Priorities for Personalized Medicine (PDF; 6.8 MB)
Source: President’s Council of Advisors on Science and Technology (PCAST)

“Personalized medicine” refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not.
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The President’s Council of Advisors on Science and Technology (PCAST) believes that the convergence of scientific and clinical opportunity and public health need represented by personalized medicine warrants significant public and private sector action to facilitate the development and introduction into clinical practice of this promising class of new medical products. In developing recommendations for such action, PCAST considered eight major policy areas – technology/tools, regulation, reimbursement, information technology, intellectual property, privacy, physician and patient education, and economics. To understand the impact of these policy areas on the development of personalized medicine, PCAST solicited input from a broad range of stakeholders representing academic institutions, medical diagnostics and imaging companies, biotechnology and pharmaceutical companies, insurance companies, patient providers and advocates, venture capital firms, trade and professional associations, and government agencies.

Based on these deliberations, PCAST determined that specific policy actions in the realm of genomics-based molecular diagnostics had the greatest potential to accelerate progress in personalized medicine. This does not mean that PCAST discounts the importance of parallel developments in genomics-linked therapeutics; rather, PCAST has concluded that, at present, the pace of change is most rapid, and the policy hurdles are greatest, in the realm of diagnostics.

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