Under the Food and Drug Amendments Act (FDAA) of 2007, the Foundation is required to establish Fellowship Training Programs. The purpose of the Fellowship Training Programs is:
- to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and identifying potential barriers to translating basic research into clinical and regulatory practice,
- train scientific or regulatory professionals in regulatory science and policy, and
- increase the exchange of scientific information between FDA and external entities.
Within the “Building Scientific Capacity” Program area, the Foundation is currently in the process of developing a number of pilot fellowship programs to bring scientific expertise to the agency targeted at areas of high priority scientific need. . We are developing program criteria and standards, conflict of interest policies, accountability systems, funding mechanisms, and processes for determining FDA training needs as well as academic/private institutional placement requirements. These pilots will enable us to test a number of models for fostering greater understanding of and expertise in new scientific tools and techniques. Once pilot projects have been approved, Fellowship opportunities will be available to train scientific or regulatory professionals who work in regulatory science and do not work in regulated industry.
Three potential areas for fellowship pilot programs include:
- Innovation in Medical Evidence and Surveillance (IMEDS).This project would train scientific professionals (i.e., pharmacoepidemiologists, medical informaticists, and statisticians) in the area of medical product surveillance, with a focus on techniques that leverage existing electronic healthcare data, and increase the exchange of scientific information between FDA and external entities.
- Research Training for International Regulatory Scientists.The National Center for Toxicological Research (NCTR) is FDA’s only center dedicated solely to regulatory science research. In 2009 NCTR established an International Scientist Exchange Program (ISEP) to recruit regulatory scientists from countries developing a regulatory infrastructure for foods and/ or medical products to work on regulatory research projects. ISEP research projects are designed to teach basic regulatory research concepts, skills and techniques The Foundation and the FDA are exploring the expansion of this program.
- Precompetitive Research. The idea being explored here is to provide improved training in areas such as computational systems biology and predictive modeling to enable research across multiple, different submissions on precompetitive issues like disease modeling, toxicology, and biomarkers. This skill development would likely include bringing external expertise into the FDA, as well as sending FDA employees out to learn in environments external to the agency.
Program Status: Exploratory/In Development