March 30-Apr 1, 2011

Transcription

Building Strategic Partnerships in an Era of Global Transformational Change
All Star Keynote Speakers
Manage Change
Drive profitability
Execute innovation
Co-Chairperson
DAn HEATH
Guy ADAMi
viJAy GOvinDARAJAn
JOHn HubbARD
New York Times and
Wall Street Journal
Best-Selling Author
of Made to Stick
and Switch
CNBC “Fast Money”
Contributor & Managing
Director, Drakon Capital
Dartmouth College,
Co-author The Other Side
of Innovation: Solving the
Execution Challenge
SVP Global
Development,
pfizer, inc.
Leverage Technology
THOMAS GOETz
Save Lives
CuRT SCHiLLinG
back by popular Demand
bOb EubAnkS
Co-Chairperson
HARRiS kOFFER
Executive Editor, WiRED
MAGAzinE, Author,
The Decision Tree
Former Major League
Baseball Pitcher and 3 Time
World Series Champion,
Founder and Chairman,
38 Studios and Founder,
Curt’s pitch for ALS
Game Show Host
President and COO,
RpS, inc.
MVP Industry Speakers
Mitchell Katz
purdue pharma
Gail McIntyre
Furiex pharmaceuticals
David Gillogy
novartis
Lauren Meyers
Genentech
Nancy Joseph-Ridge
Takeda Global Research &
Development Center, inc.
Mike Collins
pfizer, inc.
Frances Grote
Millenium
Peter Carberry
Astellas
New Content and Insights
• An all-star line-up of 200+ speakers representing the top national and global
pharma biotech innovators
• Delve deeper into nEW focus areas including emerging markets, e-clinical
technologies, quality oversight and much more
• All-access pass to 3 new targeted events for investigators and site management
professionals, medical device professionals, and biotech executives
• Partnerships Hall of Fame Awards honor MVPs over the last 20 years
• 5 all new tracks to give you the latest
SCORE!
S trategic Sourcing
C ost and Contract Management
Just 3 Days...
You Get Accesss To...
2000+
Clinical and Business Professionals
400+
Sponsor and Provider Organizations
200+
Exhibitors with Solutions for Your Next Trial
150+
Pharma, Biotech & Provider Expert Perspectives
Partnerships Hall of Fame Awards
An award ceremony will honor and celebrate
the Partnerships MVPs throughout the past 20
years. Come celebrate the achievements of your
colleagues at the industry’s # 1 meeting place for
clinical development partnering.
O perational Excellence
R egulatory Compliance and Quality Oversight
E -Clinical Technologies
Marquee Sponsor
platinum Sponsors
Gold Sponsors
March 30-April 1, 2011 • phoenix Convention Center • Arizona
Associate Sponsors
www.clinicaltrialpartnerships.com
Celebr
ate
20 years...
...in clinical development excellence at partnerships in Clinical Trials, the industry
meeting place for clinical operations and outsourcing executives. In this time of
transformational change, Partnerships is your opportunity to meet face to face with
nearly 2,000 peers and over 200 solution providers ready to help meet your trial needs.
If you’ve attended before, you know Partnerships delivers more thought-provoking
keynote speakers, practical case studies, hands-on workshops, and roundtable
discussions than any other event, but...
DID yOu KnOW the 2011 Partnerships in Clinical Trials offers:
Over 150 intermediate and
advanced sessions on how to optimize
efficiency and quality of your clinical trials through effective
partnering.
or the advanced
Just look for the intermediate icon
icon
to find the right sessions for you.
12 Sessions on globalization
and emerging markets including a
75 Brand new sessions and
workshops. Just look for the new icon to find
updates on your favorite sessions from last year. nEW
focus areas include emerging markets,
invitation only Clinical Leadership Forum which has been
expanded to dive deep into the industry’s most critical
e-clinical technologies, quality oversight, biosimilar drug
challenges including CRO oversight, quality monitoring,
development, oncology clinical trials, and much more.
site management, and patient recruitment.
3 new Events for investigators and site
Just look for the the Back By Popular Demand icon
to find updates on your favorite sessions from last year.
management professionals, medical device professionals
Stakeholders Debate on Operational Long Term Strategies
Emerging Markets game show.
Partnerships
Hall of Fame Awards
honor the most successful partners and excellence in
to find the right sessions
Personalize your schedule
and biotech executives.
for Profitability and Growth in Global Clinical Trials and an
Just look for the globe icon
15 Sessions back by popular
demand, including the Wall Street Panel and the
and set up meetings in advance to maximize your time at
the event with a cutting edge pre-event networking tool for
registered attendees.
clinical trials over the last 20 years.
Morning and afternoon breaks are carefully designed and
for you.
strategically positioned to ensure maximum networking
opportunities. Look for the networking icon
to find
times to meet with peers and key decision-makers.
PLuS...
S
Five all new CuSTOMizED TRACkS to give you the latest SCORE
C
TRATEGiC SOuRCinG
OST & COnTRACT
MAnAGEMEnT
O
Look for the
pERATiOnAL EXCELLEnCE
R
EGuLATORy COMpLiAnCE
& QuALiTy OvERSiGHT
E
-CLiniCAL TECHnOLOGy
for the bonus Globalization track!
Who Attends Partnerships in Clinical Trials
With attendance from
over 40 countries
including:
Canada, united kingdom,
india, Germany, Argentina,
Sweden, Switzerland, Finland,
netherlands, Mexico, bulgaria,
Australia, Latvia, brazil, belgium,
Singapore, China, Hungary, Czech
Republic, France, Thailand,
Denmark, portugal, South Africa,
ukraine, Greece, Chili, Spain,
Malaysia, Japan, poland, Taiwan,
Croatia, Colombia, pakistan,
Russia, ireland, israel & italy.
2
participants by industry
■
■
■
■
Pharmaceutical/Biotechnology: 46%
CRO: 44%
E-Technology: 5%
Other: 5%
participants by Title
■ Outsourcing/Contracts/Budgets: 35%
■ Business Development/Strategic
Alliances: 29%
■ R&D/Clinical Development/
Operations: 20%
■ Drug Safety/Pharmacovigilance: 8%
■ Project Management/Quality: 6%
■ Other: 2%
participants by Geographic Location
■
■
■
■
■
Northeast: 42%
Southeast: 27%
Midwest: 14%
West: 14%
Southwest: 3%
Register Now! Call +1 888.670.8200 US; +1 941.951.7885 Int’l • E-mail register@iirusa.com
DAn HEATH
Guy ADAMi
viJAy GOvinDARAJAn
Co-author of two New York Times best sellers, Switch:
How to Change Things When Change is Hard and Made
to Stick, Dan draws on case studies and decades of
scientific research to teach you the small steps needed
to create big changes. Identify the critical moves in
change management and how to spark movement in a
new direction.
As a contributor on CNBC’s “Fast Money” and
Managing Director, Drakon Capital, Guy delivers
customized market analysis, portfolio strategy and
idea generation for institutional money managers
and hedge funds. A professional investor and noted
media analyst, Guy also authors a weekly newsletter
for retail investors entitled “Advantage Point” and
contributes daily pre-market analysis and webcasts
to optionMOnSTER.com.. He joins a
distinguished group of leading industry
financial analysts to discuss pipeline
trends and debate the investment
landscape to identify business
opportunities in Pharma and biotech.
As founding Director of the Center for Global
Leadership at the Tuck School of Business at
Dartmouth College and co-author of The Other Side
of Innovation: Solving the Execution Challenge, Vijay
is regarded as one of the world’s leading experts on
strategy and innovation. Drawing on his experience
with chief executives and management teams in
Global Fortune 500 companies, Vijay discusses
their thinking on strategy and challenges your
thinking on innovation to explore
solutions for more innovative drug
development in a global economy.
THOMAS GOETz
CuRT SCHiLLinG
bOb EubAnkS
Executive editor of WIRED magazine and
author of The Decision Tree, Thomas explores
how technology will be a game changer for
health management and influence a new era of
personalized medicine. Hear about the latest datagathering and tracking tools that influence health
decisions, and how technology will change the
landscape of clinical drug development.
Major League Baseball All-star, former
Red Sox, and World Series championship
pitcher, Curt Schilling shares the story
of his son’s Asperger’s syndrome and
discusses his work for ALS patients and
research. An active fundraiser and patient
advocate through his organization, Curt’s
Pitch for ALS, he draws on his experience
to teach leadership lessons to help
save lives.
An American television/radio
personality and game show host, Bob
is back by popular demand! Join him
as he hosts This is Emerging Markets
Jeopardy! where three industry experts
compete against the audience on their
knowledge of clinical trial globalization
and emerging markets.
Manage Transformational Change
Drive profitability
Leverage Technology
Execute innovation
Save Lives
Tv
Who You Will Meet
pharmaceutical, biotech and medical device executives with the following responsibilities:
• Clinical R & D
• Strategic Sourcing
• Clinical Site Management
• Medical/Scientific Affairs
• Clinical Operations
• Strategic Planning
• Patient Recruitment
• Clinical Affairs
• Global Outsourcing
• Project Management
• Accounting/Budgets
• Data Management
• Procurement and
Purchasing
• Contracts Administration
• Legal Affairs
• Regulatory Affairs
• Drug Safety
• Business Development
• Quality Assurance/Control
• R & D Finance
CRO and other outsourcing providers with the following responsibilities:
• Business Development
• Client Relations
• Operations
• Privacy Officers
• Sales & Marketing
• Analytical Services
• Pricing Services
• Corporate Communications
• Market Research
• Account/Management
• Tools and Technology
• Strategy
• Internet Development
The event is also of value to the following markets who have a stake in clinical development partnerships:
• Outsourcing Consultants
• Clinical Sites
• E-Technology Providers
• Staffing Specialists
• Clinical Research Associates
• Data Management and Computer
Software Vendors
• Patient Recruitment
• Site Management Organizations
3
AGENDA AT A GLANCE
Wednesday March 30, 2011
8:00
Workshop Registration & Morning Coffee, Sponsored by
9:00
Workshops Begin
10:30
Networking Break
12:00
Luncheon for Workshop Participants & Main Conference Registration
1:00
Main Conference Opens – Chairpersons’ Opening Remarks
1:30
Regulatory Keynote: Clinical Partnerships at a Crossroad-The Intersection of Quality and Oversight
2:15
A Sponsor Outsourcing Dilemma: Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight
3:00
Grand Opening of the Partnerships Hall- Networking Break
3:30
Pharmerging Markets Launch the Evolution – Identify the Growth Opportunities for the Global Pharmaceutical Sector
3:55
Global Partnerships Meeting Highlights – Europe, APAC, and Latin America
4:20
Stakeholders Debate Operational Long Term Strategies for Profitability and Growth in Global Clinical Trials
5:15
This is Emerging Market Jeopardy!
6:00
Opening Day Reception in the Partnerships Hall
Thursday March 31, 2011
8:00-8:45
Market Insight Roundtable Discussions & Morning Coffee in the Partnerships Hall
9:00
Chairpersons’ Recap of Day One
9:15
An Action Plan for Business Growth – Implement Changes to Adapt to the Increased Cost of Drug Development
9:45
Fast Money Showdown – Debate Pipeline Trends and Investment Opportunities
10:30
Networking Break in the Partnerships Hall
11:00
SCORE Track Sessions and Market Insight Roundtables
S
C
trategic Sourcing
O
ost & Contract
Management
perational Excellence
R
egulatory Compliance
& Quality Oversight
E
-Clinical Technologies
11:00-11:45
Wall Street Outlook- 2011
Forecast and Analysis of
Outsourcing Trends
Contract Approach and
Development – Key Negotiation
Strategies to Help You Better
Manage Your Clinical Trials
Best Practices for How to Manage
Your Global Teams and Retain
Value While Outsourcing
Proactive GCP Compliance and
Quality Management Systems –
Ensure Quality is Stepping Up and
Staff is Stepping Back
Utilize Electronic Health Records
in Clinical Research and Drug
Development
11:45-12:30
Sponsors & CROs UnpluggedAssess the Impact of M&A on Your
Outsourcing Strategy
Structure Delivery Expectations in
Emerging Markets – Responsibility,
Liability, and Accountability
Assess the Impact of Industry
Consolidations on Change
Management and Your Outsourcing
Operational Model
Through the Eyes of a Site: What
Does Quality Mean to Me?
Achieve Closer Integration
of Clinical Operations Data
(EDC, IVRS, CTMS) to Improve
Quality and Optimize Clinical
Outcomes
12:30-1:30
Luncheon in the Partnerships Hall
1:30
SCORE Tracks Continue
1:30-2:15
Shared Risk Partnerships Spotlight
Streamline Resource Management
– How Sponsors Track Resource
Utilization in Development Across
Their Operational and Scientific
Functions
Clinical Trial Feasibility –
Roadmap to Achieving Value and
Return on Investment
Globalize Regulations for Clinical
Data Collection and Submission
Understand How to Effectively
Leverage Technology to Optimize
Your Outsourcing Strategies
2:15-3:00
Virtual Drug Development in a
Resource-Challenged Environment
Reconfigure Payment and
Contracting Strategies in Light
of Fair Market Value
Strategic Sponsor-Site Partnership
Models – Improve Site Selection
and Recruiting in a Collaborative
Environment
Inspection Readiness Strategy in
an Era of Heightened Scrutiny of
Foreign Clinical Trials – Prepare
Your Company and CRO for
FDA Inspections, Auditing and
Monitoring of the Site
The Evolution of CROs –
Convergence of Service
and Technology Providers
3:00-3:45
The Value of Strategic Alliances
vs. Transactional CRO-Sponsor
Relationships
Positively Influence Study Time
Completion in Global Trials
Outsourcing Phase IV
Observational Studies: A Different
Animal?
Achieve Compliance with the
Sunshine Legislation Act on Your
Standardized Disclosure Practices
Build Strategic Partnerships by
Leveraging Data Management
Provider Experiences to Improve
Onboarding, Training, Governance,
and Contracts
3:45
4:15
Past Present and Future of Clinical Trial Outsourcing
5:00
Create and Manage Transformational Change – How Do We Make the Switch?
6:00
20th Partnerships Celebration – Featuring a Special Guest Performance, brought to you by
Friday April 1, 2011
7:00-8:00
Stand Up 2 Cancer Morning Yoga
8:00-8:45
Market Insight Roundtable Discussions & Morning Coffee in the Partnerships Hall
9:00
Chairpersons’ Recap of Day Two
9:15
Inspirational Patient Advocate Perspective with MLB Legend Curt Schilling
9:45
Leverage the Value of Your Technology – Explore How the Patient will be the Game Changer for Clinical Drug Development
10:30
11:00-12:30
SCORE Track Sessions and Market Insight Roundtables
S
C
trategic Sourcing
ost & Contract
Management
O
perational Excellence
R
egulatory Compliance
& Quality Oversight
E
-Clinical Technologies
11:00-11:45
Committing to Two Partners –
A Look at the BMS Integrated
Strategic Sourcing Initiative
Negotiation Strategies – How to
Best Define Responsibilities
between Sponsors, Sites, and
CROs to Avoid Accountability
Disputes
The Changing Role of Central Labs
and Implications for Outsourcing
– Major Developments, Future
Trends, and Global Considerations
Implement a Comprehensive
Clinical Trial Drug Safety Program
and Improve Quality from Clinical
Development to Post-Approval
Optimize the Vendor-Sponsor
Relationship with ePRO
11:45-12:30
Co-Development Between Sponsor
and CRO: Transformational or
Conflict of Interest?
