This executive level summit explores strategies for innovation in the evolving world of data. Hear from a variety of stakeholder perspectives including industry, regulatory, CRO, and related organizations who will address the key strategies for success in the ever-changing post-marketing environment. The agenda features cutting-edge methods and in-depth case studies that provide pragmatic, real world takeaways. Attend this summit to gain critical insights and collaborate with your peers on the best methods and strategies for post-approval success. http://www.worldcongress.com/events/PB14019/

1. Organized by:
to register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.com
The World Congress Summit on
Emerging Strategies and Standards to Leverage Real World
Outcomes Data and Succeed Post-Marketing
August
11-12, 2014
Hyatt at the
Bellevue
Philadelphia, PA
real world evidence
heor and post approval
studies summit
S AVE U P TO $ 2 0 0 W H EN Y O U REGISTER B Y F RID AY, J U NE 2 0 , 2 0 1 4 !
f e a t u r e d s p e a k e r s :
Gregory W. Daniel, PhD, MPH, RPh
Managing Director, Engelberg Center for Health Care Reform
The Brookings Institution
Robert S. Epstein, MD, MS
Chief Executive Officer, Epstein Health
Former Chief Medical Officer and Chief R&D Officer
Medco
Usman Iqbal
Senior Medical Affairs Leader
AstraZeneca
Troy Sarich, PhD
Vice President, Real World Evidence
Janssen Scientific Affairs LLC
Janssen, a Johnson & Johnson Company
Josephine A. Sollano, Dr.PH
Vice President, Outcomes and Evidence
Global Health and Value
Pfizer
Robin S. Turpin, PhD
Director, US Health Care, Quality and
Outcomes, US Medical and Scientific Affairs
Takeda Pharmaceuticals USA, Inc.
Top Reasons to Attend:
• Collaborate with your colleagues on cutting-edge
strategies for leveraging real world data in
demonstrating outcomes
• Hear about the Sentinel Initiative as a
critical factor in the next steps for health care
• Understand how advocacy groups like PatientsLikeMe,
in collaboration with pharma, can produce better
outcomes for all stakeholders involved
• Gain critical insights on integrating data sources
to build networks for the future
• Hear from top executives from a variety of organizations
on how to meet the needs of payers, regulators, and
providers efficiently and cost-effectively
Address 3 Critical Factors in
Post-approval Success:
1. Innovative data strategies
and methodologies
2. Synchronize and integrate evidence
throughout product life cycle
3. Engage and develop
multi-stakeholder partnerships
for conference updates visit
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Media Partners:
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#WCRWD

2. to register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.comto register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.com
Summit Objective:
This executive level summit explores strategies for innovation in the evolving
world of data. Hear from a variety of stakeholder perspectives including industry,
regulatory, CRO, and related organizations who will address the key strategies for
success in the ever-changing post-marketing environment. The agenda features
cutting-edge methods and in-depth case studies that provide pragmatic, real
world takeaways. Attend this summit to gain critical insights and collaborate with
your peers on the best methods and strategies for post-approval success.
Who Should Attend
Senior level leaders from:
• Health Economics
• Outcomes Research
• Real World Data/Evidence
• Phase IV/Late Phase
• Post-Approval/Post-Marketing
• Patient Registries
• Disease Registries
• Medical Affairs
• Clinical Affairs
• Clinical Operations
• Scientific Affairs
• Surveillance/Safety
• Regulatory Affairs
• Pharmacovigilance
• Risk Management
This conference will also benefit
Contract Research Organizations,
consultants, and solution providers
with expertise in post-approval studies,
real world data and outcomes
research, and big data vendors.
