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Personalized Medicine: Promises and Challenges

Personalized medicine roundtable sponsored by the American Association for the Advancement of Science (AAAS) and the Food and Drug Law Institute (FDLI) and held June 20, 2008 at AAAS headquarters. Participating organizations included the American Society of Human Genetics, the Association for Molecular Pathology, Genetic Alliance, the Hastings Center, the International Pharmaceutical Privacy Consortium, the Kennedy Institute of Ethics, and thePersonalized Medicine Coalition.

Handouts: Primer

Anticipating Personalized Medicine: A Roundtable Discussion

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 was explored at the 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 — discussed a case study, which was 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.

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

Participants:

  • Joanne Armstrong, MD, MPH, Senior Medical Director, Department of Women’s Health, Aetna
  • Finley Austin, Ph.D., Head – US External Research & Innovation Environment, Hoffmann-La Roche Inc.
  • Carol Isaacson Barash, Ph.D., Principal, Genetics, Ethics & Policy Consulting
  • Annette Bar-Cohen, MA, MPH, Director of Programs, National Breast Cancer Coalition
  • Gregory Downing, D.O., Ph.D., Program Director, Personalized Health Care, Immediate Office of the Secretary, HHS
  • 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
  • Grail Sipes, J.D., Partner, Covington & Burling LLP

Implementing Personalized Medicine: A Legal, Regulatory and Policy Seminar

This half-day, nuts-and-bolts afternoon seminar focused 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 provided 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.

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

Participants:

  • 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

Press Coverage

Personalized Medicine Resources

  1. Personalized Medicine Coalition
  2. Personalized Health Care, Department of Health and Human Services 
  3. Medicine For You, National Institute of General Medical Sciences 
  4. Age of Personalized Medicine 
  5. “The Genome Gets Personal—Almost,” JAMA 299: 1351-1352. March 19, 2008. 

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