Better knowledge of the body's genetic and molecular machinery is pointing toward new drugs and treatments that are custom-designed for each individual. But this emerging era of personalized medicine, in which doctors aim to prescribe the right medicine in the right amount for the right patient, also brings concerns about genetic privacy, adequacy of insurance coverage and industry marketing strategies.
The American Association for the Advancement of Science and the Food and Drug Law Institute are sponsoring a two-part national conference on personalized medicine on June 20 at the AAAS Headquarters in Washington, D.C. from 9:00 a.m. to 5:00 p.m.
A morning roundtable session will explore personalized medicine through a hypothetical case study about a new biomarker for breast cancer recurrence. The panelists include scientists, government officials and a patient advocate.
The afternoon session on "Implementing Personalized Medicine" will feature a keynote speech by Dr. Mark B. McClellan, director of the Engelberg Center for Health Care Reform at the Brookings Institution and former head of the Food and Drug Administration. The participants include industry and FDA officials who must grapple with new regulatory and policy issues arising from advances in personalized medicine.
The morning roundtable will be moderated by Susan Dentzer, editor in chief of the journal Health Affairs.
The panelists are:
- Finley Austin, head, U.S. External Research & Innovation Environment, Hoffmann-La Roche, Inc.
- Carol Isaacson Barash, principal, Genetics, Ethics & Policy Consulting, Inc.
- Greg Downing, program director for personalized health care, Office of the Secretary, Department of Health and Human Services
- Carolina Hinestrosa, executive vice president of programs and planning, National Breast Cancer Coalition
- Dr. Howard P. Levy, assistant professor, McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University
- Dr. Kavita Patel, deputy staff director, Senate Health, Education, Labor and Pensions Committee
- Charles Rotimi, director, National Institutes of Health Intramural Center for Genomics and Health Disparities
- Grail Sipes, partner, Covington & Burling
The afternoon session will be moderated by Jeffrey N. Gibbs, principal, Hyman, Phelps & McNamara, P.C. and Gail H. Javitt, law & policy director for The Genetics and Public Policy Center, The Johns Hopkins University.
The speakers are:
- Kevin T. Conroy, president and chief executive officer, Third Wave Technologies, Inc.
- Maryellen de Mars, director for clinical biomarkers, Critical Path Institute
- Steven I. Gutman, director, Office of In Vitro Diagnostic Device Evaluation & Safety, FDA Center for Devices and Radiological Health
- Shiew-Mei Huang, deputy director for science, Office of Clinical Pharmacology, FDA Center for Drug Evaluation and Research
- David J. Hunter, professor of epidemiology and nutrition, Harvard School of Public Health
- Steve McPhail, president and chief executive officer, Expression Analysis, Inc.
- Bruce Quinn, senior health policy specialist, Foley Hoag LLP
- Dr. Allen D. Roses, director, Deane Drug Discovery Institute, Duke University Medical Center; and senior scholar at the Fuqua School of Business
In addition to AAAS and FDLI, the following groups are participating in the conference:
American Society of Human Genetics
Association for Molecular Pathology
The Hastings Center
International Pharmaceutical Privacy Consortium
The Kennedy Institute of Ethics at Georgetown University
Personalized Medicine Coalition
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