug Reactions
(ADRs), Post-Authorisation
Safety Studies (PASSs), PostAuthorisation Efficacy Studies
(PAESs).
PASS was now defined as any
study relating to an authorised
medicinal product conducted
with the aim of identifying,
characterising or quantifying a
safety issue, confirming the safety
profile of the medicinal product, or
of measuring the effectiveness of
risk management. Transparency
and communication were parts
of the new legislation: better
ADR reporting (new definition,
medication errors, patient
reporting, reduced duplication of
work, single point of access to
European-wide safety database).
The new requirements were also
aimed at the EU and national
medicines web portals, publicly
available updated product
information, NCAs’ public
assessment reports, PRAC public
hearings.
At the end of the session,
Yavor Pomakov summarised
the challenges in the updated
Session 2 – “Pharma
Package – New
Requirements in
Pharmacovigilance”
with Session Chair
Gesine Bejeuhr Christer Backman gave
an overview of the “Key
Changes in Pharmacovigilance
Legislation” from a regulator’s
67
Turkish delegates and ACE member of DIA at the DIA workshop on December 5, 2011
pharmacovidgilance legislation,
such as resources required from
both the competent authorities
and the industry. He also
highlighted possible change of the
business models and quality and
compliance activities performed
in the pharmaceutical industry
which would affect the clinical
trials in the post-authorisation
phase. He added that for PASS
and PAES studies, the industry
and CAs would need to devote
time, budgets and resources and
investigators would need to be
motivated to participate in the
reporting of the safety data from
PASS.
point of view. He presented
the required organisational
adaptation for performing the
implementation of changes in
pharmacovigilance legislation,
where the transition period was
18 months and pointed out that
the most critical issues were
the implementing measures, the
national transposition and the
EudraVigilance Database.
The EMA‘s implementation
project was in force where teams
produced “concept papers”
with problem statements and
recommendations for action, eg,
guidelines, SOPs, IT-support,
evaluations, resource implications,
gf
ISSUE 2
etc. The EMA would set up and
maintain a European web-portal
for medicines both to increase
transparency on drug safety
and to coordinate drug safety
information, public hearings and
additional monitoring.
VOL 4
68
Member states would set up and
maintain a national web portal for
medicines linked to the EMA web
portal with public assessment
reports, with summaries, SmPCs
and PLs, together with summaries
of Referent Medicinal Products
(RMPs) for national products. The
EMA would coordinate safety
announcements in those cases
where the active substance was
authorised in more than one MS
and the MS had to agree on a
common announcement and
timing for publication. For urgent
matters, the Pharmacovigilance
Risk Assessment Committee
(PRAC) may hold public hearings,
where it considered that this was
justified, particularly with regard to
DIA ACE meeting on December 5,2011 in the
Faculty of Pharmacy, University of Istanbul, Turkey
the extent and seriousness of the
safety concern.
The second report, “The New
Pharmacovigilance Legislation In
EU Challenges And Expectations,”
was presented by Maria Popova.
Based on the EU legislative
frame, the Bulgarian Drug Agency
wanted to realise better protection
of public health by strengthening
and rationalising the EU
pharmacovigilance and establish
clear roles, responsibilities
and obligations. The reduction
of unnecessary burdens and
duplication of work, rationalisation
of EU decision making, proactive
and proportionate to risk
pharmacovigilance, integration of
benefits and risks, improvement of
transparency and communication
as well as patient involvement
in Adverse Drug Reactions
(ADRs) reporting were also listed
as expected outcomes of the
updated pharmacovigilance
legislation. Dr. Popova highlighted
the new provisions in the
ICRFs ,in the PSURs and in the
PASSs. The new Committee
- Pharmacovigilance Risk
Assessment Committee (PRAC)
was also a focal point where its
role in the Union decision making
process was being followed.
At the end some Bulgarian
specific challenges were
highlighted: the implementation
of the new EU legislation on
pharmacovigilance into the
Bulgarian Law on pharmaceutical
products in human medicine had
not yet started.
Electronic submission of all ADRs
and PSURs to the EMA would
probably be a problem for some
companies and patient reporting
needed continuing patient
education. There was a plan to set
up a National Safety Committee at
the Bulgarian Drug Agency.
Session 3. “Health
Technology in the EU
and in Bulgaria” with
Session Chair Tatyana Benisheva
The first report, “Benefit/Risk
Assessment and Reimbursement
in the EU,” was presented by Luca
De Nigro. He gave an outline of
the Basic Centralised Assessment
Process, the European Public
Assessment Report (EPAR),
benefit/risk and reimbursement
after the marketing authorisation
in Italy and the potential for
monitoring (and risk-sharing
contracts). Two examples were
discussed as follows:
1) T
he case history of antidiabetes with a 2-year period of
monitoring
2) The case history of lenalidomide
Luca De Nigro stressed that the
benefit/risk assessment would be
a continuous process once the
EPAR and marketing authorisation
became available. Member states
were free to define pricing and
reimbursement parameters for all
drugs approved by centralised
procedures. In Italy, for innovative
and high-priced drugs, special
contracts with companies
(Risk-Sharing Approach) were
established in order to match, as
much as possible, costs and new
opportunities of care.
focused and seek to achieve
best value. HTA may provide
an instrument for the Bulgarian
health care authorities to make
informed and evidence-based
reimbursement decisions.
Istanbul, 5 December
2011
Faculty
ACE Members and delegates enjoy networking in the historic surroundings of
Istanbul University.
National health service
reimbursement in Italy for
innovative drugs was based
on 2 main pillars: First,
tracing treatments by case
report forms in order to verify
appropriateness in prescription,
tolerability requirements for Risk
Management Plans (RMP) and
off-label use where needed (eg,
lenalidomide and thalidomide were
given as examples) Second, risksharing contracts with companies
in order to manage public
expenditure and sustainability,
relevant data for the pricing and
reimbursement policy of NHS and
new models of HTA reporting.
The potential role of the 2-year
monitoring approach in Italy was
aimed at evaluation of clinical
outcomes and the economic
effects of contracts (if risk sharing
were applied), plus HTA reporting.
Thanks to national monitoring of
both label and off-label use of
some medicinal products, it was
possible to establish the actual
exposure of Italian patients to the
drug and to prepare preliminary
safety decisions, even before the
conclusion of the EMA scheduled
referral procedure.
The second report, “Benefit/Risk
Assessment and Reimbursement
in Bulgaria,” was presented by
Deyan Denev. Health Technology
Assessment (HTA) was a
multi-disciplinary process that
summarised information about
the medical, social, economic
and ethical issues related to the
use of a health technology in a
systematic, transparent, unbiased
manner. Its aim was to inform the
formulation of safe, and effective
health policies that were patient
•Professor Ahmet Araman,
Faculty of Pharmacy, University
of Istanbul, Turkey
Member; now chair)
•Eda Cindohhlu, Consultant to
Ministry of Health, Turkey
•Aysegül Erkahraman, Market
Access Manager, AíFD,
Association of Research-based
Pharmaceutical Companies,
Turkey
Yves Juillet, DIA President and L. Razeva, Director of Marketing Authorisation,
Department of Medicinal Products at the Bulgarian Drug Agency
69
gf
of the university’s History of the
Science and Art Activities Centre.
•Sibel Gürer, Deputy Director
GMP Inspections, íEGM
During the workshop, the
delegates from the Turkish
Ministry and Inspectorate revealed
how hard they had worked
to implement the European
legislation as a whole into Turkish
legislation in 2005. They felt well
prepared to join the European
GMP inspection scheme. With
increased inspection forces and
a strict training programme for
GMP inspectors, the Turkish
GMP supervision system should
be seen as similar to the EU
inspection system. Unfortunately,
political obstructions had
prevented the recognition of
Turkish GMP inspections for
imports into the EU. Therefore,
Turkey had decided to apply its
own controls on EU imports into
Turkey.
ISSUE 2
•Angelika Joos, Head Regulatory
Policy, EU & Most of World,
Merck Sharp & Dohme (Europe)
Inc., Belgium
VOL 4
70
•Yves Juillet, current President,
DIA
•Sevgı Okten, IEIS, Regulatory &
Medical Director, Actavis, Turkey
•Melek B. Önol, RA & Quality
Assurance Manager, Boehringer
Ingelheim Ilaç Tic A.S., Turkey
With the principal workshop
question being, “Facilitating
Regulatory Approvals in Turkey
– Opportunities for Regional
Harmonisation?”, the ACE
reached the eastern border of
the European continent at the
banks of the Bosphorus and had
the opportunity to experience
the hospitality of the Faculty of
Pharmacy at the University of
Istanbul in Turkey.
Professor Ahmet Araman, Dean
of the Faculty of Pharmacy, not
only gave his full support to the
organisation of the workshop;
he also offered the ACE a
meeting room and a lunch in the
wonderfully renovated rooms
Everyone agreed that this resulted
in a duplication of effort and
ineffective use of resources.
Angelika Joos presented
programmes on how countries
and regions aimed to align their
inspection schemes to make
best use of their resources for
GMP inspections. The workshop
showed clearly that it was a
matter of will on both sides to find
a way that allowed the protection
of patient safety and timely access
to medicines.
Where to Go From Here?
With the workshop in Turkey, the
ACE had reached out to the last
remaining very important country
within the territory of DIA Europe
where we wanted to explore
the needs of our colleagues. In
addition, the ACE welcomed a
new member from Turkey.
After reaching this geographical
landmark, it is now time to
look back and to review these
workshops. Did they fulfill the
expectations of the ACE and of
the participants? The growing
number of participants at the free
workshops clearly illustrated the
huge interest in these topics.
The assessment of geographical
distributions at other DIA
programmes showed that that the
increase in attendance from the
regions visited was less than 5%
of total. The ACE wants to analyse
the outcome of the workshops
further and to develop strategies
to make DIA’s offers more
attractive and accessible in these
regions.
This article is dedicated to all speakers
and chairs of the free ACE workshops
and to the DIA Europe staff.
UPCOMING
EVENTS
EUROPE
EudraVigilance
training
Electronic Reporting of ICSRs
in the EEA
Apr 18-20
London United Kingdom
Building the eCTD: Practical
Approaches
to Compiling Electronic
Submissions Training Course
Mar 8-9
Barcelona Spain
Conference
24th Annual EuroMeeting and
Exhibition Mar 26-28
Copenhagen Denmark
Quality Risk Management
(QRM) Training Course
March 25
Copenhagen Denmark
6th European Forum for
Qualified Person for
Pharmacovigilance (QPPV)
Apr 24-26
Extended EudraVigilance
Medicinal Product Dictionary
(XEVMPD) – Data Entry tool
April 10
EudraVigilance Information Day
April 27
April 16
Training
EMA Excellence in
Pharmacovigilance: Clinical
Trials and Post-Marketing
Training Course
Feb 13-17
European Regulatory Affairs:
In-depth review of current
registration procedures in the
EU
Feb 16-17
Vienna Austria
Information Day on the New
Identification of Medicinal
Products (IDMP) International
Standards and ICH M5/M2
February 21
DIA Clinical Project
Management Part II Training
Course
Feb 22-24
Nice France
April 17
Training Course on Paediatric
Investigation Plans (PIP)
Apr 23-24
Amsterdam Netherlands
Training Course on Paediatric
Investigation Plans (PIP)
Apr 23-24
Amsterdam Netherlands
April 24
DIA CTD Dossier
Requirements: Focus on EU
Module 1 and
Quality Module 3 Training
Course
Apr 25-27
Prague Czech Republic
71
ISSUE 2
North America
VOL 4
72
FDA/DIA Statistics
Forum 2012
DIA and the US FDA team to
present our sixth collaborative
statistics conference, FDA/DIA
Statistics Forum 2012 (#12008) at
the Bethesda North Marriott Hotel
& Conference Center in Bethesda,
MD (US), April 22 through April 25.
Developed by the FDA and the
DIA Statistics Special Interest Area
Community (SIAC), this forum will
advance a unique, collaborative
industry/agency dialogue on
FDA guidance development and
regulatory science initiatives that
focus on statistical opportunities
and challenges in the design,
monitoring and analysis of clinical
trials, and assessing safety and
efficacy in the pre- and postmarket environments. It will begin
on April 22 with two tutorials
providing in-depth instruction on
“Multiplicity in Clinical Trials” and
“Data Monitoring Committees,”
then proceed through three days
of sessions and panel discussions,
plus a few new features offered for
the first time.
The forum steering committee
is co-chaired by Barry Schwab,
PhD (Vice President, Clinical
Biostatistics, Janssen Research &
Development LLC) and Stephen
E. Wilson, DrPH, CAPT USPHS
(Director, Division of Biometrics III,
Office of Biostatistics, CDER).
A longstanding contributor to
this annual program, Jerald S.
Schindler, DrPH (Vice President,
Biostatistics & Research Decision
Sciences, Merck Research
Laboratories) serves on the forum
steering committee and also
serves as North American cochair of the DIA SIAC. “I continue
to contribute to this workshop
because it’s a good opportunity
for people who are working to
design and analyze clinical trials
to interact with our peers in other
pharma companies and our
colleagues in the government,
including and especially the FDA,”
he explains.
“One of the key aspects of this
meeting is that two senior people
from regulatory agencies will be
our featured keynote speakers,”
Jerry continues. “Dr. Lisa
LaVange, who is the new Director
of the Office of Biostatistics at
CDER; and Robert Hemmings,
head of a similar group in Europe,
the Statistics Unit Manager for the
Medicines & Healthcare products
Regulatory Agency of the United
Kingdom. It shows the value that
they put on this meeting.”
Serving in industry, on the
program committee, and in SIAC
leadership, gives Jerry a unique
perspective on how forum topics
were identified and developed
to meet the needs of today’s
statisticians. “In my personal view,
the biggest change has been the
opportunity for real-time data
analysis, which opens the door
for adaptive clinical trials and
real-time monitoring of clinical
trial results, even blinded clinical
trial results, within the context
of a data monitoring committee
looking at some unblinded data.
I have been a strong advocate
for adaptive clinical trials: One
of the things that we have to do
as statisticians – as clinical trial
professionals in general – is to find
a way to do more efficient clinical
trials and get to our results more
rapidly,” he says.
“Over the past ten years, the
internet has enabled us to collect
data quickly in some of the new
computing environments, so we
can get data into a computing
platform and make sense of the
results quickly. We don’t have to
go through old-fashioned data
entry systems and mainframes.
Rapid computing that’s emerged
from a combination of the internet
along with changes in hardware
and software has enabled us to
get to our data more rapidly, even
while the trial is in progress rather
than when the trial is over,” he
continues. “That’s opened a huge
door that we haven’t fully walked
through yet. We now have huge
opportunities for interim analyses,
adaptive clinical trials, and
Bayesian methods in our trials,
and I think that’s been the biggest
change: Statisticians in general
are not waiting for the trial to end
to do the analysis, but they’re
beginning to use appropriate
methods to interpret the data
while the study is still in progress.”
How does the Statistics SIAC
help Jerry and other members
effectively implement and adapt to
this change? “The SIAC creates a
unique forum that brings people
together to quickly communicate
new ideas, so that everyone has
an opportunity to see what best
practices are emerging from
companies in big pharma and
from smaller biotech companies
that they can share with other
statisticians. The SIAC gives us
an opportunity to share what
we do in a non-competitive
way, without discussion of any
individual product but just looking
at statistical methodology and
how we get our jobs done,” he
explains. “There aren’t very many
places where we can share ideas
and communicate with each other.
Plus, in this world where people
are online 24 hours a day, it’s
nice to have an area where we
can communicate all the time.
We communicate things online
through our SIAC community in
DIA ConneX, we communicate
other things through meetings,
and the SIAC is this big forum
which connects all these people
and ideas.”
Jerry is also looking forward to
two new features making their
debut at our FDA/DIA Statistics
Forum 2012, the scientific poster
session presented as part of
the networking reception, and
luncheon roundtable discussions.
“One way to be involved is by
speaking in the formal agenda,
but another way is to participate
in the poster and roundtable
sessions. The posters and
roundtables get people out of
their chairs to have conversations
with our colleagues in industry
and in government,” he explains.
“People get together, walk around,
sit at different roundtables, and
have open conversations that
they wouldn’t have if they were
73
gf
ISSUE 2
sitting in the audience. These turn
people from passive attendees to
active participants. Even if they’re
not presenting a poster or leading
the roundtable, just the fact that
they’re attending these sessions
gives them the opportunity to
converse with the presenters and
other people.”
VOL 4
74
“Same thing with the roundtable
discussion: We want people
to talk to each other and not
just sit quietly and listen to
somebody else speak. This is a
way to get people into a more
interactive mode. We hope that
it will encourage people to have
conversations with speakers from
other parts of the more formal
presentation, and that it will be
a fun, valuable, and rewarding
activity for our participants. We
want this to be fun.”
Sarah
Powell
RIM Conference Runs
on Two Tracks
Today’s global industry
environment seems to constantly
present regulatory information
professionals with new
challenges surrounding global
regulatory strategies, patient
safety, and compliance. To
help these professionals meet
these and other challenges,
the DIA Regulatory Affairs (RA)
Special Interest Area Community
(SIAC) has helped develop and
will present our Regulatory
Information Management
(RIM) conference, April 24-25 in
Philadelphia, PA.
