SPEAKERS

6 Annual Patient Recruitment
and Retention Summit 2014
th
Free Adobe InDesign Template
18 - 20 February 2014 I Berlin
Kempinski Hotel Bristol Berlin *****
SPEAKERS
INCLUDE:
TEVA - Yafit Stark
SANOFI - Terttu Haring
SANOFI - Julia Yang
JANSSEN - Suzann Johnson
BRISTOL MYERS SQUIBB - Susanne Busta
GET INSPIRATION ON
HOW TO
RECRUIT AND RETAIN
PATIENTS MORE EFFECTIVELY
PATIENT
RECRUITMENT &
How to bridge global
protocols with local
LEGISLATIONS
RETENTION
In 2013 we had participants
from over 30 countries
13
How can pharmaceutical companies work
together to make it easier for patients to enroll?
How to go from competition to collaboration?
Gold
sponsor:
Silver
sponsors:
Bronze
sponsor:
CASE STUDIES
FROM COMPANIES:
• Ipsen
• Janssen
• Sanofi
• Bristol Myers Squibb
SPEAKERS
Chairperson
Liz Moench
President and CEO
MediciGlobal
Peter Myrenfors
Medical Director
Ipsen
Steffan Ekman
Senior Clinical Scientist
Roche
Suzann Johnson
Director, Global Clinical
Operations
Janssen
Terttu Haring
Regional Head Clinical Study
Unit, Northern Europe
Sanofi
Cellia K. Habita
President and CEO
ARIANNE
Holger Maria Rohde
Director, Strategy
Implementation Lead
Merck Serono
Julia Yang
Senior Medical Director, North
America Clinical Study Unit,
Sanofi
Emre Basar
Medical Science Liaison
Rigosertib
Baxter Deutschland GmbH
Leo Ballering
Global Clinical Trial Manager
MSD
Yafit Stark
Vice President, Global Clinical
Advisor
Teva
Ines Koch
Head of Clinical Research
A. Menarini Research &
Business Service GmbH
Michael-Friedrich Boettcher
Senior Expert Clinical
Pharmacodynamics
Bayer
Dietrich Bosse
Head, Region Central and
Northern Europe, Global Clinical
Research and Development
Novartis Vaccines
Bonnie Brescia
Founding Principal
BBK Worldwide
Darren Cowann Bittner
Head, USA Study Start Up Unit
Pfizer
Susanne Busta
Associate Director Site & Data
Mngt.
BMS
Gretchen Goller
Sr. Director – Patient Access and
Retention Services (PARS)
PRA
Stuart Redding
Vice President - Global Business
Development, Marketing & PR
The Medical Research Network
Joel Roberts
Global Project Manager
UBC
Who should attend
The 6th Annual Patient Recruitment and Retention Summit has been designed for Members of Board,
Vice Presidents, Directors, Head and Senior Managers from pharmaceutical industry involved in:
Clinical Operations
Monitoring Operations
Clinical Development
Clinical Research
Study Management
Medical
Clinical Research & Development
Clinical Trial Operations
Patient Recruitment and Retention
6TH ANNUAL
PATIENT RECRUITMENT AND RETENTION SUMMIT
The pharmaceutical industry is highly competitive nowadays and ‘time is money’ is a more then
accurate phrase to be used, especially when it comes to clinical trials. For a new drug to be released,
the trial needs to be finished successfully. But what happens when the patient enrollment takes
too long? Or what if there are not enough patients in a study? Or even after a successful recruitment, the patients start to drop-out? The answer is simple: the release of the new drug becomes
more and more expensive. Patient recruitment and patient retention represent a challenge
itself and pharmaceutical companies are trying to find their ways to overcome these challenges.