WH Y Y OU SHOULD SPONSOR
POSITION
your company
as a leading
solutions and
service provider
MEET
your market
SHOWCASE
new technology
innovations
INCREASE
brand awareness
GENERATE
leads and new
business
DEVELOP
new and
current client
relationships
MAXIMIZE YOUR NETWORKING OPPORTUNITIES
• Present to Key Players in Your Target Market
• Take Advantage of 1-on-1 Sponsor/Attendee Meetings Facilitated On-Site
CAPTURE A TRUE ROI Through Sponsorship of the Following:
Executive Tracks • Keynote Sessions • Networking Cocktail Reception Breakfast
Symposia • Market Insight Series • Luncheon
Executive Networking Participant and Networking Breaks
To inquire about Sponsorship and Executive Networking Opportunities,
Contact Suzanne Carroll, Business Development Manager, World Congress
Call 781-939-2648 or email Suzanne.Carroll@WorldCongress.com
The World Congress Summit on
Emerging Strategies and Standards to Leverage Real World Outcomes Data
and Succeed Post-Marketing
August
11-12, 2014
Hyatt at the
Bellevue
Philadelphia,
PA
real world
data strategies

3. DAY ONE – M o n day, Au g u st 1 1 , 2 0 1 4 • P r e-S u m m i t wo r k s h o p
8:00 am –
8:30 am
Workshop Registration and Morning Coffee
8:30 am –
11:45am P r e - S u m m i t W o r k s h o p
Managing for ‘Value’ in Health Care—A Global Executive Think Tank
Learn strategies from your peers and gain pragmatic takeaways on how to leverage pre-existing data sets. Understand how other nations capture data from a
variety of sources to create one comprehensive database. Engage in high level discussion to determine the most effective methods of data analysis, including:
• Head to head data, gaps from bench to bedside, real-world outcomes
• Eco system gaps — Global evidence/local decision-making, understand the global market, and how other countries are leveraging data sets
• Novel ways to earlier integrate the insights of providers, patients, and policy makers in drug development
Robert S. Epstein, MD, Chief Executive Officer, Epstein Health; Former Chief Medical Officer and Chief R&D Officer, Medco
Dr. Robert Epstein is a physician epidemiologist with an interest in bringing true innovation and hope to those in need of novel health care
solutions. He has worked for 30 years in the public and private health care sectors and most recently left a 15 year post as Chief Medical and
Chief R&D Officer for Medco, where he managed a global department of over 2000 researchers in 33 offices. He is currently CEO of Epstein
Health, a strategic consulting company. He is a frequent speaker at conferences in the US and abroad, and is often interviewed in the media.
Dr. Epstein has published more than 100 research papers in the peer-reviewed medical literature on a wide range of topics, and is currently
tracking and engaging with developers of hundreds of new technologies.
Tehseen Salimi, MD, MHA, Vice President, Global Medical Affairs, AstraZeneca
Dr. Tehseen Salimi is the Vice President in Global Medical Affairs at AstraZeneca, a multinational pharmaceutical company. She has over 20 years of
experience leading transformative patient-centric initiatives to bridge the evidence and value gaps. Her leadership developed in complex and rapidly
changing environments, is backed with strong tenure in managed care and global pharmaceutical arenas. Recently Dr. Salimi served in Global Medical
Affairs at Sanofi, where she developed a new Global Evidence and Value Development model to ensure ‘Evidence Continuum’ with real world evidence
definition, generation, and translation, starting early in development. Dr. Salimi developed Innovative Payer/HTA initiatives to support inclusion of
relative medical value in the development program and to demonstrate impact on Health Outcomes. She previously served in leadership positions at
several managed care organizations, including Cigna and Fallon Health Care. She is currently serving on both internal and external committees. Dr.
Salimi is a board member of the e-Health Initiative, CMTP, and chair of the Population Health Alliance International Committee. Exemplifying solid
commitment to her profession and determination to succeed, she has been highly respected by her colleagues for unwavering dedication and practical
knowledge. During her tenure, Dr. Salimi was honored with accolades, including the Physician’s Recognition Award for Best Outcomes and the
Superior Achievement Award at Cigna. She was also featured in the 1998 annual report of the National Committee for Quality Assurance (NCQA) for
the Best Practice Quality Improvement Initiative. She attributes her success to commitment, perseverance, and dedication to Innovation and learning.
Additional Thought Leaders TBA
11:45 am –
1:00 pm Lunch on Your Own/Main Summit Registration
DAY ONE – M o n day, Au g u st 1 1 , 2 0 1 4 • M a i n S u m m i t a g e n d a
1:00 pm –
1:15 pm Chairperson’s Welcome and Opening Remarks
Troy Sarich, PhD
Vice President, Real World Evidence, Janssen Scientific Affairs LLC
Janssen, a Johnson & Johnson Company
1:15 pm –
2:00 pm The Future of Regulations —
Understand the Sentinel Initiative and the Next Steps for the FDA
The FDA has a number of initiatives underway to improve the safety and efficacy of drugs and improve access to health care across the continuum.
Hear from Greg Daniel, Director of Evidence Development and Innovation at Brookings Institution, the convening group for the Sentinel Initiative, and
Reagan-Udall Foundation’s IMEDS program.