As a member of the conference
program committee and Chair of
the RA SIAC, Sarah Powell, RAC
(Executive Director, Regulatory
Affairs & Writing Services, Liquent),
shares a unique perspective
regulatory information, and on
this conference. “The global
regulatory environment is
continually evolving, whether it is
through new regulations, guidance
documents, or new electronic
standards, making it challenging
for organizations to monitor
and analyze the impact of these
changes for the areas in which
they operate,” she explains. “The
increased use of global product
strategies, with an emphasis on
emerging markets, has highlighted
the difficulty in fully understanding
the regulatory requirements
necessary for a successful
product registration, launch,
and maintenance phase. Many
organizations have started projects
to evaluate and implement global
systems to improve their product
understanding and improved
efficiency at managing their
supporting regulatory information.
This DIA RIM conference is the
first, of hopefully many, that will
provide valuable insights into both
the business and technological
aspects to lessen the burden of
this challenge.”
The conference will open with two
plenary presentations by Keynote
Speaker David Hovland, PhD
(Senior Director, Global Regulatory
Affairs, Allergan, Inc.), who will
address “Issues & Challenges in
Managing Regulatory Information”;
and by Steve Gens (Managing
Partner, Gens & Associates),
whose presentation will discuss
“RIM Benchmarks & Trends.”
Conference sessions will proceed
along two “Business” and
“Tools & Technology” tracks.
The Business Track will give
participants the chance to share
experiences related to processes
for obtaining and managing
regulatory information, and
their organizational impact,
in this business age of
merger and acquisition; the
Tools & Technology Track
will focus on submission
standards and electronic/
digital tools for managing
regulatory information. “Regulatory
Information Management can
only be successfully managed
using a combination of effective
standards, business processes
and technology,” says Sarah. “By
providing two tracks, one that
focuses on the business aspects
and another on the technology
aspects, the conference attendees
can attend the session’s most
relevant to their job function, thus
receiving the most benefit from
their attendance.”
Sarah will chair the closing
plenary session on “Emerging
Markets” and looks forward to
the RA SIAC’s continuous efforts
to refine and share RIM global
perspectives and best practices
throughout the international health
care community long after the
conclusion of this conference.
“The Regulatory Affairs SIAC has a
number of active working groups
that meet on a monthly basis to
share information, best practices,
and discuss challenges related to
their focus areas. These meetings
are published on the RA SIAC
ConneX site and I encourage DIA
members to join, and actively
participate, in these calls,” Sarah
explains. “This SIAC will continue
to sponsor webinars, workshops,
and conferences such as the RIM
conference, to help our members
and the broader community benefit
from the knowledge we share.”
75
PCORI:
Its History Shapes its Future
Jennifer
Swanson
is a freelance
medical writer
and editor
based in Fort
Collins, CO. She
can be reached
at jsmedicalwriter@gmail.com.
On February 23, 2012, the DIA
hosted a webinar entitled, “The
Patient-Centered Outcomes
Research Institute’s National
Priorities and Research Agenda,”
moderated by Nanci Celini, MD
with presentations given by Joe V.
Selby, MD, MPH, first Executive
Director of PCORI and Harlan
Weisman, MD, a member of
PCORI’s Board of Governors.
gf
ISSUE 2
The main focus of the webinar
was to provide an overview of
the Patient-Centered Outcomes
Research Institute (PCORI),
including the history leading up to
its development and the timeline for
moving the agenda forward over
the next year.
VOL 4
76
PCORI was developed to address
the unique needs of individual
patients and the clinicians who
care for them. Clinicians face
many barriers when trying to
select optimal treatments for their
patients. With limited access
to relevant clinical information,
limited time, and few incentives,
clinicians are challenged to apply
new clinical evidence in practice.
Even if they have the necessary
resources, clinicians are not always
able to critically appraise the
evidence and fully understand the
clinical applicability of the findings;
therefore, they face uncertainty
when trying to determine if the new
evidence applies to their particular
patients.
When evidence is available, it
is rarely generalizable because
current research is conducted in
highly-controlled settings that are
not representative of real world
situations. Clinical trials involve
selected patients with specific
case-definitions and few, if any,
comorbidities, and study drugs are
administered alone rather than in
combination with other commonly
used medications. In addition,
follow-up is often insufficient to
detect all important outcomes
and power is insufficient to detect
statistically significant differences
between treatment groups. Overall,
evidence derived from current
research practices provides limited
guidance to clinicians and fails
to address the unique needs of
individual patients.
Several groups have attempted
to address these challenges and
promote patient-centered research,
including a 1988 proposal for
a national database of clinical,
financial, and health outcomes; the
1990 Patient Outcomes Research
Teams (PORTS); and the Medicare
Modernization Act of 2003.
Unfortunately, these groups had
few resources, modest funding,
and limited visibility within the
greater healthcare community.
controlled clinical trials will still be
required to determine initial efficacy
and safety, observational studies
will also be included, as they play
an important complementary role
in identifying patient-related factors
that may affect outcomes.
Taking this a step further, Congress
developed PCORI through the
2010 Patient Protection and
Affordable Care Act to facilitate
Comparative Clinical Effectiveness
Research. Although PCORI was
developed by Congress, it is an
independent organization. In the fall
of 2011, the Board of Governors
When Comparative Effectiveness
was formed, which includes
Research (CER) was developed,
21 members who represent all
many clinicians were skeptical,
stakeholders, and subsequently,
as the initiative appeared to
PCORI’s mission statement was
resemble government rationing.
adopted: The Patient-Centered
Indeed, these concerns were
Outcomes Research Institute
ignited by a 2007 statement from
(PCORI) helps people make
the Congressional Budget Office
informed healthcare decisions—
indicating that “…better information and improves health care delivery
about the benefits, risks, and costs and outcomes—by producing and
of different treatment options,
promoting high integrity, evidencecombined with incentives reflecting based information that comes
this information, could eventually from research guided by patients,
alter the way in which medicine caregivers and the broader health
is practiced and yield lower
care community. The research
health care spending.” In
funded by PCORI will aim to
response to these concerns, the
answer patient-focused questions,
Federal Coordinating Council for
such as:
CER redefined its role in 2010,
minimizing the focus on costs
• Given my personal
and emphasizing the needs of the
characteristics, conditions and
healthcare community,
preferences, what should I
“…to inform patients, providers,
expect will happen to me?
and decision-makers, responding
• What are my options and what
to their expressed needs,
are the benefits and harms of
about which interventions are
those options?
most effective for which patients
under specific circumstances…”
• What can I do to improve
As such, CER aims to address
the outcomes that are most
practical clinical questions in realimportant to me?
world settings to identify effective
treatments for individual patients
with unique needs. Although highly-
• How can the health care system
improve my chances of achieving
the outcomes I prefer?
To achieve these goals, PCORI
will receive approximately
$150,000,000 in 2012, which will
increase to $500,000,000 in 2014
and each year thereafter until 2019.
However, before major funding can
begin, the National Priorities (Table
1) and Research Agenda (Table
2) must be approved. The target
approval date is April 2012.
Moving forward, PCORI will initiate
an open process for its research
agenda whereby contributions from
all stakeholders will be sought,
all relevant disease conditions
will be considered, and a variety
of research priorities will be
funded, including meta-analyses,
randomized controlled trials, and
observational studies that have the
greatest potential to identify gaps in
care and unmet needs of patients
and clinicians. In addition, advisory
committees will be convened
with all stakeholders to refine the
research agenda and identify key
strategic areas.
Indeed, industry stakeholders
are integral to the success of
PCORI, yet there has been great
concern that CER and patientcentered initiatives may minimize
the role of industry; however, Drs.
Selby and Weisman emphasized
that patient-centered research
will lead to great opportunities
for innovation, especially in
the area of individualized
medicine. As research begins
to identify differences among
treatment populations (eg, gene
expression in patients with
cancer) and factors associated
with treatment response, the
need for targeted and alternative
therapies will increase, providing
great opportunities for industry
involvement. To ensure industry
participation in the research
agenda, PCORI will engage
industry stakeholders in all steps of
the process.
Patient engagement is a necessary
component of the PCORI agenda;
therefore, a public comment period
is required before the priorities
and research agenda are finalized.
In addition, the National Patient
and Stakeholders Dialogue was
held at The National Press Club in
Washington, DC, on February 27,
2012. A portion of the agenda was
devoted to a patient and caregiver
advocate discussion panel, which
was moderated by Susan Dentzer,
Editor-in-Chief, Health Affairs, and
included members Marc M. Boutin,
Executive Vice President and Chief
Operating Officer, National Health
Council; Otis W. Brawley, MD, Chief
Medical Officer, American Cancer
Society; Adolph Falcon, Senior
Vice President, National Alliance for
Hispanic Health; Andrew Sperling,
Director of Legislative Advocacy,
National Alliance on Mental Illness;
and Stuart Spielman, Senior Policy
Advisor and Counsel, Autism
Speaks.
The panel discussed several issues
surrounding patient-centered
research, including challenges in
trying to engage patients in the
research process. A common
concern among the panel and
noted by Adolf Falcon was that
Table 1. Draft National Priorities
Priority
Assessing
outcomes of
prevention,
screening and
treatment options
Improving
Healthcare
Systems
Communication
& Dissemination
Fairness/
Attention to
Disparities
Accelerating
Patient-Centered
Research
Description
Comparing the effectiveness and safety of
alternative preventive, diagnostic, treatment,
surveillance and management options.
Comparing system-level approaches to
improving access, supporting patient selfcare, innovative use of health information
technology, coordinating care for complex
conditions, and deploying workforce
effectively.
Comparing approaches to providing CER
information and supporting shared decisionmaking between patients and their providers.
Identifying potential differences in treatment
effectiveness or preferred clinical outcomes
across patient populations and the health
care required to achieve best outcomes in
each population.
Improving the nation’s capacity to conduct
patient-centered outcomes research, buy
building data infrastructure, improving
analytic methods, training researchers,
patients and other stakeholders.
77
gf
ISSUE 2
current research “is conducted on
people instead of with people,”
which prevents important
interactions with patients that
could help to identify patientspecific needs. Therefore, moving
forward, research must include the
patient perspective and should be
targeted to address the issues that
are important to patients and the
clinicians who care for them.
VOL 4
78
The panel also emphasized
that getting patient “buy-in”
for the PCORI process may be
challenging, in part due to their
misconceptions about health care.
Patients often assume that the care
they are receiving is supported by
strong evidence, although that is
not always the case. For patients
to understand PCORI’s mission,
they first need to understand that
clinical evidence is imperfect and
data are not always generalizable
to their specific needs, which may
be difficult for many patients to
grasp. Moreover, because patients
may not understand clinical science
or the drug development process,
they may find it difficult to use
information about comparative
effectiveness and the risks and
benefits of specific treatments to
Table 2. Draft Research Agenda
Agenda Items
Assessment
of Prevention,
Screening and
Treatment Options
Improving
Healthcare
Systems
Communication
& Dissemination
Research
Addressing
Disparities
Accelerating
PCORI and
Methodological
Research
Research Aims
•Comparisons of alternative clinical options
•Identifying patient differences in response
to therapy
•Studies of patient preferences for various
outcomes
•Improved support of patient selfmanagement
•Coordination of care for complex conditions
•Improvements in the effectiveness and
efficacy of care
•Understanding and enhancing shared
decision-making
•Alternative strategies for dissemination of
evidence
•Alternative interventions/strategies to
eliminate disparities
•Improvements in alignment of decisions
with preferences
•Improving study designs and analytic
methods of PCOR
•Building and improving clinical data
networks
•Methods for training researchers, patients
to participate in PCOR
•Facilitating the study of rare diseases
make decisions about their care.
Added to these challenges is the
confusion among clinicians and
patients about what is believed
and what is truly supported by
evidence. Even when evidence
is available for particular
treatments, potential biases
among clinicians and patients may
influence the treatment choice.
For example, clinicians may feel
more comfortable prescribing
treatments that they have found
to be effective in their own clinic,
regardless of whether the larger
body of evidence supports those
decisions. Additionally, patients
may request treatments on the
basis of what they have seen in
advertisements or have heard
about from friends and family,
even if the treatment may not be
the best option for them. In cases
of rare or life-threatening illness,
great emotional conflict results
as clinicians try to determine
the best course of action with
few available options. Therefore,
critical healthcare decisions must
be made, even in the absence of
strong evidence. PCORI will need
to develop a process for educating
patients about this sensitive issue
and engaging them as important
stakeholders who have the
potential to improve the quality and
strength of clinical evidence.
Another common concern among
the panel was that current research
is conducted on patients who are
not representative of the American
population. Patient-centered
research should focus on issues
such as chronic illness; patients
with multiple comorbidities; diverse
populations, including differences
in gender, ethnicity, and genetics;
and environmental factors, culture,
and “real life” issues that may
affect healthcare delivery and
effectiveness. Indeed, as Adolf
Falcon noted “research needs to
look like the country we’re trying
to serve.” Other important areas
of study would be prevention
of conditions such as obesity,
diabetes, and heart disease;
adherence to treatment regimens;
and access to care. After research
has commenced, data should be
reported back to the community
to promote trust, belief, and
understanding.
Finally, the panel outlined issues
that will need to be considered
regarding patient engagement,
including timelines and
expectations, when and how to
engage the community, and the
use of public relations to promote
patient engagement. In addition,
the panel emphasized that patient
advocacy organizations must first
understand the issues faced by
their constituents to determine the
best strategies for engaging them
in this process.
Although PCORI’s work is well
underway, several issues still
need to be addressed before the
National Priorities and Research
Agenda can be finalized and
approved. PCORI has set a timeline
for rolling out the agenda over
the next year. Several advisory
panels will be appointed to
address specific issues of the
agenda, although the specific
charges of these panels are still
under consideration. The Board
of Governors will convene to
define the roles of the advisory
committees. One such committee,
the Methodology Committee, will
be charged with developing criteria
for the research process, including
guidelines for research conduct
and reporting. Other committees
may focus on areas such as clinical
trials, rare diseases, and electronic
medical records (ie, how electronic
data may be incorporated into
the research activities), among
others. Following approval of the
priorities and agenda, funding
announcements will be issued, and
funds will be awarded to research
activities that meet PCORI criteria
and have the greatest opportunity
to address the needs of patients
and clinicians. DIA will continue
to cover issues related to PCORI
as more information becomes
available.
For more information on PCORI,
please visit the Web site,
www.pcori.org
REFERENCES:
DIA webinar. The Patient-Centered
Outcomes Research Institute’s
National Priorities and Research
Agenda. February 23, 2012.
PCORI webcast. National Patient
and Stakeholders Dialogue.
February 27, 2012.
Patient-Centered Outcomes
Research Institute. Draft National
Priorities for Research and
Research Agenda. Version 1.
2012. http://www.pcori.org/assets/
PCORI-Draft-National-Prioritiesand-Research-Agenda.pdf.
Accessed March 8, 2012.
Timeline for National Priorities and Research Agenda
Date
January 23 –
March 15, 2012
February 8 – 16, 2012
February 27, 2012
March – April 2012
April 2012
May 2012
June 2012
December 2012
Spring 2012
June 2012
Summer 2012
October 2012
December 2012
February 2013
Task
Public comment period
Clinician Focus Groups on the draft
priorities and agenda
National Patient and Stakeholder
Dialogue
Analysis of public comment received
Adoption of first National Priorities
and Research Agenda
Broad funding announcements
issued
Broad funding applications due
Broad funding awards announced
Issue conference grants to advance
agenda specificity
Brainstorming workshop to advance
agenda specificity
Advisory Groups formed to advance
agenda specificity
Targeted funding announcements
issued
Targeted funding applications due
Targeted funding awards announced
79
ISSUE 2
gf
Craig
Lipset
VOL 4
80
Paul
Pomerantz
Innovation: Engine Driving
DIA 2012
In the midst of preparations
for DIA 2012: Collaborate
to Innovate, Annual Meeting
Program Chair Craig Lipset (Head
of Clinical Innovation, Worldwide
Research & Development, Pfizer,
Inc.) and Paul Pomerantz, DIA
Worldwide Executive Director,
took a few moments to share their
thoughts on “innovation” and how
it provides the impetus to much of
this year’s program.
But first: What does “innovation”
mean? “I define innovation as
‘turning an idea into value.’ There
are lots of ideas out there. Ideas
are easy to get. We have more
than one hundred thousand
employees where I work, and
if I opened up a suggestion
box on the internet, it would be
flooded with ideas in absolutely
no time,” Craig suggests. “The
challenge is, how do you convert
those ideas into value? If you’re
an entrepreneur coming up
with Angry Birds for iPhones,
for example, it’s pretty easy to
measure value: You calculate how
many ninety-nine cent downloads
you moved, multiply ninetynine cents times the number
of downloads, and there’s one
measure of your value. But for
us, a lot of different definitions
of value exist for different parts
of our enterprise. When we’re
conducting clinical trials, value
might mean speed, for example,
or improved quality or reduced
cost. Regardless, no matter how
you define value, you need to
define it and apply that definition
of value to that idea. If an idea
doesn’t derive value, then it is not
truly innovative. It may be a clever
idea, but it’s not much more than
that.”
Along with dedicating an entire
track to “Innovative Partnering
Models & Outsourcing Strategies,”
DIA 2012 will expand upon
innovative educational topics
and learning formats that were
introduced at last year’s Annual
Meeting in Chicago. “DIA’s Annual
Meeting is an important global
forum for the range of partners
involved in bringing new therapies
to market. Historically, this has
certainly been focused on the
drug development segment, but
today those partners include a
very diverse range of companies
from diagnostics to medical
devices, biologics, and so on,”
Craig explains. “Certainly, the
diagnostic segment, for example,
is a very important ally in enabling
the future of personalized
medicine, a future that many in
the healthcare sector are looking
eagerly to us, as pharmaceutical
and biotech companies, to help
enable.”