KEY TOPICS
•
•
•
•
•
Recruitment challenges
Patient retention
Site selection and its impact on patient recruitment
Online technologies for successful patient recruitment
The effect of legislation and regulatory environment on clinical trials
EVENT
PROMISE
By attending this event you will :
• Gain the new ideas on identification and targeting of the quality patients
• Discover the influences of study procedures on
clinical laboratory parameters
• Improve your ability to recognize the ‘right’ trial
sites
• Get new ideas on how to ensure successful and
on time recruitment
• Learn how to support patient satisfaction & retention by using mobile health applications
• Explore new approaches how to motivate your
patients to be engaged in a study and avoid
drop-outs
Benefits of attending
• Learn how the BIG pharmaceutical
players deal with challenges related to
patient recruitment
• Discover how some of the pharma
companies approach patient retention
• Hear about how novel online technologies
can be used for successful patient
recruitment
• Learn about best practices when it comes
to picking the right trial site and how
Back-to-Back interviews can support the
search
• Find out more about Variability of clinical
laboratory parameters and new exploratory biomarkers under typical Phase I Study
conditions
• Learn how to enhance patient enrolment
into clinical trials
SCHEDULE
TUESDAY I 18 February 2014
CASE STUDY
Tracking subject recruitment and real time statistical power analysis enable dynamic decision making in a Phase 2 clinical trial
Leo Ballering I MSD
Networking Coffee Break
11:15
Optimizing the feasibility process to optimize patient recruitment
Terttu Haring I Sanofi
12:00
SPECIAL FEATURE: Round table discussion
Open discussion time
Lunch
Berlin City Tour (Complimentary)
THURSDAY I 20 February 2014
WEDNESDAY I 19 February 2014
Registration and Morning Coffee
Registration and Morning Coffee
09:00
Opening Remarks from the Chairperson
09:00
Opening Remarks from the Chairperson
09:15
Challenges in Patient Enrollment into Very
Complex Indications, such as Early Disease
Stage
Yafit Stark I Teva
CASE STUDY
08:20
09:15
Efficient strategies for patient
retention
Suzann Johnson I Janssen
10:00
Variability of clinical laboratory parameters
and new exploratory biomarkers under typical
phase I Study conditions
Michael-Friedrich Boettcher I Bayer
CASE STUDY
08:20
10:00
Augmenting Patient Recruitment:
Having Feet on the Street
12:00
12:45
14:00
Seven new-school solutions to old-school
challenges
Bonnie Bresca I BBK Worldwide
Lunch
Recruit to retain, quality vs quantity
Steffan Ekman I Roche
14:45
15:30
16:00
17:30
Interactive panel discussion
Moderator:
Stuart Redding I The Medical Research Network
Group of speakers
Cocktail reception
10:45
Networking Coffee Break
11:15
Clinical Trial Data Transparency and
Patient Communication
Holger Maria Rohde I Merck Serono
12:00
MENA role in Clinical Research vs
more established NEEs
Cellia K. Habita I ARIANNE
Lunch
14:00
Novel Online Technologies for
Successful Patient Recruitment
Emre Basar I Baxter Deutschland GmbH
14:45
Innovative Approaches to Patient Retention in
Long-Term Studies and Registries
Joel Roberts I UBC
15:30
Networking Coffee Break
How to pick the right trial sites? Can
Back-to-back Interviews support the Search?
Gretchen Goller I PRA
12:45
Reducing Clinical Trial Costs with New
Strategies for Patient Recruitment
Liz Moench I MediciGlobal
Susanne Busta I Bristol-Myers Squibb Gmbh
16:45
CASE STUDY
Medical Operation Strategy and Success
in Patient Recruitment
Julia Yang I Sanofi
CASE STUDY
11:15
Networking Coffee Break
CASE STUDY
10:45
CASE STUDY
14:00
CASE STUDY
CASE STUDY
12:45
CASE STUDY
CASE STUDY
10:45
Opening Remarks from the Chairperson
Accelerating Study Start Up
Darren Cowan Bittner I Pfizer
CASE STUDY
10:00
Registration and Morning Coffee
Networking Coffee Break
16:00
Recruitment challenges
Peter Myrenfors I Ipsen
16:45
SPECIAL FEATURE: Round table discussion
Open discussion time
17:30
Closing Remarks from the Chairperson
CASE STUDY
08:20
09:00
09:15
CASE STUDY
CASE STUDY
CASE STUDY
DAY 1
18 FEBRUARY 2014
6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014
08 : 20
Registration and Morning Coffee
09 : 00
Opening Remarks from the Chairperson
09 : 15
Darren Cowan-Bittner
Head, USA Study Start Up Unit
Pfizer
Accelerating Study Start Up
The presentation will address key acceleration topics:
• Are we asking the right site selection questions?
• What is the industry standard timelines to start a site
• What strategies do those in the top tier percentile apply to accelerate?