Key Legal Considerations in Global
Outsourcing – Use Critical Tactics
to Create Effective Contracts
Best Practices for Patient
Recruitment and Retention in
Clinical Trials
Next Generation Post-Marketing
Research (PMR) – Meet Regulatory
Standards and Enhance Patient
Safety – Risk Maps, Registries,
and REMS
Proactive Medical Monitoring –
Planning for Success through
Better Safety, Design, and
Enrollment
12:30-1:30
Luncheon in the Partnerships Hall
1:30
Strategy is Innovation: Solving the Execution Challenge
2:15
Industry Future – C-Suite Fireside Chat
3:00
Partnerships Hall of Fame Awards Ceremony
3:20
Main Conference Concludes
3:30-5:00
Post-Conference Intensives
4
AGENDA AT A GLANCE
Three Co-Located Events
Medical Device Clinical
Trials Forum
Medical Device Clinical Trials Forum is the only event
designed specifically for medical device clinical trial
professionals to improve clinical strategy development and
deliver high quality clinical trial monitoring, data management,
and project management to guarantee first time market
access.
partnerships inSites
Clinical biotech Forum West
A brand new co-located event specifically designed for site
management professionals looking for strategies to improve
trial management with CROs and Sponsors.
A unique co-located event specifically designed for senior
biotech executives looking for the tools needed to execute fast,
effective and compliant clinical trials to maintain funding and
ensure regulatory approval.
Who Should Attend: Physician Investigators (PI), Study
Coordinators, Site Managers, Directors of Site Services,
Clinical Project Managers, Managers of Site Identification,
Clinical Operations Executives
Who Should Attend: CEOs, CSOs, CFOs, CTOs, Directors, VPs
of Clinical and Outsourcing Executives, and Operations from
Biotech Companies
Who Should Attend: CEO, CMO, CFO, CTO, Engineers,
VP of R&D, Directors/ VPs of Clinical Affairs, Directors/VPS
Regulatory Affairs
Clinical Trial Leadership Forum – Where Strategy Meets Tactics
Forum Moderator
During this forum, participants engage in an open exchange among peers to discuss current shared challenges
and feed off each other’s ideas for solutions to optimize clinical trials. Each discussion topic will be led by 4-6
leading industry experts who will facilitate a discussion around your most pressing issues.
Steve Whittaker, President,
pHARMApM COnSuLTinG, LLC;
p
former COO, Sr. Director, CV/
Acute Care Platform, ELi LiLLy
AnD COMpAny
invitation
Only
Who Should Attend: EVPs and VPs of Clinical Development, R&D and Outsourcing
*This Leadership Forum is a participant-driven format open to registered and paid pharmaceutical and biotech executives who
have attended Partnerships for three or more years. If you are interested in participating, please email dburakoff@iirusa.com.
Wednesday March 30, 2011
9:00am-12:00pm
Closed Door Trial Sponsor Only Session: The intersection of Quality and Oversight –
A Sponsor Outsourcing Dilemma: Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight
12:00-1:00pm
Luncheon
1:00-6:00pm
partnerships General Session and Regulatory and Globalization keynotes
6:00-7:00pm
Partnerships Opening Day Reception
Thursday March 31, 2011
9:00-10:15am
partnerships General Session and Financial keynotes
10:15-11:00am
Networking Break in Partnerships Hall
11:00am-12:30pm
Topic i: Design Trials in a More Meaningful and Cost-Effective Manner – The interface between Science and Study Management and
Strategic Outsourcing
Hear the 10 year evolution of partnerships in clinical outsourcing examining models such as Preferred Provider Relationships, Functional Service Provider Relationships,
Offshore Modeling, CRO Investments in Pharma, and “Strategic Alliances”. Discuss the future business modeling within service providers to meet the needs of tomorrow’s
biopharmaceutical organizations. Panelists characterize the disruptive change biopharmaceutical companies are forced to make in order to survive in today’s environment
and the origin / transformation of today’s new business models driven by:
• Increasing cost pressures and need for enhanced efficiencies
• Increasing complexity of industry needs driven by tougher regulatory environment
• Increasing globalization of clinical trials
Ralf Kohnen PhD, ScD, Prof Executive Vice-President & Head, Global Scientific Affairs, RpS, inC.
12:30-1:30pm
Luncheon
1:45pm
Topic ii: Participants will be surveyed in advance of the meeting to include the topic of their choice for discussion.
(Globalization, Patient Recruitment, Site Management, Impact of M&A on Trial Management)
2:30pm
Topic iii: Participants will be surveyed in advance of the meeting to include the topic of their choice for discussion.
4:15-6:00pm
partnerships General Session and Change Management keynotes
6:00pm
partnerships 20th Anniversary Celebration and Concert
Friday April 1, 2011
9:00-10:30am
partnerships General Session and Technology keynotes
10:30-11:00am
11:00am-12:30pm
Topic iv: next Generation Clinical Operations Technology in Clinical Trials
As the life science industry continues to battle with escalating costs, executives are naturally looking for ways to increase efficiency in the most expensive phase of drug
development- the clinical trial. This session examines the evolution of technology for the use of clinical trials and how changes are influencing data capture, quality,
integration, and management to improve the efficacy of trials. Discuss where the emerging technology is headed and how to prepare for what clinical research might look
like in 2015.
• Discuss how the new government funds for the Office of Comparative Effectiveness might transform the clinical trials community
• Explore the use of open source software in clinical trials
• Implement procedures today to prepare for the future
12:30-1:30pm
Luncheon
1:30-3:30pm
partnerships General Session and innovation keynotes
Tentative Schedule (Check the Website for Updates)
5
Wednesday | March 30th, 2011 | Workshops
8:00
Workshop Registration & Morning Coffee, Sponsored by
9:00
Workshops begin
10:30
networking break
12:00
Main Conference Registration & Luncheon Workshop for participants
LEGEnD
Workshop Schedule
Globalization
back by popular Demand
networking
intermediate Level
keynote
personalized
Advanced Level
Case Study
biosimilar product Development – navigate
Global Regulatory Challenges and Operational
Considerations to Ensure Approval
Technology-based Solutions and Social
Media Strategies for patient Recruitment,
Enrollment and Retention
Globalization Strategies for Small pharma
and biotech – Tools to Optimize your pipeline
Through Creative partnering Solutions
Some of the biggest-selling biologics are losing their patent
protection, opening up a global market for biosimilars
worth billions. Pharma and biotech companies are trying to
navigate global regulations and the new biosimilar approval
pathway in the U.S. in order to create the most effective
strategy for drug approval. During this workshop, you will
profit from practical lessons on European regulatory policy
and market experience with biosimilars and learn how to
navigate the legislation and current regulations in order to
seize opportunities and ensure approval in the U.S. and
abroad.
Recruiting patients for clinical trials and retaining them
once they have entered studies continue to be two of the
toughest challenges for drug developers. With increasingly
limited budgets and aggressive timelines for clinical
development, it is critical to meet patient recruitment
targets. This session takes a close look at new tools to
attract patients to a clinical trial including how to:
This practical workshop explores the globalization of
clinical trials and the reasons for young companies to
consider the need for global trials to be considered as
part of program development. Taking the global arena into
account as part of a development program can increase the
value of a product by increasing the probability of clinical
success, improving the odds of partnering the product, and
reducing research and development costs. The workshop
explores the rationale for conducting research ex-US
and considerations related to international trials. C-level
executives from emerging biotech and pharma companies,
specifically companies with less than 75-100 people and
only a few compounds in development, will benefit most
from this workshop. The workshop explores:
• Hear multiple perspectives on legislation that has passed
and current regulations in development around the globe
• Learn what the biotech and pharmaceutical strategies are
to develop and maintain this line of product
• Determine where we are going and how we will get there
• Understand issues in global biopharma litigation
and how to manage them
• Learn about the global jurisdictional “trends”
• Develop effective marketing and communication by
leveraging technology for patient recruitment
• Overcome the challenge of managing online communities
with social media
• Compare best practices of the use of technology in
patient recruitment abroad vs. in the U.S.
• Determine the key considerations in your strategy with
different therapeutic areas
• Gain innovative techniques to apply tele-monitoring for
compliance and patient retention in a clinical setting
• Ensure compliance with rapidly evolving FDA regulations
for social recruitment
Workshop Faculty
Gillian Woollet, MA, DPhil
Chief Scientist
EnGELL & nOviTT, LLp
Workshop Faculty
John Burnett
CEO/ Founder
JApA ASSOCiATES, inC.
Bernie Chiasson, Executive Director Strategic Regulatory
Services, i3
Rodeina Challand, Director of Clinical Programs, HOSpiRA
• Risk mitigation strategies and how to increase portfolio
value through global studies
• How to optimize limited staffing and budgetary resources
• Develop an RFP that recognizes your company’s core
competencies
• Benchmarking statistics from foreign studies
• How emerging biotechs stay “top of mind” when working
with a large CRO
• Insights into CRO staffing to deliver to smaller companies
• Ethical considerations when conducting
international trials
Workshop Faculty
Ann Wang, Vice President, Clinical Operations
and Data Management
HuMAn GEnOME SCiEnCES
Deirdre BeVard
Vice President, Clinical Operations and Data
Management, EnDO pHARMACEuTiCALS
Jason A. Gross, PharmD, Vice President of Scientific
and Medical Affairs, CipHER pHARMACEuTiCALS inC
1
2
build Effective partnerships with your CROs
to Succeed in Oncology Clinical Trials and
Optimize the Development of next-Generation
Cancer Therapies
MCC Clinical Trial performance Metrics
– improve Timelines, Cost, and Quality to
Enhance CRO and Sponsor performance in
Clinical Outsourcing Collaborations
Advanced Strategies in Request For proposal
(RFp) Excellence
Cancer is the fastest growing healthcare priority within the
worldwide pharmaceutical industry. The market is expected
to surpass US$78 billion by 2012. There are a number of
challenges in conducting efficient clinical trials to deliver
new oncology drugs to the marketplace. This workshop
presents case studies of innovative approaches to help you
understand what works and doesn’t work in partnering with
CROs for oncology clinical trials and drug development.
Biotechnology and pharmaceutical companies that
outsource to CROs and other service providers are
continuously looking for ways to improve operational
efficiencies – a top priority for R&D outsourcing
professionals. Can there be a common language for
metrics? What are the pressure points for sponsors and
providers? Explore site performance and patient recruitment
metrics, protocol metrics, quality metrics, M&A metrics,
and the use of benchmarking data to improve your clinical
outsourcing. This workshop provides you with tools to
develop strategies for organizing your clinical trial data for
better utilization and decision-making in your outsourcing
decisions and to drive process improvement and operational
excellences for sponsors and providers.
A bidding process is one of the best methods for leveraging
a company’s negotiating ability and purchasing power
with suppliers. The RFP process brings structure to the
procurement decision and allows the risks and benefits
to be clearly identified upfront. This workshop addresses
outsourcing from targeted RFI preparation to selecting
vendors for an RFP; what the RFP should contain and
how to conduct a face-to-face proposal defense meeting.
The workshop leaders discuss making the vendor selection,
building and maintaining successful relationships, setting
and managing project expectations, and oversight of
the CRO.
• Hear about the latest partnership models between
sponsors and CROs for oncology trials
• Discuss the right balance of oversight needed for
operational excellence
• Explore how the healthcare reform law will impact patient
enrollment in oncology trials
• Develop operational strategies to overcome practical
challenges
Workshop Faculty
Bryant Wales
VP, Strategic Sourcing
iMCLOnE SySTEMS
• Determine which metrics are the true indicators of
performance timelines
• Understand new MCC initiatives and develop best
practices within different partnerships
• Incorporate performance metrics into CRO contracts
• Optimize data for risk management and mitigation
• Discuss the future of metrics-What does benchmarking
mean for the pharmaceutical industry?
Karen Zuklie
Director of Outsourcing
puRDuE pHARMA
Nagaraja Srivatsan
Senior Vice President, Head of Life Sciences
North America, COGnizAnT
Patty Alameda, MBA
Manager, Clinical Outsourcing
SupERGEn
Krishnan Rajagopalan, PHD
Global Head of Life Sciences BPO
COGnizAnT
Ratan Ratnesh, Associate Director, Development
Strategic Sourcing, nOvARTiS pHARMACEuTiCALS
CORpORATiOn
David Zuckerman, President, CuSTOMizED iMpROvEMEnT
STRATEGiES LLC
Amanda Sax, Senior Director, Clinical Datat Management,
ASTRAzEnECA
4
• Develop a vendor assessment and criteria
selection process
• How to implement targeting RFIs and how to design
the RFP
• Manage the bid defense to get what you need from
the CRO
• Best practices for choosing an outsourcing model based
on your project goals and setting up an oversight process
Workshop Faculty
Rikki Bouchard
President and CEO
RH bOuCHARD AnD ASSOCiATES
Workshop Faculty
Guy Mascaro
President
METRiCS CHAMpiOn COnSORTiuM
Bryant is currently Vice President, Strategic Sourcing with
ImClone Systems, a wholly-owned subsidiary of Eli Lilly
and Company. He joined ImClone two years ago to create
a Strategic Sourcing team to support all functional areas,
with a focus on Clinical Development. Bryant’s team is
now sourcing all Phase I – III clinical studies for ImClone’s
biotech oncology pipeline globally.
6
3
5
6
Wednesday | March 30th, 2011 | General Session
Regulations
12:00
Registration for Main Conference, Sponsored by
1:00
Co-Chairpersons Opening Remarks
2:15
1:30
Many sources of information suggest that clinical research outsourcing is on the
rise, and that sponsors’ outsourced work will be increasingly consolidated within a
smaller number of more intense partnerships. These trends, coupled with recent
high-profile warning letters and the proliferation of clinical trials in less-experienced
developing regions, have increased industry focus on quality. The 2011 Avoca
Industry Survey asked sponsors and service providers to share their views and
specific practices regarding oversight of quality for outsourced clinical trials. This
session presents survey data and case studies regarding selected topics covered in
the 2011 Avoca Survey, including: the review of CRO’s quality systems as part of CRO
selection, upfront planning of quality oversight using risk-management approaches,
incorporation of quality requirements and expectations into contracts and other
agreements, and effective, proactive monitoring of quality and escalation of quality
issues throughout trial conduct. Panelists will be asked to comment on the data and
discuss their companies’ best practices around:
Harris Koffer, PharmD
President and COO
RpS, inC.
John W. Hubbard, PhD, FCP,
Senior Vice President, Head
of Worldwide Development
Operations Worldwide Research
& Development, pFizER, inC.
Clinical partnerships at a Crossroad – The intersection of Quality
and Oversight
The growth of outsourcing presents many new challenges and growing international
work for the FDA, EMA and ICH regarding safety and quality management. What
level and how much oversight is needed and when does it begin and end? This
presentation discusses the oversight of the FDA, EMA and ICH on the conduct of
pharmaceutical clinical research, including trends when comparing research with
different standards for design, conduct, performance, monitoring, auditing, recording,
analysis, and reporting of clinical trials. Explore how to work with regulatory authorities
to ensure GCP compliance while conducting clinical trials.