“We’re looking forward to sharing
a number of new tracks and
topics at DIA 2012. Rare and
neglected diseases are an area
of focus that our membership
has demonstrated, through the
abstract submissions that we’ve
received, is an area of importance
to them,” he continues. “We’re
also going to continue to build
our collaboration with the Gates
Foundation and with other
organizations to make sure that
we offer fresh content that speaks
to these important new topics.”
“We’ll be continuing to build
out around health information
technology: The Interoperability
Showcase℠ introduced last year
will continue to grow in new
directions as we make sure
that collaboration with health
information technology and data
are reflected in the content. We’re
also looking forward to continue to
build on the success of the Patient
Advocate Fellowship Program
from 2011. I had the pleasure
of participating in many of their
breakout sessions in 2011, and
that group of Patient Fellows was
very engaged. It’s a great voice to
continue to capture at the Annual
Meeting going forward,” Craig
concludes.
“We try to provide a diverse array
of educational opportunities, and
focus on interactive and quality
learning,” Paul explains. “Eighteen
different topic tracks at the Annual
Meeting represent all the different
disciplines of biopharmaceutical
development. We also offer a
variety of different instructional
formats, everything from symposia
to workshops to panels and
other sessions that are intended
to provide an array of learning
opportunities.”
Craig also sees the need to
continually innovate DIA’s annual
meeting as a reflection of the
healthcare community’s broad
need to innovatively respond
to constant changes in our
scientific, industry, regulatory,
economic, social, and legislative
landscapes. “Innovation requires
a certain culture that enables
people to take risks, to try new
things and to appreciate that it’s
okay to deviate from the status
quo. For many years, we were
comfortable as an industry and
there was not much of a reason
to do things differently. Revenues
were coming in from products
that had plenty of patent life left,
so there really wasn’t a great
sense of urgency to do things
differently,” Craig suggests.
“Fast forward to today: This is
a very different environment. It
seems that every week, there’s
another press release about
another large pharmaceutical
company doing another round
of staffing cuts or organizational
changes,” he continues. “For
those of us who work in this
culture and see these changes
again and again, there is no
safety net of doing things the
way that we always have. There
is a sense of urgency and of the
need for doing things differently.
Fast forward across academic,
government, and other
organizations, and I don’t think
they’re very different. Everybody
wants to try to do things
differently. We need cultures that
allow us and almost encourage
us to take calculated risks.”
DIA will present DIA 2012:
Collaborate to Innovate, our
48th Annual Meeting, at the
Pennsylvania Convention Center
in Philadelphia, PA, June 24-28.
81
ISSUE 2
gf
Julia
Nable
VOL 4
82
Q
A
&
Social Media 2.0: The Power
of Online Rare Disease
Communities to Connect &
Engage ePatients
Session Chair: Julia Nable
Speakers: Brian Loew (Inspire); Mary Dunkle (NORD, The
National Organization for Rare
Disorders); Erin Grinstead (Synageva Biopharma Corporation)
DIA 2012 Social Media
& Rare Disease Patient
Communities
The internet and
social media tools
have brought together
online communities
for almost every topic
and purpose, and
the global healthcare
community is no exception. On
Wednesday June 27, the DIA 2012
Annual Meeting Rare/Neglected
Diseases track will present the
forum Social Media 2.0: The
Power of Online Rare Disease
Communities to Connect &
Engage ePatients, chaired by Julia
Nable (Director of Marketing Strategy,
SandorMax).
Julia looks forward to how this
forum aligns within the overall
Annual Meeting theme, “Collaborate
to Innovate.” “These patient
community sites truly collaborate
and innovate, so it seemed like the
perfect fit. Social media is providing
unprecedented access to diseasespecific education and support for
ePatients, and recent advances
in online patient communities
incorporate innovative technical
capabilities with the goal of fostering
connections between rare disease
patients on a global level. It really is
an example of innovation being put
to good use: To improve the lives of
individuals living with rare diseases,”
she explains.
“It also gives us the opportunity
to look at how social media
innovations and different platforms
that support rare disease patients
are a collaborative effort. Our panel
will include diverse perspectives
and partners in collaboration from
the patient organization side, a
pharmaceutical industry executive,
and service providers, who will
talk about how collaboration is
vital in creating successful online
patient communities. A perfect
example is NORD, the National
Organization for Rare Disorders, who
has partnered with their European
counterpart EURORDIS, as well as
patient organizations and medical
experts. We will have someone from
NORD on our panel to discuss their
collaboration.”
Who are the ePatients this forum
will discuss? “Anyone who has
gone online to research healthcare
information or exchange experiences
with other patients is technically
an ePatient. According to recent
studies, 80% of internet users look
for medical information online. 50%
of people who are affected by rare
diseases are children, so ePatients
are often the caregiver for a young
child or family member. It’s a patientcentered approach that empowers
individuals to get the information
they need to participate in their own
healthcare decisions,” Julia explains.
“Online patient communities add
another level to this empowerment
and engagement because they offer
trusted communities where patients
can share how they cope with a
specific disease and share firsthand information about treatments,
physicians and hospitals. People in
small towns and villages all over the
world suddenly have access through
the internet to information about
treatment and coping with their
medical condition.”
This forum will discuss how social
media can serve the unique
challenges faced by the global
rare disease patient community.
“Individual rare diseases affect such
an incredibly small percentage
of the population, so patient
websites that focus on a specific
condition bring together people
who would never find each other by
traditional means,” Julia explains.
“For example, we worked with a
patient organization for a very rare
LAL deficiency disorder. The early
onset form of this disease, called
Wolman Disease, affects only one
to two babies out of one million.
The disease is rapidly fatal before
the first year, so an online resource
for knowledge, advocacy and care
is invaluable to these families. The
founder of the organization lost her
own baby to Wolman Disease, and
started the organization with the
goal that no other family would feel
that void of information and support
she experienced. So we worked
with her to create the LAL Solace
patient community website and
literally, within days of its launch, it
was found through search engines
and added members from different
countries. This is a clear example
that encapsulates the power of
online patient communities.”
“NORD and EURORDIS are taking
this to another level,” she continues.
“Their website RareConnect.org is
a patient community platform that
offers on-demand translation to
overcome the language barrier that
is inevitable when you bring together
people from different countries. It’s
amazing how gaps are being bridged
in the rare disease community.”
Patient confidentiality and data
privacy are absolutely essential
to maintaining trust in these
communities. “Patient privacy
is critical in two aspects,” Julia
suggests. “There’s the privacy of
the information that’s displayed on
the website; For example, forum
posts that display their names and
location – the patient must have
the ability to control display of that
information. The other critical issue
is how that information is used.
There must be transparency if this
information is going to be used in any
other way. ePatients in general don’t
have a problem posting very private
information that, in traditional medical
practices, would have been kept
private by HIPAA and other privacy
rules.”
“But it does fall upon the provider
of the service to ensure that privacy
preferences are controlled by the
patients, and how their information
is going to be used must be
carefully stated and controlled,”
Julia concludes. “When someone
is in a vulnerable position because
they’re coping with a rare disease,
it’s inappropriate for them to be
bombarded by unwanted email and
for their contact information to be
shared in any way. When someone
is in dire need like this, they’re often
willing to share their experience
openly with others. At the same time,
it’s critical that this information is
respected and kept carefully guarded
because trust is the foundation that
these websites are built upon.”
83
ISSUE 2
gf
VOL 4
84
Content Partners Collaborate
on DIA 2012
“Collaborate to Innovate” the
theme for our upcoming DIA
2012 48th Annual Meeting, also
describes how the Annual Meeting
program committee has received
commitments from a variety of
organizations and associations to
collaboratively develop, co-host,
and present several new, innovative
sessions and meetings throughout
the DIA 2012 program.
“We have a lot of different
content partners contributing to
DIA 2012. The diversity of these
partners reflects the types of
diverse collaborations that are
needed within industry, whether
from professionals working
within regulatory systems, from
the biopharmaceutical industry,
from patient organizations or,
importantly, from the community of
service and technology providers
and partners who are enabling
all this work. There’s been such
tremendous evolution in the
types of collaborations that exist
today,” explains Annual Meeting
Program Chair Craig Lipset (Head
of Clinical Innovation, Worldwide
Research & Development, Pfizer,
Inc.) “Once upon a time, those
technology providers were
really just vendors trying to sell
a service; today, they’re a vital
and essential part in how this
work gets done. We use new
jargon, it seems, every few years
– ‘functional service providers’
or ‘alliance partners’ – but they
are providing an essential, core
part of how we do our business,
and are now true partners at the
table. In that regard, the diversity
of content partners participating
in DIA 2012 really reflects the
diversity of collaborators that are
needed to bring innovations to the
marketplace.”
While still being developed at press
time, the list of planned DIA 2012
collaborative/co-hosted offerings
includes:
Sunday June 24: Trusted
Identities for Cloud
Collaboration: A One-Day
Conference on How Standards
Accelerate Collaboration in the
Cloud, co-hosted by DIA and
SAFE-BioPharma®
Sunday June 24: Win-Win
Strategies for the SponsorInvestigator Relationship,
developed by the Academy of
Physicians in Clinical Research
(APCR)
Monday June 25: Challenges
& Opportunities for Drug
Development in China, hosted by
the Sino-American Pharmaceuticals
Professional Association (SAPA)
Tuesday June 26: Executive
Program: Pioneering
Partnerships: Session 1:
Collaborative Research
with Members of the Payer
Community; Session 2:
Challenges of Precision
Medicine: Diagnostics,
Reimbursement, Partnership
Co-Development: Co-hosted by
DIA with Tufts Center for the Study
of Drug Development
Wednesday June 27: Benefit
Versus the Risk of Harm: How
to Interpret the Meaning of a
Therapeutic Response, hosted by
Outcome Measures in Rheumatoid
Arthritis Clinical Trials (OMERACT)
doing the entire process end to end,
from research and development
through commercialization, no
longer exists. Even the largest
companies are actively partnering
across that continuum with a variety
of stakeholders from nonprofits
to the venture capital community,
patient organizations, other biotech
and pharma companies, and the
list goes on. These novel, creative
collaborations are helping to ‘derisk’ programs, helping to fund
programs, answering key research
questions, and are the true engine
that will continue to deliver new
medicines for unmet medical
needs.”
Wednesday June 27: Partnering
for Impact in Global Health, an
overview of the Bill & Melinda Gates
Foundation’s “Decade of Vaccines”
effort
85
Wednesday June 27: Active
Surveillance Using Large,
Electronic Health Care
Data Networks, hosted by
the International Society for
Pharmacoepidemiology (ISPE)
Wednesday June 27: Oncology
Medications: State-of-the-Art
Identification & Management
of Potential CV Safety Issues
During Development, hosted
by the Cardiac Safety Research
Consortium (CSRC)
Craig and the DIA 2012 Program
Committee are confident that these
collaborative learning opportunities
will help Annual Meeting attendees
determine how to bridge the gap
between scientific innovation and
product delivery. “DIA 2012 is
about bridging that gap by featuring
and demonstrating the types
of collaborations needed today
across the entire continuum of
drug discovery and development,”
Craig explains. “In today’s world, an
integrated pharmaceutical company
DIA 2012 Spotlight on Social
Media & Patient Recruitment
The emergence of social media
seems to present a potentially
valuable set of tools for identifying
and recruiting clinical trial
patients. At the same time,
the technology landscape for
digital social networking seems
to constantly evolve, as do the
online expectations of patient
populations whose understanding
and use of social media grows
more sophisticated daily. In such
a changing environment, how can
professionals determine the best
way to use these tools for patient
recruitment?
On Monday June 25, the DIA 2012
Annual Meeting Clinical Operations
gf
ISSUE 2
track will present a special
symposium on Social Media: The
Promise and Pitfalls for Patient
Recruitment to help answer
this question. Jane E. Myles, MS
(Global Head, Patient Recruitment,
Roche) will serve as symposium
chair.
VOL 4
86
But what does “social media”
mean? “This is the first question
I ask many clinical teams I work
with because there is no generally
accepted definition. It’s pretty
common for clinical teams to think
about using a Facebook ad, for
example. This is not leveraging
the power of social media; it’s
simply, in that context, a different
medium for advertising,” Jane
explains. “We’re learning what it
means in the clinical trial space.
Social media is meant to be a
truly interactive space that’s much
more like an ecosystem than one
single platform. True social media
is a way to engage and share
information with patients or other
people in the clinical trial domain.”
“We’re still learning how to use
social media for clinical trial
recruitment. Maybe that’s not
the most important use for social
media, quite frankly; maybe the
connection between the clinical
research process and patients’
needs is more important than
the initial patient recruitment
outcomes,” she continues. “Maybe
our first entry point needs to be
engaging with patients around
what they need, as opposed to
trying to fill our own objectives. If
we start from that point of view,
perhaps we can shift things so
that it’s a true collaboration.”
Jane also quickly points out how
this symposium reinforces the
Annual Meeting’s “Collaborate to
Innovate” theme. “I was excited
when I saw this theme because
social media is the way that we
can collaborate differently with
patients. My aspiration is that we
as an industry somehow find the
means to engage patients in a
radically different way, so that we
are serving their healthcare needs
– not just thinking about them as
clinical trial patients or as users of
our drugs but shift things so that
patients see the pharmaceutical
industry as a trusted partner for
information about their treatment
options, and engage them in
finding new ones. Then we would
be collaborating to innovate.
I’m thrilled to see that several
companies seem truly interested
in moving out of the ‘clinical trial’
space or the ‘pharma’ space into
a ‘healthcare community’ space.”
Jane believes that patient and
patient group websites will play
critical roles in these emerging
online healthcare communities.
“PatientsLikeMe.com and Inspire.
com are patient-fueled, patientoriented websites where a
tremendous amount of data is
voluntarily shared. People want
to share information in that space
because they believe that they’re
communities built on trust and
openness, and that they get
something back by sharing it,”
she suggests. “There are definitely
groups of people who don’t want
to share information. But there are
a tremendous number of patients
who are surfing and registering on
websites, and a lot of patients who
are actively participating in online
places like PatientsLikeMe.com
who want to drive change around
their treatment.”
This symposium will not just
discuss but will also employ social
media. “We hope to use some
interactive social media in our
session, and we invite people
to come and explore that with
us,” Jane explains. “We’d like
this to be a place where we’re
learning together as opposed to
a didactic set of presentations, so
we encourage people who have
experimented in this space to
share their ‘light bulb moments’
in trying to shift this into a
collaborative space
for innovation.”
Social Media: The Promise
& Pitfalls for Patient Recruitment
Session Chair: Jane E.
Myles, MS
Speakers: Richard
Mayewski, Merck & Co.,
Inc.; Rodney William Butt
(MBA, MSc, MT); Elizabeth A.
Moench
Get the information you need
to successfully do your job
at these upcoming Project
Management training offerings:
*Essentials of Project
Management (#12422)
April 16-18, 2012
Horsham, PA
Project Risk Management
(#12425)
April 19-20, 2012
Horsham, PA
Enterprise Resource
Management (#12468)
Six-part online training series
April 23, 25, 27, 30,
May 2, 4, 2012
Fundamentals of Project
Management for Nonproject
Managers (#12404)
June 24, 2012
Philadelphia, PA
*Executing and Controlling
Biopharmaceutical Projects
(#12467)
Six-part online training series
July 10, 12, 17, 19, 24, 26, 2012
Introduction to Portfolio
Management and Performance
Metrics (#12471)
Five-part online training series
August 2, 7, 9, 14, 16, 2012
New Drug Product
Development and Lifecycle
Management (#12423)
Horsham, PA
August 6-7, 2012
Clinical Project Management
(#12421)
Horsham, PA
August 8-10, 2012
*Purchase Essentials of Project
Management (#12422) training
course and Executing and
Controlling Biopharmaceutical
Projects (#12467) online training
course in one transaction and
save $200.
For more information about these
courses or to register, please
visit the DIA website at www.
diahome.org, select Training, Find
an Educational Offering, and enter
the five-digit number as the key
word.
UPCOMING
EVENTS
NORTH AMERICA
Conferences
DIA/FDA Oligonucleotidebased Therapeutics 2012:
Leveraging
Regulatory and Industry
Knowledge for Future
Advancements
Apr 16-18
Washington DC
Regulatory Information
Management
Apr 24-25
Philadelphia PA
Cardiovascular Safety
and State-of-the-art
Development
Issues: Type 2 Diabetes
Mellitus Medications, QT,
Benefit/Risk Assessment,
Arrhythmias, Thrombosis,
and
Cardiotoxicity
Apr 17-18
Washington DC
Using Pharmacokinetic and
Pharmacodynamic
Principles to Enable IND and
NDA Submissions
Apr 16-17
Bethesda MD
6th Annual FDA/DIA
Statistics Forum
Apr 23-25
North Bethesda MD
Clinical Data Quality Summit
Apr 24-25
Philadelphia PA
Training
IND Phase
Apr 11-13
Horsham PA
Project Risk Management
Apr 19-20
Horsham PA
Introduction to Signal
Detection and Data Mining
April 23
North Bethesda MD
87
gf
ISSUE 2
Latin America
VOL 4
88
Q
A
&
Dr. Diana Valencia
pACLA Member
Colombia
Q: What inspired
you to become a
pACLA voluntary
board member ?
A: As a research
professional, I
have experienced
the benefits of
the continued
educational
programs provided
by DIA around
the world. I realized there is an
opportunity to expand those
benefits to other professionals in
emergent regions by bringing DIA
to Latin America and by avoiding
geographical distance, travel
and expenses costs. It would
be beneficial for the research
community in Latin America to
have a DIA presence in countries
other than those considered as
the main countries developing
clinical trials (Brazil, Argentina
or Mexico). On the other hand,
expanding DIA’s presence in
emergent regions within Latin
America will provide greater
visibility to those countries in the
global market. Those are the main
reasons that motivated me to
become a pACLA member.