Tracking subject recruitment and real time statistical power analysis enable dynamic
decision making in a Phase 2 clinical trial
10 : 00
Leo Ballering
Global Clinical Trial Manager
MSD
• Monitorin-g Subject Recruitment
• Prediction of total enrollment
• Statistical Power Analysis
10 : 45
Networking Coffee Break
11 : 15
Terttu Haring
Optimizing the feasibility process to optimize patient recruitment
Northern Europe Regional
Head Clinical Studies
Sanofi
12 : 00
Round table discussion
• Real-time identification, approach and recruitment of eligible patients for clinical
trials
• The Whole Recruitment Population: Tips and Tricks to Reach Out to All
• How to measure the feasibility of a protocol accurately?
SPECIAL FEATURE: Round table discussion
Suggested topics:
•
How can pharmaceutical companies work together to make it easier for patients to
enroll? How to go from competition to collaboration?
•
Patient Recruitment in Emerging Markets
•
Development in vaccines and and differences to regular drug development
•
Electronic informed consent form – do you utilize the opportunity offered by the
evolution in technology
12 : 45
14:00
Lunch
Complimentary Berlin City Bus Tour
CASE STUDY
BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225
www.patientrecruitmentsummit.com
CASE STUDY
CASE STUDY
CASE STUDY
DAY 2
19 FEBRUARY 2014
08 : 20
Registration and Morning Coffee
09 : 00
Opening Remarks from the Chairperson
09 : 15
Yafit Stark
Challenges in Patient Enrollment into Very Complex Indications, such as Early
Disease Stage
• The Challenges in Diagnosis of Early Disease before Switching into Definite Disease
• The Involvement of Imaging Technology in Diagnosis
• Recruitment of Qualified Centers with Capabilities of Enrollment of Early Disease
Patients
10 : 00
Michael-Friedrich
Boettcher
Variability of clinical laboratory parameters and new exploratory biomarkers under
typical phase I Study conditions
Clinical Pharmacodynamics
Bayer Pharma AG
• Intra- and inter-day-to-day variability
• Influences of study procedures on clinical laboratory parameters
• The role of new exploratory liver, kidney and vascular biomarkers
10 : 45
Networking Coffee Break
11 : 15
Julia Yang
Medical Operation Strategy and Success in Patient Recruitment
Vice President, Global Clinical
Advisor
Teva
CASE STUDY
Senior Medical Director, North
America Clinical Study Unit
Sanofi
• Development and implementation of global recruitment strategy and patient
identification pathway
• Effective site recruitment model and success experiences
• Above and beyond the medical/clinical operation strategy and excellence
12 : 00
Bonnie Brescia
Seven new-school solutions to old-school challenges
12 : 45
Lunch
Founding Principal
BBK Worldwide
CASE STUDY
6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014
14 : 00
Steffan Ekman
Senior Clinical Scientist
Roche
CASE STUDY
14 : 45
Liz Moench
President and CEO
MediciGlobal
No matter how much the pharmaceutical R&D industry and patient recruitment
sub-specialty evolve, some challenges remain the same. What’s exciting is that now
we have new innovations with which to take on these challenges. This presentation
will review the top “new-school” solutions, including mobile apps as a recruitment and
retention tactic, new technologies for site selection and engagement, mobile website
optimization to increase your referrals, and more. Attend this session to learn about
what you need to implement in order to more effectively tackle “old-school” challenges,
and graduate to a higher level of understanding about new technologies and solutions
for enrollment success.
Recruit to retain, quality vs quantity
• Understand the importance to recruit the right patients
• Plan upfront, prevent later challenges
• Being flexible to maximize information
Reducing Clinical Trial Costs with New Strategies for Patient Recruitment
•
•
•
•
Using digital strategies to set up recruitment for rapid enrollment
How to avoid costly delays and keep trials on track
Using metrics for cost and time management
The role of patient-centric approaches to optimize success
BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225
www.patientrecruitmentsummit.com
DAY 2
19 FEBRUARY 2014
CASE STUDY
15 : 30
16 : 00
Susanne Busta
Associate Director Site & Data Mngt.
Regional Clinical Operations DACH
Bristol-Myers Squibb Gmbh
6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014
Networking Coffee Break
How to pick the right trial sites? Can Back-to-back Interviews support the Search?
