Giacomini, Professor and Co-Chair, Department of Bioengineering and Therapeutic Sciences, UCSF, presented their ideas on academic career paths for regulatory scientists. Henrietta Ukwu, Senior Vice President for Global Regulatory Affairs, PPD, Inc., then offered comments on regulatory science career paths in industry.
Barriers and Opportunities in Academia1
Given the lack of established programs in regulatory science in academia, this gap could be addressed by increasing opportunities for exchanges among academia, industry, and government, as described in this chapter and in Chapter 7. Such collaborative approaches would support an ecosystem that will foster the development of career paths within all three sectors. Chin listed questions for consideration in defining a regulatory science career path:
• Is there a clear definition of the field?
• Are tools and technologies available to answer research questions?
• Are multiple training options available that involve innovative research?
• Who are the role models?
• Is the career track clear, and is there a clear path for professional development and promotion in an academic home?
• What is the availability and sustainability of research funding?
• Are academic societies and publications available that provide opportunities for impact and recognition?
• Are alternative career pathways available?
The biggest barrier to the development of an academic discipline is that the nature of academia does not lend itself to a regulatory mindset, said Chin. Furthermore, the unsupportive funding climate makes it unlikely that many universities would commit the resources needed to create the necessary educational and research programs that would cross disciplinary boundaries.
There are, however, opportunities to associate regulatory science with areas that are getting support, such as translational science and therapeutics, or with rapidly developing fields whose progress eventually will depend on good regulatory science, including personalized medi-
1This section is based on the presentation by William Chin, Executive Dean for Research, Harvard Medical School.