Q: What aspects of your
new role are you particularly
looking forward to?
A: I am determined to support the
research community in the Latin
American region. I am focusing on
areas such as education, research
networks and global visibility,
so that we bring about new
opportunities in the global market.
Q: What is one goal you have
set for yourself as a member
of pACLA to advance the
mission in this area?
A: It would be my honor to bring
Colombia to the international
forefront by showcasing an
analysis of new and unexplored
opportunities in Latin America-show the advantages and
potential in a country that has
been stigmatized for decadeslong violent conflicts involving
outlawed armed groups. DIA
presence would certainly help in
presenting Colombia in a positive
way to the world. As a member of
the Andean Regional Community,
Colombia is the country
offering the greatest research
opportunities because many of
the people living in this region are
considered “treatment naïve” and
“trial naïve”
•Heart disease, arthritis,
cancer, and infections are
as prevalent as in the United
States
•Many of the seasonal disease
states occur 6 months out of
phase with North America,
which permits year-round
recruiting in trials of seasonal
ailments by combining Latin
American with North American
subjects
to make progress in improving
the security of the country, which
is an essential building block for
stability and democracy.
Q: What are the most pressing
issues to be addressed in
Colombia?
Q: In your view, what should
be the priorities for DIA to
address in the Latin American
region?
A: I would say the most
pressing issue to consider
is how the government and
private institutions work on
standardizing regulations and
procedures in order to offer
high-quality research to the
international community. This is
supported by legislations, such
as 2378 resolution launched by
INVIMA and MoH on June 27,
2008, which establishes the
new standards for accredited
institutions for clinical research.
Q: How do you see the
industry evolving in Colombia
in the next 5 years?
A: Industrial activity observed
this year, along with production
and sales rates, have Colombian
business executives thinking
that the positive trend will
continue into the following years.
The results from the National
Association of Businesses
(Andi) said that, despite
difficult circumstances faced
by developed economies, the
outlook is positive for Colombia;
they are predicting a growth of
9.5% in sales, 10% in exports
and a real economic growth rate
of 6.7%.
Despite the fact that 45.5%
of Colombians live below the
poverty level--and the country
continues to face large income
disparities and inadequate social
services — Colombia continues
A: Initiating collaborations with
scientific societies, academia and
the industry will be a good step to
promote the DIA benefits around
the research community. Then,
evaluate Colombian cities that
may offer a good location for the
Latin American Conference. The
presence and benefits of DIA in
Colombia may extend the benefits
to the closest countries, such
as Peru, Ecuador, Venezuela,
Panama and the Caribbean.
Q: What are the unique
challenges faced by the
Latin American market that
differentiate it from the other
global regions?
A: The FDA positively views the
inclusion of Hispanics in clinical
trials since they are the largest
minority in the US at 12% of the
population; but, they are often
under-represented in clinical trials,
with only 3% participation (David
Lepay, Head of the GCP Office
of the FDA, at the DIA 1st Latin
American Congress of Clinical
Research, March 1st, 2002). This
means a huge opportunity to
grow rapidly exists.
Q: What is the current role of
the Industry in Latin America
and how do you see it
positioning itself in the global
market?
A: The past few years have
89
ISSUE 2
gf
seen a challenge for the Clinical
Research sector to adjust its
business models to meet the
changing needs of pharmaceutical
and biotech companies. Industry
would position itself by embracing
the 4 major trends – globalization,
an increased use of preferred
provider relationships, greater
willingness to invest in new
technology and versatility to adapt
to change. Latin America has
the challenge to become a major
player in the global market given
its willingness to adopt the major
market trends.
Q: What advice would you
give to other industry leaders
looking into applying for a DIA
pACLA position in the future?
A: As with any other activity you
undertake, you should make the
commitment with passion and
conviction. This is the way to hit
the goal in any activity you may
decide to start. Focus on the most
cherished value:
THE PEOPLE.
VOL 4
90
Q
A
&
Dr. Daniel Mazzolenis
pacla Member
Argentina
Q: What inspired
you to become a
pACLA voluntary
board member
position?
A: I strongly believe
that this is a very
special moment
for our region since DIA is truly
expanding its presence in Latin
America. I believe it is my duty—
as a pharmaceutical industry
professional—to partake and
contribute so that this opportunity
before us yields tangible results
and is taken advantage of by the
generations to come.
Q: What aspects of your
new role are you particularly
looking forward to?
A: The opportunity to attract
and incorporate new, diverse
generations that are actually
connected and involved with
DIA—ensure that these new
generations’ networks participate
in the DIA neutral forums
Q: What is one goal you have
set for yourself as a member of
pACLA to advance the mission
in this area?
A: I think continuity and
institutionalization are critical
components of the work we
are doing- that is to make sure
we are building upon what we
have already created instead of
starting from scratch over and
over. A second goal would be
making sure the DIA presence is
expanded beyond the three top
tier countries.
Q: What would be the
most pressing issues to be
addressed in Argentina?
A: I would like to focus n the
issues that DIA can help us
solve: Advanced Education and
the Creation of Neutral, unbiased
forums. The former is an aspect
that is still difficult to find in our
countries, so DIA can certainly
fulfill that much demanded
educational vacuum. The latter
is definitely a very valued aspect
of DIA—which allows us, the
stakeholders, to meet on equal
footing environments. This is
definitely a unique characteristic
of DIA and just the fact that these
forums exist helps the regional
industry a great deal. Q: How do you see the industry
evolving in Argentina in the
next 5 years?
A: In Argentina, We—as an
industry—have evolved rapidly to
adapt ourselves to the technical
and regulatory changes taking
place in the last few years. However, there is a series of very
complex technical issues that still
have to be addressed—such
as Biosimilar products, directed
therapies, outcast elements,
etc—that must be approached
and solved in order to increase stakeholders efficiency. Both
Companies and regulators have
been working on these issues
(including the international
trade aspects of the same);
nonetheless, the complexity
degree presented along with
a lack of pecuniary resources
(compared to the old times) lead
us to realize we have to make
sure there is a maximization of
resources and an optimization of
results in every industry aspect. Q: In your view, what should
be the priorities for DIA to
address in the Latin American
region?
A: As I mentioned before, I think
that both Education and providing
neutral forums in our countries
will make a big difference. I
suggest DIA should focus on
issues such as the latter that are
not being covered at all in our region, because just the existence
of these forums bring about
opportunities for us interact freely
among us.
Q: What are the unique
challenges faced by the
Latin American market that
differentiate it from the other
global regions?
A: I believe that Latin America is
very diverse in regards to technical
and regulations. Despite the fact
that we have a common language,
and similarities in history and
background. There are certain
nuances that can create a
completely different situation
depending on the topic and the
circumstances, so I believe we
have the challenge to make sure
that we approach both similarities
and differences correctly.
Q: What is the current role of
the Industry in Latin America
and how do you see it
positioning itself in the global
market?
A: I think that our
commonalties and our capacity
understand each other allow us
to work together very well. In
practical terms working as a
group is an asset as a region.
Although we are multi-national
region our work structures across
country flow better than other
regions that might be more
homogeneous like North America. Q: What would you advise to
other industry leaders looking
into applying for a DIA pACLA
position in the future?
A: I would actually encourage
prospects to approach DIA.
This is truly a unique time for
professionals to become part of
this DIA effort that I am certain will
grow rapidly. So joining the pACLA
will provide prospects with an
opportunity to greatly contribute
and make an impact in both their
countries and the whole region.
91
gf
ISSUE 2
india
VOL 4
92
Dr. S. M.
Sapatnekar
Comprehensive Program on
Effective Project Management
January 31, 2012 Mumbai, India
DIA’s India Region kick started the
year 2012 with a workshop on
“Effective Project Management”
held in Mumbai on January 31,
2012. The speakers included
Program Chair, Deven Parmar,
Sapna Parekh, Shreekant
Sapatnekar, Rushikesh Borania,
Sorabh Kapoor, and Nidhi Saxena.
DIA India’s Director Mr Kaushik
Desai started the program with
the information on the activities
of DIA India as well as DIA Global
events. Deven Parmar opened the
session on project management
and gave an overview of the
topic that was comprehensive
and interesting. Success/
Failure of Projects, Constraints &
Uncertainties, Key Performance
Indicators, Planning, and Risk
Management were discussed with
examples and analogies given
for each topic. The difference
between strategic and tactical
outsourcing was discussed.
Metrics in project management
progress were overviewed and
their role was explained. Earned
Value Analysis was also discussed
with appropriate graphics.
Human factors like motivation,
communications and planning
were touched upon as they
pertain to successful project
management.
Sapna Parekh offered insight
in Optimizing Clinical Trial
Management and provided
a Sponsor-CRO partnership
planning and management
approach. She first touched upon
the metrics, then the management
process and, lastly, the fusion of
the two to enhance the accuracy
of sponsor-CRO partnership
planning processes. Advantages
in terms of Sponsor-CRO
relationship and opportunities of
early intervention to correct the
course of a slipping project were
succinctly discussed.
Shreekant Sapatnekar initially
explained the paradigm shifts
and the special circumstances of
Project Management in Clinical
Research. He shared his thoughts
and experiences on human
resource procurement, motivation
and retention - on which projects
heavily depend. He then went
on to elaborate on Creativity in
Project Management. With help
of case studies, he explained
how problem solving can be done
with a little out-of-box thinking.
He inferred that the creativity is
need based; needs are identified
by design and review of metrics
and collective brainstorming to
come to practical innovations. He
also sold the concept of “Impact
Diamond”, logic on lines of
“Quadruple constraints”.
Rushikesh Borania brought to life
the topics of Critical Path Analysis
and Developing a Skill Matrix to
Maximize a Project Portfolio. His
emphasis was elaborating on
the relationship between project,
program and portfolio. He then
addressed the key components of
portfolio management.
Sorabh Kapoor complemented
the above talk with a session
on Project Scheduling & Risk
Management. The conventional
topics of project management
(Life Cycle, Critical path, Planning
& Control, Leadership and Risk
Management) became meaningful
with his elaboration and examples.
Nidhi Saxena provided inputs on
Quality in Project Management at
conclusion. Speed breakers and
stonewalls to quality and intrinsic
conflict between operations
and quality were explained. Key
quality tools and techniques were
overviewed. Development of
Ethos for Quality and Objectivity
in measurement was brought
out with suitable examples.
The audience was provided live
examples with the kQua system.
The event was well attended and
the participants interacted well
with the speakers.
93
Left to Right the order is:
1. Dr Deven Parmar,Vice President, Gobal Clinical Research,Wochardt Limited
2. Dr S M Sapatnekar, Medical Director ,Karmic Lifesciences
3.Sapna Parekh,Senior Manager, Outsourcing and Program Management,Piramal Lifesciences Limited
4. Rushikesh Bhorania,Clinical Project Manager,Quintiles
5. Saurabh Kapoor-Associate,Clinical Project Manager,Therapeutic Delivery Unit, Quintiles India
6. Mr Kaushik Desai- Director-DIA India
ISSUE 2
gf
VOL 4
94
Dr.
Nandkumar
Chodankar
CMC: Converting Science
into Regulatory Submission
February 10- 11, 2012, Ahmedabad, Gujarat
The conference started with Manoj
Trivedi’s presentation on the
highlights of the Pharmaceutical
Industry in Gujarat state and the
contribution made in the progress
of the country. This was followed
by introduction to DIA, highlighting
its neutrality and salient features
by DIA India Director, Kaushik
Desai. The program co-chair,
Hemant Koshia (Commissioner of
FDCA, Gujarat State), introduced
the key note speaker, Pankaj
Patel, Chairman and MD of Zydus
Cadila. The other Program chair,
Dr. Nandkumar Chodankar,
welcomed and thanked the
Key note speaker Pankaj Patel,
Dr. Koshia and invited guests,
speakers and the delegates, DIA
Staff, and volunteers for the time
and effort that they have put into
organizing the conference.
Pankaj Patel in his key
note address stressed the
importance of the training that
DIA can give to pharmaceutical
industry professionals. He
also suggested that the Indian
regulatory system needs to
attain the Global regulatory
requirement in a step-wise
manner as quickly as possible.
He indicated the importance of
the Indian Regulatory System
taking a cautious approach
in matching with the US and
European regulatory systems.
India requires affordable drug
products and any sudden change
in the regulation can disturb
industry progress, which is
mainly manufacturing products
for the domestic consumption.
However, the industries involved
in the manufacturing of the drug
products for the US, Europe
and other highly regulated
countries need to meet those
countries’ required regulations.
In order to achieve the required
level of cGMP, one needs to
fully understand the ongoing
changes. He mentioned that the
conferences, training programs
and workshops that DIA is
conducting help the industry in
understanding the requirements,
and encourage exchange of
knowledge with global regulators,
speakers and instructors.
The Scientific Sessions started
with “Analytical Method
Development during Product
Development” by Anirudha Vaidya,
Director of Analytical Solution.
He stressed the importance of a
continual improvement program
required for analytical method
development, including method
validation, clarity in stating the
specification and importance of
Method Transfer process. The
presentation focused on how
to communicate the scientific
knowledge gained during the
analytical method development
stage, not only to the routine
quality control colleagues, but also
to regulatory reviewers during the
submission process.
The second presentation “Product
Development Strategy Based
on Quality by Design (QbD)
Principles” was given by Pratibha
Pilgaokar (founder and CEO
of Rubicon) and explained the
modern approach for product
development using Quality by
Design Principles through which
one can meet the expectations
of the patients with intended
performance. The importance
of Quality Target Product Profile
(QTPP) as key to the product
success along with critical
quality attributes and product
understanding, building design
space, specification of APIs,
excipients and control strategy
etc., was discussed at length.
She stressed the importance of
using the ICH guidelines during
the entire product development
lifecycle.
Prof. Mukesh Gohel (Director,
Ahmedabad University) explained
how QbD can be approached
using simple methodology, with
minimum knowledge in Statistic
and probability theory. He
shared his experience in product
development using design of
experiment (DoE) principles and
building design space. He cited
examples with mathematical
formulas and solution.
Rajinder Singh Director,
Regulatory Affairs at Ranbaxy,
shared his expertise on the
regulatory submissions to the
Global Regulatory Authorities
during his presentation on
“Deficiencies Identified in
Regulatory Applications’.
Rajinder explained the intent
and criticality of some of the
common deficiencies identified
in recent regulatory applications
submitted across the globe.
He covered the common
deficiencies, such as drug
substance - API specifications,
excipients, compatibility, drug
product development program,
pharmaceutical equivalence for
generic drugs, analytical method
validation, container closure and
new requirements for
stability, etc. in his presentation.
Ruchika Rawal, President
of Global Pharmaceutical
Regulations, presented her
views on the subject of “Vendor
Management”. She defined
the terminologies used, vendor
oversight that can take place
in planning and importance of
risk management in selecting
vendors, the on-site audits of the
Tier I, Tier II and Tier III vendors.
She explained the best practices
that are used during audits, the
importance of audit reports with
action plan and recommendations.
She explained the benefits of
developing the “Partnership”
concept and an unbroken supply
chain procedure with sound
quality agreements.
Alpesh Patel, Vice President
of Global Regulatory Affairs at
Amneal Pharmaceuticals, New
York, discussed the new and
probable future requirements
of the QTPP and the product
equivalency. His views on the
future regulatory requirements
(QbR & QbD) and Pharmaceutical
Quality of 21st Century, including
stability requirements, were
also presented. The proposed
GDUFA fees structure for new
submissions in 2013 was also
briefly discussed.
Ashwin Soaris from Cadila
Healthcare Ltd. spoke on the
importance of development
of packaging materials during
his presentation on “Impact
of Packaging on Stability of
Products”. He shared slides with
photographs indicating different
effects due to the packaging
material, size of the containers,
quantity of desiccant used, bottles
with inbuilt desiccant layers for
sensitive products, different types
of strip packaging, etc. on the
finished product.
95
gf
ISSUE 2
The first day concluded with Panel
discussion and Q &A chaired by
Dr. Nandkumar Chodankar.
VOL 4
96
The second day started with a
presentation on “Risk Assessment
in Regulatory Submission- ICH
Q9” by G. Gurudatta, COQ,
Director, Semler Research Centre.
In his presentation, he shared his
views on role of regulatory bodies,
the common technical document,
new Quality Road Map, QbA vs
QbD, QRM for regulatory filings,
QRM Applications for Regulatory
filings, etc. New Paradigm on
Pharmacovigilance and the safety
Risk Management Plan were also
discussed.
Dr.Vinay Nayak, President,
Technical Operations at Alembic
Pharmaceuticals Limited shared
his views on “Compliance Issues:
FDA Perspective” and experience
of various inspections in which
he was involved. He discussed
key issues like application
commitment, cGMP compliance,
current FDA thinking, and
Industry trends. The common
cGMP concerns, the systembased inspections, risk-based
compliance programs, along with
the documentation requirements
program, etc. were discussed at
length with examples. He advised
on the strategy for preparation
for an inspection, preparedness
and approach to inspection,
strategy for technology transfer,
production issues, process
controls, packaging and labeling
systems, sampling program,
laboratory controls, stability
program, OOS investigation,
qualification, validation including
cleaning validation, microbiology
lab, building/facility design, HVAC,
compressed air, water systems,
training, and other topics.
Dr. Ramkishan, Asst. Drugs
Controller (India), Gujarat, West
Zone, expressed his views as
a regulator and stressed the
importance of the points that
Dr. Nayak discussed in his
presentation. He explained the
importance of adhering to the
WHO cGMP and Schedule M
OF Drugs and Cosmetics Act
along with other requirements.
