•  There are more career opportunities and paths for regulatory scientists than might be commonly understood, including international, national, and state regulatory agencies, the Federal Trade Commission, Congress, payers, investors, and journals.

•  The collaborative, multidisciplinary nature of innovative regulatory science may undermine the ability to identify a champion or lead stakeholder charged with advancing the science.

•  Considering that one goal of the investment in basic health sciences research is to improve health outcomes, investing in regulatory science could support the case for such investment.

The following are suggestions for a way forward from the panelists:

•  Create a standing panel sponsored by FDA and/or NIH that would focus on ways to strengthen the regulatory science workforce.

•  Ensure that social science research and evidence is built into regulatory science research and practice.

•  Identify a champion that can take responsibility for advocacy for support of regulatory science and the workforce to support regulatory science. It was suggested that proposed NCATS could serve as a key champion for the discipline.

•  Design regulatory science training programs to reflect the different training backgrounds of the individuals who come to regulatory science. The “menu” approach applied in the European PharmaTrain program could be a good model.

•  Convene a series of conferences that would be charged with defining the big needs or “big questions” in regulatory science. Link this effort to RFAs that would support pursuit of these big questions.

•  Opportunities to increase interest in the discipline among students and investigators include reinvigorating and expanding research fellowships in clinical pharmacology and embedding regulatory science research fellowships in translational medicine and therapeutics through such programs as the CTSA institutions and the proposed NCATS.

•  Researchers who have lost jobs as the pharmaceutical industry has downsized could offer a pool of scientists that could be recruited to do regulatory science in the federal agencies and in academia through innovative and creative pilot projects.

•  Make it clear that “if innovation is the goal, regulatory science is essential.”



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