2005N-0311 Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
FDA Comment Number : EC5
Submitter : Dr. Robert Vestal Date & Time: 11/01/2005 05:11:22
Organization : Amer Soc for Clinical Pharmacology & Therapeutics
Category : Drug Association
Issue Areas/Comments
In response to the request for comment regarding the planning of a two-day workshop to explore approaches and potential obstacles to developing new therapies to prevent or reduce the risk of illness, the American Society for Clinical Pharmacology and Therapeutics (ASCPT) concluded that the proposed questions and topics in the Federal Register announcement are comprehensive and appropriate. Missing, however, is an acknowledgement of the critical importance of training clinical investigators for work in the field of translational medicine and research.

A recent series of articles and commentaries in JAMA (September 21, 2005) and the NEJM (October 13, 2005) highlights some of the issues that we face as a nation committed to advancing knowledge in the pathophysiology, diagnosis and treatment of disease. In the JAMA article, Drs. Ley and Rosenberg (JAMA 2005;294:1334-1351) point out that the physician-scientist population in the United States is smaller and older than it was 25 years ago. Although there are hopeful signs, continued funding of new programs and sustained support of young physican-scientists are essential. Dr. Zerhouni (JAMA 2005;294:1352-1358; also see Science 2003;302:63-72; and NEJM 2005;353:1621-1623 and Science 2003;302:63-72;) outlines the NIH Roadmap effort to bolster the development and availability of modern scientific tools and information resources, to foster novel methods of research collaboration, and to markedly enhance the nation's clinical research enterprise. A recent initiative by the NIH is a program that will fund institutional Clinical and Translational Science Awards (CTSAs). Beyond this, Dr. Zerhouni discusses the growing need to integrate support for translational and clinical science, leveraging the investment in the new biology to enhance human health. ASCPT concurs that we must re-engineer the research enterprise from the laboratory to the patient and community. The discipline of clinical pharmacology respresents an under-recognized embodiment for this, integrating drug discovery, development for human application, regulation for public safety and rational therapeutic utiization to optimize healthcare. In view of the importance and fundamental nature of translational medicine in the development of new, effective and safe therapies for disease, and the need for training clinical investigators, it would be appropriate to include this topic in the agenda for the meeting.

ASCPT, as an organization, is committed to fostering translational research efforts related to the discovery of novel therapeutics to treat human disease. We believe that a critical component of this effort must be the effective training of the next generation of translational researchers.