He shared his experience of
WHO joint inspections and gave
valuable leads to continue to
remain in compliance. He stressed
the importance of following the
ICH guidelines especially ICH Q7,
8, 9 and 10.
Dr. Rajiv Desai, President,
Quality at Dishman, during
his presentation, “ICH Q11”
discussed the importance of the
API process development and
manufacturing. He explained how
the ICH guidelines 8,9,10 and
11 are interlinked. He explained
how to apply the guideline ICH
11 principles for developing
design space for API process,
citing the examples given in the
guideline. He also touched upon
QTPP, critical quality parameters
and risk based approach and
explained how one can develop
and establish a commercial
manufacturing process for drug
substance that is capable for the
intended use in the drug product.
He discussed the new concept
of selecting the starting material,
material attributes to process
parameters and process validation
with an example of selecting the
critical step in the process.
Dr. Nandkumar Chodankar, Group
CEO, Pharma business unit at
Excel Industries Ltd., presented
his views on “Simplification
and Optimization for Time
and Cost”. He explained how
Compliance Risk management
can be managed with business
efficiency in the Pharma industry
by practicing a proactive
approach to compliance. He
discussed why the pharma
industry is not as efficient as
other industries like automobile,
IT, aircraft, etc. Simple solutions
were put forth for improving their
efficiency, like synchronizing
the manufacturing process. He
categorized different wastes
including intellect, overproduction,
inventory management, waiting
period, uncalled to- and fromotion, transportation, process
waste, rework, to name a few.
He discussed the importance of
the development of appropriate
processes using QbD principles,
process transfer and the use
of PAT. He also stressed the
importance of appropriate facility
design, like U or C shape design
where flow can be unidirectional
right from dispensing to
packaging. The benefits of having
quality control and/or IPQC (PAT)
laboratory in the manufacturing
area was explained. He explained
the initiatives which can be taken
for “Slim or Lean Manufacturing”.
It was stressed that rather
than a defensive approach to
compliance, one needs to take a
proactive approach that benefits
both industry and society.
Bhavesh Patel, General
Manager, Astron Research, in his
presentation on “Development
Challenges & Scale-up
Consideration in Lyophilization”
discussed the basics of the
lyophilization process, the
challenges faced during
development of this process and
during commercial scale-up. He
explained the steps involved,
like freezing, primary drying
and secondary drying, and the
importance of selecting the right
equipment, right temperature
range and the correct vacuum,
etc. Issues that may be faced
during lyophilization, like product
melting, lump formation, product
evacuation, content uniformity,
product flow, vial-to-vial variations,
vial breakage etc. were also
discuss as well as suggested
solutions to these challenges.
R. Tuljapurkar, President,
Corporate QA at Zydus Cadila,
discussed the old guideline
concept with the new guidelines
issued on January 25, 2012, by
the US FDA in his presentation
entitled, “Process Validation”.
He explained how the legacy
products can be exempted from
early- and mid-stage validation
and subjected to continuous
process validation during routine
manufacturing. The use of PAT for
process control is recommended.
He also mentioned the importance
of DoE studies, as well as risk
analysis at process development
stage to gain process knowledge.
The importance of ongoing
assurance during routine
manufacturing to keep the
process in a study state of control
and homogeneity within a batch
and consistency was explained.
He mentioned that the companies
which do not use these 21st
century concepts may not able to
remain in business in future.
An overview on “Technology
Transfer for Process and Analytical
Methods” was presented by
Dr. Sanjay Kapadia, Site Head,
Apotex. In his presentation, he
explained why technology transfer
is required, the basic concepts on
when and how this can be done,
the success criteria requirements,
and the importance of method
transfer and validation criteria. In
his presentation, he stressed that
technology transfer is nothing but
a knowledge transfer and it needs
to be smooth and seamless.
The presentations were followed
up with a panel discussion
under the chairmanship of Dr.
Hemant Koshia and Nandkumar
Chodankar.
The Conference was attended by
more than 100 delegates from
the pharmaceutical industries.
This is one of the most successful
conferences in terms of the
subjects discussed, the expert
team of the speakers, the Q &
A, panel discussions and overall
enthusiasm of the delegates and
speakers.
97
The Curtain Raiser
Conference, Mumbai
April 13 – 14, 2012
ITheme: Evolving Global
Regulatory Environment
It remains an undisputed reality
that running the pharmaceutical
business of making drugs to
alleviate pain and disease is
operating under a highly regulated
environment. By the fact that
this business involves “Lives”,
the industry is seen as a highly
regulated industry.
Drug Regulatory Affairs by
its basic definition means ‘a
function which regulates the
gf
ISSUE 2
pharmaceutical science in order
to facilitate trade/business in and
outside of the country of origin
for public interest.’ It does so
through designing appropriate
laws and enforcing the same so
that the drugs meeting the highest
standards of quality are brought
into global trade. Nonetheless,
the laws are written by regulatory
agencies in conjunction with
academia/industry.
VOL 4
98
India, which is becoming one
of the biggest economies
of the modern era, has also
been regarded as a big hub
for pharmaceuticals following
Information Technology. India,
throughout its rich history, is
known for the herbal cure, the
Ayurveda; over the years, India is
recognized for its modern system
of medicine. However, Allopathy.
Homeopathy, Unani and other
historical systems of medicines
run parallel in India. India is a mix
of diverse cultures and religions
which makes it unique in many
ways in this modern world.
India has its global foot prints in
the science of pharmaceuticals –
from drug discovery to low- cost
generic medicines to biologicals.
State-of-the-art research and
development centers have
the most fertile brains working
on discovery. Pharmaceutical
engineers are managing the
pharmaceutical manufacturing of
world-class drugs at a cost which
makes medicines affordable.
India in the last 25 years has
been recognized as one of the
largest exporters of medicines
to the western world – the world
where highest standards of quality
are practiced. India is known
for that quality manufacturing of
modern medicines which is also
recognized by the fact that India
is the only country outside the US,
which has the largest number of
USFDA approved manufacturing
plants.
Having said the above, the world
of pharmaceuticals is dynamic
in itself. This dynamism creates
a great force over regulators
who are bestowed with this
responsibility of ensuring that the
drugs are safe, efficacious and
meeting the highest standards of
quality are “only” being brought
into the trade and made available
to mankind. This dynamism
needs a great deal of academic
knowledge to understand what
the diseases are, a great deal of
scientific excitement leading to
discovery and then compliance
while executing operations.
Conference at Mumbai between
April 13 and 14, 2012 touches
upon this joint aspect through a
conclave of academia, industry
and agency. Academia focus
on the field of regulatory affairs
to churn out bright scientists
who also understand regulatory
science – and decide the space of
freedom to operate, industry who
runs huge cost incurring research
thus exploring newer and newer
horizons of drug discovery/drug
manufacturing but walking the
tight rope of compliance, agency
– who ensuring that the tenets of
Safety, Efficacy and Quality are
observed – remains the key focus
of this conference.
This conference brings together
experts and accomplished
leaders from the three streams of
Pharmaceutical Sciences on the
same platform. This conference
is expected to generate lot of
intellectual excitement around
what’s happening – Industry
transformation from Chemicals
to Biologics, underlying needs
of industry, from Discovery to
affordable (low cost) but quality
generics in India/world.
UPCOMING
EVENTS
INDIA
CONFERENCE
5th Regulatory Conference:
Evolving Global Regulatory
Requirements Environment
May 13-14
Mumbai, India
JAPAN
Makoto
Yokobori
is the Program
Vice-Chair,
15th Annual
Workshop in
Japan for
Clinical Data
Management
and the President of Suxac
Inc.
99
Japan Hosts Clinical Data
Management Workshop
The 15th Annual Workshop
in Japan for Clinical Data
Management was held on January
26 - 27, 2012 in Tokyo. There
were approximately 200 attendees
in the workshop from Japan and
other countries.
The workshop was entitled,
“Innovative Decisions in Our
Hands!” this year. The IT
environment is evolving every
day in this area. However, some
processes are still carried out in
the same way as during the paper
age. The main theme was loaded
with our hope that CDM should
make innovative decisions.
The workshop started with
a keynote address, entitled
‘Expectations for Future Clinical
Development’ presented by Dr.
Satoshi Toyoshima, Chairman
of Board of Directors, Japan
Pharmacists Education Center.
He gave a lecture about the
present condition of clinical study
in Japan, future expectations
in that field; he commented the
importance of CDM will continue
to grow.
Two sessions were held the first
day of the meeting: ‘Business
Continuity’ what it is and how
to ensure it was discussed in
gf
session 1. Japan experienced
the massive earthquake last
year; and some damages remain
even now. Therefore, we talked
about how we should prepare our
businesses in the event of another
catastrophe of this kind.
The topic of ‘EDC New Genesis’
was talked in session 2. EDC is
not only data capturing system;
EDC can capture some metrics,
too, and also be used as an
operational control system.
VOL 4
ISSUE 2
The ‘CCS report’ was given also
on day 1. CCS (CDM Chatting
Session) has been the special
program in the workshop since
2005. The attendees divided
100 into small groups (around 8
persons per room) and discussed
concerns about their daily work in
an engaging exchange of ideas.
There were 2 sessions in
the morning of 2nd day.
‘Standardization of CDM Activities
by CDISC’ was discussed in
session 3 and covered the
benefits of standardization. Most
of audience reconfirmed the
importance of standardization.
Session 4 was devoted to ‘Data
Quality for Efficient Clinical Trials’
from three different perspectives:
Hospital, Academia and
Regulatory agency (PMDA).
The session that faced the
most challenges was held
the afternoon of 2nd day. It
included 6 presenters from
pharmaceutical companies who
explained their activities in and
around global studies. After
that, a panel discussion was
held by these presenters where
they discussed global trials and
the ability of Japan to take an
initiative in this area; the audience
also participated in this robust
discussion.
This workshop closed with
success. Plans are underway
to schedule another meeting in
2012.
UPCOMING
EVENTS
JAPAN
CONFERENCE
2nd DIA Labeling Workshop
in Japan
April 21
Tokyo, Japan
6th Annual Conference in
Japan for Asian New Drug
Development
May 26-27
Kanagawa, Japan
3rd DIA Cardiac Safety
Workshop in Japan
May 28-29
Tokyo, Japan
1st CMC Forum in Japan:
Challenges for Quality
Improvement in Asia
June 11
Tokyo, Japan
UPCOMING
EVENTS
CHINA
& AFRICA
CONFERENCE
4th DIA China Annual
Meeting: Collaboration &
Innovation in China
May 20-23
Shanghai, China
3rd African Regulatory
Conference (ARC) –
Partnering for earlier access
to good quality medicines in
Africa
May 3-4
Akkra, Ghana
Contact
Information:
Conference, Workshops
and Posters:
Fei XIE: fei.xie@diachina.org
RunShan Chen: ting.chen@
diachina.org
(Tel) +86.10.5923.1222,
(Fax) +86.10.5923.1180
CHINA
4th Annual
China Meeting
to be Held in
Shanghai,
May 20-23
The 4th DIA China Annual Meeting will
be held in Shanghai and bring together
professionals from the pharmaceutical
industry, academic and research institutions, regulatory agencies, and health
ministries. In accordance with the annual
meeting’s main theme - “Collaboration
and Innovation in China” - experts and
leaders will discuss and address various
hot topics related to China and global
pharmaceuticals.
The Conference will have plenary and
parallel sessions, including pre-conference
workshops, special regulatory workshops
on API inspections participated by US
FDA, EDQM, Asia and China regulatory
officials, roundtable discussion, debate,
posters, and exhibition.
Programs in the Conference feature not
only traditional topics like regulatory affairs, clinical research and safety, statistics, CMC, etc., but also new areas such
as regional research and development,
entrepreneurial creativity in high-tech
parks, CRO collaboration and services,
active pharmaceutical ingredient supplies,
clinical research of medical devices, and
translational medicine.
The city of Shanghai seems the logical
choice to hold a conference on innova-
101
tion. Having the largest rate of expansion of any city in the world, Shanghai
boasted 14 million permanent residents
in 2011 and 9 million “migrant” residents.
Described as those “who are only in
Shanghai for a short stay, many coming
for medical treatment or for travel,” these
migrant residents accounted for 2 million
people, which means that the additional
7 million migrants lived in the city for more
than six months.¹
To handle the influx, developers are planning to build, among other things, seven
satellite cities on the fringes of Shanghai’s
2,400 square miles. Shanghai opened its
first subway line in 1995; today it has 11;
by 2025, there will be 22. In 2004, the
city also opened the world’s first commercial high-speed magnetic levitation
train line. Shanghai lies on the Huangpu
River, about 15 miles upstream from
where the mighty Yangtze, the lifeblood of
China’s economy for centuries, empties
into the East China Sea.²
TIME Magazine recently ran an article on
some of the don’t miss things to do while
in Shanghai. Here is just a sampling of
them:
• Ride the magnetic-levitation train from
the international airport to the city for a
trip of a lifetime at 267 miles an hour
• Visit the Shanghai Museum (201 Renmin Rd; 86-(0)21-6372-3500)
• Try the local cuisine, especially the
soup dumpling, or xiaolong bao
• Even though this riverfront boardwalk is
touristy, the BUND, is a don’t miss for
people watching in Shanghai
• Browse the variety of antique and curio
shops on Dongtai Road off Xizang
Road
1. Shanghai population may top 23 million. Wang
Hongyi, China Daily, Updated: 2011-02-23
2. http://www.smithsonianmag.com/travel/Shanghai-Gets-Supersized.html#ixzz1oC36DHF0
3. http://www.time.com/time/travel/cityguide/article/0,31489,1851908
_1851830_1851810,00.
html#ixzz1odziofPB
EDUCATE just
EDUCATE
just does
does that:
that: Keeps
Keeps you
you abreast
abreast of
thethe
association,
membership,
regulatory,
and
of
association,
membership,
regulatory,
legislative
newsnews
whilewhile
including
features
such
and
legislative
including
features
as career
advice,
book book
reviews,
patient
persuch
as career
advice,
reviews,
patient
spectives andand
more.
perspectives
more.
gf
EDUCATE
PROFILE
MARY
BAKER
DIA Enters
the World
of Social
Media
CAREER TIPS
REGULATORY
ROUNDUP
103
PROFILE: Mary Baker
104
New World of Knowledge
109
DIA Enters the World of Social Media
Joe Krasowski
111
CAREER TIPS
It’s not just for fun…
Social Media Means Business
114
REGULATORY ROUNDUP
FDA Releases Long-Awaited Guidances
on Biosimilars
118
gf
GLOBAL FORUM | EDUCATE
ISSUE 2
Profile
Mary Baker
VOL 4
104
Q
A
&
Mary G. Baker, MBE, currently serves as President of
the European Brain Council, and is in her second term
of service as one of the patient representatives appointed
by the Council of Europe to serve on the Management
Board of the European Medicines Agency. She has
also served as President of the European Federation
of Neurological Associations, and as President of the
European Parkinson’s Disease Association.
Mary has received
many public and
scientific service
awards, including an
Honorary Doctorate
in recognition of her
work within the world
of Parkinson’s disease,
and the prestigious
British Neuroscience
Association Award for
her contributions to
British neuroscience.
Mary’s was the first
signature to appear
on a letter sent to
European Commission
President JoséManuel Barroso
in October 2011,
requesting that he
“formally endorse
2014 as the European
Year of the Brain.”
This letter was
countersigned by more than
190 representatives of industry
and brain and brain disease
associations, plus several panEuropean and international
federations and alliances, and
reads in part:
“The European Year of the Brain
2014 is an ambitious programme,
developed by the European Brain
Council (EBC) which will create
a lasting legacy for the whole
of Europe. EBC has already
brought together a committed and
enthusiastic coalition of patients,
carers, healthcare professionals,
scientists, politicians and industry
and is keen to engage many more.”
“Your support with this initiative
is vital, but time is also of the
essence. To plan and then
implement activities of a scale
never previously seen for a
European Year requires several
years and delay will limit what can
be achieved. We have already
been working on this project for
several years and your leadership
is critical to ensure that EU citizens,
especially the 1 in 3 who suffer
from and /or live with a brain
disorder, can truly benefit from our
ambitious plans.”
Mary has also found time to
participate in numerous DIA
educational programs, especially
in Europe. She was scheduled
to present on designing and
implementing assessments
for patient performance at our
recent 24th Annual EuroMeeting:
Copenhagen 2012. During the
plenary session that opened last
year’s 23rd Annual EuroMeeting:
Geneva 2011, Mary served as the
panel’s patient representative for
the Oxford-style debate on, “The
current regulatory system does
not support timely patient access
to beneficial medicines.” As you’ll
read, this topic remains very close
to the busy workings of Mary’s
mind – and heart.
Q: How did you first hear about
DIA and how did you begin
participating in DIA events?
A: My first introduction was through
Professor Yves Juillet, who I believe
is now your Board President. He
asked me to come to, of all places,
wonderful Boston. Of course, I
accepted with alacrity. I’m not
quite sure what meeting it was
exactly, but it was one of the very
first experiences I had with DIA.
The discussion was interesting
and he was thought-provoking
in his responses to some of the
questions,so I was impressed very
much by him.
At that point, I had been asked to
serve on the Patient Consumer
Working Party of the EMEA. I
was asked to speak by DIA pretty
regularly after that; I remember
Basel and Rome and some other
well-run conferences. I have always
been impressed not just with the
efficiency of these conferences,
but that there really seems to be a
genuine reaching out from DIA to
patients, which I think is marvelous.
