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Agenda

Comparative Effectiveness and Personalized Medicine:
An Essential Interface

Tuesday, October 19, 2010; 8:15 AM – 6:15 PM
Wednesday, October 20, 2010; 8:00 AM – 1:10 PM

Masur Auditorium
Building 10 (Clinical Center)
National Institutes of Health
Bethesda, Maryland

AGENDA

 

Tuesday, October 19, 2010

7:00am

Registration

7:30am - 8:15am

Networking Coffee

8:15am - 8:30am

Introductory Remarks

Jeffrey C. Lerner, PhD
President and Chief Executive Officer
ECRI Institute
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Michael Lauer, MD, FACC, FAHA
Director
Division of Cardiovascular Sciences
National Heart, Lung and Blood Institute
National Institutes of Health (NIH)
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Jean Slutsky
Director
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality (AHRQ)
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8:30am - 9:15am

Session I
Illuminating Clinical Decision-Making with Whole Genome Sequencing: One Person’s Story

Learning Objective: Physicians will recognize how the use of genetic testing might lead to more effective treatment and improve a patient’s prognosis due to the early identification of disease and subsequent personalized treatment. Physicians will also learn why a patient might choose not to use available personal genetic information to change their own behavior. Finally, physicians will also learn more about the environmental impact of genetic propensities.

Moderator: Susan Dentzer
Editor-in-Chief
Health Affairs

Euan Ashley, MRCP, DPhil
Assistant Professor
Cardiovascular Medicine
Stanford University

Bruce (Ned) Calonge, MD, MPH
Chair
US Preventive Services Task Force
Chief Medical Officer
Colorado Department of Public Health and Environment
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Stephen Quake, DPhil
Professor of Bioengineering, Co-Chair, Department of Bioengineering
Investigator, Howard Hughes Medical Institute
Department of Bioengineering
Stanford University
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9:15am - 9:30am

Q & A

9:30am - 10:15am

Session II
CER in Personalized Medicine: What Evidence Do We Need?

Learning Objective: Physicians will be able to differentiate between substantive and non-substantive evidence upon which medical decisions are being made regarding comparative effectiveness research and its interface with research on personalized medicine.

Moderator: J. Sanford Schwartz, MD
Leon Hess Professor of Medicine and Health Management & Economics
School of Medicine and Wharton School
University of Pennsylvania

What’s Needed to Make Personalized Medicine Evidence-based?
Steven Teutsch, MD, MPH
Chief Science Officer
Los Angeles County Department of Public Health
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Predicting Risk
Bruce Psaty, MD, PhD
Professor of Medicine
Epidemiology and Health Services
University of Washington
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10:15am - 10:30am

Q & A

10:30am - 11:00am

Break

11:00am - 12:00pm

Session III: Keynote Address
The CER Vision of Tomorrow: Tailoring Medicine to the Individual

(Includes discussion of orphan diseases, innovation, and special populations)

Learning Objective: Physicians will be able to recognize the importance of and the possibilities for the effective use of personalized medicine research in years to come, including for treating special populations and/or orphan diseases and developing innovative treatments. They will also learn how to approach these issues from the perspective that starts from the framework of comparative effectiveness research informing personalized medicine.

Francis Collins, MD, PhD
Director
National Institutes of Health
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Carolyn M. Clancy, MD
Director
Agency for Healthcare Research and Quality
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12:00pm - 12:30pm

Keynote Dialogue and Q & A

12:30pm - 1:45pm

Lunch Break (food can be purchased on NIH campus)

1:45pm - 2:45pm

Session IV
Cancer: A Case Study from the Scientific Frontier

Learning Objective: Physicians will be able identify and integrate relevant aspects of comparative effectiveness based on the key trends in cancer research specifically from the National Institutes of Health’s basic research program; through cost-effectiveness research; and from a clinician/patient perspective.

Moderator: Barry Kramer, MD, MPH
Director
Office of Disease Prevention
National Institutes of Health

Viewpoints from the National Cancer Institute
Robert Croyle, PhD
Director
Division of Cancer Control and Population Sciences
National Cancer Institute
National Institutes of Health
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Viewpoints from Scientists in the Field
Scott Ramsey, MD, PhD
Associate Professor of Medicine and Health Services
Associate Member, Cancer Prevention Research Program, Fred Hutchinson
Cancer Research Center
Division of Internal Medicine, University of Washington
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The Democratization of Research: Bringing the Public Into the Process
Susan Love, MD, MBA
President
Dr. Susan Love Research Foundation
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2:45pm - 3:00pm

Q & A

3:00pm - 3:30pm

Break

3:30pm - 4:30pm

Session V
The Role of Venture Capital in Fostering CER and Personalized Medicine

Learning Objective: Physicians will recognize the changing requirements and perspectives of venture capitalists who fund innovative medical products. These changes include adapting to new conditions linked to the adoption of comparative effectiveness research in the healthcare system.

