| 7:30-8:30 AM |
Continental Breakfast |
| 8:30-8:45 AM |
Welcome and Introductions
Mark S. Frankel, PhD, Director, Program on Scientific Freedom, Responsibility and Law, AAAS, and Peter Agre, MD, President, AAAS and Director, Johns Hopkins Malaria Research Institute
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| 8:45-9:45 AM |
Implementing Personalized Medicine
Chair: Peter Agre, MD, President, AAAS and Director, Johns Hopkins Malaria Research Institute
Speaker: Francis Collins, MD, PhD, Director of the National Institutes of Health [PowerPoint Presentation] [PDF]
Dr. Collins will discuss the scientific and translational challenges for implementing personalized medicine.
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| 9:45-10:15 AM |
BREAK |
| 10:15-11:15 AM |
The FDA Perspective
Chair: James Kelly, JD, President and CEO, Food and Drug Law Institute (FDLI)
Speaker: Margaret A. Hamburg, MD, Commissioner of the U.S. Food and Drug Administration [PDF]
Commissioner Hamburg will discuss that agency's role in implementing personalized medicine.
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| 11:15-12:00 PM |
Comparative Effectiveness Research and Personalized Medicine
Chair: Deborah Runkle, Senior Program Associate, AAAS
Speaker: Harold Sox, MD, Editor Emeritus, Annals of Internal Medicine, Adjunct Professor, Dartmouth Medical School [PowerPoint Presentation] [PDF]
Dr. Sox will discuss policy issues associated with comparative effectiveness research in the context of personalized medicine.
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| 12:00-1:15 PM |
LUNCH (on your own) |
| 1:15 - 2:15 PM |
Panel: Health IT and Personalized Medicine
Speakers will discuss the opportunities and challenges presented by health IT from a variety of perspectives. |
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Chair: Michael Stebbins, PhD, Assistant Director for Biotechnology, Office of Science and Technology Policy, The White House
Policy Implications
Speaker: John Glaser, PhD, Senior Advisor, National Coordinator for Health Information Technology, U.S. Department of Health and Human Services [PowerPoint Presentation] [PDF]
Health IT as a Research Tool
Speaker: Rex Chisholm, PhD, Dean for Research, Center for Genetic Medicine, Feinberg School of Medicine, Northwestern University [PowerPoint Presentation] [PDF]
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| 2:15-2:45 PM |
BREAK |
| 2:45-4:30 PM |
Health IT and Personalized Medicine (Continued)
Health IT in Clinical Practice
Speaker: Linda Fischetti, RN, MS, Chief Health Informatics Officer, Veterans Health Administration, US Department of Veterans Affairs [PowerPoint Presentation] [PDF]
Legal and Ethical Considerations
Speaker: Mark A. Rothstein, JD, Herbert F. Boehl Chair of Law and Medicine, University of Louisville School of Medicine [PowerPoint Presentation] [PDF]
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| 4:30 PM |
Adjourn |
| 7:30-8:30 AM |
Continental Breakfast |
| 8:30-9:30 AM |
Biomarkers and Clinical Care
Chair: Mark S. Frankel, PhD, Director, Program on Scientific Freedom, Responsibility and Law, AAAS
Speaker: Mark J. Ratain, MD, University of Chicago [PowerPoint Presentation] [PDF]
Dr. Ratain will discuss the status of discovery of molecular biomarkers that improve understanding of disease and individual differences.
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| 9:30-10:30 AM |
Panel: Case Studies
Chair: Katrina L. Kelner, PhD, Editor, Science Translational Medicine, AAAS
Directing the Course of Treatment – development of drugs to treat disease subgroups (lung cancer)
Speaker: William Pao, MD, Assistant Director, Personalized Cancer Medicine, Vanderbilt University [PowerPoint Presentation] [PDF]
Getting the Dose Right (Plavix)
Speaker: Alan Shuldiner, MD, John L. Whitehurst Professor of Medicine, University of Maryland Medical Center [PowerPoint Presentation] [PDF]
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| 10:30-11:00 AM |
BREAK |
| 11:00-11:30 AM |
Case Studies (Continued)
Avoiding Adverse Events (Abacavir)
Speaker: Hawazin Faruki, DrPH, Vice President, Clinical Development, Laboratory Corporation of America [PowerPoint Presentation] [PDF]
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| 11:30-12:15 PM |
Lessons Learned from Case Studies
Speaker: Steven D. Averbuch, MD, Vice President, Oncology Transition Strategy & Development and Head, Pharmacodiagnostics, Global Clinical Research
Bristol-Myers Squibb Company [PowerPoint Presentation] [PDF]
Dr. Averbuch will discuss the obstacles ahead in the clinical application of biomarkers.
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| 12:15-1:30 PM |
LUNCH (on your own) |
| 1:30-4:00 PM |
Audience/Panel Interaction: Making Difficult Choices
Using electronic audience-response technology, a panel will interact with the audience as together they try to decide how they would react to a difficult case. Panelists will represent the following perspectives:
Chair: Joseph G. Perpich, MD, Chair, AAAS Committee on Scientific Freedom and Responsibility and President, JG Perpich, LLC.
Physician: Nilofer Azad, MD, Assistant Professor, Gastrointestinal Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Patient Advocate: Nancy Davenport-Ennis, Founder and CEO, National Patient Advocate Foundation |
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| 4:00 PM |
Closing Remarks
Mark S. Frankel, PhD, Director, Program on Scientific Freedom, Responsibility and Law, AAAS
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