Gradually, perhaps because I got
a little more confident, I was able
to be a bit more challenging about
the importance of listening to the
patient, daring to suggest that
patients might be industry’s real
customers, and then becoming
more critical of the very long
regulatory process.
Q: What are some of your other
motivations for continuing
to support DIA educational
programs?
A: I’ve never been able to fully
understand why some patients are
so poor at following the instructions
of taking their medicines when they
are living with the most frightening
diseases. Their ability to track
taking their prescribed medicines in
the right way is very poor. Research
shows that we’re very good at the
short-term urinary tract infection,
the chest infection – we’re pretty
good at the short-term, tenday course. And we’re not bad
at trauma – go to the hospital
and return home with a short
prescribing regimen.
But patients with long-term
conditions are very poor at taking
their medicine in a sensible,
balanced way. This is really the
challenge to our health systems
now: The long-term, chronic,
progressive illnesses which don’t
kill but you go on living with, so
you’ve got to manage them the
best you can. Our compliance to
these medications is very poor, and
I find that intriguing.
Q: What is your current
professional position?
A: I serve as President of, and
absolutely believe in, the European
Brain Council. It’s most innovative
because it’s brought together
neurologists and psychologists –
which I’m delighted about because
I hate this division between mind
and body – and neurosurgeons,
neuropharmacologists,
neuroscientists, the pharmaceutical
industry, the biotech industry,
patients of the neurological
105
associations, and patients of
mental illness. It’s a unique bringing
together, and you can imagine,
the Board is very distinguished, all
professors in elevated positions in
universities and associations. The
first president was a neurologist,
the second was a psychiatrist, and
I’ve ended up as the third.
It, frankly, rather surprised me to be
elected and it’s not false modesty
because patient groups usually
aren’t put in this sort of position.
What is emerging, as I deal with
the European Commission, is the
societal piece, which is now very
central to our work in Europe.
Can we prevent more disease?
Prevention was not a high priority
in brain disease, but it is now. How
can we extend two years of aging
without too much cost to the health
system? An interesting concept for
brain patients.
Our Board now needs widening to
encompass the advances in brain
science: We need a pharmacist
on board, we need regulators,
we need ethics because things
gf
ISSUE 2
are getting so difficult now, and I
think we need informatics. It’s an
incredible, changing scenario.
DIA truly attempts to bring people
out of their silos. Lots of the
conferences that I go to are just
so narrow: Neurologists talking to
neurologists, psychiatrists talking
to psychiatrists, which is not
awfully challenging. But DIA tries to
bring the regulators, the clinicians,
and the patients, together. It really
does attempt to widen the forum,
and I think that’s to be absolutely
applauded. There’s been a sincere
attempt to create opportunities to
involve more voices.
VOL 4
Q: What is your undergraduate
106 and graduate training?
A: My degree is in sociology
and political theory. I am also a
trained medical social worker
and I’ve received a doctorate for
my work in neurology. That’s not
the clever stuff of neurology, it’s
about politically driving forward the
importance of neurological science.
Q: Have you ever considered
working, or been invited to
work, in the pharmaceutical
industry?
A: I’ve never been asked. They’re
a fascinating industry. They’ve
been quite slow to adapt to this
changing world. I really admire
them. God knows how but they
have dug themselves into quite
a hole in the media. Perhaps it’s
a British thing that anything that
acquires a lot of wealth gets bad
press. In our current economic
time, for example, “the bankers
are so bad,” and yet there’s little
understanding, I think, of the
premise that you need wealth to
generate wealth for society. The
pharmaceutical industry is a fine
industry. We owe it a great deal,
and it saddens me that it gets such
bad press.
Frankly, we need them desperately
in the health systems. They are
the authority about our medicines.
They make them. They know
them. It makes me sad that,
when medicines have saved
so many lives, all the public
seems to understand about the
pharmaceutical industry is that it’s
greedy and rich. I have a theory
about this: It’s because the patients
are our true customers, and people
have kept industry and patients
apart. There’s a ditch between us,
and you know what happens to a
ditch? It fills up with rubbish.
Q: What other career
experiences have been
particularly relevant to your
current work?
A: I learned a great deal from
being the chief executive at the
Parkinson’s Disease Society
because that showed me the
tensions that exist between
research and the welfare, the
giving of care, of people living
with an illness. This led me to
the Presidency of the European
Parkinson’s Disease Association.
That was probably the biggest
learning experience of all. To
actually get any money, and you
always need money for activity,
was very very difficult in Europe.
We could not get money that
would actually provide for research,
projects, or challenging legislation.
Working on the European level
was different. This was dealing
with government affairs and policy.
This was where we were absolute
partners. We wanted the same
thing: To improve the quality of
life for the people living with these
brain diseases in Europe. I really
loved that.
Q: Was it difficult for you to
leave your position as President
of the EPDA?
A: No, because the Commission
made it very clear that the time
to pursue individual diseases is
coming to an end. The Commission
wants to deal with umbrella groups.
Now, cynics can say, “That’s
so they can pick off the fifteen
diseases that you represent.” But I
don’t believe that. I’ve been asked
to present and chair many, many
meetings in Europe around not
just neurology but rheumatology,
cancer, skin diseases, etc., and
frankly, all these patients have the
same concerns. Trajectories of
illnesses are different, some move
faster than others, but, by and
large, patients are concerned with
better understanding medicines,
how to access medicines, how
to have a good conversation with
good clinicians, how to preserve
dignity, and how to pursue a better
quality of life. Really, that’s it,
whether you’ve got cancer, lupus,
rheumatoid arthritis, or Parkinson’s.
There is more similarity than
difference between patient groups.
You find more similarities than
differences, in the people that you
meet.
Q: How does your current work
serve patients, and how can
organizations such as DIA help
you serve patients even better?
A: However hard I might work, my
life only touches a few people –
let’s say one hundred. If you work
with clinicians, your work perhaps
touches one thousand people. But
if you impact the policy makers,
you start to change things for
cities, areas, and countries, and
that’s much better.
Here’s where DIA has helped me.
When I worked in my own little
silo as a patient group, I thought
that regulatory agencies and
payers were barriers in our way
to accessing treatment. But by
working in the EMA, first in the
Patient Consumer Working Party
and, for the past six years, on the
EMA’s Management Board, and
going to more and more of your
DIA events, you begin to see that,
indeed, these are not barriers. They
are challenges which are necessary
– safety of medicines and good
information are very important.
If we could work together more,
we might improve the regulatory
process. We actually have a role
to play in the regulatory process.
If we’re careful, and without using
that awful expression “patient
empowerment,” we could actually
improve the process together by
sharing our respective expertise.
This is my top priority now. I’ve
been around patient groups for
thirty years, but today we have a
very different population. We have
the ability to live longer on this
planet than ever before. But there’s
no question that, in this age of old,
the challenges are very different
for doctors, social workers, and
the poor hospital nurses. The
elderly are now in every ward of the
hospital except pediatrics, and they
require a different nursing skill.
We’ve got to somehow speed up
the regulatory process because
at the moment it takes about
thirteen and one half years to get a
medicine to market. The big excuse
is, “We don’t want to sacrifice
safety.” But it’s not about safety. It’s
about this process of not involving
patients right at the beginning and
asking them what would make a
difference to their lives. It’s about
a clinical trial process that’s fifty
years old and is ethically not right
because it leaves out the very
young and the very old. It’s about
the health technology assessments
that have now crept into the
picture, about how the EMA is
measuring one thing and the
payers are measuring something
else.
Everything is happening as a
reaction to something else, and this
is slowing the process. Most public
health conditions were improved by
good reforms; you know, getting
the kids out of the chimneys
and into school, and gradually
getting some vaccinations. Then
came “The Industry”: Wonderful
strides forward, and low-hanging
fruit grabbed. And then came
thalidomide.
That led to regulatory: We had
to have regulatory so that we’ll
never have the thalidomide crisis
again. But this meant ensuring
that clinical trials were properly
widened, to generate and collect
more information, and the price
of the medicine started to go up.
The payers said, “We won’t pay for
this.” The reaction to that? You set
up health technology assessments
to help you get ‘round the payers.
Everything we do is a reaction. It’s
analogous to a house: You don’t
keep building onto a house with a
greenhouse here and an outhouse
there. It looks ugly, and it’s not
efficient.
Instead, we should all say together,
“We are in the age of the elderly.
How are we going to move
medicines forward so that they
are safe? How can we involve the
public more? How can we help
them understand benefit/risk?
How can we streamline this whole
process without throwing away
safety?” That’s going to be our
challenge, now and for the future,
and one that requires us to get out
of our silos and work together.
DIA is one of the few places where
you bring people from different silos
together. We had five thousand
neurologists attend a conference
in Geneva, and held a session
on HTA – twenty came. One of
the vice presidents of the board
came, and said that we must have
this in a plenary session. She was
overruled. They still want to work,
107
eyes down, on just the disease,
and it’s a pity.
Q: Is a quantitative measure
the best way to measure the
success of the regulatory
systems in Europe?
A: We need to develop patient
reported outcomes that are
acceptable to both regulatory
authorities and payers. If the
patients were more involved in
producing medicines, patients
would comply with their treatment
regimens much better.
Q: What is your position on
more patient involvement
in early stages of drug
development, and on practical
ways this may be brought
about?
A: Do you know Marks & Spencer,
from the UK? Marks & Spencer
conducts customer surveys: What
else would you like us to make?
For instance, in women’s dresses,
they don’t just make green dresses,
size 12. They put together a range
gf
of sizes, a range of colors, and ask
for continual feedback. This never
happens in the pharmaceutical
industry. We’re kept at arms’ length
from one another. You have key
opinion leaders who are clinicians,
but there is no attempt to establish
a clear opinion leader who brings
the patient’s view in.
VOL 4
ISSUE 2
Here’s an example from the world I
know better, Parkinson’s Disease.
I remember one company thinking,
“It must be the tremor. Let’s do
something about improving tremor.”
Yet, we did a survey on quality
of life, and although this illness is
called a “movement disorder,” what
disturbed the patients most was
their mood – the depression from
108 what they had to live with. Only
seventeen percent who thought
it was the actual movement –
the slowness and smallness of
movement from their medication,
and the tremor. But what really
concerned forty percent of them
was their depression – and behind
that was pain, sleep, bowels,
bladders, and sexual dysfunction.
Yet everything in medication
focuses on movement. Forty
percent! If you talk to patients,
they will amaze you with what they
think is important.
Q: With the new law, do you
see a change in cooperation
among the health care
industry’s various stakeholders
in Europe for better benefit/risk
assessment?
A: There are a number of laws
going on at the moment. One
of them is whether patients in
Europe can talk directly with the
pharmaceutical industry. That’s
very divided between Western and
Eastern Europe: Scandanavia, UK,
Ireland, the Dutch, all think that
we have every right to talk to the
industry. And we’re very simplistic
about it: If we ask the industry
for some information, that is not
promotion, that is seeking advice.
A lot of the Eastern and Latin
countries are still very unsure about
being close to the industry.
The other Directive, which is
going through the courts at the
moment, is a requirement that all
pharmaceutical industry clinical
data must be released into the
public sector. The industry is very
nervous about this because this
information release contains data
that is totally unrecognizable to
patients. It’s almost a different
language, and they’re very worried
that the media will have the
take: “Well, here’s the industry,
once again, pretending to be
transparent, releasing all of this
into the public domain, where they
won’t understand any of it. There
goes the industry again.”
It’s really our whole challenge: How
can we communicate information
about medication to Mr. & Mrs.
Average? How can they begin
to understand benefit and risk?
Because we’ve got to somehow
transfer informed decision making
to society. It’s only when society
takes on more responsibility for its
health care that we can get a better
understanding of benefit/risk and of
taking medicines.
Q: What message would you
like to deliver to industry?
A: Let’s work together to reduce
the time of getting your medicine
from the bench into the mouths
of this aging population. Because
they’re going to live to be eighty
plus, and we know that they’ve got
three diseases by the time they’re
sixty, so you’re not even giving
your medicines much of a chance.
We must somehow work together
to reduce the time that it takes
medicine to advance through the
regulatory process.
Q: What else would you like
to discuss, or leave as a final
comment?
A: I really think it is partnership.
You can learn so much from
working with all diseases together.
Let’s get out of these silos, and
let’s applaud conferences that bring
us all together.
I understand how it’s happened.
In order to understand the
organs better, doctors developed
cardiology, oncology, neurology,
and so on, and of course the
pharmaceutical industry followed
suit with medications for cardiology,
oncology, and neurology. I do
understand it, but I think it is a pity.
We particularly need to address the
challenges of CNS (central nervous
system) more, because once
the brain goes down, you can’t
manage other diseases. We’ve
already got evidence that diabetics
who become depressed – which
is a pretty fair reaction to diabetes,
get depressed – then begin to miss
their hospital appointments, then
get muddled up with their insulin or
whatever treatment, and everything
escalates. It’s very important that
the brain is given as much chance
as possible to be kept safe, to help
manage other diseases. That’s
really a very big worry.
New World of Knowledge
109
Many EuroMeeting attendees who visited the DIA booth in the
exhibit hall were treated to a special sneak preview of the new
www.diahome.org website that will be officially released on April 9.
This first phase of our new
website reflects many years of
planning, design, and refinement,
dedicated to creating a new
and improved online experience
for DIA’s global community. Our
forthcoming website will provide
several new and enhanced
features designed to give you
a more personalized online
experience. Subsequent iterations
are also planned that will provide
additional functionality and
content resources.
While still in development at press
time, features of this initial roll-out
include:
•A new “I am interested in”
feature which customizes the
content you view and search
results you receive by interest
areas you specify
•A more robust, personalized
“My DIA” that consolidates your
personal account information,
your event (purchase) history,
available downloads from
“
ISSUE 2
events you’ve attended, SIAC
membership, eLearning courses
in-progress, plus the ability
to renew your membership,
change your personal details,
change your communication
preferences, or invite a
colleague to discover DIA, from
one location
•A more robust internal search
engine that refines your search
for educational offerings by
date, location, and format (type
of offering), expanded to include
type of continuing education
credit offered and speaker name
•Eliminating “pop up windows”
and tabbed navigation that
encumbered navigation
VOL 4
110 •New resources for students and
patients among our “Networking
& Communities”
•Help boxes located throughout
the site to help you find what
you’re looking for
“This new website really signals a
new era for DIA,” suggests Linda
Amoroso, Worldwide IT Director.
“While this effort and our website
redesign team were based in
DIA worldwide headquarters,
we’re very grateful for the input
we received from our regional
offices as well as from numerous
individual volunteer contributors
who suggested requirements,
assisted with functional testing,
and helped with many other steps
in this process.”
This new website deeply
aligns with the globalization,
digitalization, and culture of
quality aspects of our DIA
strategic plan. We are confident
that it heralds a new era for
DIA as a knowledge resource
that can digitally deliver ideas
and information to DIA’s
constituents all around the
world, instantly. Delivering the
knowledge that you want, when
you want it and in the format
you want it, can only improve
the quality of your online DIA
experience. Our entire digital
website team looks forward
to welcoming you to the new
world of knowledge that you’ll
soon discover at
www.diahome.org
“
gf
DIA Enters the
World of Social Media
Joe
Krasowski
111
DIA Marketing
Co mmu n i c a tions Manager
I can’t help but reflect on the large
number of organizations that still
do not recognize the power of
social media. Unlike many forms
of traditional marketing, whose
reach tends to be linear, social
media’s reach is exponential,
empowering brands to leverage
their content and messaging more
efficiently than other marketing
channels.
Companies are using social media
to engage with consumers on
a number of levels. Consumers
want more from the brands they
are following on social media,
including better experiences,
rewards for engagement and
deeper engagement. Given all
of this, only about one-third
of brands feel they have the
resources or time to fully invest in
social media strategies.
Even companies that recognize
the importance of social media
and consumer engagement are
having trouble understanding how
to effectively manage their social
media channels. Many businesses
are still using traditional “push”
marketing techniques, with 65%
of companies with a Facebook
page using it for one-way
communications and 96% of
blogs simply broadcasting article
and news content without inviting
responses.
Even technology companies that
understand social networking
are having trouble implementing
proper social media management
practices. In fact, only 31% of
brands with a Facebook account
use it to engage with users and,
of those that used Twitter, only
14% of tweets were replies and
re-tweets.
gf
How to Effectively Use
Internal Collaboration
and Social Networking
Technology
Here are a few considerations to
help you establish the framework
for a sustainable and successful
social media program.
VOL 4
ISSUE 2
Be present. If you’re going to
create an account in any space,
be there and spend time there.
And pick your platform first. You
can’t start from scratch and be
everywhere at once. Everybody
wants 10,000 views on YouTube,
112 10,000 blog views, 10,000
followers and 10,000 fans on
Facebook. That takes a lot of
time. Pick a platform to start, and
grow from there.
Make sure someone with deep
institutional knowledge is
managing your social media.
The people managing your social
presence are managing the way
that hundreds of millions of people
could be looking at your brand.
Develop a distinct personality
to show who you are. Give
people a true flavor of who you
are and what you stand for, and a
reason why they should trust you.
If you’re considering using a lot of
automation to push out updates
(so you can look busy, popular,
and active), think again. You
have a phenomenal opportunity
to excite, educate, and motivate
prospective consumers about
your product, service, or cause.
Be interesting using your own
brand and content, and don’t
become that guy that sends those
forwarded emails.
Become a content curator. Too
few companies understand the
value of sharing other people’s
content because it’s counterintuitive to traditional marketing
folks. However, YouTube is video
sharing. Flickr is photo sharing.
