Carl Peck, UCSF, presented an overview of certain existing training programs in regulatory science. Emma Meagher, Director of Translational Research Education, University of Pennsylvania Perelman School of Medicine, and Annette Mollet, Head of Training and Education, European Center of Pharmaceutical Medicine (ECPM), University of Basel, discussed the necessary components of an effective education and training strategy and how to develop those components. A panel discussion focused on fellowship and exchange programs.
Training Opportunities Within FDA
FDA is the major locus of regulatory research and training in the United States, Peck observed. Peck noted that the so-called “Subpart E Regulation,” passed by Congress in 1989, included a provision that gave FDA authority to conduct regulatory research: “At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation.”2 Regulatory research is an inherent component of FDA’s activities, and the agency has contributed to the advancement of the drug development field through its work with sponsors to advance development and evaluation of products more rapidly. FDA advancements span a wide range and include, for example, evaluation of diagnostic biomarkers for HIV/AIDS. FDA has innovated in clinical trial design and in modeling and simulation. FDA’s Critical Path Initiative also has led to the establishment of numerous consortia for advancing the development of predictive safety biomarkers and advanced physiologically based modeling. Over the past 3 years, FDA scientists have published more than 1,000 papers.3
Peck commented that FDA has created a university-like environment that generates both debate and important science. And, as with any good university, FDA has developed strong training programs, according to
1This section is based on the presentation by Carl Peck, Professor of Pharmacology and Medicine, UCSF. The section is intended to offer a broad but brief look at certain regulatory research and training opportunities currently available. It is not necessarily complete or exhaustive.
221 CFR § 312.86, Focused Regulatory Research, available at http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol5/pdf/CFR-2011-title21-vol5-sec312-86.pdf (accessed November 28, 2011).
3Vicki Seyfert-Margolis, Senior Advisor for Science Innovation and Policy, Office of the Commissioner, FDA, commented that, as of September 2011, there was a total FDA workforce of 13,800.