•
•
•
•
•
•
•
•
Fulfill U.S. FDA, EMA and ICH requirements on data quality and compliance
Discover where auditors are finding quality concerns
Avoid pitfalls in choosing qualified trial conducting sites
Gain insights into the GCP auditing process and inspections
The Partnerships conference is to be commended for providing
a forum that provides both industry fundamentals and advanced
topics of interest for strategic leaders. The timely inclusion of topics
related to our changing healthcare environment confirms that this
conference is the one to attend as we partner together to manage the
uncertainties within our industry.
– Deirdre BeVard, Vice President, Clinical Operations and Data Management,
ENDO PHARMACEUTICALS
3:30
3:00
”
Globalization
SteveWhittaker, President, pHARMApM COnSuLTinG, LLC;
former COO, Sr. Director, CV/Acute Care Platform, ELi LiLLy AnD COMpAny
(Moderator)
Global Clinical Trials are increasing at a rapid rate. This latest study analyzes who is
going overseas, where, and why. It explores how the global landscape will revolutionize
the marketplace over the next five years. Learn about the top emerging markets and
the opportunities for clinical development.
Mitchell Katz, PhD, Executive Director, Medical Research Operations,
puRDuE pHARMA
Paul Colvin, Executive Vice President, Global Clinical Development, ppD
Alan Morgan, Group President, iCOn CLiniCAL RESEARCH
Patrick Lindsay, Executive Vice President, ubC
Nancy Joseph-Ridge, MD, Head of Global Development/General Manager,
Pharmaceutical Development Division, TAkEDA pHARMACEuTiCALS
inTERnATiOnAL, inC.
Ira Spector, SVP, Global Development Operations, ALLERGAn
Four key implications for the industry are discussed:
3:55
Launch earlier in pharmerging markets
Don’t underestimate the potential for innovative launches
Plan to maximize the 6-month launch window
Address the complexities in pharmamerging markets
Global partnership Meetings Highlights – Europe, ApAC,
and Latin America
Conference chairs from all Partnerships global events present key learnings from all
three 2010 global meetings.
Jeffrey Kasher, PhD
Vice President and COO, Global Clinical Development
ELi LiLLy & COMpAny
© 2010 Institute for International Research, Inc. All rights reserved
Fidela Moreno, MD, Vice President, Global Development Operations,
Clinical Site Management and Monitoring
ALLERGAn inC.
4:20
Grand Opening in the partnerships Hall –
networking break
Join your fellow attendees at the Grand Opening – Your first
opportunity to check out the latest products and services from
a variety of partners, many of which will be hosting fun activities
and unique giveaways.
pharmerging Markets Launch the Evolution – identify the Growth
Opportunities for the Global pharmaceutical Sector
•
•
•
•
Aligning goals of sponsors and CROs and how to achieve mutual interests
Quality delivery as it applies to outsourced clinical trials
How sponsors manage and ensure CROs are meeting quality expectations
How sponsor-CRO interactions can either support, or interfere with, the quality
execution of outsourced clinical trials
Patricia Leuchten
President
THE AvOCA GROup (Moderator)
Denise Calaprice-Whitty, PhD, Executive Director, Survey Research and Relationship
Management Programs, THE AvOCA GROup
Wayne Langlois, Vice President and General Manager Global Phase II-III Clinical
Development, COvAnCE
Peter Carberry, MD, Senior Vice President, Global Development Operations, ASTELLAS
John Oidtman, VP, Clinical Operations, Emerging Markets, pFizER pHARMACEuTiCALS
Michael Marcarelli
Director, Office of Bioresearch Monitoring, CDRH
FDA (invited)
“
A Sponsor Outsourcing Dilemma: Reducing Micro-Management of
CROs while Maintaining Effective Quality Oversight
5:15
This is Emerging Market Jeopardy!
Bob Eubanks, the American television/radio personality and game show host, best
known for hosting the game show The Newlywed Game will host as three leading
experts in global clinical trials compete with the audience on knowledge in emerging
markets Jeopardy style in answer-question format.
Jorge Guerra, MD
Sr. VP, Global Clinical Operations
biOGEn iDEC
*Partnerships Europe meeting has not yet taken place. Speaker will be announced shortly.
Jeffrey Kasher, PhD
Vice President and COO, Global Clinical Development
ELi LiLLy & COMpAny
Operational Long Term Strategies for profitability and Growth in
Global Clinical Trials
Alan Braverman, PharmD, VP,
Clinical Operations, North America,
pSi
While cost savings is often the cited reason for going global, those with experience
know that cost is not always the key driver. Patient availability, market access
and decreased timelines are often the more important factors that drive a global
strategy. In this session, leading experts from Pharma companies and CROs review
commonalities and differences in their long term operational strategies for profitability
and growth in global clinical trials and debate the following questions:
•
•
•
•
•
•
Bob Eubanks, Host
What are the best opportunities in emerging markets?
What are the key strategic deals and developments in BRIC?
How do you leverage globalization of clinical trials in emerging markets?
How do you overcome the increasingly complex regulatory landscape?
What are the most important quality considerations?
What are the fair market value norms in different regions?
6:00
Opening Day Reception
in the partnerships Hall
7
Thursday | March 31st, 2011 | General Session
Finance
9:45
8:00-9:00
8:00-8:45
Morning Coffee in the Partnerships Hall
Designed like the American financial stock trading talk show, Fast Money, leading
industry financial analysts debate the investment landscape and identify business
opportunities in Pharma and biotech. Experts discuss pipeline trends, hot areas of
investment, and debate the following questions:
Market insight Roundtable Discussions
Moderators facilitate roundtable discussions on a selected group of topics.
Once you are a registered attendee, you will receive information on how
to sign up for roundtables. Please see page 10 for the schedule of topic
discussions during this time.
9:00
9:15
• Rapid Recap – Where is the money going?
• pipeline Review – What investments have the most risk? And what will have the
most ROI?
• behind the Money – What are the influencing factors that determine the value
and risk assessment of a target company?
• Futures – Where does the profitability lie with developing drugs for general public
vs. personalized medicine and therapeutic drugs for specialized populations?
Co-Chairpersons Recap of Day One
Operations Worldwide Research
& Development, pFizER, inC.
Fast Money Showdown – Debate pipeline Trends and investments
Opportunities
President and COO
RpS, inC.
Guy Adami
CNBC “Fast Money” Contributor & Managing Director
DRAkOn CApiTAL
Michael Obuchowski, Chief Investment Officer, 1ST EMpiRE ASSET MAnAGEMEnT
Blaine Davis, VP of Investor Relations and Corporate Communications, EnDO
pHARMACEuTiCAL
Michael Martorelli, Director, FAiRMOnT pARTnERS
An Action plan for business Growth – implement Changes to Adapt
to the increased Cost of Drug Development
The pharmaceutical industry has experienced slower revenue growth, compressing
margins, shorter duration of exclusivity in market, and rising regulatory and pricing
demands. This session frames the challenges sponsors face through an in-depth
analysis of R&D spending, margin pressures, and the challenges in sourcing
new products. It also identifies the opportunities and threats for CROs working
with sponsors. Gain a balanced direction between sponsor and vendor and learn
about some of the new business models and the changes your company needs to
implement to prepare for the future.
• Then and now – revenue growth, margin, return on invested capital, return on
equity, industry employment
• Explore the domestic challenges in pricing products and reimbursement
• Diversify your business model – OTC, M&A, licensing, identifying therapeutic areas
of increasing R&D spend, slicing target markets
• Identify reactions and survival tactics for small pharma vs. big pharma and the
future of virtual pharma
• Find the bottlenecks – Best practices to conserve cash by focusing on a limited
number of programs
• Discuss opportunities in emerging markets
• Opportunities: Obama squeezes the Balloon here - where does it pop out?
10:30
Networking Break in Partnerships Hall
(see page 16 for networking activities)
11:00-12:30
S C O R
E
tracks and Market
insight Roundtable
Discussions (see pages 10-11)
12:30-1:30
Networking Luncheon
1:30-3:45
S C O R
3:45-4:15
“
David Windley, CFA, CPA
Managing Director, Healthcare Equity
JEFFERiES & COMpAny, inC
E
tracks (see pages 12-13)
Networking Break
Well done to the IIR Partnerships conference for creating this
platform on Outsourcing which offers excellent exchanges
of experiences and knowledge that help drive process
improvement as we move forward.
– Aize Smink, Vice President of Project Management, CHILTERN
”
Change
4:15
past, present, and Future of Clinical Trial Outsourcing
5:00
Hear a 10 year perspective of the evolution of partnerships in clinical outsourcing
examining models such as Preferred Provider Relationships, Functional Service
Provider Relationships, Offshore Modeling, CRO Investments in Pharma, and
“Strategic Alliances”. Discuss the future business modeling within service providers
to meet the needs of tommorow’s biopharmaceutical organizations. Panelists
characterize the disruptive change biopharmaceutical companies are forced to make
in order to survive in today’s environment.
•
•
•
•
Examine the origin and transformation of today’s new business models
Enhance efficiencies to adapt to increasing cost pressures
Improve the conduct of your global clinical trials
Learn how to work in an increasingly complex and tough regulatory environment
Kenneth Getz, MBA
Senior Research Fellow, Assistant Professor
TuFTS CEnTER FOR THE STuDy OF DRuG DEvELOpMEnT
Daniel Perlman
Chairman and CEO
RpS, inC.
Create and Manage Transformational Change – How Do We Make
the Switch?
The landscape of the pharmaceutical industry is changing. The framework imposed
by the regulatory process often makes innovative business models and development
paradigms difficult to explore. In addition, there has been a change in the direction
of information flow as it relates to a company’s products, where it is often distributed
and discussed by outside agents that they don’t control, such as social media. This
loss of control over the pharmaceutical data will consequently make drug marketing
more difficult. Plus, health care reform legislation has created added visibility in
the industry which has given patients and consumers more control. Your company
must change with the shifting landscape in order to survive. How do you get your
company to avoid short-term thinking? This keynote presenter draws on case studies
and decades of scientific research to teach you the necessary small steps needed to
create big changes. Identify the critical moves needed to make the switch and learn
how to motivate organizational change to spark movement in a new direction.
• Create a framework to transform a set of ambiguous goals into concrete behaviors
• Identify the common patterns necessary in creating successful changes
• Learn how to engage with people’s emotional side with components that “hit you
in the gut”
Dan Heath, Best-selling author of Switch –
How To Change Things When Change Is Hard
and Made-to-Stick
6:00 - 7:00
Join us at the 20th Annual
partnerships Gala Celebration
Special Guest Performance
Featuring a Special Guest Performance
Brought to you by
8
Friday | April 1st, 2011 | General Session
Technology
7:00
Stand up 2 Cancer Morning yoga
9:45
Bring your gear to work up a sweat during some morning stretches that will keep
you energized throughout the day! RPS will generously make a donation for all
participants. Yoga will be held at the Sheraton Phoenix Downtown Hotel. Sign up in
advance at the RPS booth.
8:00-8:45
8:00-9:00
9:00
9:15
Science and medicine journalist and acclaimed author, Thomas Goetz, shares insights
from his new book “The Decision Tree” and how it applies to the pharmaceutical
marketplace. This lively discussion identifies trends on how consumers engage with
technology in the healthcare space.
• Explore how consumers interact with data, and how variables are broken down
into metrics, analyzed, and factored into health decisions
• Learn how data-crunching tools and bioinformatics influence the knowledge
of how diseases work in the body and the discovery of new drug targets that
impact the future of clinical drug development
• Hear about the latest tools patients use to share their health experience
and manage disease
• Identify specific trends and approaches that help patients selectively use
information to elevate sound science in a relevant, personalized way
Market insight Roundtable Discussions (see page 14 for details)
Morning Coffee in the Partnerships Hall
Chairpersons Recap
Operations Worldwide R&D,
pFizER, inC.
Leverage the value of your Technology – Explore How the patient
will be the Game Changer for Clinical Drug Development
President and COO
RpS, inC.
Thomas Goetz, MPH
Executive Editor, WiRED MAGAzinE
Author, The Decision Tree
10:30
inspirational patient Advocate perspective with MLb Legend
Curt Schilling
Curt Schilling shares the story of his son’s Asperger’s syndrome and how it changed
his family’s journey. As an active patient advocate for amyotrophic lateral sclerosis
(ALS) sufferers, Schilling’s organization, Curt’s Pitch for ALS, allows fans and
organizations to sponsor him and donate to the ALS Association for every strikeout
he throws. In 2007, Schilling released a charity wine called Schilling Schardonnay
with 100% of the proceeds supporting Curt’s Pitch for ALS. He also supports his wife
Shonda’s personal charity, The Shade Foundation of America, an organization devoted
to eradicating melanoma through the education of children and the community in
the prevention and detection of skin cancer and the promotion of skin safety. Come
hear Schilling draw on his personal and professional experiences to teach leadership
lessons to help save lives.
Networking Break and photo opportunity with Curt Schilling
in the Partnerships Hall
S C O R
11:00-12:30
E
tracks and Market
insight Roundtable
Discussions (see pages 14-15)
12:30-1:30
“
Curt Schilling, Former Major League Baseball Pitcher and 3 Time World Series
Champion; Founder and Chairman, 38 Studios and Founder, Curt’s pitch for ALS
Networking Luncheon in the Partnerships Hall
Great introductions, good ability to drill down in tracks,
and fun after hours sponsored activities.
– Jane Brennan, Associate Contracts Manager, Corporate Purchasing,
GENZYME CORP
”
Innovation
1:30
Strategy is innovation: Solving the Execution Challenge
2:15
We live in an era of almost constant change. First, new technologies continue
to emerge at an ever-more rapid pace. Second, globalization brings with it new
markets, new customers, nontraditional competitors, and new challenges. Third, the
Internet has created much greater transparency to any company’s strategy, actions,
and performance. As a result of these forces, companies find that their strategies
need almost constant redefinition – either because the old assumptions are no
longer valid, or because the previous strategy has been imitated and neutralized
by competitors, or because technological developments and globalization offer
unanticipated opportunities. Rooted in these premises, the strategic challenges for
organizations become: How do we identify the market discontinuities that could
transform our industry? How do we analyze the opportunities and risks as a result of
our understanding of market discontinuities? How can we create new growth platforms
with a view to exploit the market discontinuities? What are our core competencies and
how can we leverage them in the growth platforms? How do we allocate resources to
support growth? What kind of organizational DNA must we have in order to anticipate
and respond to changes on a continual basis? How do you execute breakthrough
strategies? Develop a framework to answer the following questions:
For the past several years, an economic recession, mergers and acquisitions, patent
cliffs, product pipeline rationalizations, and changes in the way pharmaceutical
companies invest in R&D have been impacting the healthcare industry. This session
looks at macroeconomic trends, strategies, and practices as well as analogies drawn
from other R&D intensive industries to project where sponsor-CRO relationships are
headed. Discuss some of the recent factors driving change in the industry and explore
new business paradigms for partnering with clients to enhance value and expedite
drug development. Panelists explore the following issues:
• Why do companies need to continuously innovate strategically?