There’s an emphasis on sharing,
and what do businesses have that
they can share? They have a lot
of information, but they also know
their industry really well and they
know who the authorities in their
industry are. Take the industry
news you read in the morning and
share it with your followers. You
play an invaluable role by doing
so and filtering what your industry
needs to know.
Invest your social currency.
“Social currency” is the amount
you give to a social network
before trying to withdraw
monetary currency from it. Build
a conversation or relationship
first. That’s a huge thing that
businesses don’t understand.
Engage proactively with people.
Twitter is a very social atmosphere
and consumers feel empowered
by it. When they have a complaint,
companies that are Twitter-savvy
actually respond to them. It feels
good. But what people forget is
that when companies reach out
and directly contact a consumer
who made a positive comment –
that’s extremely powerful. That’s
how you create a brand advocate
from a customer.
Don’t litter. Your followers and
fans receive everything you post.
When you leave a trail of waste
that has no redeeming value,
people will turn you off.
Nonprofit organizations are
increasingly adopting social
networking tools to create a sense
of community among members.
According to a recent poll by
the Association of Fundraising
Professionals, two-thirds of
nonprofits are using social media,
and 39% of respondents said they
feel these tools are important for
reaching the greatest number of
donors. Additionally, the Weber
Shandwick Social Impact survey
found that 88% of nonprofits are
widely experimenting with social
media, 51% are active users, and
92% of executives said their online
presence raises awareness of their
organizations. Although these
statistics reinforce nonprofit’s
acceptance of social media, the
numbers do not show whether
organizations have adopted
internal or external tools.
While many nonprofits appear
to be actively participating in
external social networks, such as
Twitter, Linkedin, and Facebook,
many don’t realize the risks of not
fostering these groups within their
organizations’ website itself.
Why Internal Tools?
By offering internal social
networking capabilities, especially
those that are tied directly to
your website, your organization
can maintain its branding,
while deepening interactions
with constituents. An internal
community is also a great way to
increase Web traffic and search
engine optimization (SEO).
Creating an internal community
also offers additional value to your
members. Online communities
can serve as a venue for users
to express ideas, share valuable
information and contact details
within a trusted network. As they
contribute to discussions within
the community, members will gain
recognition for their expertise and
feel a closer connection to your
organization.
In 2010, DIA launched an internal
professional networking platform.
DIA ConneX is an exclusive
member benefit that brings
together powerful, professional,
web-based applications
specifically designed to improve
collaboration and networking.
Seeding Your Online
Community to Promote
Growth
•Organize and publicize
conferences, seminars,
teleconferences, meetings
and other events of interest to
community members
•Manage their own community
experience based on changing
professional profile
With many nonprofits actively
participating on external social
networks, it is essential that an
organization creates an internal
community to provide members
or donors with additional value
add. An online community
will also present nonprofits
with the opportunity to collect
valuable information about their
constituents, promote greater
online engagement, keep
members invested and make
improvements that will lead to
your organization reaching its
goals.
The feedback that DIA has
received from these pilot members
What Can Social Media Do for
You?
•Discuss online conversations
grouped by issues and topics,
ask and answer questions, and
share expertise to develop best
practices
•Upload, manage and share
media files, images, video,
audio, and podcasts
Once your organization recognizes
the benefits of creating an internal
social network, it’s important
to look to your most engaged
members to serve as pilot users.
DIA’s SIACs (Special Interest
Area Communities) were the first
DIA stakeholder group to utilize
the networking platform. SIACs
are discipline-specific, global
communities where members
can share common experiences
and knowledge and connect
with others in their particular
field. Every SIAC has its own
community homepage through
which members can:
•Share breaking news of interest
to community members
•Store, organize and manage
community information and
documents
•View and edit documents and
respond with comments in real‐
time
has helped the association make
improvements to the network.
DIA currently has a social media presence on Twitter, Facebook, LinkedIn, YouTube, Flickr, and Google+.
www.twitter.com/druginfoassn
www.facebook.com/DrugInformationAssociation
www.linkedin.com/groups?mostPopular=&gid=2541
www.youtube.com/user/DrugInformationAssoc
www.flickr.com/photos/druginfoassn/
https://plus.google.com/u/0/?tab=wX#
113
gf
ISSUE 2
CAREER TIPS
It’s not just for fun…
Social Media Means Business
VOL 4
114
Not so long ago, companies
advertised in the “Yellow Pages,”
and broadcast special promotions
on radio, while job seekers
knocked on employment agency
doors with printed resumes in
hand. Since then, the immediacy
and widespread popularity of
social media has dramatically
changed all that. Companies send
targeted messages to consumers
via Twitter and other social media
while individuals find employment
opportunities online and are
discovered through LinkedIn.
So, what must corporate leaders
know about Facebook, Twitter
and LinkedIn in order to help their
companies thrive? And, which of
these, and other related methods,
offer the best avenue for finding
a new position or advancing your
career?
COMPANIES E-CONNECT
WITH CONSUMERS
Businesses of all kinds use social
media to interact with customers
for a variety of purposes. Lee
Bogner, a consulting marketing
technologist and social business
analyst, has implemented a range
of platforms for retail, food and
beverage, media, and technology
companies. But the unconvinced
still ask, “What’s in it for us?”
Bogner advises business leaders
to stop hesitating. “Social media
is not going away – and your
competitors are already using it.”
But how does a company leader
know which vehicles to utilize?
Web strategist Randy Shannon
(www.webstrats.com) advises
company executives to ask, “Who
are their customers and what
social media platforms are they
likely to frequent?” He and other
experts agree that for consumers,
Facebook and Twitter are the
logical choices.
Bogner reports that “these
platforms give companies a
tremendous opportunity to hear
what consumers think of them
-- both the good and the bad.”
That’s because social media offers
companies a ‘pipeline into the
thoughts, perceptions and attitudes
of their customers.’ ” Monitoring
online consumer conversations
allows companies to create
better customer service policies.
Companies can also be proactive in
responding quickly to emergencies
or product recalls. This preserves
the reputation of the company and
builds a positive brand image.
“All companies should use social
media as part of their public
relations strategy,” adds Bogner.
In fact, Facebook and Twitter offer
excellent ways to promote and
help brand firms in a favorable
light from their very inception.
This was recently exemplified:
both of these platforms were
employed when three-way social
media conversations were initiated
between a clothing manufacturer,
an e-retailer and consumers.
Brendan Kownacki, a social media
strategist, feels “Social media
isn’t a choice anymore; the only
choice is what interactive vehicles
companies decide to use.” Here
are several examples:
•Location-based technology is
used as a marketing tool by
some retailers and restaurants.
Foursquare and Yelp utilize the
“GPS” built into mobile phones.
Participating businesses
offer incentives and online
game rewards to encourage
customers to drop by when
they are in the vicinity of their
locations. Kownacki utilized
Yelp on behalf of a manufacturer
of flu vaccine materials. A
notification system alerted
potential patients on their cell
phones when they were close to
a location where flu shots were
available. Conversations ensued
on Twitter among participants.
•A consumer brand recently
attracted 3,000 You Tube
viewers less than twelve hours
after filming a promo. In this
instance, viral marketing caused
a national response, even
though it was targeted to people
in the Washington, DC area.
•Shannon recently set up a
LinkedIn account for a statewide
association in order to “give
individual members a wider
networking opportunity.” He also
initiated an association Twitter
account through which leaders
provide valuable insights to
members. Both platforms built
added value to the association
membership.
And businesses are not the only
ones to benefit from social media.
Job seekers and careerists hoping
to move up the corporate ladder
are being advised to promote
themselves using social media
tools in order to differentiate
themselves from their competition.
SOCIAL MEDIA CAREER TIPS
Career length employment with one
or two employers in a lifetime is a
thing of the past. That is one reason
why Dan Schwabel, author of “Me
2.0 Building a Powerful Brand for
Career Success,” suggests that job
seekers develop themselves as if
they were a name brand starting
with these three steps:
•Create your own personal
website which will continue to
work for you during all stages of
your career.
•Develop a core message – a
phrase to distinguish yourself.
•Use search engine optimization
(SEO) which utilizes key
words (your name + niche
skills associated with your job
specialty).
Schwabel recommends utilizing
all three major social media sites:
LinkedIn, Facebook and Twitter.
Get LinkedIn to Career
Opportunities
Experts concur that LinkedIn is
the premier social media career
development tool.
Kevin Palisi, an executive recruiter
with Korn Ferry International labels
115
it “the gold standard of social
media.” He suggests keeping all
information up-to-date and filled
out completely at all times. Include
current job title and education
(which recruiters search for),
as well as any off-line industry
associations to which you belong.
•Utilize your core message as
your profile headline, offers
Schwabel.
•Palisi suggests, “Join and
participate in the online industry
groups, such as “RAPS,” which
is appropriate for regulatory
affairs professionals.” See who
the discussion leaders are and
link to them, adds Shannon.
•Find actual job openings on a
company’s LinkedIn corporate
profile pages. Also, check
to see if you have a direct
connection to anyone in the
company who could serve as a
referral.
(For more in-depth information on
utilizing LinkedIn, see DIA’s Global
Forum Issue I Volume 4, August
2009, page 25.)
gf
To Facebook or Not to
Facebook
ISSUE 2
•For careerists on the lookout for
positions, Facebook has two
job search tools or applications:
Branchout and Beknown.
The latter is associated with
Monster.com and is also
available through a Twitter
account.
116
•Most experts DIA spoke with
do not endorse Facebook for
corporate career advancement.
Most agreed that LinkedIn is the
social media platform of choice
for this purpose, especially in
combination with Twitter.
•A Facebook profile is considered
primarily a tool for connecting
with friends and family.
According to the pundits, the
danger of Facebook is having
profile pages that contain both
personal and business contacts.
•If you choose to use Facebook
for both personal and
professional connections, make
sure your career information
is visible on your “wall”. Both
Shannon and the CEO of
jibberjobber.com, Jason Alba,
suggest using one of the
following options to prevent
social situations from potentially
harming your professional
image.
-- Carefully select your privacy
settings. Some include the
ability to review potential
posts and photos (so
friends don’t “tag you” in
embarrassing situations) and
allow you to choose your
audience when you enter a
post.
-- For extra safety, make your
Facebook profile 100%
private so that business
people cannot access the
social information on your
profile. Establish a discrete
Facebook account, known
as a “business page” or “fan
page” for your professional
connections. Google
“business page + Facebook”
to view the current rules.
VOL 4
A Few Words Go a Long
Way on Twitter
•Twitter, a microblogging
platform, is used by
entrepreneurs and small
business persons to brand
themselves – and ultimately to
sell products and services. It is
also used by individuals for job
searches/career development,
and by recruiters to find qualified
job candidates.
•Twitter users send
140-character (or less)
messages in “real time” to
connections called “followers.”
To begin using this social
media platform, first become
a “follower” of others who are
well-known in your or other
related industries.
-- Use Twitter as a lead
generation tool: Go to the
Twitter search bar; type
in search words to find a
directory in your area of
expertise. In the directory,
find individuals with whom
you would like to contact.
-- Seeking career
advancement? “Don’t forget
to link to where you want to
go, not necessarily where
you are now,” Schwabel
advises. Seek out titles of
positions that you hope to
attain in the future.
•Executive recruiters or hiring
managers may put out a tweet
using the hashtag (#) to indicate
specific jobs openings. To find
a pharma sales rep job, for
instance, Bogner suggests: “Go
to the search bar in Twitter and
type in “#jobs pharma sales.”
Or look on Google’s search bar
and type in “twitter jobs pharma
sales”.
•The hashtag (#) indicates a
subject topic. The tweeting
conversation takes place in
real-time. The first to “tweet”
on this issue creates the
name of the discussion and
precedes that phrase with a
#. To brand yourself, insert a
(#) somewhere in your tweet,
explains Shannon
•To brand yourself as an expert
in your field, “tweet” (or create
a message) about your industry.
The aim: When someone likes it,
they will “retweet” (or send it on)
to their followers.
•Tweet about industry trends,
events, news items or link to
your own articles, presentations,
blogs, podcasts or You Tube
videos to become known as an
industry thought leader.
Social media is not just social
anymore. While it’s amusing to
see status updates of celebrities
or tweets from friends, don’t
underestimate social media’s
usefulness for business. As a
corporate decision-maker at
the top, it can help connect
your company to customers
and distribute news about your
services. For corporate job
holders at all levels, don’t forget
to use social media’s tools to
develop your career. In other
words, emphasize your strengths
and abilities using branding
techniques and social media. And
build your success communicating
the 21st century way.
117
gf
ISSUE 2
REGULATORY ROUNDUP
FDA Releases Long-Awaited
Guidances on Biosimilars
VOL 4
118
Carol H.
Danielson
M S , D r P H,
R A C h a s p ro v i d e d re g u l a tory expertise
a n d l e a d e r sh i p
f o r mo re t h a n
25 years for
drugs, biologics and Medical devices
f ro m d i sc o v e r y
t h ro u g h p o s t ma r k e t i n g .
She is the
P re si d e n t o f
Regulatory
Advantage in
Tu c so n , A Z
and can be
re a c h e d a t
re g a d v a n t a g e @
a t t .n e t o r ( 5 2 0 )
9 0 7 -5 1 9 3 .
On February 9, 2012 FDA released
the first 3 in an anticipated series
of long-awaited guidances for
the development of biosimilars
in the United States. These
guidances are intended to help
define the pathway for approval of
biosimilars under an abbreviated
licensure pathway allowed under
section 351(k) of the Public
Health Service Act (PHS Act) as
established under the Biologics
Competition and Innovation Act of
2009 (BPCI ACT).
The 3 guidance documents now
released for comment include:
1) Questions and Answers
Regarding Implementation of
the Biologics Price Competition
and Innovation Act of 2009;
2) Scientific Considerations in
Demonstrating Biosimilarity for a
Reference Product; and 3) Quality
Considerations in Demonstrating
Biosimilarity to a Reference
Protein Product.
For a product to be a biosimilar
it must be shown to be “highly
similar” to an approved
reference product and must
be interchangeable in clinical
practice. Key approaches
emphasized in the guidances
include a “risk-based totality of the
evidence approach” and a “stepwise approach” in developing
evidence to support biosimilarity.
Sponsors and applicants are
encouraged to seek FDA advice
early and at important decisions
points in the development
process. FDA stated that a
Federal Register Notice
will be issued shortly with a
separate docket for submitting
comments.
gf
GLOBAL FORUM
ASSOCIATION NEWS
First DIA Student Day
ISSUE 2
On March 1, DIA worldwide headquarters
hosted 37 students from the newly
chartered DIA Student Chapter at the
University of the Sciences in Philadelphia
(USP), PA, for the first DIA Student Day.
VOL 4
120
Danny
Benau,
Chapter
Co-Advisor
After lunch with DIA staff, students
received an overview of DIA’s
mission, vision and strategic
initiatives from Susan Cantrell
(DIA Director of North American
Operations). Lauren Edelstein
Henry (Principal Operational
Specialist, Janssen Pharma)
spoke about careers in the
pharmaceutical industry; and, via
SKYPE, Dr. Stephen Sonstein
(Director, Clinical Research
Administration and DIA Student
Chapter Advisor, Eastern Michigan
University) shared best practices
for student chapters. Students
were accompanied by Chapter
Co-Advisor Dr. Danny Benau
(Director, Biomedical Writing
Programs, USP). Dr. Benau
is a longstanding supporter of
DIA initiatives for students and
emerging professionals and also
serves on the Core Committee for
the DIA Professional Education,
Training & Development Special
Interest Area Community (SIAC). Members of the DIA Student
Chapter at the University of
Medicine & Dentistry of New
Jersey (UMDNJ), Newark, will visit
DIA headquarters in Horsham on
April 5. DIA plans to make onsite visits for students an annual
event.
ASSOCIATION NEWS
Worldwide ED Named to NHC Board
The National Health Council, Washington
DC, has named Paul Pomerantz, DIA
Worldwide Executive Director, to its board.
Paul
Pomerantz
The National Health Council (NHC)
provides a united voice for millions
of people with chronic diseases
and disabilities and their family
caregivers. This past February, DIA
served as a Supporting Sponsor
for the NHC’s 25th Annual
Voluntary Health Leadership
Conference, which brings together
the chief executive officers and
lead volunteers from member
patient advocacy organizations to
share information about medical
research and health care policy,
and best practices for serving
people with chronic diseases and
disabilities.
121
gf
GLOBAL FORUM
ASSOCIATION NEWS
2012 EuroMeeting Award Winners
ISSUE 2
Every year DIA distributes service awards
that recognize significant accomplishments
in the discovery, development, regulation,
surveillance or marketing of pharmaceutical
and/or related products as well as recognizing
significant volunteer contributions to DIA and
the advancements of our mission and vision.
VOL 4
122
Dr. Daniel
Brasseur
We congratulate this year’s
winners who are highlighted
below.
on pediatric procedures linked to
the launch of the recent pediatric
regulation.
Distinguished Career Award
Dr. Daniel Brasseur
AFMPS, PDCO Chairman
Excellence in Volunteer
Leadership - EU
Dr. Marisa Papaluca-Amati MD
Head of Scientific Support and
Projects
European Medicines Agency,
European Union
Daniel Brasseur is a pediatrician
having developed his research
activities in the field of nutrition
and infectious diseases in Africa
first. Thereafter he acted in the
pharmaceutical Industry (1985-7)
as a medical director at KabiPharmacia for parenteral nutrition
and growth hormone.
