real world evidence heor and post approval studies summit

Organized by:

to register, visit www.worldcongress.com/rwd | 800-767-9499 | [email protected]

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 Av e U P t o $ 2 0 0 w H e n Y o U r e g i s t e r B Y F r i d AY, J U n e 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

www.worldcongress.com/rwd

Media Partners:@wrldhealthcare

#WCRWD


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.

w h Y Y o u s h o u l d s p o n s o r

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 [email protected]



August 11-12, 2014

Hyatt at the Bellevue

Philadelphia, PA

real world data strategies

d aY o n e – m o n d aY , a u g u s t 1 1 , 2 0 1 4 • p r e - s u m m i t w o r k s h o p8:00 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

d aY o n e – m o n d aY , a u g u s t 1 1 , 2 0 1 4 • m a i n s u m m i t a g e n d a1:00 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 FDAThe 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


August 11-12, 2014


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d aY o n e – m o n d aY , a u g u s t 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

d a Y t w o – t u e s d aY , a u g u s t 1 2 , 2 0 1 48:00 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



d a Y t w o – t u e s d aY , a u g u s t 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

RegistRation Fee: Register By6/20/2014

Register By8/11/2014standaRd

Conference $ 2595.00 $ 2795.00Conference Plus 1 Workshop $ 2895.00 $ 3095.00PhaRMa / BiOteChConference $ 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 [email protected].

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.

WeBsiTeWorldcongress.com/ RWD

RegisteR [email protected]

Best value

PRsRT sTDu.s. Postage

PaiDGallery

World Congress500 West Cummings Park, Suite 5200Woburn, MA 01801PB14010

VenUe: Hyatt at the bellevue 200 south Broad street Philadelphia, Pa 19102 888-421-1442 philadelphia.bellevue.hyatt.com Room Rate: $199 Cut-off Date: 7/21/14

ATTN Mail Room: If undeliverable please forward to health outcomes/economics

s Av e U P t o $ 2 0 0 w H e n Y o U r e g i s t e r B Y F r i d AY, J U n e 2 0 , 2 0 1 4 !



August 11-12, 2014


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


@wrldhealthcare

#WCRWD

real world evidence heor and post approval studies summit

Health & Medicine