• How can firms identify market discontinuities that shape the future evolution
of the industry?
• How can firms exploit accelerating global opportunities as a result of the
discontinuous shifts in the marketplace?
• How can firms build the requisite organizational DNA to create the future while
managing the present?
• How do you execute breakthrough strategies in the pharmaceutical industry?
Vijay Govindarajan, Founding Director of the Center for Global Leadership at the Tuck
School of Business, DARTMOuTH COLLEGE, Co-author, The Other Side of Innovation:
Solving the Execution Challenge (Moderator)
Vijay Govindarajan, Founding Director of the Center for Global Leadership at the Tuck
School of Business, DARTMOuTH COLLEGE, Co-author, The Other Side of Innovation:
Solving the Execution Challenge
“
industry Future – C-Suite Fireside Chat
As we struggle with the pressure of doing more with less in our
motivation to develop new therapies for patients in need, Partnerships
provides a forum to hear leading sponsors and providers discuss
the challenges, present creative solutions and permits interactive
dialogue that I find unlike another meeting in our industry
– Larry Blankstein, Senior Director, Clinical Research, GENZYME
• What will Pharma look like in 5 years time and how will we get there?
• How will comparative effectiveness research impact the industry with strategies for
clinical trial designs and drug development?
• What are the projected changes in discovery, preclinical, early clinical, and later
stage clinical outsourcing?
• How do you improve the organizational efficiency as a part of the new
value equation?
• How do you expect the CRO-Sponsor relationship to change in the next decade?
James T. Ogle, CEO, inC RESEARCH
Jeffrey P. McMullen, CEO, pHARMAnET
3:00
An awards ceremony will honor and celebrate Partnership MVPs throughout the
past 20 years. Come celebrate the achievements of your colleagues! Winners for
the following categories will be announced: Technology and Innovation, Lifetime
Achievement Award, Operational Excellence, Change Management, Most Valuable
Attendee, and more.
3:30
”
partnerships Hall of Fame Awards Ceremony
Main Conference Concludes
3:30-5:00
post Conference intensives
These 90 minute intensives take a deep dive into some specialized topic
areas in the industry. See page 15 for a list of sessions offered. Please visit
our website for updates.
9
Thursday | March 31st, 2011 |
S
TRATEGIC SOURCING
C
Chairperson: Frances Grote, Senior Director, Strategic
Sourcing, Millennium: The Takeda Oncology Company
11:00
OST & CONTRACT
MANAGEMENT
E
O
Tracks
PERATIONAL EXCELLENCE
Chairperson: Jessica Bowler, Associate Director
Procurement, Pfizer, Inc.
Who Should Attend: Senior Executives including VPs
Who Should Attend: Clinical Contract Management,
Who Should Attend: Professionals responsible for Clinical
of Global Outsourcing, Clinical Operations, Clinical R&D,
R&D Finance, Strategic Sourcing, and Strategic Planning
Clinical Budgeting and Finance, Contract Analysis,
Procurement and Purchasing, Grant Management
Description: Discover business drivers for small,
Description: Greater scrutiny of financial ties to
Operations, Project Management, Patient Recruitment,
Clinical Affairs, Clinical Site Management, Protocol
Development, Clinical Trial Monitors/CRAs, Site Monitoring
medium, and large companies in model selection and the
outsourcing of specific functional areas. Discuss obstacles
preventing the formation of effective partnerships and
the incidence and growth of new emerging collaboration
models. Engage in discussions around global outsourcing
of clinical trials. Discover how to survive in this economic
environment and the future outlook for the CRO industry.
clinical investigators coupled with increased focus on
accountability and drug safety puts more pressure on
contracting executives to clearly outline responsibilities
from the start. This track provides clinical trial budget
and contracting executives with the tools to streamline
processes and better define accountability and
responsibilities.
Description: Build and maintain alliances with internal
Wall Street Outlook – 2011 Forecast and
Analysis of Outsourcing Trends
Contract Approach and Development –
Key Negotiation Strategies to Help you
Better Manage your Clinical Trials in an Era
of Increased Consolidation
Best Practices for How to Manage
Your Global Teams and Retain Value
While Outsourcing
Wall Street offers an assessment of the outsourcing
environment from 2010-2011 as well as an outlook for
the next few years. Our presenters each offer a brief
commentary to kick off this very interactive session that
welcomes audience questions and comments. Special
focus is given to the following issues, with a Wall Street
view on:
• Determine the standards by which you calculate risk
and measure investment value
• Examine the trade-offs of being a public vs.
a private company
• Prepare your firm’s strategy for 2011 and identify how
the drivers will differ from 2010
John Lewis, Vice President for Public Affairs, ACRO
(Moderator)
Stephen Unger, Director, Senior Analyst, Life Sciences
Sector, Lazard Capital Markets
David Windley, CFA, CPA, Managing Director, Healthcare
Equity, Jefferies & company
Eric Coldwell, Managing Director, Healthcare Distribution
and Services Equity Research, Robert W. Baird
11:45
S C O R
Sponsors & CROs Unplugged – Assess the
Impact of M&A On Your Outsourcing Strategy
Explore the best practices in rapid renegotiation strategies,
and how to shift control from one company to another in
a post M&A environment to maximize ROI. Listen in as
executives of various size companies share their insights
and outlook for the future of the CRO industry.
• Identify critical considerations when considering a
merger or acquisition of a company
• How have companies who come together consolidated
their sourcing strategy?
• What do you need to compare and evaluate?
Frances Grote, Senior Director, Strategic Sourcing,
Millennium: The Takeda Oncology Company
(Moderator)
David Grange, CEO, PPD
Lawrence Florin, Section Director, U.S. Clinical
Outsourcing, Astrazeneca
Stephen Cutler, PhD, Senior Vice President and Chief
Operating Officer, Kendle
The tumultuous state of the drug manufacturing industry
impacts every line of business, but perhaps is felt
strongest in clinical trials. More than ever, it is critical for
clinical trial executives to forecast correctly and adapt
to their changing surroundings. In the highly regulated
pharmaceutical sector, understanding the key points
of negotiation and drafting a proper contract can be
challenging, especially when you don’t have a law degree.
As clinical outsourcing managers lead negotiations, draft
and manage key contracts on a daily basis, it is essential
to have a firm grasp of tactics for creating effective
contracts.
Anthony Carita, Director, Clinical Outsourcing, Otsuka
Pharmaceutical Development & Commercialization
stakeholders so you are continuously up to date with
each other’s needs towards your common goal. Leverage
project management methodology and build quality into
the process to leverage and manage outsourced work.
The global economic climate is changing in terms of
reinforcing the need for greater throughput and greater
tracking. How do you handle things that are not done
in your own shop? This session provides best practices
for managing team members in different regions and
adapting to a changed economic landscape.
• Manage virtual teams across the globe from an
operational standpoint
• Create new ways to propagate the pipeline through risk
management techniques
• Understand differences in cultural expectations to
enable better working relationships
• Integrate country requirements, guidance, and work of
team members for multiple emerging markets into the
U.S. core team
Eurona Tilley, Managing Editor, PHARMSOURCE
(Moderator)
Kent Thoelke, Senior Vice President, Scientific & Medical
Affairs, PRA International
Austen Eddy, Director of Clinical Operations,
Avi Biopharma
Structure Delivery Expectations in Emerging
Markets – Responsibility, Liability, and
Accountability
Assess the Impact of Industry Consolidation
on Change Management and Your
Outsourcing Operational Model
As more companies ramp up their clinical operations
in new markets, contract and budgeting executives are
faced with the task of adjusting to a new set of rules. This
session explores the challenges in structuring delivery
expectations in emerging markets and reviews countryspecific requirements and best practices for contracting
global agreements.
With the uptake of more mergers and acquisitions in the
industry, there is the need for clearly defined roles and
responsibilities to harmonize the language and culture of
two offices. How are companies restructuring themselves
internally? How are they managing that operational
change? During this roundtable discussion, you address:
• How to determine which projects to keep moving
forward in a post-merger stage
• Critical cultural factors within an organization that will
affect the transitions of staff
• How to make integration and work flow easier
• Proactive risk management approaches
• New strategic approaches for your vendor management
• Review implementation techniques across different
delivery models
• Pinpoint key differences in accountability when working
with CROs and sites in emerging markets
• Observe local norms regarding fair market value to
avoid complications
• Obtain negotiation strategies to ensure global
responsibilities and liabilities match your U.S. contracts
• Learn how to create templates that work with different
policies, regulations, and data points
Peter Pitts, President, Center for Medicine in the
Public Interest (Moderator)
James Tsui, Contracts and Outsourcing Manager,
Roche Product Development in Asia and Pacific
Robert J. Davie, PhD, Vice President & General Manager
Europe, Clinical Development Services, Covance
Thomas Lawler, Senior Director, Clinical Project
Management, AstraZeneca (Moderator)
Mike Collins, Vice President, Development Operations,
Pfizer, Inc.
Lauren Meyers, Alliance Leader, Product Development
Strategic Outsourcing (PDAS), Genentech
Luncheon in Partnerships Hall
12:30
Continued on pg 12-13
8:00-8:45 Market Insight Roundtable Discussions
HIPAA Compliance for Sponsors and CROs
Jeremy Stoloff, Associate General Counsel, Banner Health
Impact of Reform on Biosimilar Drug Development
Gregory Skalicky, Senior Vice President, Worldwide Business Development,
10
PHARMANET, LLC
Dalvir Gill, President, Late Stage Development, PHARMANET LLC
Virtual Sponsor Team Outsourcing
Christina S. DiArcangelo, CEO, Armonia Clinical Research, LLC
Prepare for FDA Clinical Trial Inspections
Sandra L. Shire, DMD, MPA, Director, MS in Regulatory Science and Health Safety
Program, Arizona State University
R
EGULATORY COMPLIANCE
& QUALITY OVERSIGHT
E
S C O R
-Clinical Technology
E
Tracks
Globalization
Bonus track
Chairperson: David Marks, RQAP-GCP, Senior Director
& Global Head, Quality Management, RPS, Inc.
Who Should Attend: Drug Safety, Legal Affairs, Medical/
Who Should Attend: Executives responsible for Clinical
Who Should Attend: Directors/Presidents/VPs/SVPs/
Scientific Affairs, Regulatory Affairs, Quality Assurance/
Control
Data Management, Clinical Research Informatics, Global
Clinical Technology, Clinical Applied Informatics and
Modeling, Electronic Data Capture (EDC) Operations and
Implementation, Electronic Clinical Trial Data Submission
(eCTD), Clinical Trial Management Systems (CTMS),
Clinical Documentation, Document Control Software,
Biostatistics, Biometrics, and Clinical Software Engineering
Heads of Global Clinical Development, Global Clinical
Operations, Strategic Outsourcing Management,
Worldwide R&D, Global Scientific Affairs, and Global
Regulatory Affairs
Description: Avoid warning letters, understand and
comply with international regulations, prepare for audits,
and create best practices for quality oversight.
Description: Obtain cutting edge data management
strategies, innovative technologies, and prepare for the
future of electronic health records, ePRO, and latest
standards from CDISC and HL7.
Proactive GCP Compliance and Quality
Management Systems – Ensure Quality is
Stepping Up and Staff is Stepping Back
Quality is part of the philosophy and culture of the
sponsor-CRO relationship. When you go through the
selection process, you have to determine what quality and
micromanagement is going to look like. You must define
the roles and responsibilities of the sponsor, monitors, and
investigators as it relates to the quality of clinical trials.
This session looks at best practices to ensure proper
interpretation of regulatory requirements for GCP in the
current regulatory environment.
• Sponsor perspective: How to oversee what you are
accountable for
• Create a roadmap for evaluating study conduct,
source documents, case report forms and other study
documentation to be accurate, factual, and inspectionready
• How to detect, correct, and prevent clinical study
misconduct and fraud and identify proactive solutions
to prevent further problems
John W. Hubbard, PhD, FCP, Senior Vice President,
Head of Worldwide Development Operations Worldwide
Research & Development, Pfizer, Inc.
Through the Eyes of the Site: What does
Quality Mean to Me?
Timelines to get drugs to market are being shortened,
budgets are being decreased, and quality expectations
are increasing. Most of outsourcing focus is on time,
cost, and scope but a major challenge is the quality of
the process and the major deliverables. The future will
require that quality management be more proactively
and comprehensively integrated into study planning and
execution. Quality must be considered not as something
imposed, but as something that helps a company achieve
its goals. How do you go about defining quality, specifying
quality standards, and managing a team with those
standards? This session explores the perspective of a site
in defining and measuring quality in clinical trials.
• Identify how quality is defined and measured by sites
• Understand how a site manages the contradiction
between reducing cost and increasing quality
• Identify the skills and characteristics needed for team
members and leaders
Christine Pierre, President, RX Trials
Utilize Electronic Health Records in Clinical
Research and Drug Development
The use of EHR in the clinical research will likely
transform the entire industry. Hear a case study of the
Partnership to Advance Clinical Electronic Research
(PACER) initiative and the collaboration’s progress in
developing data sets to be incorporated into EHRs to
improve the reliability of clinical-trial outcomes data.
Understand the technical advances and the appropriate
use of EHRs needed to facilitate clinical research and
drug development.
• Explore the possibilities and challenges of launching
a large-scale effort to link clinical-trial recruitment
activities to EHR
• Explore how data sets can be used to identify and
recruit clinical trial participants
• Does the integration of EHR and EDC make sense?
Who is going to pay for that?
• Discuss how to overcome interoperability, financial
and adoption issues
• See how Public-Private partnerships can be shaped
for mutual benefit of all stakeholders.
• Understand how a value-based sustainability framework
can be established to support HIT infrastructures
David P. Leventhal, MBA, Director, Healthcare
Informatics, Pfizer, Inc
Achieve Closer Integration of Clinical
Operations Data (EDC, IVRS, CTMS) to
Improve Quality and Optimize Clinical
Outcomes
This session focuses on the integration and streamlining
of data for site and sponsor users when faced with
multiple technology solutions to manage data in a single
clinical trial. It is important for sponsors to understand
both the technology issues and the business issues in
using multiple technologies, whether they are provided
from one vendor or several. Look at examples of e-clinical
technology integration and explore advantages and pitfalls
of various approaches available to sponsors in order to
build business-process driven solutions to facilitate the
enrollment, monitoring, and integrated flow of data.
• Discuss interoperability approaches that create a more
unified view of data and drive trial efficiency
• Obtain best practices for ensuring data integrity across
clinical systems
• Establish appropriate system and security controls, as
well as cyber security and system maintenance plans
• Identify how to overcome challenges of the learning
curve with new technologies
John Humphreys, Product Director, CTMS, Perceptive
Informatics
Ravin Warna, Vice President of Clinical Operations,
North America, Averion International Corporation
Description: As globalization becomes increasingly
important in the pharmaceutical industry, we added
a bonus track by strategically positioning sessions on
globalization and emerging markets within our SCORE
tracks.
*Please note that each session within this track will be held in a
different room.
Best Practices for How to Manage Your
Global Teams – Retain Value While
Outsourcing
11:00
The global economic climate is changing in terms of
reinforcing the need for greater throughput and greater
tracking. How do you handle things that are not done
in your own shop? This session provides best practices
for managing team members in different regions and
adapting to a changed economic landscape.