• In order to ensure successful & on time recruitment, identification of the ‘right’
trial sites is of utmost importance
• Since patient potential is easily over-estimated, this poses a challenge for both
parties, sponsor as well as site
• In order to guide this process a wide range of feasibilities tools is already utilized
• The Back-to-Back interview can be a valuable addition to this toolbox
16 : 45
SPECIAL FEATURE: Interactive Panel Discussion
Moderator:
Stuart Redding
In this session, the audience has an opportunity to ask questions and have an open
interactive discussion with the discussion panelists
Vice President - Global Business
Development, Marketing & PR
The Medical Research Network
Yafit Stark
Michael-Friedrich Boettcher
Dietrich Bosse
Ines Koch
17 : 30
Suggested topics:
•
Tools for successful patient recruitment (classic/on-line)
•
Local regulations and their impact on patient recruitment/retention
•
Retention of patients in long term, patient outcome studies
•
Recruitment obstacles - excl/incl criteria, study design, ICF
•
How can you use virtual environment technologies to fuel your own organizations’
clinical trial processes?
Cocktail Reception
BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225
www.patientrecruitmentsummit.com
CASE STUDY
DAY 3
20 FEBRUARY 2014
08 : 20
Registration and Morning Coffee
09 : 00
Opening Remarks from the Chairperson
09 : 15
Suzann Johnson
Patient retention
10 : 00
Gretchen Goller
Augmenting Patient Recruitment: Having Feet on the Street
Director, Global Clinical Operations
Janssen
CASE STUDY
• Retaining enrolled patients with effective ‘customer service’
• What is truly essential in retention of qualified subjects in clinical trials?
• High retention rates are crucial. How to achieve them?
Sr. Director – Patient Access
and Retention Services (PARS)/
PRA
• Discuss the strategy of having enrollment specialists/ managers work with clinical
sites at their site to devise recruitment plans, build referral networks, and utilize
local resources
• Present case studies and results of using this strategy
10 : 45
Networking Coffee Break
11 : 15
Holger Maria Rohde
Clinical Trial Data Transparency and Patient Communication
12 : 00
Cellia K. Habita
MENA role in Clinical Research vs more established NEEs
President and CEO
ARRIANE
• Region
• Regulations
• Issues to consider
12 : 45
Lunch
CASE STUDY
CASE STUDY
6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014
Director, Strategy Implementation
Lead
Merck Serono
14 : 00
Emre Basar
Medical Science Liaison
Rigosertib
Baxter Deutschland GmbH
CASE STUDY
• Data Transparency from Clinical Trials - History and Landscape
• The empowered patient as relevant stakeholder and data requestor
• Industry commitments and other obligations to communicate clinical trial results
to the patient
• Communication of Clinical Trial Results to the Patients - preparing grounds for the
next clinical trial recruitment
• Increase the “share of voice” from your developmental program by proactively
communicating clinical trial results
• Clinical Trial Registries and patient advocacy groups - Information broker and
interpreter for the patient as well as for the industry
Novel Online Technologies for Successful Patient Recruitment
• Digital Pharma Solutions to Promote Disease Awareness & Patient Communication
• Social Media Strategies to Enhance Patient Enrollment into Clinical Trials
• Mobile Health Applications to Support Patient Satisfaction & Retention
BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225
www.patientrecruitmentsummit.com
CASE STUDY
CASE STUDY
DAY 3
20 FEBRUARY 2014
6TH ANNUAL PATIENT RECRUITMENT AND RETENTION SUMMIT 2014
14 : 45
Joel Roberts
Innovative Approaches to Patient Retention in Long-Term Studies and Registries
15 : 30
Networking Coffee Break
16 : 00
Peter Myrenfors
Recruitment challenges
16 : 45
Round table discussion
SPECIAL FEATURE: Round table discussion
Global Project Manager
UBC
Medical Director
Ipsen
• Understand the unique challenges for patient retention in long-term studies and
registries and those factors that most impact patient adherence and compliance.
• Provide innovative, effective tools to enhance retention while observing the regulatory, ethical, cultural and budgetary considerations impacting patient retention.
•
•
•
•
Patient populations
Study endpoints
Treatment rational vs clinical practice
Recruitment time and falling inclusion rates
Open round table discussion for the attendees to summarize the information
learned throughout the 2 days, opportunity to raise the final questions and comments. Open discussion time.
Suggested topics:
17 : 30
•
How to increase number of patients in small disease studies?
•
What are the best methods to integrate your global protocols to local legislations?
•
What are the other tools outside the regular ways to recruit patients?
•
How to increase patient recruitment and retention in rare diseases?
Closing Remarks from the Chairperson
BOOKING LINE: Tel.: +421 252 444 224 / Fax: +421 252 444 225
www.patientrecruitmentsummit.com
6th Annual Patient Recruitment
and Retention Summit 2014
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