• Understand the Sentinel Initiative as a critical element in the future of health care, and the next steps for this project
• Discuss the role of the Reagan-Udall Foundation’s new IMEDS program as an avenue for pharma manufacturers to participate with sentinel data partners
• Prepare for regulatory changes in the next few years
• Discuss issues surrounding safety
Gregory W. Daniel, PhD, MPH, RPh
Managing Director, Evidence Development and Innovation, Engelberg Center for Health Care Reform
The Brookings Institution
to register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.comto register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.com
Thereisa15minutecoffeeandnetworkingbreakfrom10:00am–10:15am

4. DAY ONE – M o n day, Au g u st 1 1 , 2 0 1 4 ( c o n t i n u e d )
2:00 pm –
2:45 pm Develop Better Treatment Pathways and Optimize Efficacy in
Comparative Effectiveness Research
• Discuss methodological challenges in Big Data analytics
• Optimize efficacy assessments in CER through competitive positioning and patient-centered outcomes
• Understand physician network analyses in Big Data to assess switching pathways and insights into prescribing patterns
• Analyze the application of CER in drug development and trial design optimization — Evidence continuum from effectiveness to efficacy
Usman Iqbal
Senior Medical Affairs Leader
AstraZeneca
2:45 pm –
3:30 pm Maximize Value of Registry Data for Improved Discovery and Innovation
• Develop a Collaborative Chronic Care Network for research and improvement
• Create a strong value proposition for improved patient enrollment and retention
• Data in Once — Re-purpose data for clinical care, improvement, and research
• Engage and sustain patient and family participation for optimum registry value
Richard Colletti, MD
Executive Network Director
ImproveCareNow
Sean Kennedy, MPH
Senior Director, Global Late Stage Operations
PPD, Inc.
3:30 pm –
4:00 pm
Networking and Refreshment Break
4:00 pm –
4:45 pm Case Study: Disease Registries — Real World Study Design
• Gain strategies for obtaining real world observational data within study budget — A balancing act
• Overcome challenges of real world disease registry protocol design
• Understand how data and outcomes are directly impacted by real world patients and their conditions
Todd Berner, MD
Director, Urology, Health Economics & Clinical Outcomes Research
Astellas Scientific and Medical Affairs, Inc
4:45 pm –
5:30 pm Create Interoperability Between Electronic Data Sources to Enhance Data for
Demonstrating Improved Outcomes
• Achieve meaningful communication between systems
• Address issues involving clinicians, customized EHR interfaces, and creating interoperability
• Gain insight to networks that are building health learning systems of the future
• Address socio-technical considerations in working with Big Data sets
Erin Holve, PhD, MPH, MPP
Senior Director
Academy Health
5:30 pm –
6:30 pm
Cocktail and Networking Reception
DA Y t w o – T u e s day, Au g u st 1 2 , 2 0 1 4
8:00 am –
8:30 am
Registration and Morning Coffee
8:30 am –
8:45 am
Chairperson’s Welcome and Review of Day One
Troy Sarich, PhD
Vice President, Real World Evidence, Janssen Scientific Affairs LLC
Janssen, a Johnson & Johnson Company
to register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.comto register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.com

5. to register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.comto register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.com
DA Y t w o – T u e s day, Au g u st 1 2 , 2 0 1 4 ( c o n t i n u e d )
8:45 am –
9:45 am
Balancing Data Expectations of Regulators and Payers for an Efficient Post-Marketing Strategy
• Advancement to the forefront in the regulatory space — Balancing benefits and risks and how that is translating into payer assessment of value
• Develop strategies for using sources of real world data in a way that aids both industry and payers
• Redefine cost effectiveness — Assessment of short term versus long terms costs, and meeting of the minds with payers
Kimberly McCleary
Director of Strategic Initiatives
FasterCures, A Center of the
Milken Institute
Michael Pollock
Vice President,
Real World Outcomes
PPD, Inc.
Josephine A. Sollano, Dr.PH
Vice President, Outcomes and Evidence
Global Health and Value
Pfizer
9:45 am –
10:30 am
The Intersection of Pharmaceutical Manufacturers and ACOs —
Leveraging Data for New Payment Models
• Forge new partnerships with ACOs and providers to mutually benefit all stakeholders
• Understand how data can be used to support performance tracking of drugs and devices for new payment models
• Evaluate outcomes-based contracting and other new uses for outcomes and economic data
Robin Turpin, PhD
Director, US Health Care, Quality and Outcomes, US Medical and Scientific Affairs
Takeda Pharmaceuticals USA Inc.