He continued his career at the
Children’s Hospital in Brussels
and joined the Federal Agency for
medicines and Health Products
in 1997 as a coordinator of
medical assessors. He became
a member (1997) and then the
chair of CHMP (2000-2007), of
the vaccine working party (2007)
and since 2007, he is chairing the
PDCO. In his regulatory activities
he has been participating in many
DIA meetings both in the US and
in Europe and been an active
organizer of several DIA meeting
sessions both on vaccines and
Graduated in
Medicine in
Rome in June
1978 Marisa
engaged in
the emerging
Clinical
immunology research area and
worked in clinical practice as
specialist in internal medicine
(1978-1988).
Medical director at the Italian
Ministry of Health (1984 – 1994)
she actively contributed to
Pharmacovigilance, Safety and
Efficacy of pharmaceuticals as
Rapporteur for a number of
products and member of National
and International Committees
and expert groups such as the
CPMP and the ICH . In 1991
she established the first national
Operational Centre for Community
Procedures, leading innovative
activities in collaboration with
EU and international regulatory
partners and since contributed to
the drafting of Regulation 2309/93
establishing the European
Medicines Evaluation Agency.
From 1994 to date at the EMA,
she took scientific and managerial
leadership maintaining
special focus on innovation
in pharmaceuticals and in
regulatory science and processes
Being an engaging communicator
Marisa has been active in the
DIA global platform since 1991
bringing into the stakeholders’
debate clear and independent
information from Regulators.
Landmark contributions
include the workshops on
Pharmacogenomics, on
Biosimilars, on the Qualification
Process for Biomarkers and the
recent track on Personalised
Medicine. Marisa also contributed
to 14 books and published more
than 40 articles in scientific and
regulatory Journals.
Outstanding - EU
Ms. Janet E. Davies
Director, International Medical
Information
Gilead Sciences
Janet Davies
qualified as a
pharmacist and
has spent the
majority of her
career in the
pharmaceutical
industry. She joined the industry
as a medical information
pharmacist and has worked at
a number of different pharma
companies as her career has
progressed. She has continued to
specialise in medical information
and has also gained experience
in pharmacovigilance and broader
medical affairs activities.
Janet has been an active member
of the UK professional association
PIPA (Pharmaceutical Information
and Pharmacovigilance
Association; formerly AIOPI) and is
a former committee member and
past president of the association.
She was previously a co-chair of
the DIA Medical Communications
SIAC and chaired the first
European programming by the
SIAC, which was a single day
track at the DIA EuroMeeting in
2005. Following the success
of this initial track she worked
with the DIA team in Europe to
include Medical Information and
Comunications in the inaugural
multi-track Clinical Forum.
Janet chaired the first Medical
Information and Communications
conference at the DIA Clinical
Forum in 2006. She has
continued to chair the Medical
Information and Communications
track at subsequent meetings
through 2011 and has developed
the programme content to ensure
that it attracts an increasing
audience. Janet is the chair of
the 2012 Clinical Forum which will
be held in October in The Hague.
She has also served two terms as
a member of the Advisory Council,
Europe.
Dr. Nermeen Y. Varawalla
Founder & CEO
ECCRO
Dr Nermeen
Varawalla is
the founder
and CEO of
ECCRO, a
differentiated
India specialist
clinical CRO. Dr Varawalla is
an acknowledged industry
expert in the conduct of global
clinical trials and has previously
established and grown two
organisations in this sector. Firstly,
PerinClinical which she sold to
PRA International, following which
as Vice President she led the
establishment of PRA India. Dr
Varawalla has participated in the
design & conduct of numerous
global clinical trials that have
included emerging countries and
has greatly contributed to raising
the standards of clinical research
in India
Dr Varawalla trained at Seth
GS Medical College and KEM
Hospital, University of Bombay
and is a Fellow of the College of
Physicians & Surgeons of India.
She was Rhodes Fellow at the
123
University of Oxford where she
obtained a doctorate for molecular
genetics research and is a
Member of the Royal College of
Obstetricians & Gynaecologists.
Dr. Varawalla obtained her
MBA from INSEAD and joined
Accenture’s UK Healthcare and
Life Science business strategy
consulting practice.
Dr Varawalla is a frequent invited
speaker at industry conferences,
serves on the editorial board of
the Journal for Clinical Studies
and on the Program Committee
for the DIA Euro Meeting and
DIA Clinical Forum. Dr Varawalla
Chaired the Programme
Committee for the recent 2011
DIA Clinical Forum.
gf
GLOBAL FORUM
PATIENT PERSPECTIVE
Dwindling Time and Lingering Hope:
A researcher discusses the challenges her family faced when
considering clinical trial participation
ISSUE 2
Life can change in an instant,
but one thing always abides: hope.
VOL 4
124
Linda Strause understands
that better than most. She also
understands how hope – the
unfailing feeling and expectation
that tomorrow will be better
– can prevent a person from
participating in a clinical trial; even
when that person is a clinical trial
expert.
April 5, 2008 was a sunny
Saturday morning in Del Mar,
California. Linda woke up thinking
about the dinner party she and her
husband, Randy, were throwing
that night. But plans hit a hitch
when 58-year-old Randy, with
noticeable concern in his voice,
remarked that he just “didn’t seem
right.” Linda called the doctor,
who advised a trip to the ER.
“Everything seemed so normal
until we took him into the
emergency department,” Linda
says. “But all of a sudden
someone was asking my husband
of 35 years to count backwards
by 10 and he couldn’t do it.”
A brain scan showed a highly
vascularized tumor on Randy’s
brain. Rather than enjoying a
pleasant dinner with friends, Linda
and Randy embarked on their new
reality.
The New Reality
“For patients and families dealing
with a critical illness, time is a
void,” says Linda. “It doesn’t move
fast or slow; it’s just a void.”
And the Straus’ had fallen into
the void. Linda canceled dinner,
called family members and, all
alone, followed the ambulance
transporting Randy to a different
hospital where he was admitted
to the ICU. A few days later,
Randy underwent brain surgery,
which produced a diagnosis of
glioblastoma multiforme (GBM),
an extremely aggressive and
incurable brain cancer.
A glioblastoma tumor is like
an octopus. It’s difficult to
surgically remove all the tendrils
without jeopardizing the brain.
Consequently, even when
the main tumor is removed,
microscopic ones remain.
Doctors recommended a threephase treatment plan. A balloon
implanted during surgery would
be injected with radioactive iodine
and removed after six days. Randy
would later receive local radiation
five days a week as well as lowdose chemotherapy daily for five
weeks. In mid-summer he would
receive high-dose chemotherapy
five times over the course of a
month.
The Other Side of the
Desk
Even with a plan in place, Linda
began exploring options. It’s
hard to imagine anyone better
suited to navigating the clinical
trial process. Linda has a
doctorate in neurophysiology
and is executive director and
head of clinical operations at
Vical Incorporated. She’s been
conducting oncology research for
years and is herself the manager
of a Phase III melanoma trial. Not
surprisingly, given her experience,
Randy depended on her to make
decisions about his care.
For the first time Linda came
face to face with the reality of
just how hard it is for patients
to wind their way through the
clinical trial process. Much as
she liked, respected, and trusted
Randy’s medical oncologist
– he was a friend and a subinvestigator on Linda’s melanoma
trial – he was primarily familiar
with the trials in which he was
personally involved or that were
being conducted at the cancer
center where he worked. She
found www.clinicaltrials.gov more
suited for researchers’ needs
than would-be participants. She
asked colleagues and friends for
opinions and recommendations,
but couldn’t help wondering how
people who didn’t have access to
such a network coped.
“I read and I read,” she says. “I
read all about clinical trials. But
there’s nobody there to help you
navigate. You’re alone. You are
truly alone,” she says.
As she read about different trials,
Linda would present the literature
to Randy’s doctor. “He rightly and
correctly would not try to influence
me. He wouldn’t and shouldn’t
say ‘I think this is the best thing.’”
As ethical and proper as that
neutrality may be, it puts an
enormous burden on the patient
and the family who are trying
desperately to discern the best
care path.
“I’d walk around with my 3-ring
binders and my son would email
me dozens of articles, but in the
end, you make the best decisions
you, and you alone, can,” she
says, because there is no one to
guide you.
Hope as a Deterrent to
Participation
But even these obstacles were
small compared to the greatest
roadblock of all: hope.
“You get these little glimmers,”
Linda says. “Randy would have
a positive scan or he’d be going
to work every day and not having
symptoms and I’d think, ‘This is
working. There’s hope’ and I’d
keep on. I understand why only
3% of cancer patients participate
in clinical trials. I do. It’s because
of hope. ”
Randy augmented his care
with myriad complementary
and alternative therapies. He
tried nutraceuticals, pilates,
yoga, medical marijuana, and
acupuncture. Because the tumor
was in his frontal lobe, he suffered
nominal dysphasia, often losing
simple words. Still, he continued
with his life, spending time with his
wife and grown sons, enjoying his
huge circle of friends, remodeling
houses, traveling, and enjoying
as many Pacific Coast sunsets as
possible.
Linda knew the odds were
against Randy. Standard of care
treatment works for only about
2% of patients. Still, she knew the
odds of success with a Phase I
or Phase II trial were worse, or at
the best, unknown. Linda wasn’t
interested in generalizable results.
She wanted to keep Randy alive.
So when she came to a
crossroads about whether to
continue with standard of care or
participate in a trial, she chose the
former. By the time it was clear
that traditional treatments weren’t
working, Randy no longer qualified
for the Phase II trial Linda had
been considering: he had had too
many treatments.
On April 16, 2010, Randy Strause
died at home, surrounded by his
loved ones.
Looking back, does Linda second
guess her decisions? Does she
play Monday morning quarterback
and lie awake wondering, “What
if?”
Of course she does. Anyone
would.
Challenging Design
Protocols
Knowing that she can’t change
the past, Linda is making it
her goal to try to change the
future. She wants researchers
to understand the enormity of
the decisions they are asking
would-be participants to make
and challenging them to consider
ethical issues pertaining to
treatment of patients facing lifethreatening diseases.
“If a patient goes into a trial with
the attitude that, ‘This is my only
hope,’ are they truly making an
autonomous decision?” she asks.
“We have to somehow balance
the needs of the patient and the
needs of the companies that are
125
gf
GLOBAL FORUM
ISSUE 2
trying to introduce new therapies
to prolong the life of the patients
while maintaining quality of life.”
VOL 4
126
Linda says that means making
an effort to design protocols that
maintain the trial’s validity while
enabling seriously ill participants
to receive both standard of care
and investigational agents. It
also means providing patients
with trial information soon after
diagnosis so that they can make
decisions about their care that
will not preclude trial participation
in the future. Such changes will
help ensure autonomous decision
making and improve participation
in clinical trials,” Linda says.
“In the end researchers need
to take a moment and put
themselves in the position of the
patient and the family. They need
to understand the elements of
time and hope because if they
do, then we will learn to create
protocols that better meet the
needs of these patients and their
physicians.”
his story is from a series of articles
created by CISCRP as part of their
educational awareness campaign
to increase public understanding
that those who volunteer to
participate in clinical trials are
genuine Medical Heroes.
127
gf
GLOBAL FORUM
BOOK REVIEW
The World’s Health Care Crisis:
From the laboratory bench to the patient’s bedside
by Ibis Sanchez-Serrano
ISSUE 2
This book is advertised by its publisher (Elsevier
Insights) as the “…first book to examine health
care in such great depth, by bringing together all
the varying elements (ie, health insurance, science
and innovation, pharmaceutical development,
public policy and business management) under
one cover.”
VOL 4
128
Reviewed
by Betty R.
Kuhnert,
PH.D ., M BA i s
an independent
c o n s u l t a n t wi t h
over 30 years
of experience
re l a t e d t o
clinical
re se a rc h i n
academia
and the
p h a r ma c e u t i c a l
i n d u s t r y. S h e
is on the
e d i t o r i a l b o a rd
o f t h e DIA’s
Gl o b a l F o r u m .
This is somewhat deceiving
because the book is primarily
about the pharmaceutical and
biotech industries. The major
premise is that the global health
care crisis is not due to lack of
affordable access to health care
insurance coverage per se, but
lack of access to better, safer and
more affordable medicines. This
is due, in turn, to a severe crisis in
innovation.
It should be noted that the
author has no connection to the
pharmaceutical industry. He has
a BS in genetics and art history
from Iowa State University, and
an MS in international business
and technology management
and monetary theory and policy
from Tufts. He is an independent
corporate strategy and policy
consultant in the areas of biotech,
pharmaceuticals and health care,
and is a writer and advisor for
several Panamanian newspapers
who presents some anti-industry
bias. Nevertheless, he manages
to provide a reasonably big picture
of how the biopharmaceutical
industry functions.
The book was financed by a
mysterious private philanthropist
and published electronically by
Elsevier as part of its new online
book series. Elsevier is known
for its high-quality medical
textbooks and journals, but this
book’s primary value is probably
as a quasi text/reference that
provides an overview of the
biopharmaceutical industry and
its relationship to academia and
the health care industry. While
executives involved in strategic
planning might enjoy the book,
it would also be helpful for those
new to the pharmaceutical/
biotechnology/health care
industries or involved in a related
university program. The book has
extensive “notes” at the end of
each chapter based on interviews
and newspaper articles. The list
of terms at the end of the book
was also helpful because the book
spans several disciplines. But
better editing throughout, and a
list of abbreviations at the end
would have also helped.
Whether or not you agree with
the book’s premise, the book
has some worthwhile information
and suggestions to solve the
innovation issues. The book
addresses all the elements that
play an important role in the
process of drug discovery and
development: (1) the industry
base (“big pharma” and “biotech”);
(2) the regulatory infrastructure;
(3) the academic/innovative
base; (4) the financial/investment
platform (ie, venture capitalists);
and (5) government-sponsored
research agencies. In particular,
the chapters on the commercial
history of the biopharmaceutical
industry, and the chapters on the
complexity of innovation and the
life cycles of biotech companies
were quite interesting.
The author makes some good
points and suggestions to fix
the problems, but his bias
detracts from his message.
For example, the introduction
states: “Unfortunately, the
biopharmaceutical industry (and
investors) has been more focused
on the financials inherent to its
endeavor than on a long-term
vision of productivity, high-quality
research, product safety and,
of course, transparency and
integrity.” Later, the author’s
bias is even more evident with
statements such as, “The major
issue we encounter with the
pharmaceutical industry is that
it has been abusive on all fronts,
and people know it.” He goes
on to temper this with, “But at
the same time, it is necessary
to remember that there are
many risks looming on the
horizon if our attitude toward
the biopharmaceutical industry
becomes too negative.” He then
suggests that, “It is ‘lucky’ that
the pharmaceutical industry is
going through the deepest crisis
in its 150-year history – with a
severe lack of productivity and
loss of sales to generics, not to
mention shorter patent exclusivity
time, poor public image, and
great concern from regulators
about safety issues.” According
to the author, this is “lucky”
because it makes the industry
more receptive to external input
and forces it to consider some
real internal metamorphoses to
fix the research and development
productivity issues.
The author’s conclusion is that
in order to fix the world’s health
care crisis, health care reform,
“should be not only about health
insurance reform, but also about
biopharmaceutical industry
reform, intellectual property law
reform, regulatory system reform,
university-industry collaboration
reform, basic science reform,
pricing reform, prevention reform,
tort reform, and other types of
reform – all of which contribute
directly and indirectly to the
cost of the health care system”.
Although probably warranted, this
statement seemed rather broad
in view of the fact that health
insurance reform, prevention
reform, tort reform, and “other”
types of reform, were barely
addressed.
129
gf
GLOBAL FORUM
Members on the Move
ISSUE 2
DIA is committed to improving
the professional performance
of our members and volunteers
through our educational and
networking forums. Please join
us in congratulating the following
DIA members for their recent
professional accomplishments:
VOL 4
130
Daniel
Pruski
Mark A.
Hovde
Daniel Pruski, PharmD, RPH,
MS, PhD, FASCP, was recognized
by Cambridge Who’s Who for
Excellence in Pharmaceutical
Research & Consulting. Dr. Pruski
currently serves as Researcher
and Pharmacist for Rx Pharmacy.
He was named a Professional
of the Year in Pharmaceutical
Research & Consulting in 2010 by
Cambridge Who’s Who. Dr. Pruski
earned his MS from the Albany
College of Pharmacy (NY), his
PhD in epidemiology from William
Cullen Bryant University (AZ), and
his Doctor of Pharmacy from the
University of Florida.
Mark A. Hovde was appointed
as Vice President of Sales &
Marketing for Entelos Holding
Corp. Mark previously served as
Senior Vice President of Business
Development for Certara. Mark
earned his MBA in Marketing from
Harvard Business School, and
was a Benjamin Franklin Scholar
while earning his BS in Economics
& Finance at the University of
Pennsylvania.
On the Move? Let Us Know – If you’re an active DIA member and would like to share your professional
or career news with other members in our Global Forum, please send your announcement (and highresolution digital photograph, if you have one) to Chris.Slawecki@diahome.org. All submissions are subject to
DIA editorial review and approval. Please remember to keep your DIA member profile current by logging into
“MyDIA” and updating your contact information to reflect your new job title, employer, or email address, too.

inform advise reach educate april 2012 vol 4 • issue 2

Transcription

Similar documents

lror"**rW - Neighborhood House Association

Gun-Style Infrared Thermometer with Dual Laser Sighting 422 / 423

SAN JAMAR SIMPLICITY

MFHutton

Shusaku`s famous ear-reddening game

ePortefolio`s

Calfskin Heads, Goatskin Heads, and Flesh Hoops

Research Centre for Child Studies, Univ. of Minho, Braga, Portugal

Please join us on Facebook: www.facebook.com/einsteinaward

TruPay HR Forum.cdr