PERSONALIZED MEDICINE
Promises & Challenges

Sponsored by
American Associaiton for the Advancement of Science (AAAS)
Food and Drug Law Institute (FDLI)

June 20, 2008
AAAS Headquarters | Washington, D.C.

Participating Organizations:
To learn how your company can participate, please contact us!
American Society of Human Genetics
Genetic Alliance
Hastings Center
International Pharmaceutical Privacy Consortium
Kennedy Institute of Ethics
Personalized Medicine Coalition
More organizations to be announced.

For only the Roundtable, Anticipating Personalized Medicine, RSVP Online Now! No Registration Fee

For the whole conference, or just the afternoon seminar, Implementing Personalized Medicine, please click here. Registration Fee Required

Doors open at 8:00 AM on the day of the event.

Anticipating Personalized Medicine: A Roundtable Discussion

Moderated by
Susan Dentzer
Editor-in-Chief, Health Affairs
On-air health analyst for the PBS NewsHour

9:00 AM - 12:00 PM

Participants include:

• Finley Austin, Ph.D., Head - US External Research & Innovation Environment, Hoffmann-La Roche Inc.
• Gregory Downing, D.O., Ph.D., Program Director, Personalized Health Care, Immediate Office of the Secretary, HHS
• Carolina Hinestrosa, MA, MPH, Executive Vice President of Programs and Planning, National Breast Cancer Coalition
• Howard. P. Levy, M.D., Ph.D., Assistant Professor, Division of General Internal Medicine and McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University
• Kavita Patel, M.D., M.S.H.S., Deputy Staff Director, Senate Health, Education, Labor and Pensions Committee, Office of Senator Edward M. Kennedy
• Charles Rotimi, Ph.D., Director, NIH Intramural Center for Genomics and Health Disparities; Senior Investigator, Inherited Disease Research Branch, NHGRI
• Joan A. Scott, MS, CGC, Deputy Director, Genetics and Public Policy Center, Johns Hopkins University
• Grail Sipes, J.D., Partner, Covington & Burling LLP
• More TBA

Predictions about the future course of medical care generally include some form of personalized medicine.  The scientific basis and individual and societal implications of personalized medicine will be explored at this morning Roundtable, Anticipating Personalized Medicine.

Rather than one size fits all medicine, personalized medicine is tailored to account for individual differences.   Although doctors have long incorporated personal information like family history into treatment plans, personalized medicine holds the promise of revolutionizing medical care by using knowledge of molecular biology and genetics that will allow more precise diagnoses, better diagnostic tests, greater predictability of disease course, more successful therapies by targeting the right treatments to the right patients, and improved patient safety by selecting drugs and their proper dosage to reduce adverse side effects. 

The prospect of offering patients more precise and effective treatments without inflicting mayhem on the rest of the body is tantalizing.  Scientific “progress,” however, like life, comes with no guarantees, and the medical and policy challenges are daunting.  Personalized medicine may lead to increased concerns regarding privacy and discrimination based on medical information and uncertainty about the costs of research and of medical care. 

The stakeholders participating in the Roundtable — including scientists, physicians, the pharmaceutical and insurance industries, government, patient groups, and others —will discuss a case study, which will be used as a springboard to confront issues from the highly technical to the economic, ethical, and regulatory that will need to be addressed if personalized medicine is to be incorporated into the mainstream of health care.  

Who Should Attend:

RSVP Online Now! No Registration Fee

Implementing Personalized Medicine:
A Legal, Regulatory and Policy Seminar

Keynote Speaker
Mark B. McClellan, M.D., Ph.D.
Senior Fellow and Director, Engelberg Center for Health Care Reform, The Brookings Institution and
former FDA Commissioner

Moderated by
Jeffery N. Gibbs, Principal, Hyman, Phelps & McNamara, P.C.
Gail H. Javitt, J.D., M.P.H., Law & Policy Director, The Genetics and Public Policy
Center, The Johns Hopkins University

1:00 pm - 5:00 pm

Participants include:

• Kevin T. Conroy, President and CEO, Third Wave Technologies, Inc.
• Steven I. Gutman, Ph.D., Director, Office of In Vitro Diagnostic Device Evaluation & Safety, CDRH, FDA
• Shiew-Mei Huang, Ph.D., Deputy Director for Science, Office of Clinical Pharmacology, CDER, FDA
• David J. Hunter, M.B., B.S., Sc.D., Vincent L. Gregory Professor in Cancer Prevention, Department of Epidemiology, and, Professor of Nutrition, Harvard School of Public Health, Harvard University
• Maryellen de Mars, Ph.D., Director, Clinical Biomarkers, Critical Path Institute
• Steve McPhail, President and Chief Executive Officer, Expression Analysis, Inc.
• Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP
• Allen D. Roses, M.D., Jefferson-Pilot Professor of Neurobiology and Genetics, Professor of Medicine, and Director, Deane Drug Discovery Drug Institute, Duke University Medical Center; Senior Scholar, Fuqua School of Business; Member, Duke Institute of Genome Sciences and Policy

This half-day, nuts-and-bolts afternoon seminar focuses on the legal, regulatory and policy implications of developing drugs, biologicals and diagnostics for the rapidly emerging field known as personalized medicine.

Expert panelists from government, private industry, science and medicine will provide invaluable information on the legal and regulatory challenges faced by professionals practicing in areas affected by personalized medicine, including labeling issues, laboratory developed tests, IVD approval and reimbursement and PGx-tailored drugs and companion diagnostics.

You’ll want to take advantage of this unprecedented opportunity to hear directly from government regulators about their plans for dealing with novel issues arising from personalized medicine. And you’ll want to participate in our final Q&A policy panel about how personalized medicine issues should be regulated by FDA and others.

Who Should Attend:

Pharmaceutical, biological, medical device, healthcare or venture capitalist professionals working in the legal, regulatory, policy, scientific, research and development, and economic arenas.

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For more information: Please visit: http://www.fdli.org/conf/435/