Comparative Effectiveness and Personalized Medicine: An Essential Interface

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 Download presentation Michael Lauer, MD, FACC, FAHA Director Division of Cardiovascular Sciences National Heart, Lung and Blood Institute National Institutes of Health (NIH) Download presentation Jean Slutsky Director Center for Outcomes and Evidence Agency for Healthcare Research and Quality (AHRQ) Download presentation
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 Download presentation Stephen Quake, DPhil Professor of Bioengineering, Co-Chair, Department of Bioengineering Investigator, Howard Hughes Medical Institute Department of Bioengineering Stanford University Download presentation
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 Download presentation Predicting Risk Bruce Psaty, MD, PhD Professor of Medicine Epidemiology and Health Services University of Washington Download presentation
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 Download presentation Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality Download presentation
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 Download presentation 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 Download presentation The Democratization of Research: Bringing the Public Into the Process Susan Love, MD, MBA President Dr. Susan Love Research Foundation Download presentation
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 Download presentation Sue Siegel, MS Partner Mohr Davidow Ventures Download presentation
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 Download presentation 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 Download presentation
5:45pm - 6:15pm	Q & A
6:00pm - 7:15pm	Networking Meet and Greet at NIH
back to top
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 Download presentation
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 Download presentation Barry Straube, MD Chief Medical Officer and Director Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services Download presentation
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 Download presentation 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 Download presentation
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 Download presentation 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 Download presentation 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 Download presentation
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 Download presentation 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
back to top