Biotechnology Regulatory Fellowship Program

Biotechnology Regulatory Fellowships are six-month, full-time (37.5 hours per week), hands-on professional development fellowships structured to engage Fellows in developing the evidence basis needed to meet future regulatory challenges presented by novel products of biotechnology. The Fellowships, which take place in Washington, D.C., are conducted and administered under the auspices of the Committee on Science, Technology, and Law (CSTL) of the National Academies of Sciences, Engineering, and Medicine (National Academies). Fellows will identify new, as needed, regulatory frameworks for the anticipated cutting-edge products expected to emerge over the next several decades and thereby expand options for thoughtful, effective regulation. Fellows will participate in a series of seminars led by subject-matter experts, conduct horizon-scanning activities to identify potential products of biotechnology that lack existing or conflicting regulatory risk assessment pathways, and identify foci for capstone projects that will be undertaken by pairs of fellows. For capstone projects, Fellows will: Work alongside a mentor currently or formerly employed at the U.S. Department of Agriculture, the U.S. Environmental Protection Agency, or the U.S. Food and Drug Administration to choose and execute their projects; Work with a paired member of their cohort with varied background/expertise (ideally, individuals with scientific, engineering, and/or medical experience will be paired with individuals with legal, policy, and/or regulatory experience); Brainstorm early solutions to project ideas collectively across the cohort to encourage creative thinking and build relationships amongst the multidisciplinary cohort; Establish where/how to communicate final project results to provide greatest value to agencies; and Present capstone projects to the Biotechnology Regulatory Fellowship Advisory Committee, mentors, and agency staff at the end of the fellowship session. They may also have the option to select projects curated and requested by agencies. As part of the Fellowship, Fellows will have the opportunity to participate in topic-specific activities such as attending informational events inside and outside the National Academies (e.g. workshops and convenings, Congressional hearings, seminars at think tanks, etc.) and relevant industry conferences.