• Managing virtual teams across the globe from an
operational standpoint
• Create new ways to propagate the pipeline through risk
management techniques
• Understand differences in cultural expectations to
enable better working relationships
• Integrate country requirements, guidance, and work of
team members for multiple emerging markets into the
U.S. core team
Eurona Tilley, Managing Editor, PHARMSOURCE
(Moderator)
Kent Thoelke, Senior Vice President, Scientific & Medical
Affairs, PRA International
Austen Eddy, Director of Clinical Operations,
Avi Biopharma
Structure Delivery Expectations in Emerging
Markets – Responsibility, Liability, and
Accountability
11:45
As more companies ramp up their clinical operations
in new markets, contract and budgeting executives are
faced with the task of adjusting to a new set of rules. This
session explores the challenges in structuring contracts
in emerging markets and reviews country-specific
requirements and best practices for contracting global
agreements.
• Pinpoint key differences in accountability when working
with CROs and sites in emerging markets
• Observe local norms regarding fair market value to avoid
complications
• Obtain negotiation strategies to ensure global
responsibilities and liabilities match your U.S. contracts
• Learn how to create templates that work with different
policies, regulations, and data points
Peter Pitts, President, Center for Medicine in the
Public Interest (Moderator)
James Tsui, Contracts and Outsourcing Manager,
Roche Product Development in Asia and Pacific
Robert J. Davie, PhD, Vice President & General Manager
Europe, Clinical Development Services, Covance
12:30
Continued on pg 12-13
11:00AM-12:30PM
Market Insight Roundtable Discussions
Timeline Excellence: Effectively Manage Timelines Across Multiple
Sites in Asia
Eric Morfin, MBA, PMP, PhD, Founder and First Vice Chair, www.BioPharmaPM.org
Process Optimization in Clinical Trials
Kathleen Dolan, Operations Director, Knowledge Management and Innovation,
Merck (former)
Strategies for Clinical Trials in India
Best Practices in Virtual CRO Management
Joy Frestedt, PhD, RAC, CCTI, President and CEO, FRESTEDT INCORPORATED
Jacqui Mardell, Director and Founder, Anhivita Biopharma Consulting
11
S
1:30
TRATEGIC SOURCING
Shared Risk Partnerships Spotlight
Over the past few years we have seen pharma/CRO
partnerships move beyond traditional outsourcing
agreements to those that share risk to a much greater
degree. The presenter focuses on partnerships involving
capital at-risk transactions where third party capital
partners take on risk for the ultimate outcomes of the
products either in the development or commercial areas.
In discussing case studies of shared-risk partnerships
with pharmaceutical companies including Eisai, Eli Lilly
& Co and Solvay Pharmaceuticals, our speaker highlights
the financial commitment Quintiles has made to its
partnerships and how this has been adapted to suit the
needs of partnerships with biotech and large pharma
clients. The case studies will be explored within the
context of current changes in the industry, the drivers for
these changes, and the progress of the industry.
• Evaluate risk and assess return mechanisms in these
shared-risk partnerships
• Review how and why Quintiles moved into
shared-risk partnerships and their operational
and governance elements
• Discuss how to split up financial commitments
C
S C O R
OST & CONTRACT
MANAGEMENT
Streamline Resource Management – How
Sponsors Track Resource Utilization in
Development across their Operational and
Scientific Functions
This session looks at the evaluation and assessment
of internal resource requirements for in-house and
outsourced studies across functions. Panelists discuss
their methods for using data to understand what the
different resources across organizations are contributing
in order to identify opportunity areas for improvement
activities.
• Get enough money to sustain a robust portfolio
• Maximize your resources, whether it’s your internal
FPEs or out of pocket dollars
• How to be a lean project manager when facing pressure
to succeed with limited resources
Christa A. Maurer, Director Outsourcing and Contract
Management, Bristol-Myers Squibb
Michael Cox, Manager, Resource Performance
Management, Medimmune
Peter Payne, VP, Corporate Development,
NOVAQUEST, The Investment Arm of Quintiles
Transnational Corp
2:15
Virtual Drug Development in a ResourceChallenged Environment
Virtual companies essentially outsource every component
of development. These new companies are being formed
by those who are recognizing that the big Pharma model
is losing its sustainability. Now the model is beginning
to move into a construct where there is a whole portfolio
of products being managed virtually. This session will
focus on the virtual pharma model and their strategic
partnerships with CMOs, CROs and consultants. CROs
discuss innovative ways to accommodate the virtual
pharma model by having a real stake in the success of the
client with risk-sharing models of rising interest.
• Is the rise of virtual pharma a fad or a permanent
change in the industry?
• Define virtual pharma’s expectation of the CRO
• Hear lessons learned from virtual companies that can
benefit big pharma
• How to manage virtual development in a small company
• Is there a happy medium- semi-virtual?
3:00
E
O
Tracks
Clinical Trial Feasibility – Roadmap to
Achieving Value and Return on Investment
Many pharmaceutical companies have begun
implementing lessons learned from past trials throughout
the industry with proactive feasibility studies. Feasibility
analyses can help mitigate risk to the success of the trial
even before it begins. Done correctly, feasibility allows
sponsors to transform clinical development planning by
taking extra time in advance, saving time and money in
the long run through better trial design. Hear from both
sponsor and provider perspectives on an internal and
external approach to clinical trial feasibility:
• Explore the value in bringing a CRO in early
• Develop protocols, site feasibility and selection,
documentation, and site activation
• Obtain best practices for finding the best clinical
trial investigators and managing clinical investigator
compliance
Peter Dibasio, Clinical Development Operations,
Vertex Pharmaceuticals
Katherine Tranotti, VP Clinical Operations,
ICON Clinical Research
Jay Turpen, Advisor, Clinical Project Management,
Eli Lilly and Company
Reconfigure Payment and Contracting
Strategies in Light of Fair Market Value
(FMV)
Strategic Sponsor-Site Partnership Models–
Improve Site Selection and Recruiting in a
Collaborative Environment
As the FDA and global regulatory bodies become
increasingly involved with Fair Market Value, drug and
device sponsors need a clear direction on how to proceed
with both domestic and international clinical trials,
physician disclosure issues and proper documentation.
Understand what FMV means to sponsor-site relationship
and establish a protocol for setting up payments and
contracts with new CROs and sites.
This session focuses on new collaboration models that
sponsors, CROs and investigative sites are entering into
in response to rising drug development inefficiencies
and cost. Results from original research will shed light
on obstacles preventing the formation of effective
partnerships and the incidence and growth of new
emerging sponsor-site collaboration models. Strategic
objectives and structural components of these partnership
models will be discussed and their advantages and
disadvantages explored. Collaborative models drawn from
other research-intensive industries will also be discussed
and applied to sponsor-site partnerships.
• Learn what information is required to be reported
• Avoid penalties for infractions designated by the DOJ
and comply with latest FDA guidelines to prevent
serious negative implications to your clinical trial
• Learn how private and public manufacturers are
required to report physician involvement in clinical trials
• Deal with and report for the various state regulations
about investigator compensation
• Illustrate new approaches to structure sponsor, CRO-site
relationships to better leverage the partnership
• Highlight obstacles preventing the formation of more
effective sponsor-site interactions and collaborations
• Convey trends in the adoptions and usage of various
sponsor-site relationship structures
Tomasz Sablinski, MD, Managing Director, Head of
Development, Celtic Therapeutics
Mark Milberg, Sr. Contract manager, Clinical Contracts
and Alliance Management, MEDTRONIC
Cory Gutterman, Independent Pharmaceutical Consultant
The Value of Strategic Alliances vs.
Transactional CRO-Sponsor Relationships
Positively Influence Study Time Completion
in Global Trials
Outsourcing Phase IV Observational Studies:
A Different Animal?
As drug development and outsourcing industries continue
to mature and as cost pressures continue to increase,
progressive players are starting to look for more value in
their relationships. This session explores the definition
of clinical delivery alliances and the value these alliance
partnership models bring to the drug development process
from both the sponsor and CRO perspective. Per these
industry movements, this session answers the following
questions:
Drawing upon extensive industry data from the cost
benchmarking databases and extensive industry clinical
trial performance data from the Centre for Medicines
Research (CMR), this analysis draws on 20 year’s worth of
data from both pharma companies and CROs on the costs
and time it takes to complete clinical trials. The research
will help you identify the most influential variables in study
time completion and why some clinical trials finish faster
than others across therapeutic areas and regions.
• How do more strategic relationships positively affect
performance and outcomes?
• When do alliance partnerships make sense for a
sponsor or a CRO?
• What alliance partnership models are emerging?
• Lessons learned from current clinical delivery alliance
models – what works and what doesn’t?
• How can both large pharma and biotechs benefit from
creative partnership structures and a process driven
methodology for managing strategic development
programs?
The database contains extensive cost data at the
Procedure, Cost Per Visit, and Cost Per Patient levels from
North America, Europe, Asia, Latin America and other
important countries involved in drug testing.
This session presents strategic issues underlying
post-approval observational research as a foundation
for considering different operational approaches in
outsourcing. New findings from a multi-disciplinary survey
provide insights into industry needs, expectations, and
approaches to their design and operational factors. Hear
sponsor and CRO perspectives on the mechanics of
outsourcing Phase IV to gain clarity on strategies needed
to optimize the relationship between CROs and research
sponsors.
David Gillogly, Global Head, Clinical Contracting and
Category Management, Novartis
Tim Dietlin, VP Alliance Development, INC Research
• Learn about the trends and comparative costs of clinical
trials around the world
• Assess the elements of study design that have the
biggest impact on study completion times, including
inclusion/exclusion criteria, protocol design and the
countries involved
• Determine the impact of the use of CROs on study costs
and study completion times
• Examine how payment levels to CROs and sites
influence study completion times and data quality
Joseph Kim, MBA, Clinical Operations Director,
Shire Pharmaceuticals Ltd
• Examine the role of comparative effectiveness research
in Phase IV strategic initiatives
• Obtain less costly approaches that yield high quality,
on-time results
• Determine critical considerations that need to be given
to selection and training of individuals supporting Phase
IV studies
• Get guidance for Phase IV protocol development and
operational planning
Jeffrey Trotter, Executive VP, Phase IV Development,
Pharmanet
Colleen McCoy, Associate Director, PDAOR Contracts and
Outsourcing, Genentech Inc. (invited)
Harold E. Glass, MD, Research Professor of Health Policy
& Adjunct Professor, Pharmaceutical and Healthcare
Business, University of the Sciences
Philadelphia
Return to General Session pg 8
12
R
& QUALITY OVERSIGHT
Globalize Standards for Clinical Data
Collection and Submission
Data protection obligations in clinical trials have become
heavily regulated in recent years around the world. In
addition to them being relatively new obligations of both
sponsors and CROs, understanding of these obligations
has been made more difficult because they are regulated
and enforced differently from jurisdiction-to-jurisdiction.
This creates a great deal of uncertainty and risk for
sponsors and CROs with respect to a significant aspect
of clinical trials-data generation, collection and handling.
This session provides a clear overview of this challenge
and provides suggestions on how to minimize uncertainty
and risk.
• Understand the global framework of data protection
regulation
• Examine the pros and cons of various options of
addressing data protection obligations
• Discuss best practices to minimize the uncertainty
and risk presented by data protection obligations in
clinical trials
• Understand the overall standards of clinical trials to
submissions to improve processes
Inspection Readiness Strategy in an Era
of Heightened Scrutiny of Foreign Clinical
Trials – Prepare Your Company and CRO
for FDA Inspection, Auditing and Monitoring
of the Site
The number of foreign clinical trials currently being
conducted under INDs has more than doubled in the
past decade. The FDA is expected to increase oversight
of countries they perceive as lacking oversight capabilities
to ensure compliance with GCP standards. The FDA is
working on improving its monitoring in foreign clinical
trials including entering into inspection agreements with
foreign counterparts, increasing the number of foreign
sites inspected and developing new oversight models. Are
you prepared for increased scrutiny of ethics committees,
trials, and investigator sites? Panelists discuss:
• Risk assessments and audits your company needs to
conduct to avoid potential FDCA and FCPA liability in
foreign clinical trials
• How to determine the clinical monitoring program that’s
right for you
• Tackle challenges sponsors face when implementing
less than 100% Source Data Verification
Bruce M. Wagman, RN, MBA, RAC, VP Regulatory Affairs
& Quality Assurance, COVANCE
Larry Fiori, Associate Director, Clinical Trial
Outsourcing & Compliance, Compliance and Quality
Management, Boehringer Ingelheim, USA
Nadina C. Jose, MD, CPI (Hon), Regional Director,
Global Clinical Site Management and Monitoring
Asia-Pacific, ALLERGAN PTE. LTD
Achieve Compliance with the Sunshine
Legislation Act on Your Standardized
Disclosure Practices
The Physician Payments Sunshine Act requires
companies to begin recording any physician payments
that are worth more than $10 in 2012 and to report them
on March 31, 2013. That includes stock options, research
grants, knickknacks, consulting fees and travel to medical
conferences. Panelist during this session share what their
companies are doing to prepare for the implementation
of this legislation and the system changes they will use to
track and report spending.
• Explore the impact of this legislation on your company’s
bottom line
• Share methods to track spending and best practices to
report information
• Examine the implications the Sunshine Act has on
selecting investigator sites
• Discuss considerations around sponsors getting CROs
to be compliant
Douglas Peddicord, PhD, Executive Director, ACRO
(Moderator)
Fredrick L. Naids, PhD, Senior Strategic Sourcing
Director, Clinical Development Operations & Biometrics,
Shire Pharmaceuticals
E
S C O R
Understand How to Effectively Leverage
Technology to Optimize Your Outsourcing
Strategies
This session take a close look at different technologies
available to monitor the performance of your operations
and outsourcing strategies. Determine the success rate of
the different technologies and the extent to which they can
support or enhance outsourcing for your company.
• Understand how to successfully integrate all available
technologies
• External sources vs. internal build- determine if
your requirements document supports a make or
buy decision
• Establish an implementation plan for your business
Anthony Carita, Director, Clinical Outsourcing,
Otsuka Pharmaceutical
E
Tracks
Globalization
Bonus track
Clinical Trial Feasibility – Roadmap to
Achieving Value and Return on Investment
1:30
Many pharmaceutical companies have begun
implementing lessons learned from past trials throughout
the industry with proactive feasibility studies. Feasibility
analyses can help mitigate risk to the success of the trial
even before it begins. Done correctly, feasibility allows
sponsors to transform clinical development planning by
taking extra time in advance, saving time and money in
the long run through better trial design. Hear from both
sponsor and provider perspectives on an internal and
external approach to clinical trial feasibility:
• Explore the value in bringing a CRO in early
• Develop protocols, site feasibility and selection,
documentation, and site activation
• Obtain best practices for finding the best clinical
trial investigators and managing clinical investigator
compliance
Peter Dibasio, Clinical Development Operations,
Vertex Pharmaceuticals
Katherine Tranotti, VP Clinical Operations,
Jay Turpen, Advisor, Clinical Project Management,
Eli Lilly and Company
The Evolution of CROs – Convergence of
Service and Technology Providers
The global biopharmaceutical industry faces a daunting
array of challenges. In this difficult and rapidly changing
environment, biopharmaceutical companies must
continue to find new ways to improve the efficiency of
every part of the drug development process. Whether you
call them eCROs, biopharmaceutical service providers, or
strategic development partners, the companies with the
right combination of technology, clinical resources, and
development expertise will play a critical role in finding
new efficiencies. This new generation of companies is
arising from a growing convergence between companies
that provide clinical development services and those that
provide technology solutions. Companies that successfully
bridge this gap will be uniquely positioned to move beyond
the initial gains from technologies such as electronic
data capture, clinical trial management systems, and
integrated voice/web response systems, to provide further
innovations and enhanced performance. This presentation
will address the following issues:
• The case for convergence between service and
technology providers
• Technology trends supporting this evolution
• Benefits and predicted impact on partnership models
• Future technology directions
Mark Goldberg, MD, Chief Operating Officer, PAREXEL
International
Mark Hill, Executive Director, Early Stage Development
and Global Clinical Trial Operations IT,
Merck & Co. Inc.
