From jlstaana at aaas.org Tue May 13 16:06:16 2008 From: jlstaana at aaas.org (Jennifer StaAna) Date: Tue May 13 15:41:33 2008 Subject: [PER] AAAS/FDLI - Personalized Medicine: Promises and Challenges Message-ID: <20080513T160616Z_94CC000E0000@aaas.org> PERSONALIZED MEDICINE: PROMISES AND CHALLENGES June 20, 2008 | AAAS Headquarters | 1200 New York Ave., NW | Washington, DC Participating Organizations: American Society of Human Genetics | Genetic Alliance | Hastings Center | International Pharmaceutical Privacy Consortium | Kennedy Institute of Ethics | Personalized Medicine Coalition Anticipating Personalized Medicine: A Roundtable Discussion Morning Session | 9:00 AM - Noon Moderated by: Susan Dentzer Editor-in-Chief, Health Affairs On-air correspondent for the PBS NewsHour The scientific basis and individual and societal implications of personalized medicine, treatment tailored to individual needs, will be explored at a Roundtable on Anticipating Personalized Medicine hosted by the American Association for the Advancement of Science (AAAS) and the Food and Drug Law Institute (FDLI). Personalized medicine holds great promise by using knowledge of molecular biology and genetics for more targeted therapies, improved patient safety, and reduction of adverse side effects. Such advances, however, pose significant medical and policy challenges, including increased concerns about privacy and discrimination and uncertainty about the costs of research and health care. The stakeholders participating in the Roundtable will discuss a case study from their particular professional and institutional perspectives as a springboard to assess a possible future of personalized medicine. 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, 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, 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, M.S., C.G.C., Deputy Director, Genetics and Public Policy Center, Johns Hopkins University Grail Sipes, J.D., Partner, Covington & Burling LLP More TBA Who Should Attend: Implementing Personalized Medicine: A Legal, Regulatory and Policy Seminar Afternoon Session | 1:00 PM - 5:00 PM 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, Johns Hopkins University This half-day, nuts-and-bolts seminar focuses on the legal, regulatory and policy implications of developing drugs, biologicals and diagnostics in an era of personalized medicine. Expert panelists from government, private industry, science and medicine will assess 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. Hear directly from government regulators about their plans for dealing with novel issues arising from personalized medicine, and participate in a final Q&A policy panel about how personalized medicine issues should be regulated by FDA and others. 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 Maryellen de Mars, Ph.D., Director, Clinical Biomarkers, Critical Path Institute 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 Drug Institute, Duke University Medical Center; Senior Scholar, Fuqua School of Business; Member, Duke Institute of Genome Sciences and Policy More TBA 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. For only the morning roundtable, Anticipating Personalized Medicine, visit: http://www.aaas.org/spp/sfrl/PMRoundtable/ or RSVP Online Now! (no registration fee) For the whole conference, or just the afternoon seminar, Implementing Personalized Medicine, visit: http://www.fdli.org/ or RSVP Online Now! (registration fee required) If you are unable to view, please make sure you are viewing in HTML format. -------------- next part -------------- Skipped content of type multipart/related