10:30 am –
11:00 am Networking and Refreshment Break
11:00 am –
11:45 am
Case Study: Patients Like Me — The Evolution of a Patient Powered Research Network
• Expand opportunities to share patient insights with the pharmaceutical industry through our Global Network Access
• Build models to integrate patient generated data with other health data to support improved health outcomes
• Collaborate with researchers and patients through the Open Research Exchange to develop patient-centered outcome measures suitable for use
across the drug development process
Sally Okun, MD, MMHS
Vice President, Advocacy, Policy, and Patient Safety
PatientsLikeMe
11:45 am –
12:30 pm
Data Linkages — How Real World Data can be Maximized to Support Development
and Post-Marketing Research Programs
• Understand the applications of real world data, and how it can be most effectively utilized
• Discuss how to implement rapid-cycle analysis for insight generation
• Discuss data mash ups and how to prepare for Big Data and advanced analytics
James Harnett, PharmD, MS
Senior Director Real World Data and Analytics
Pfizer
12:30 pm –
1:30 pm
Luncheon
1:30 pm –
2:15 pm
Enhance Large Scale Clinical Data Association Studies with Privacy Protections
• Learn how to de-identify large health data repositories in accordance with regulatory requirements
• Characterize how to tailor de-identification to different environments and organizational requirements
• Understand the types of investigations that can be accomplished with de-identified data and biomarkers
Bradley Malin, PhD
Associate Professor, Vice Chair of Biomedical Informatics in the School of Medicine
Vanderbilt University
2:15 pm –
3:00 pm
Prepare for the Future of Big Data — How to Create Richer Data Sources Now
• Understand the future of Big Data and its impact on the pharmaceutical industry
• Identify how to make data more applicable in day-to-day decision making
• Address ownership issues and how to work around business models
Sean McElligott
Associate Director, Customer Data and Analytics
Merck
3:00 pm Close of Summit

6. Registration Fee: Register By
6/20/2014
Register By
8/11/2014standard
Conference $ 2595.00 $ 2795.00
Conference Plus 1 Workshop $ 2895.00 $ 3095.00
pharma / biotech
Conference $ 1795.00 $ 1995.00
Conference Plus 1 Workshop $ 2095.00 $ 2295.00
Fee for conference includes welcome coffee, lunch, reception,
refreshments, and web-based conference documentation available pre-
and post-event, accessible through password-protected website. Checks in
U.S. funds drawn from U.S. bank payable to: WC Research Inc. No personal
checks accepted. Verification may be required for rate approvals.
SPECIAL TEAM DISCOUNTS: With so much great
content, you can’t possibly cover it alone. Sign up your
team and save. Find out more about special group
package discounts by calling 800-767-9499 or
emailing wcreg@worldcongress.com.
Participant Substitution and Cancellations:
Your registration may be transferred to a member of your organization
up to 24 hours in advance of the conference. Cancellations received
in writing on or before 30 days prior to the start of the event will be
refunded, less a $395 administrative charge. No refunds will be made
after this date; however, the registration fee less the $395 administrative
charge can be credited to another World Congress conference if you
register within 6 months from the date of this conference. In case of
conference cancellation, World Congress’ liability is limited to refund of
the conference registration fee only. World Congress reserves the right
to alter this program without prior notice.
Satisfaction guaranteed: World Congress stands behind the
quality of its conferences. If you are not satisfied with the quality of
the conference, a credit will be awarded towards a comparable World
Congress conference of your choice.
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Venue:
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888-421-1442
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Room Rate: $199
Cut-off Date: 7/21/14
ATTN Mail Room: If undeliverable please forward to health outcomes/economics
S AVE U P TO $ 2 0 0 W H EN Y O U REGISTER B Y F RID AY, J U NE 2 0 , 2 0 1 4 !
The World Congress Summit on
Emerging Strategies and Standards to Leverage Real World Outcomes Data
and Succeed Post-Marketing
August
11-12, 2014
Hyatt at the
Bellevue
Philadelphia,
PA
real world
data strategies
Topics include:
• Develop better treatment pathways
and optimize efficacy in comparative
effectiveness research
• Maximize value of registry data for
improved discovery and innovation
• Balancing data expectations of
regulators, payers, and providers for an
efficient post-marketing strategy
• Data linkages — How real world data can
be maximized to support development and
post-marketing research programs
featured speakers:
James Harnett, PharmD, MS
Senior Director,
Real World Data
and Analytics
Pfizer
Sean McElligott
Associate Director,
Customer Data
and Analytics
Merck
Sally Okun, RN, MMHS
Vice President
of Advocacy, Policy
and Patient Safety
PatientsLikeMe
Tehseen Salimi, MD
Vice President,
Global Medical Affairs
AstraZeneca
to register, visit www.worldcongress.com/RWD | 800-767-9499 | wcreg@worldcongress.com
@wrldhealthcare
#WCRWD