Build Strategic Partnerships by Leveraging
Data Management Provider Experiences to
Improve Onboarding, Training, Governance,
and Contracts
Hear a case study of Biogen Idec’s data management’s
strategic sourcing model with three separate functional
service provider (FSP) relationships. Look at how
each partner has provided value to Biogen Idec data
management and how its outsourcing model has required
the FSP vendors to work with each other and establish
joint partnership goals to be equally invested in the Biogen
Idec process.
• Learn how to overcome challenges associated with
FSPs working with each other
• Examine the infrastructure required for operations and
management efficiency
• Learn how to develop a flexible system that
accommodates continuous industry changes
Toni LaPorte, Vendor Manager, Data Management,
BIOGEN IDEC
Cindy McLaughlin, Vendor Manager, Data Management,
BIOGEN IDEC
George Weir, Group Manager, Data Management, PPD
Esther Ninan, Cognizant, Service Delivery Manager,
COGNIZANT
Dan Benzing, Client Manager, CLIENT ASSOCIATED
BUSINESSES
Inspection Readiness Strategy in an Era
of Heightened Scrutiny of Foreign Clinical
Trials – Prepare Your Company and CRO for
FDA Inspection, Auditing and Monitoring of
the Site
2:15
The number of foreign clinical trials currently being
conducted under INDs has more than doubled in the
past decade. The FDA is expected to increase oversight
of countries they perceive as lacking oversight capabilities
to ensure compliance with GCP standards. The FDA is
working on improving its monitoring in foreign clinical
trials including entering into inspection agreements with
foreign counterparts, increasing the number of foreign
sites inspected and developing new oversight models. Are
you prepared for increased scrutiny of ethics committees,
trials, and investigator sites? Panelists discuss:
• Risk assessments and audits your company needs to
conduct to avoid potential FDCA and FCPA liability in
foreign clinical trials
• How to determine the clinical monitoring program that’s
right for you
• Tackle challenges sponsors face when implementing
less than 100% Source Data Verification
Bruce M. Wagman, RN, MBA, RAC, VP Regulatory Affairs
& Quality Assurance, COVANCE
Larry Fiori, Associate Director, Clinical Trial
Outsourcing & Compliance, Compliance and Quality
Management, Boehringer Ingelheim, USA
Nadina C. Jose, MD, CPI (Hon), Regional Director, Global
Clinical Site Management and Monitoring Asia-Pacific,
ALLERGAN PTE. LTD
Positively Influence Study Time Completion
in Global Trials
3:00
Drawing upon extensive industry data from the cost
benchmarking databases and extensive industry clinical
trial performance data from the Centre for Medicines
Research (CMR), this analysis draws on 20 year’s worth of
data from both pharma companies and CROs on the costs
and time it takes to complete clinical trials. The research
will help you identify the most influential variables in study
time completion and why some clinical trials finish faster
than others across therapeutic areas and geographies.
• Learn about the trends and comparative costs of clinical
trials around the world
• Assess the elements of study design that have the
biggest impact on study completion times, including
inclusion/exclusion criteria, protocol design and the
countries involved
• Determine the impact of the use of CROs on study costs
and study completion times
• Examine how payment levels to CROs and sites
influence study completion times and data quality
The database contains extensive cost data at the
Procedure, Cost Per Visit, and Cost Per Patient levels from
North America, Europe, Asia, Latin America and other
important countries involved in drug testing.
Harold E. Glass, MD, Research Professor of Health Policy
& Adjunct Professor, Pharmaceutical and Healthcare
Business, University of the Sciences Philadelphia
13
Friday | April 1st, 2011 |
S
C
TRATEGIC SOURCING
Chairperson: Frances Grote, Senior Director, Strategic
Sourcing, Millennium: The Takeda Oncology Company
11:00
Committing to Two Partners – A Look at the
BMS Integrated Strategic Sourcing Initiative
In order to resource a rapidly increasing volume of clinical
trials with limited internal headcount, BMS developed
their Integrated Strategic Sourcing advanced model
for outsourcing. This model was designed to promote
improved delivery, quality and cost efficiency in clinical
outsourcing. In this session, executives describe how this
initiative differs from traditional transactional models, and
discuss the relationship management structure put into
place to ensure the model’s success.
• Understand the rationale and expected benefits of
committing to strategic outsourcing relationships from
each of BMS’ partners
• Learn the mechanics of managing two strategic
relationships and how the management differs from the
management of traditional transactional relationships
• Gain insights on the obstacles faced in a strategic
relationship model and learn about methods to
overcome them
• Understand how agreements can be constructed and
performance managed to ensure high quality
Lisa McKay Hines, Senior Director, The Avoca Group
(Moderator)
Joan Millsaps, Director, Business Operations and
Outsourcing Management, Bristol-Myers Squibb
Cynthia Hauck, Associate Director, Outsourcing
Management, Bristol-Myers Squibb
Bari Kowal, Senior Director, Strategic Programs,
Joshua Schultz, Corporate Vice President,
Strategic Account Leader, PAREXEL
11:45
E
Tracks
O
OST & CONTRACT
MANAGEMENT
Chairperson: Jessica Bowler, Associate Director
Procurement, Pfizer, Inc.
Negotiation Strategies – How to Best Define
Responsibilities between Sponsors, Sites,
and CROs to Avoid Accountability Disputes
The Changing Role of Central Labs and
the Implications for Outsourcing – Major
Developments, Future Trends and Global
Considerations
It is critical to conduct due diligence and outline
accountability in a contract. This session helps you
pinpoint accountability checkpoints and create clear
and defined responsibilities to avoid legal and regulatory
complications down the road. You will examine how
accountability between CROs and sponsors has shifted
due to the evolution of the relationship and determine
the best practices for creating CRO/site management
contracts.
Building strong lab partnerships is essential to improving
outsourcing efficiencies. This session reviews the major
trends and developments in the central lab market, and
analyzes the role central labs play in reducing sponsors
costs and timelines in clinical trials. Explore how central
lab partnerships have evolved in recent years and best
practices in creating strategic partnerships that create
mutually beneficial opportunities for both the sponsor and
central lab.
• Determine and outline CRO/site management
responsibility from the onset of the relationship
• Include measurements of accountability and
checkpoints into your CRO contracts
• Why negotiations are different with a long-term
strategic partner
• Effectively using negotiation to accelerate a project
Jonathan Lee, Vice President, Development Operations,
CEREXA INC (Moderator)
Rikke Winther, Divisional Director, Outsourcing
Management, LUNDBECK
Jeffrey Rosen, MD, Medical Director, CLINICAL RESEARCH
OF SOUTH FLORIDA
• Review major trends and developments in the central
lab market
• Identify best practices to establish and nurture strategic
relationships
• Better understand the changing global landscape of
clinical trials
• Streamline communications and processes to reduce
unnecessary and unexpected trial costs and delays
• Identify how central labs assist in the validation of
biomarker assays
Rich Polgar, Associate Director, Global Procurement,
Bristol-Myers Squibb
Marc Hamm, Associate Director Procurement,
Pfizer, INC.
Lewis Cameron, CEO, CLEARSTONE CENTRAL
LABORATORIES
Co-Development Between Sponsor and CRO:
Transformational or Conflict of Interest?
Many sponsors have implemented a co-development
model with CROs that creates a true partnership with a
vested financial interest in a trial’s success. Integrated
clinical outsourced programs are designed to reduce
costs, improve quality, and expedite drug development
processes. This model involves engagements that are
long-term, span entire development pipelines, involve
strong governance oversight, and require significant trust
on both the sponsor and partner’s end. This case study
explores the co-development and risk-sharing model
adopted by PPD and Takeda to develop their diabetes
compound.
• Learn how they split up the financial and operational
capabilities during this risk-sharing partnership
• Describe the process of aligning risk/reward models
with evolving corporate strategy and objectives
• How to establish clear accountability across delivery
platforms
• Identify the key drivers of a shared risk model
S C O R
Key Legal Considerations in Global
Outsourcing – Use Critical Tactics to Create
Effective Contracts
In the highly regulated pharma sector, understanding the
key points of negotiation and drafting a proper contract
can be challenging, especially if you don’t have a law
degree. Draw from lessons learned of other highlyregulated industries and hear experts on:
• The top ten ‘must haves’ in an outsourcing agreement
• The top ten pitfalls in putting together an outsourcing
agreement
• What questions should be asked when setting up an
outsourcing agreement
• Product liability insurance for U.S. and global clinical
sites
Best Practices for Patient Recruitment and
Retention for Clinical Trials
As a result of the critical importance of patient
recruitment, and the inherent complexity of dealing with
agency and clinical partners as well as managing the
expectations of patients, it has become a distinct area of
potential competitive advantage. Learn how to best deliver
on your patient recruitment and retention objectives to
gain a comparative advantage in late stage clinical trial
delivery, completing trials with greater levels of costefficiency, timeliness and success.
• Learn about trends in patient recruitment efforts
across the varying parameters – the number, length,
completion failure rate and size of clinical trials
• Examine key patient recruitment performance
benchmarks based on up to date clinical trial data
• Manage the relationship between different partners with
an essential role in recruiting and retaining patients
Julie A. Ross, Senior Vice President, Clinical Operations,
inVentiv Clinical Solutions, LLC (Moderator)
Jeffrey M. Zucker, Senior Director and Global Head,
Patient Recruitment, Kendle
Gretchen Goller, Patient Recruitment/Compliance
Strategist-Operations, Sanofi-Aventis
Gail McIntyre, PhD, DABT, SVP Research,
Furiex Pharmaceuticals Inc
12:30
8:00-8:45AM
How to Use Technology to Create Proactive Behaviors in Clinical
Trial Patients
Kimberly Shea, RN, PhD, Assistant Professor, Arizona State University College of
Nursing and Health Innovation
The Clinical Trial Management Role and Responsibility in a
Preferred Provider Relationship
Janice Hutt, Vice President, the Avoca Group
11:00AM-12:30PM
Clinical Operations Technology- Open Source vs. Propriety Systems
and Unified vs. Integrated Systems
George Miller, Editor-in-Chief, FIERCE MARKETS
Strategies for Clinical Trials in India
Jacqui Mardell, Director and Founder,
Anhivita Biopharma Consulting
Best Practices for REMS Strategy
Jacqui Mardell, Director and Founder,
Anhivita Biopharma Consulting
Impact of Reform on Biosimilar
Drug Development
Gregory Skalicky, Senior Vice President, Worldwide
Business Development, PHARMANET, LLC
Dalvir Gill, President, Late Stage Development,
PHARMANET
14
Impact of Cultural Awareness on Your Global Trials in Asia
Eric Morfin, MBA, PMP, PhD, Founder and First Vice Chair, www.BioPharmaPM.org
HIPPA Compliance for Sponsors & CROs
Jeremy Stoloff, Associate General Counsel,
BANNER HEALTH
Leverage Academic Partnerships to
Grow the Clinical Research Industry
Linda Mottle, MSM-HAS, RN, CCRP, Director Center
for Healthcare Innovation & Clinical Trials Associate
Clinical Professor, ARIZONA STATE UNIVERSITY, COLLEGE
OF NURSING & HEALTH INNOVATION
Friday | April 1st, 2011 |
R
& QUALITY OVERSIGHT
E
S C O R
E
Tracks
Globalization
Bonus track
Chairperson: David Marks, RQAP-GCP, Senior Director
& Global Head, Quality Management, RPS, Inc.
Implement a Comprehensive Clinical Trial
Drug Safety Program and Improve Quality
From Clinical Development to Post-Approval
Staying informed on the latest requirements related
to medical product safety in both the U.S. and abroad
is essential to ensure favorable inspection outcomes.
More than ever before, trial development professionals
must build in active management of drug safety, risk
management and patient health during the entire
lifecycle of a product from preclinical through the
conclusion of the marketing period of a product. In this
session leading safety experts discuss how to:
• Integrate technology to achieve operational excellence
• Significantly lower overall cost base for drug safety
activities
• Lower recruitment and headcount expenses
• Implement a quality systems approach to ensure
compliance, leading to a reduction in business risk due
to favorable inspections outcomes and faster time to
market
Optimize the Vendor-Sponsor Relationship
with ePRO
As quality of life becomes an increasingly important
measure in clinical trials, the need for clean PRO data
becomes more critical. This data-based discussion
evaluates how sponsors view and assess electronic
vendors in ePRO and provides a vendor perspective on
what makes a good sponsor-vendor relationship.
• Hear 2011 survey results around the new ePRO
technologies and systems sponsors are using to
improve the collection of subjective patient experience
in clinical trials
• Ensure that ePRO is institutionalized in your
organization
• Identify best practices in developing and validating
electronic patient reported outcomes
Dwight Cooper, Vice President, Client Services,
PHT Corporation
Post-marketing requirements (PMRs) are becoming
more demanding and increasing in complexity. As more
companies are focusing on developing biologically based
products, the FDA will expect increased attention to postmarketing plans and registries. Regulators are becoming
increasingly more interested in requiring longer and more
rigorous follow-up after approval to ensure patient safety
and facilitate rapid risk communication strategies.
• Discover how clinical partners are collaborating to
address REMS
• Explore best practices for mitigating problem areas in
sponsor-CRO PMR collaborations
• Discuss how comparative effectiveness research might
change clinical trial design, clinical development, risk
taking, and strategic decisions
• Obtain best practices for media communications and
marketing to drive REMS strategy and compliance
• Create a risk management plan integrated within your
commercialization strategy
11:00
It is critical to conduct due diligence and outline
accountability in a contract. This session helps you
pinpoint accountability checkpoint and create clear and
defined responsibilities to avoid legal and regulatory
complications down the road. You will examine how
accountability between CROs and sponsors has shifted
due to the evolution of the relationship and determine
the best practices for creating CRO/site management
contracts.
• Determine and outline CRO/site management
responsibility from the onset of the relationship
• Include measurements of accountability and
checkpoints into your CRO contracts
• Why negotiations are different with a long-term strategic
partner
• Effectively using negotiation to accelerate a project
Jonathan Lee, Vice President, Development Operations,
CEREXA INC (Moderator)
Rikke Winther, Divisional Director, Outsourcing
Management, LUNDBECK
Jeffrey Rosen, MD, Medical Director, CLINICAL RESEARCH
OF SOUTH FLORIDA
Ramita Tandon, Senior Portfolio Director, Late Phase,
Parexel International
Charles Calvert, Senior Director, Pfizer, Inc.
