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AAAS, FDLI Sponsor Landmark Meeting on Personalized Medicine June 20, 2008

Mark McClellan to Keynote Afternoon Session on Legal, Regulatory and Policy Issues

WASHINGTON, May 5 /PRNewswire-USNewswire/ -- Will personalized medicine revolutionize healthcare in the United States?

That's a key question that will be discussed at a national conference, Personalized Medicine: Promises and Challenges, sponsored by the American Association for the Advancement of Science (AAAS) and the Food and Drug Law Institute (FDLI), June 20, 2008, at AAAS Headquarters in Washington, D.C.

The meeting will include a high-level roundtable discussion in the morning and a seminar on legal, regulatory and policy issues on personalized medicine in the afternoon.

The personalized medicine stakeholders participating in the morning 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 as this new treatment and delivery system is incorporated into mainstream healthcare. The panel will be moderated by Susan Dentzer, Editor-in-Chief of Health Affairs.

Mark B. McClellan, M.D., Ph.D., Senior Fellow and Director at the Engelberg Center for Health Care Reform, The Brookings Institution and former FDA Commissioner and CMS Administrator, will keynote the afternoon session, which will focus 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.

The following groups are participating organizations in this landmark event:

> American Society of Human Genetics

> Genetic Alliance

> Hastings Center

> International Pharmaceutical Privacy Consortium

> Kennedy Institute of Ethics

> Personalized Medicine Coalition

Morning panelists include:

> Finley Austin, Ph.D., Head, US External Research & Innovation Environment, Hoffmann-La Roche, Inc.

> Greg Downing, D.O., Ph.D., Program Director, Personalized Health Care, Immediate Office of the Secretary, Department of Health and Human Services

> Carolina Hinestrosa, M.A., M.P.H., 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, Health Subcommittee of Senator Edward M. Kennedy

> Joan A. Scott, M.S., C.G.C., Deputy Director, Genetics and Public Policy Center, Johns Hopkins University

> Charles Rotimi, Ph.D., Director, NIH Intramural Center for Genomics and Health Disparities; Senior Investigator, Inherited Disease Research Branch, NHGRI

> Grail Sipes, J.D., Partner, Covington & Burling

Afternoon panelists 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

> 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 Institute, Duke University Medical Center; Senior Scholar, Fuqua School of Business; Member, Duke Institute of Genome Sciences and Policy

Jeffery N. Gibbs, Principal at Hyman, Phelps & McNamara, P.C. and Gail H. Javitt, J.D., M.P.H., Law & Policy Director of the Genetics and Public Policy Center at Johns Hopkins University, will moderate the afternoon session.

To learn more about this program, visit or call (800) 956-6293 or (202) 371-1420. To register for the morning session, visit To register for the afternoon session or the entire program, visit

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.

AAAS ( is the world's largest general scientific society, including some 262 affiliated societies and academies of science, serving 10 million individuals, and publisher of the journal, Science (, which has the largest paid circulation (~one million readers) of any peer-reviewed general science journal in the world. AAAS fulfills its mission to "advance science and serve society" through initiatives in science policy; international programs; science education; and more. For the latest research news, log onto EurekAlert!,, the premier science-news Web site, a service of AAAS.

SOURCE Food and Drug Law Institute
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