Recognizing the complexity of the US biotechnology regulatory system and the need for a better understanding of future products and the regulatory regime, The National Academies of Sciences, Engineering, and Medicine will establish a Biotechnology Regulatory Fellowship Program to help build capacity to meet the regulatory challenges presented by novel products of biotechnology. The fellowship program, housed at the National Academies, will select 12 fellows annually for a six-month in-person term to:
1. develop new capacity and technical expertise in academia, industry, government, and society;
2. foster cross-fertilization, coordination, and engagement among key sectors;
3. improve understanding of the US regulatory regime at key federal agencies as well as international regulation;
4. consider new regulatory pathways for novel biotechnology products; and
5. create a network of professionals able to actively engage in the biotechnology economy.
The fellows will be provided a stipend. The program will consist of seminars, interactions with key personnel at federal regulatory agencies, the White House, and congressional staff, and a capstone project in which the fellows will conduct horizon-scanning activities to identify potential future projects of biotechnology that lack existing regulatory risk assessment pathways. Engagement with relevant Academy committees, staff, and projects will be encouraged.
An oversight committee will be appointed to identify key topical areas that will be covered during the Fellowship program and to review and rank the applicants.
The Program will be carried out in two phases:
Phase 1: Year 1, will involve creation of the program office infrastructure, appointment of the oversight committee, development of an on-line application and an outreach campaign and review, ranking, and selection of the fellows.
Phase 2: Year 2, will host the first cohort of fellows for their 6-month term at the National Academies.
At the end of year 2, an initial assessment will be made of the fellowship experience and program and the program will be revised as needed. Evaluation instruments for both short term assessments and long-term impact will be developed.
Years 3-7, will each host a cohort of 12 fellows. Assessments will be made each year and the program refined.

At the completion of the program, fellows will have a solid understanding of the complex regulatory system that must be navigated in order to bring a product to market and an understanding of the barriers that exist in moving products forward.