Next Generation Post-Marketing
Requirements (PMR) – Meet Regulatory
Standards and Enhance Patient Safety – Risk
Maps, Registries, and REMS
Negotiation Strategies – How to Best Define
Responsibilities between Sponsors, Sites,
and CROs to Avoid Accountability Disputes
Proactive Medical Monitoring – Planning for
Success through better Safety, Design, and
Enrollment
During this presentation, you will discover the top
reasons to use adaptive clinical trial designs and assess
how medical monitors can anticipate and aid in the
early recognition and management of SAEs in clinical
trials. Obtain best practices in accumulating data to
direct potential modifications to the trial as it progresses
while maintaining the validity and integrity of the study.
Acquire strategies to overcome regulatory, logistical, and
operational issues in adaptive designs and tools to avoid
premature discontinuation of a drug or trial for preventable
and treatable SAEs.
George Miller, Editor, FIERCE BIOTECH IT (Moderator)
Jeffrey Weisberg, DO FACO, Head of Therapeutic
Oncology for the Americas, i3 Global
Stephen A. Goldman, MD, FAPM, DFAPA, Managing
Member, Stephen A. Goldman Consulting
Services LLC
Best Practices for Patient Recruitment and
Retention for Clinical Trials
11:45
As a result of the critical importance of patient
recruitment, and the inherent complexity of dealing with
agency and clinical partners as well as managing the
expectations of patients, it has become a distinct area of
potential competitive advantage. Learn how to best deliver
on your patient recruitment and retention objectives to
gain a comparative advantage in late stage clinical trial
delivery, completing trials with greater levels of costefficiency, timeliness and success.
• Learn about trends in patient recruitment efforts
across the varying parameters – the number, length,
completion failure rate and size of clinical trials
• Examine key patient recruitment performance
benchmarks based on up to date clinical trial data
• Manage the relationship between different partners with
an essential role in recruiting and retaining patients
Julie A. Ross, Senior Vice President, Clinical Operations,
inVentiv Clinical Solutions, LLC (Moderator)
Jeffrey M. Zucker, Senior Director and Global Head,
Patient Recruitment, Kendle
Gretchen Goller, Patient Recruitment/Compliance
Strategist-Operations, Sanofi-Aventis
12:30
3:30-5:00PM
Post Conference Intensives
Adaptive Clinical Trials: Innovations in Trial Design and
Management
Design Safe and Efficient Phase I Studies to Expedite Clinical
Development
Pediatric Drug Development – Challenges and Opportunities in the
Global Arena
What Outsourcing Managers Need to Know about Biomarkers,
Imaging and Other Technologies
“
I believe that Partnerships has eclipsed other conferences to now
become the premier conference in our industry.
-Mark A. Lanfear, Regional Manager, rKFORCE Alliance,
ROCHE PHARMACEUTICALS
”
“
As the transformation of our industry gains momentum, there is no
better conference than Partnerships in Clinical Trials to help drug
development professionals gain the necessary knowledge to be at the
leading edge of that transformation.
-Solomon Babani, Director, Outsourcing and Vendor Management,
CELTIC PHARMA DEVELOPMENT SERVICES
”
15
PARTNERSHIPS HALL
2011 Partnerships in Clinical Trials
ADVISORY BOARD
Partnering Events and Highlights
Daniel Amatulli, Outsourcing Manager,
Celgene
partnerships Hall Tour
Solomon Babani, Sr. Director, Outsourcing
and Alliance Management, Celtic
Therapeutics Development
We know there are many solution providers that you would like to meet with and we will be
arranging brief tours to navigate you through the large exhibit hall.
Deirdre BeVard, Vice President,
Clinical Operations & Data Management,
Endo pharmaceuticals
Meet the 2011 Speakers and Advisory board
Speakers and advisory board members will be on hand at the Partnerships Lounge at select times
throughout the conference to discuss program sessions or other questions or ideas you may have.
Larry Blankstein, PhD, Senior Director,
Clinical Research, Genzyme pharmaceuticals
Christina Bodurow, PhD, Senior Director,
External Sourcing, Development Center of
Excellence, Eli Lilly and Company
20th Anniversary Celebration – Featuring a Special Guest performance,
sponsored by
Jessica Bowler, Associate Director, Worldwide
Procurement, pfizer, inc.
Marisa Bower, Contracts & Outsourcing,
pfizer, inc.
Don’t miss the 20th Anniversary Celebration of Partnerships. Each year, the Partnerships
networking reception offers a wonderful opportunity to meet with colleagues in a fun and informal
setting. This year promises to ROCK!
The Clinical Expert is in the Hall
Christina S. DiArcangelo, Chief Executive
Officer, Armonia Clinical Research, LLC
During breaks the Partnerships MVP speakers will be at the Partnerships lounge to meet, greet
and take your questions on clinical development.
Peter DiBiaso, Senior Director, Clinical
Planning & Performance, vertex
pharmaceuticals
Speed networking
Larry Florin, Section Director, U.S.,
Clinical Outsourcing, Astrazeneca
Back by popular demand, the speed networking has been expanded to improve your face time
with new contacts in clinical development and your overall networking experience. Don’t forget to
bring your business cards!
Elisabeth Overend-Freeman, Global Brand
Manager, Clinical Development Services,
Covance inc
Solution Showcase
Frances Grote, Senior Director, Strategic
Sourcing, Millennium pharmaceuticals
New this year our sponsors and exhibitors will be providing presentations in the hall to help you
evaluate and compare services of leading full service, specialized and ancillary service providers.
Erica Hill, Senior Manager, Marketing,
iCOn Clinical Research
Kevin L. Keim, PhD, MSc, Chief Development
Officer, inC Research
Arizona biotech pavilion
Mary Rose Keller, Vice President, Clinical
Development and Operations, prometheus
Therapeutics and Diagnostics
Back in Arizona for the first time in a few years, we’ve partnered with the Arizona Biotech
Association to show you the best of what Arizona has to offer. Be sure to visit the special area of
the Partnerships Hall to visit the sites and providers ready to help execute your trials.
Jack Lawler, Director Clinical Operations,
Cephalon
Jonathan Lee, Vice President, Development
Operations, Cerexa
Lauren Meyers, Strategic Relationship
Manager, Product Development Operations,
Strategic Outsourcing, Genentech
Theresa Musser, Vice President,
Development Operations, Rigel
pharmaceuticals
E-Clinical pavilion
In addition to a brand new track on e-Clinical technologies, we are making it easier for you to find
the e-Clinical providers in the hall this year. Just look for the e-Clinical logo on the floor plan and in
the company description to find the services you are looking for.
Market insight Roundtable Discussions
Fredrick Naids, PhD, Senior Director,
Clinical Operations, Shire pharmaceuticals
Maximize your networking experience in a fun and relaxed setting as industry experts facilitate
discussions on top challenges to foster the sharing of experiences and best practices. Space will
be limited and registered conference attendees must sign up for the roundtables in advance of the
conference. Visit us online for more details.
David Reasner, PhD, Senior Vice President,
Biostatistics, Data Management, and Health
Outcomes, SepracorMary
Find the Clear Stone
Redge Santos, Executive Director, Strategic
Alliances, kendle international
hosted by
Samir Shah, Executive Vice President, Global
Strategic Development, RpS, inc
internet Hospot
Greg Skalicky, Senior Vice President,
Strategic Global Business Development,
pharmanet
Keep in touch and check your email at our Wireless Internet Hotspot, hosted by
Jay Turpen, Director, Clinical Strategic
Sourcing, Eli Lilly & Company
Ann Wang, Vice President, Clinical
Operations, Human Genome Sciences
Steve Whittaker, Former Chief Operations
Officer, Director of Project Management CV/
Acute Care, Eli Lilly & Company
Get Connected Before the Event!
personalized Scheduling and pre-Event networking Tool – We have partnered
with a leading provider of event scheduling and networking software to provide
you with an easy way to schedule your time before the event and manage your
time onsite through the mobile application.
We’ve created the Partnerships group on linked in to encourage year-round
discussion, knowledge sharing, and idea generation. At time of print, the group
has over 4,000 members!
Join us on LinkedIn – partnerships with CROs or visit the Partnerships
website and click on the “Linkedin” icon
Meet the 2011
Partnerships Team
Danya Burakoff, Program
Director, Biopharmaceutical
and Healthcare Division
Megan Antonelli, Managing
Director, Biopharmaceutical
and Healthcare Division
Join our partnerships in Clinical Trials Community Facebook group for
updates on regional events, dinners, and more!
Allison Rigels, Senior
Marketing Manager
Partnerships in Clinical Trials Blog –
partnershipswithcros.blogspot.com
Andrew Sinetar, Sales
Manager, Pharmaceuticals
Follow us on twitter: @partnershipscros
16
PARTNERSHIPS HALL
2011 Partnerships in Clinical Trials Exhibitors (to date)
Partnerships Hall Hours
*Exhibit hours subject to change
WEDNESDAY, MARCH 30, 2011
6:00-7:00pmPartnerships Opening
Day Reception
THURSDAY, MARCH 31, 2011
8:00-8:45amMorning Coffee
• Market Insight Roundtables
• Partnering Meetings
10:30-11:00amNetworking Break
• Speed Networking
• The Clinical Expert is In the Hall
• Solution Showcase
12:30-1:30pm
Luncheon
3:45-4:15pmNetworking Break
6:00-7:00pm20th Anniversary
Partnerships Celebration
7:00-8:00pmSpecial Guest Performance
Sponsored by
FRIDAY, APRIL 1, 2011
8:00-8:45amMorning Coffee (Market Insight
Roundtables & Partnering
Meetings)
10:30-11:00amNetworking Break
12:30-1:30pm
Luncheon
1:45pm
Hall Closes
3:20pmConference Concludes
reserve your booth –
space is limited
Join a wide range of US-based and global CROs,
central labs, core labs, e-technology providers,
clinical staffing companies, patient recruitment
providers, and more, already confirmed to be in
the exhibit hall.
The 20th Annual Partnerships in Clinical Trials
offers you an excellent opportunity to promote
your products and/or services in front of key
decision-makers.
Please contact Andrew Sinetar at
asinetar@iirusa.com for more information.
Save the Date for
Partnerships 2012!
March 5-7, 2012
Marriot World Center
ORLANDO, FLORIDA
17
THANK YOU TO OUR SUPPORTERS
MARQUEE
PLATINUM
RPS, a next
generation CRO,
provides
comprehensive
global Phase
1-4 clinical
development
solutions to the pharmaceutical, biotechnology and
medical device industries. By combining an
experienced clinical research operations infrastructure
with the industry’s largest resourcing engines, RPS is
uniquely positioned to offer our Clients both integrated
and full service global outsourcing solutions. These
solutions are powered by highly experienced and
seasoned study teams providing innovative,
cost-effective and high quality services.
http://www.rpsweb.com
ICON is a global provider
of outsourced
development services to
the pharmaceutical,
biotechnology and
medical device industries. We specialize in the
strategic development, management and analysis of
programs that support Clinical Development – from
compound selection to Phase I-IV clinical studies.
These services include clinical research, biometrics,
data management, interactive technologies, laboratory,
imaging, clinical pharmacology, resourcing and
consulting services. ICON’s global services are offered
through the expertise of our five combining
international divisions. Each of our service divisions
work in tandem with each other to provide a fully
deliverable outsourced solution for your global
pharmaceutical, biotechnology and medical needs.
• Central Laboratories
• Development Solutions
• Clinical Research
• Medical Imaging
• Contracting Solutions
INC Research is a
therapeutically focused
contract research
organization with a high
performance reputation for
conducting global clinical
development programs of the highest integrity. With
operations in 40 countries, our worldwide clinical trials
teams are deployed regionally to support our
customers’ unique project requirements.
Pharmaceutical and biotechnology companies look to
INC Research for a complete range of customized
Phase I through Phase IV programs in therapeutic
areas of specialty including the central nervous
system, oncology, infectious diseases, endocrine,
respiratory and cardiovascular, and in innovative
pediatric and women’s health trials. The company’s
The Trusted Process® methodology and therapeutic
foresight leads customers to more confident,
better-informed drug and device development
decisions. For more information please visit
www.incresearch.com
www.iconplc.com
PharmaNet Development Group, a global, drug
development services company, provides expertise to
the pharmaceutical, biotechnology, generic drug, and
medical device industries. PharmaNet companies offer
clinical development solutions including consulting
services, Phase I clinical studies, bioequivalency and
pharmacodynamic studies, bioanalytical analyses, and
Phase II, III, and IV clinical development programs.
PharmaNet is a recognized leader in outsourced
clinical development. www.pharmanet.com
PPD is a leading global
contract research
organization, celebrating
25 years of providing
discovery, development and lifecycle management
services. Our clients and partners include
pharmaceutical, biotechnology, medical device,
academic and government organizations. Through
strong strategic alliances and close partnership with
our clients, we apply innovative technologies,
therapeutic expertise and quality services to help
maximize returns on R&D investments and accelerate
delivery of safe, effective therapeutics. For more
information, visit www.ppdi.com
GOLD
Clearstone
Central
Laboratories is
the largest and
most
experienced private company exclusively focused on
providing central lab services to support late-stage
drug development with accurate and timely test data.
With over 20 years of experience in mature and
emerging markets, we offer world-class laboratory
testing, project and data management, and logistical
support to leading pharmaceutical and biotech
companies around the world. Clearstone’s
500-member global workforce delivers these services
from our wholly-owned CAP-accredited laboratories
and global kit production facilities in Beijing,
Hamburg, Paris, Singapore and Toronto. We also own
and operate APOLLO CLPM™ – the leading
proprietary central laboratory protocol management
system. www.clearstonelabs.com
Covance, with headquarters in Princeton, New Jersey,
is one of the world’s largest and most comprehensive
drug development services companies with annual
revenues greater than $1.8 billion, global operations in
more than 30 countries, and more than 10,000
employees worldwide.
Through its discovery, nonclinical, clinical and
commercialization services, Covance has helped
pharmaceutical and biotech companies develop onethird of all prescription medicines in the market today.
Guided by a mission to help bring the miracles of
medicine to market sooner, Covance is committed to
consistently delivering superior service.
www.covance.com
Look to i3 for the
full-spectrum
functional and
therapeutic expertise,
proven regulatory
strategy leadership, unrivalled data and seamless
service that can help you bring products to market
faster and more efficiently, with less risk and expense,
anywhere around the world.
