Now Accepting Applications: Available Positions for 2020 1
Regenerative medicine (RM) is an interdisciplinary field, which aims to repair diseased or damaged tissues using biological or cell-based technologies. This rapidly growing area of biomedical research encompasses cell biology, tissue engineering, drug delivery, and advanced manufacturing, among others. Regulatory science research at FDA helps to maintain and expand knowledge at the Agency to support development and regulatory review of cutting-edge RM products and associated technologies.
The Office of Tissues and Advanced Therapies (OTAT) within FDA’s Center for Biologics Evaluation and Research (CBER) regulates biological products and certain medical devices related to these products. FDA’s Center for Devices and Radiological Health (CDRH) regulates most medical devices. The Centers facilitate product innovation by advancing regulatory science and assuring consumer confidence in regulated products marketed in the U.S. As many RM products combine biologic and device technology, OTAT and CDRH collaborate to support development and regulatory review of such products.
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The Multi-Center Regenerative Medicine Fellowship aims to enhance FDA’s ability to regulate RM products and support the development of highly trained scientists and engineers with unique multi-center experience. Since many RM products involve a combination of biologics and device technology, RM fellows will work across both CBER/OTAT and CDRH to facilitate cross-agency collaboration and conduct regulatory science projects related to the regulation of RM products. In connection with a Preceptor(s), each fellow will develop a non-laboratory based regulatory science project to address critical regulatory science priorities and enhance the science that supports regulatory decision-making at FDA, particularly in CBER/OTAT and CDRH. Projects are intended to enhance the clinical development of RM products and increase collaboration among CBER, CDRH, and the regulated community.
Multi-Center Regenerative Medicine Fellowship appointments are 2-3 years. During their appointment, fellows will complete rotations in both CBER/OTAT and CDRH, where they will gain “hands-on” experience in the scientific and regulatory premarket review of devices, cell therapy, gene therapy, and tissue-engineered products. Fellows will concurrently develop and finalize a regulatory science project focused on a specific aspect of RM products under the guidance of Preceptors.
The curriculum will include CBER- and CDRH-focused training to provide an in-depth understanding of the science behind regulatory review, as well as encompassing FDA activities across product jurisdictions (e.g., drugs, devices, biologics, and combination products). Coursework will also cover FDA law and policy (including biologics and medical device) and public policy. Fellows will also attend relevant external meetings to increase their scientific and/or regulatory knowledge base.
This opportunity is open to U.S. citizens and permanent residents (Green Card holders), who are early-career candidates within 5 years of obtaining a Ph.D. or equivalent doctoral degree (e.g., M.D., Sc.D.), awarded by a U.S. science program or a foreign science program certified by national or regional accrediting institutions in the U.S. as meeting all the appropriate requirements leading to a doctorate. Candidates without a doctoral degree may be considered on a case-by-case basis. See the project descriptions for additional, project-specific eligibility criteria. CBER/OTAT will sponsor 1-3 new RM fellows each year. Stipend will be commensurate with experience.
Interested applicants should provide: 1) a CV, 2) a copy of doctoral degree and transcripts 3) two to three letters of professional reference from non-government references, and 4) a 1500-word statement of interest to email@example.com no later than August 15, 2020. Accepted applicants will be notified in September 2020 and will work with preceptors to determine a mutually-acceptable start date.
- Framework for the Regulation of Regenerative Medicine products
- Regenerative Medicine Advanced Therapy Designation
- Cellular & Gene Therapy Products
- 1. under the Service Fellowship for CBER