Moderator: Jean-Paul Gagnon, PhD
Pharmaceutical Public Policy Consultant

G. Steven Burrill
Chief Executive Officer
Burrill & Company
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Sue Siegel, MS
Partner
Mohr Davidow Ventures
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4:30pm - 4:45pm

Q & A

4:45pm - 5:45pm

Session VI
Personalized Medicine and CER Challenges in the Regulation of Drugs, Devices & Biologics

Learning Objective: Physicians will come to better understand the critical role that comparative effectiveness research needs now plays in the regulation of drugs, medical devices and biologics as seen through the eyes of U.S. government regulatory officials at FDA.

Moderator: Amy Patterson, MD
Director, Office of Biotechnology Activities
Acting Director, Office of Science Policy
National Institutes of Health

Methods
Robert Temple, MD
Director
Office of Medical Policy
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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Drug Development in the Era of Comparative Effectiveness
Janet Woodcock, MD
Director
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Devices - The Interface of Personalized Medicine and CER: FDA’s Perspective on the Use of Medical Devices
Jeffrey E. Shuren, MD, JD
Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
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5:45pm - 6:15pm

Q & A

6:00pm - 7:15pm

Networking Meet and Greet at NIH

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Wednesday, October 20, 2010

7:30am - 8:00am

Registration & Networking Coffee

8:00am - 8:30am

Session VII
Putting Research into Practice: CER and Personalized Medicine in Hospitals

Learning Objective: Physicians will examine and judge the relevance of comparative effectiveness research and its impact on personalized medicine based on the experiences of a hospital chief executive officer with an extensive research background.

Moderator: Richard N. Gottfried, JD
Chair, Health Committee
New York State Assembly

Elizabeth G. Nabel, MD
President
Brigham and Women’s Hospital
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8:30am - 8:45am

Q & A

8:45am - 9:25am

Session VIII
CER, Personalized Medicine and Coverage

Learning Objective: Physicians will recognize the ever widening role that comparative effectiveness research and personalized medicine will play in healthcare coverage decisions as presented by U.S. government and private insurance experts.

Moderator: Murray Ross, PhD
Vice President
Kaiser Foundation Health Plan, Inc.
Director
Kaiser Permanente Institute for Health Policy

Lee Newcomer, MD
Senior Vice President
Oncology
United Healthcare
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Barry Straube, MD
Chief Medical Officer and Director
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
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9:25am - 9:40am

Q & A

9:40am - 10:20am

Session IX
Enhancing CER Evidence with Personalized Data from Large Health Care Systems

Learning Objective: Physicians will judge the importance of clinical registries and other new sources of comparative effectiveness data on changing diagnosis and treatment in large health systems.

Moderator: Wilson Pace, MD
Department of Family Medicine
University of Colorado DARTNet

Large, Integrated Data Sets Pave the Way to Personalized CER
Joel Kupersmith, MD
Chief Research and Development Officer
Veterans Health Administration
Department of Veterans Affairs
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Ralph Brindis MD, MPH, FACC, FSCAI
President
American College of Cardiology
Clinical Professor of Medicine
University of California, San Francisco
Senior Advisor for Cardiovascular Disease
Kaiser Permanente
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10:20am - 10:35am

Q & A

10:35am - 11:00am

Break

11:00am - 12:00pm

Session X
Clinical Exemplars of Personalized Medicine in Ongoing CER

Learning Objective: Physicians will recognize and be able to better formulate an educated opinion on the proper use of comparative effective research findings to improve the treatment of medical conditions that have historically had a widespread impact on the general public. These include anti-coagulation.

Moderator: Philip Wang, MD, DrPH
Deputy Director
National Institute of Mental Health
National Institutes of Health

Anti-coagulation
Julie Johnson, PharmD, FCCP, BCPS
Professor and Chair, Department of Pharmacotherapy and Translational Research
Professor of Medicine (Cardiology)
Director, University of Florida Center for Pharmacogenomics
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Bidil
Clyde W. Yancy, MD, FACC, FAHA, MACP
Medical Director, Baylor Heart and Vascular Institute
Chief, Cardiothoracic Transplantation
Baylor University Medical Center
President, American Heart Association
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What Do Large Diabetes “Outcomes” Trials Tell Us About Managing the Patient in Front of You?
Hertzel Gerstein, MD, MSc, FRCPC
Professor
Department of Medicine
Department of Clinical Epidemiology and Biostatistics
McMaster University
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12:00pm - 12:15pm

Q & A

12:15pm -1:00pm

Session XI
Societal Implications of CER and Personalized Medicine: Panel Discussion

Learning Objective: Physicians will learn to appreciate social, legal, and economic perspectives on how comparative effectiveness and personalized medicine can interface productively.

Moderator: Sean Tunis, MD, MSc
Founder and Director
Center for Medical Technology Policy

Gail Wilensky, PhD
Economist and Senior Fellow
Project HOPE

Frances Miller, JD
Professor of Law
Boston University School of Law
Professor of Public Health, Boston University School of Public Health
Professor of Health Care Management, Boston University School of Management
Visiting Professor of Law, University of Hawaii at Manoa
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David Meltzer, MD, PhD
Associate Professor
Department of Medicine
University of Chicago

1:00pm - 1:10pm

Wrap-Up

Jeffrey C. Lerner, PhD
President and Chief Executive Officer
ECRI Institute

Jean Slutsky
Director
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality

Michael Lauer, MD, FACC, FAHA
Director
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute, NIH

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