available is not new, but never before have funds been deliberately appropriated for the accomplishment of this task. FDA’s 2011 budget proposal includes $25 million specifically allocated to the building of a regulatory science infrastructure at the agency. In anticipation of this event and as an acknowledgment of the “reform-ready” political atmosphere, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop with the following goals in mind:

  • Establish a clear definition of regulatory science, and engage the public and the policy community in a discussion of its challenges and opportunities.

  • Increase awareness of inadequate funding for regulatory science and the impact on the development of new therapies on patients.

  • Articulate priorities and strategies for building or rebuilding the infrastructure for regulatory science.

The one-day workshop featured leaders from government, such as Representative Rosa DeLauro (D-CT); Department of Health and Human Services Deputy Secretary, William Corr; and FDA Commissioner, Margaret Hamburg. Speakers from academia, industry, and patient advocacy groups provided a variety of perspectives and illuminated examples of the urgent need of a regulatory science infrastructure. Leaders in emerging technologies, such as genomics, biostatistics, and information technology—whose fields of study are influenced daily by regulatory decisions—deliberated on potential consequences arising from the failure to establish a robust scientific base at the agency level. In addition, moderated panels considered mechanisms for building a regulatory science infrastructure at FDA, analyzed existing implementation models, and posed strategies for engaging the public and policy makers.

This was a timely workshop that provided a valuable opportunity to bring together a diverse group for thoughtful discussion about improving drug development and strengthening regulatory science. I would like to thank all of the individuals—speakers, moderators, and panelists—who contributed to and participated in the workshop. In particular, I would like to thank a small team of participants in the workshop who spent many hours in advance of the workshop discussing the merits of Centers of Excellence in Regulatory Science and the critical characteristics of these centers including: K. Ahlport, M. Anderson, L. Benet, R. Califf, G. FitzGerald, S. Kim, J. Kramer, R. Nerem, D. Nordenberg, M. Osterholm, K. Schneeman, J. Shoemaker, E. Sigal, N. Sung, and J. Tobias. I would also like to thank the members of the Forum and Forum staff for their dedication and commitment to developing and executing this workshop.


Gail H. Cassell, Co-Chair

Forum on Drug Discovery, Development, and Translation



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