• Therapeutic specialties: cardiology, CNS, oncology,
RID, endocrinology & metabolic disease
• Solutions: clinical research, strategic regulatory
services, data services, drug safety & epidemiology,
late phase research, health economics &
outcomes research, pharma informatics, staffing &
outsourcing
www.i3global.com
Kendle is a leading
global clinical research
organization providing
the full range of early- to
late-stage clinical
development services for the world’s
biopharmaceutical industry. Our focus is on innovative
solutions that reduce cycle times for our customers
and accelerate the delivery of life-enhancing products
to market for the benefit of patients worldwide. As one
of the fastest-growing global providers of Phase I-IV
services, we offer experience spanning more than 100
countries, along with industry-leading patient access
and retention capabilities and broad therapeutic
expertise, to meet our customers’ clinical development
challenges. www.kendle.com
Perceptive
Informatics, the
industry’s leading
eClinical solutions
provider, helps customers accelerate drug
development through innovation. We combine clinical
knowledge and experience with leading technology to
decrease the risk and cost associated with clinical
trials. Our portfolio includes medical imaging, RTSM
(randomization/trial supply management), EDC,
CTMS, ePRO and integration services.
www.perceptive.com
PSI is a full-service CRO
operating in 30+ countries.
PSI’s key strength is
predictable patient
enrollment across multiple
therapeutic areas. PSI’s high repeat business rate is
the best testimony to our proactive and determined
project management philosophy that leads the
industry with on -time results while ensuring high
quality data. www.psi-cro.com
ASSOCIATE
Cardiocore is a leading
global provider of
centralized cardiac testing
services including ECG,
ABPM, ECHO, Holter monitoring, protocol consulting
and statistical analysis. The company’s global
experience includes Phase I-IV, and Thorough QT
clinical trials in all major therapeutic areas for Top Ten,
mid-tier and emerging biopharmaceutical drug
developers. Cardiocore is headquartered in Bethesda,
Maryland, with offices in South San Francisco,
California, London, England and Singapore.
www.cardiocore.com
Established in 1982, Chiltern is
a leading global Contract
Research Organization with
extensive experience
conducting and staffing
international Phase I to Phase IV clinical trials across a
broad range of therapeutic areas for a wide variety of
clients. Chiltern has conducted trials in more than 40
countries, has 24 offices and legal entities within 20
countries, resources in 37 countries and employs
nearly 1,400 people globally. Chiltern provides Early
Phase, Global Clinical Development, Late Phase,
Biometrics, Medical and Regulatory Affairs and
Resourcing Solutions services. www.chiltern.com
Cognizant Life
Sciences partners with
27 of the top 30 global
pharmaceutical/
biotech organizations. We enable business
transformation by delivering consulting, analytics, IT
and business process outsourcing support. Our
comprehensive clinical data management and
biostatistics solutions improve clinical outcomes by
increasing the productivity, quality and efficiency of
the drug development process. www.cognizant.com
With over 20
years experience,
Eurofins Global
Central Laboratory serves the pharmaceutical industry,
providing unsurpassed quality in laboratory testing,
while integrating specialized laboratory services into
one project. Eurofins Global Central Laboratory owns
laboratories in Breda, Washington DC, Singapore,
Shanghai, and Bangalore (coming in 2011). Discover.
Experience. Visit us at http://pharma.eurofins.com
As a strategic partner, inVentiv
Clinical provides comprehensive
and flexible clinical development
services built to FIT your specific
needs, complimented by
industry-leading contract staffing
capabilities. As a division of inVentiv Health, Inc. we
can also leverage expertise from clinical to
communications and commercialization to build
cutting edge solutions. www.inventivclinical.com
PAREXEL knows
scientific drug
development from
end-to-end of the product development cycle: clinical
development, integrated technologies, regulatory
affairs, communications, and commercialization
services. We complement your capabilities with our
global reach, strategic insight, deep scientific
knowledge, and tactical expertise—providing you
support and guidance to secure strategic advantage.
With nearly 30 years of experience and 10,000
professionals in more than 50 countries, we provide
the precise fit of expertise when, where and how you
need it.
www.PAREXEL.com
PHT is the global innovator
in electronic Patient
Reported Outcome (ePRO)
systems that simplify
clinical data management and streamline clinical
trials. Over 100 biopharmaceutical companies have
captured successfully patient experiences using PHT’s
ePRO System in over 450 global trials. Sponsors
collect high-quality time-stamped assessments and
run safer, more conclusive clinical programs, resulting
in significant R&D cost savings for at least 14
regulatory submissions and 11 approvals. View
educational content and interactive PHT
demonstrations at www.phtcorp.com
PRA International, a leading
global clinical research
organization, conducts clinical
trials in 85+ countries across six
continents. PRA provides Phase
I through Phase IV outsourced clinical services for all
therapeutic areas, across all phases of pharmaceutical
and biotech drug development, with particular focus
on: Oncology & Hematology, Neurosciences,
Cardiovascular, Infectious Diseases and Allergy/
Respiratory. www.praintl.com
SUPPORTING
Almac Clinical
Technologies
specializes in
technology and
service solutions that increase the quality and
efficiency of the clinical trial process. Our core suite of
integrated technologies includes Interactive Voice and
Web Response (IXRS™) for patient tracking,
randomization and inventory management, our
interactive reporting platform, our electronic phone
and web-based patient diary solution (ePRO), as well
as statistical services. Our facilities are located in
Souderton and Newtown (PA, USA), San Francisco
(CA, USA), and Craigavon (UK). www.almacgroup.com
18
UBC is a global medical and
scientific affairs organization
that partners with life
science companies to
develop and commercialize their products. We help
clients generate authoritative, real-world evidence of
product effectiveness, safety and value, to assist
health care decisions and enhance patient care.
UBC brings together recognized scientific and
industry experts, research operations professionals,
and leading-edge technologies to provide innovative
solutions across the product lifecycle.
With experts and operations in strategic locations
worldwide, UBC offers the global reach and local
expertise necessary to support the largest and most
complex multinational product development programs.
For more information, visit unitedbiosource.com
OFFICIAL MEDIA PARTNERS
Beardsworth
is a
full-service
CRO
specializing in business solutions for complex clinical
trials & difficult therapeutic areas with a specific focus
on oncology /supportive care and vaccine trials. Our
multi-disciplined staff averages 20+ years experience
supporting research studies from trial design through
clinical project management to FDA approval.
Beardsworth is the founding partner of OncologyOne
– an alliance of “best in class” regional CROs
providing full service business and research strategies
for global oncology trials. Celebrating its 25th year,
Beardsworth is a WBENC-certified, women-owned
business and CCR registrant. www.beardsworth.com
As the industry leader
in cardiac safety drug
research, respiratory
research and
multi-mode ePRO
solutions ERT
(www.ERT.com) has provided unparalleled scientific
and regulatory leadership to biopharmaceutical,
Contract Research Organizations (CROs) and medical
device companies – around the globe. ERT is the one
experienced partner to turn to for best-in-class
solutions and best-in-class advisement, whenever you
need to collect and manage clinical data to deliver
quality results that support getting your new drugs to
market. It’s time to let ERT put our experience to work
for you.
SUPPORTING ASSOCIATIONS
THANK YOU TO OUR SUPPORTERS
MEDiA pARTnERS
3 EASY WAYS
TO REGISTER
CALL
+1 888.670.8200 u.S. or +1 941.951.7885 int’l
EMAIL
register@iirusa.com include code p1600
WEB
DATE
March 30-April 1, 2011
vEnuE
phoenix Convention Center – South building
100 N. 3rd Street, Phoenix, AZ 85004
Phone: 602.262.6225 or 1 800.282.4842.
• General Sessions, keynotes and all track sessions
• The pre-event scheduling and partnering tool
• Choice of any Wednesday morning workshop
• All Partnerships networking breaks and two receptions
including the 20th Anniversary Celebration Gala
• Three new events for site management, medical devices
and investors
• The Partnerships Hall with over 200+ service providers
• All conference documentation in electronic format
• The exclusive 2011 Partnerships in Clinical Trials attendee
Linked In Group
COnFEREnCE pACkAGES
before
Dec 17, 2010
before
Jan 28, 2011
before
Feb 25, 2011
Standard/On-Site Rate
After Feb 25, 2011
Full Conference: 1 Pre-Conference Workshop,
Main Conference & Exhibit Hall
best value!
$2,295
$2,595
$2,895
$3,095
Main Conference & Exhibit Hall Only
$1,895
$2,195
$2,495
$2,695
pharma/biotech Manufacturers*
Exhibit Hall Only
$75 All Times
Other participants
(non pharma/biotech Manufacturers)**
All Times
Full Conference: 1 Pre-Conference Workshop,
Main Conference & Exhibit Hall
best value!
$3,595
Conference & Exhibit Hall Only
$3,195
Tiered pricing is valid through expiration date. New pricing takes effect at specific dates indicated. All fees must be paid in full by expiration date
or your price will increase to the next level tier
* Pharma/Biotech Rate: To qualify for this discount, your company must manufacture and sell pharmaceutical products. This rate is subject to
IIR approval.
** Other Participants Rate: This rate is for Vendors/CROs/Service Providers
*** Exhibit Hall Only does not include access to any sessions
DO yOu QuALiFy FOR A DiSCOunT?
25% off
Bring one peer
(group of 2 in total)
receive 20% off standard
and onsite pricing
25% off
the standard rate if your company
is a sponsor or exhibitor
Bring two peers
(group of 3 total)
Receive 25% off standard
and onsite pricing
25% off
the standard rate if you are a Government,
Non-profit or Academic Professional
Bring three peers or more
Call Millison Thenor at
+1 646 616 7625
* All discounts are off the standard and onsite fees. No two discounts can
be combined. Please note that early registration discounts may be a better
value than some of the discount opportunities here, so please register today.
HOTEL ACCOMODATiOnS
Sheraton phoenix Downtown Hotel*
340 North 3rd Street
Phoenix, AZ 85004
Phone: 602.262.2500
Room Rate: $219+tax/night (single or double occupancy)
Cut off date: Saturday, March 5, 2011 (This rate is available
on a first-come, first-served basis. After March 5, 2011,
rooms and/or the conference rate may not be available.)
*The Sheraton Phoenix is the Partnerships in Clinical
Trials Headquarter Hotel
Hyatt Regency phoenix
122 North Second Street
Phoenix, AZ 85004
Phone: 602 252.1234
Room Rate: $209+tax/night (single or double occupancy)
Cut off date: Saturday, March 5, 2011 (This rate is available
on a first-come, first-served basis. After March 5, 2011,
rooms and/or the conference rate may not be available.)
*Note all conference sessions/breaks/exhibits will take
place at the Phoenix Convention Center, South Building
GROup DiSCOunTS:
the standard rate if someone from
your company is a speaker
pAyMEnTS: Payment is due within 30 days of registering.
If registering within 30 days of the event, payment is due
immediately. You may pay by check, VISA, MasterCard,
Discover, Diner’s Club or American Express. Please make all
checks payable to the “Institute for International Research,
Inc.” and write the name of the delegate(s) and our reference
number P1600 on the face of the check. If payment has
not been received prior to registration the morning of the
conference, a credit card hold will be required.
pRESS: Press permission must be obtained prior to the event
and is dependent upon speakers’ approval. The press may not
quote speakers or delegates unless they have obtained their
approval in writing. For press inquiries please contact Allison
Rigels at arigels@iirusa.com.
EvEnT DOCuMEnTATiOn ORDER: If you are unable to attend
the program, or would simply like to order additional sets of
documentation for your colleagues, they are available for $495
per set. The documentation is a compilation of the speaker
presentations including overheads, power point presentations,
articles and charts. The documentation is available online two
weeks after the event takes place. Credit Card Payments Only.
All speakers and topics listed are confirmed as of press
time. When substitutions must be made due to speaker
cancellations, IIR makes every effort to find a replacement of
equal caliber to present the scheduled topic.
DRESS CODE: Casual and comfortable attire is suggested. We
recommend bringing a sweater, as the conference room may
be cool.
* All registrations must take place at the same time for discount structures
to apply
CAnCELLATiOn pOLiCy: If you need to make any changes
or have any questions, please feel free to contact us via
email at register@iirusa.com. Cancellations must be in
writing and must be received by IIR prior to 10 business
days before the start of the event. Upon receipt of a timely
cancellation notice, IIR will issue a credit voucher for the
full amount of your payment, which may be applied towards
registration fees at any future IIR event held within 6 months
after issuance (the “Expiration Date”). All credit vouchers
shall automatically expire on the Expiration Date and shall
thereupon become void. In lieu of issuance of a credit
voucher, at your request, IIR will issue a refund less a $795
processing fee per registration. Registrants are advised that
no credit vouchers or refunds will be issued for cancellations
received less than ten business days prior to start of the
event, including cancellations due to weather or other causes
beyond the Registrant’s control. IIR therefore recommends
that registrants allow for unexpected delays in making travel
plans. Substitutions are welcome at any time. If for any
reason IIR decides to cancel this conference, IIR accepts no
responsibility for covering airfare, hotel or other costs incurred
by registrants, including delegates, sponsors, speakers and
guests.
Any disabled individual desiring auxiliary aid for this
conference should notify IIR at least 3 weeks prior to the
conference in writing, by faxing to +1 212 661 6045.
inCORRECT MAiLinG inFORMATiOn: If you are receiving
multiple mailings, have updated information, or would like to
be removed from our database, please contact our database
department at +1 212. 661.3876 or fax +1 212.661.3014.
P1600
19
PRSRT STD
U.S. Postage
pAiD
IIR
Institute for International Research
708 Third Avenue, 4th Floor
New York, NY 10017-4103
P1600
Building Strategic Partnerships in an Era of Global Transformational Change
Deirdre bevard
Vice President,
Clinical Operations
and Data Management
Endo pharmaceuticals
Hear from these Industry Insiders and Many
More on Today’s Most Important Challenges
Frederick naids, PhD
Senior Strategic
Sourcing Director,
Clinical Development
Operations & Biometrics
Shire pharmaceuticals
• Obtain strategies for reducing micro-management of CROs while
maintaining effective quality oversight
Mark Milberg
Senior Contract Manager,
Clinical Contracting
Medtronic
• Learn how sponsors an CROs create long term strategies for
profitability and growth in global clinical trials
• Hear from an expanded faculty of financial experts to determine
how to adapt to the increased cost of drug development, identify
hot areas of investment, and develop an action plan for business
growth
• Attain techniques for change management and develop a strategic
plan for executing innovation
David Gilogy
Global Head, Clinical
Contracting and Category
Management
novartis
Ann Wang
Vice President,
Clinical Operations
Human Genome Sciences
bryant Wales, VP
Strategic Sourcing
imClone Systems
• Explore how to leverage the value of your technology for clinical
drug development
David Leventhal, MBA
Director, Healthcare
Informatics
pfizer, inc.
• Get an all-access pass to three new targeted events for investigator
and site management professionals, medical device professionals,
and biotech executives
• 5 all new tracks give you the latest S
peter Dibasio
Clinical Development
Operations
vertex pharmaceuticals
C O R
E
nancy Joseph-Ridge, MD
Head of Global
Development/General
Manager, Pharmaceutical
Development Division
Takeda pharmaceuticals
international, inc.
Mitchell katz, PhD
Executive Director,
Medical Research
Operations
purdue pharma L.p.
S trategic Sourcing
C ost and Contract Management
O perational Excellence
Thomas Lawler
Sr Director, Clinical
Project Management
Astrazeneca
R egulatory Compliance and Quality Oversight
E -Clinical Technologies
March 30-April 1, 2011 • phoenix Convention Center • Arizona
Jeff kasher, PhD
Vice President and
COO, Global Clinical
Development
Eli Lilly & Company

March 30-Apr 1, 2011

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