The Commissioner’s Fellowship Program: A Win-Win for FDA and Public Health

By: Dr. Stephen M. Ostroff

As part of my FDA Voice blog series on the important work going on in FDA’s Office of the Chief Scientist (OCS), I’d like to highlight an FDA program that is giving top-tier, early career health care professionals, scientists, and engineers the chance to gain broad exposure to FDA regulatory science and scientific review opportunities. Led by OCS’s Office of Scientific Professional Development, the Commissioner’s Fellowship Program (CFP) is accepting applications from April 16 to May 26, 2014. Those who are accepted into the CFP will be joining FDA’s 7th class of Fellows.

Stephen OstroffDuring the two-year program, Fellows complete rigorous graduate-level coursework and conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior-scientist preceptor.

In the CFP, a Fellow is able to gain real experience in an FDA biology, physics, or engineering lab, work with a clinical review team, or work at a regional field laboratory or office. The coursework provides a common core understanding of the science behind regulatory review, encompassing activities across all FDA-regulated product areas.

Specific Fellow projects may focus on FDA review of sponsor applications for new products, monitoring product quality and safety, or other scientific or engineering topics. Fellows work closely with FDA scientists to create better research and evaluation tools and approaches, like assays for chemical or pathogen detection, or methods to assess clinical or health care data. Other science and policy areas of focus may involve foods or medical products in disciplines ranging from laboratory sciences to engineering, law, and ethics.

FDA launched the Fellowship Program in 2008 to achieve three critical goals:

1)      Attract to FDA top-tier scientists who can help tackle targeted regulatory science areas;

2)      Provide regulatory science training to expand the pool of experts;

3)      Recruit top scientific talent — scientists who may not have considered FDA in planning their career.

Since the program started, FDA has graduated 164 Commissioner’s Fellows, 75% of whom continued to work at FDA after completing the program. Our graduates have produced 175 publications based on their Fellowship work, represented FDA with 211 regulatory science presentations, authored or co-authored 917 reviews – ranging from original applications to supplements – and 26 Fellows have been the proud recipients of FDA Honor Awards.

The Fellows have brought an infusion of innovative ideas, new talents, and skills to FDA to help build the strong scientific foundation we need in our research and review activities. In turn, the CFP has enabled Fellows to develop their regulatory expertise and work confidently in the FDA environment.

Those Fellows who pursue careers outside FDA bring a deeper understanding of regulatory science and of FDA to their organizations. They enrich the regulatory science enterprise, whether by improving the quality of applications to FDA or by applying the knowledge and tools they’ve acquired through the CFP to develop practical solutions to an important public health challenge.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

For more information on eligibility criteria for the FDA Commissioner’s Fellowship Program and to apply for the upcoming class, please visit this Web link:

FDA Commissioner’s Fellowship Program Application Checklist

The Commissioner’s Fellowship Program: Fostering Scientific Talent at FDA

By: Jesse L. Goodman, M.D., M.P.H.

As the May 25th application deadline for the Commissioner’s Fellowship Program rapidly  approaches, it’s time to acknowledge the tremendous contributions our Fellows and their FDA mentors have made in support of FDA’s Advancing Regulatory Science effort. I also want to highlight the opportunities the Fellowship Program offers health care professionals, scientists, and engineers who may not have considered FDA in planning their career path.

FDA launched the Fellowship Program in October 2008 to achieve three essential goals: to attract outstanding scientists who could tackle Center-selected and targeted research or regulatory issues, to train these scientists in regulatory science, and to help build our scientific staff. Since then, FDA has graduated 48 Fellows from the class of 2008 and 50 from the class of 2009. The class of 2010 will graduate this coming Sept. 25th.

This two-year program is open to scientists and medical professionals with doctoral level degrees, although we also welcome applicants with a bachelor’s in an engineering discipline.  Fellows pursue a rigorous regulatory science curriculum and conduct research that addresses a scientific or regulatory gap, under the mentorship of an FDA senior scientist.

Hundreds of applicants from leading labs, institutions, and industry apply to the program each year, attracted by the opportunity to participate in research on critical issues in product development, evaluation, and safety. They also come for the unique and comprehensive training and the chance to make a difference in our nation’s health. In addition to peer-reviewed publications, during their tenure Fellows complete regulatory reviews and work with FDA staff scientists to develop research tools, like new protocols, assays, screening methods, detection, and characterization methods. Many Fellows also work in a variety of scientific and policy areas, ranging from laboratory and population sciences to engineering.

Dr. Khaled Bouri, a former Fellow and current FDA staff member, had this to say about his experience:

As a research scientist, with a focus on the use of genomic technologies, I was struck by the lack of progress in medical product development, despite the enormous advances seen in scientific knowledge and medical technologies over the last decade.  I wanted to identify the reasons behind this gap and participate in building a bridge from bench to bedside. The Fellowship Program gave me a deep appreciation of the complexity of the medical product development process and provided me with the tools and knowledge to more effectively help FDA achieve its mission.

Former Fellow and current staff scientist in FDA’s Center for Drug Evaluation and Research, Dr. Dionna Green, adds:

I came to the program seeking experience in the drug development process from the unique perspective that only the FDA can offer.  As a clinician with training in pediatrics, I was interested in the regulatory and scientific considerations that are pertinent when developing drugs and biologics to treat diseases and conditions affecting neonates, infants, children, and adolescents.  In the Fellowship program, I participated in the extensive work underway at FDA to advance pediatric therapeutics.  The program gave me a comprehensive understanding of how all of the agency components work together toward the goal of promoting and protecting the public’s health.

The research performed by the Commissioner’s Fellows highlights the breadth of creativity fellows bring to their projects — from testing the potential toxicity of nanomaterials, to developing methods to evaluate process controls for fresh produce, to predicting side effects of drugs in genetically predisposed subpopulations, to advancing pediatric cardiovascular device development. It is just the kind of innovative work the program aims to foster. And, it is the infusion of new ideas and tools FDA needs as we work to transform regulatory science in the 21st century.

Many Fellows have stayed on at FDA, while others have sought careers in industry and academia. Those who do pursue careers outside the agency bring a deeper understanding of regulatory science to their organization or institution.

A highly skilled workforce capable of conducting cutting-edge research and addressing complex regulatory issues is core to FDA’s capacity to protect and promote the public health. FDA’s Critical Path, Advancing Regulatory Science and Global initiatives have all described the enormous challenges and opportunities the agency faces as it transforms its operational model to accommodate a globalized economy, new areas of science, and rapidly evolving technologies. Together with our own outstanding scientists, the Fellows tackle the challenges of emerging science and technology to enable innovation while at the same time ensuring the safety, effectiveness, and quality of the products FDA regulates.

Jesse L. Goodman, M.D., M.P.H., is FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health