On February 24th, 2023, sixteen NIH Oxford-Cambridge (OxCam) Scholars, from first- to final-year graduate students, had the opportunity to visit the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). IBRA Board Director Dr. Kathryn Zoon, who served as the FDA CBER Principal Deputy Director (and first female Director) from 1992-2002, paved the path for the NIH OxCam Scholars to visit the FDA as a Career Development and Exploration Initiative. Scholars had the opportunity to learn about CBER’s role in integrating innovative science with regulations to protect public health. In addition to Dr. Zoon, included on the career exploration planning team were Scholar-lead organizer, Marya Sabir, NIH OxCam Scholars Program leadership, Dr. Kristi Porter, Dr. Racquel Collins, Kara Rothberg, Dr. Elodie Ghedin, Dr. Sonja Best and FDA’s Dr. Karen Elkins and Dr. Monica (Burts) Young. Alexandra Ambrico, Director of Communications, Education, and Professional Development represented the sponsor International Biomedical Research Alliance on the planning committee.
CBER is the Center within FDA that regulates biological products for human use and both protects and advances public health by ensuring that biological products are safe, effective, and available to all. Dr. Karen Elkins, CBER’s Associate Director for Science and Principal Investigator, provided welcome remarks and gave an overview of the FDA and CBER, including its history and current-day operations. Within CBER, there are 65 lead investigators whose research ranges from basic to targeted therapy studies. She described the different phases of drug approval and shared how less than 10% of drugs make it past the New Drug Application (IND) phase. IND is a request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans and is the first submission on the drug development timeline.
Following Dr. Elkins’ talk, the Scholars embarked on tours of the laboratories and research facilities. Scholars had the opportunity to ask questions and learn more from the research staff, engaging in small group discussions with CBER Principal Investigators with a range of expertise from vaccines to blood/blood products. “I never knew the extent of the collaborative research that the FDA performed until today,” remarked Class of 2018 Ph.D. Scholar Taylor Farley.
Dr. Young provided an overview of training and career opportunities at the FDA, beginning with the organization of the FDA. She highlighted professional career paths at the FDA, mission-critical occupations, how to apply for these fellowships and jobs, and the different paths to the FDA. Poorva Jain, a Class of 2022 M.D./Ph.D. Scholar commented, “This visit helped me better understand the dynamics of how a career at the FDA looks and also the people involved in monitoring and assessing novel therapies. It made the FDA go from a black box entity to a really comprehensive and dynamic research and regulatory institute. It was an unparalleled opportunity to network with some outstanding scientists”.
To conclude the Career Development and Exploration Initiative at the FDA, a training and careers panel and networking session was held. The panel discussion included postdoctoral fellows, biologists, reviewers, and investigators to share their backgrounds and current research. The networking session included panelists and additional principal investigators to engage with the scholars. Marya Sabir, a Class of 2019 Ph.D. Scholar notes, “I left inspired by the innovative research and fundamental regulatory work being done by CBER investigators. Not only are they safeguarding the public’s health with their work, but they are also pushing the frontiers of science – it is truly a unique place.”
The International Biomedical Research Alliance is committed to providing Career Development and Exploration Initiatives to Scholars in the NIH Oxford-Cambridge Scholars Program. The goal of these initiatives is to ignite Scholar thinking around career opportunities where they can play a key role in the future of biomedical research enterprise. Please reach out to our Director of Communication, Education, and Professional Development, Alexandra Ambrico, at aja@biomedalliance.org if you would like to be involved in hosting future exposure visits.