In October of 2016, Kendall Beck completed a one month rotation with the FDA’s Gastroenterology and Inborn Errors Products (DGIEP) division through ACG’s Visiting Fellowship Program. Dr. Beck, a third year fellow at the University of California, San Francisco (UCSF), was chosen by the ACG’s FDA Related Matters Committee last year at our annual meeting in Hawaii. Selected fellows then work with their respective program directors, the FDA, and ACG to find a suitable month to be at the FDA as well as a tailored curriculum for that month.
About the Fellowship
The goal of the program is to allow the selected candidate an opportunity to integrate into the daily activities at the FDA, and gain first-hand knowledge and valuable experience in the drug and device approval process. The candidate, a second or third year fellow, is vetted and chosen by ACG’s FDA Related Matters Committee. The College provides a stipend for travel and daily living expenses for a one-month rotation at the FDA. Upon completion of the rotation, the selected-fellow presents his or her experiences at the following ACG Annual Scientific Meeting.
More information about the fellowship can be found on the ACG website. (Submissions are currently closed at this time, but please stay tuned in 2017 for the next application cycle.)
Dr. Beck summarizes her experience below:
“As a third year Gastroenterology fellow at UCSF, I was honored to be selected for the Oak Ridge Institute for Science and Education (ORISE) visiting fellowship program – a collaboration between the American College of Gastroenterology (ACG) and the Food and Drug Administration (FDA) aiming to provide fellows with an understanding of drug development programs and the interchange between the FDA and industry. Through the program I spent the month of October as a visiting fellow at the FDA, embedded with the Gastroenterology and Inborn Errors Products division (DGIEP) of the FDA’s Center for Drug Evaluation and Research (CDER).
From the outset my team leader made sure I had a packed schedule. The warm welcome by team leaders, medical officers, project managers and administrative staff across a number of cross-functional teams made it possible for me to hit the ground running and integrate easily. I had the opportunity to audit medical officer training which encompassed a wealth of knowledge ranging from the history of the FDA, including the laws and Federal Code of Regulations that govern the FDA and regulatory approval process, to the drug development process, how the FDA regulates investigational new drugs, and evaluation of new drug applications.
The process of labeling was emphasized in the medical officer training, and I had an opportunity to learn more about labeling requirements for the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsection of prescription drug and biological product labels. As a physician, it is easy to underestimate the wealth of information that is contained in the label for an approved therapy. Not only did I learn about the labeling process, I had an opportunity to meet with labeling experts and can truly appreciate the attention to detail paid to the creation of labels for an approved therapy.
I was given opportunities to attend meetings with our industry counterparts, and witness the collegial interaction between the FDA and industry, as they collaborate to bring safe and effective new drugs to market. As a part of my fellowship, I met one on one with experts throughout the FDA on a variety of topics. Specifically, I had meetings with several experts involved in designating policy on orphan diseases, and learned about the grant programs the FDA has in place for investigators interested in rare diseases. In addition, I spent part of my time with the medical officers who regulate fecal microbiota transplants in the Center for Biologic Evaluation and Research (CBER), along with the GI division within the Center for Devices and Radiological Health (CDRH). At CDRH, I learned about the regulation of the device industry, and how it differs from the regulation of the pharmaceutical industry. The team showed me the innovative ideas they are helping to implement for reducing duodenoscope infections, and reducing complications of enteric feeding tubes.
Another important program the FDA offers are Advisory Committee meetings, and I attended one on the opioid epidemic, and the expansion of the availability of opioid reversal agents. Advisory committee membership is both an interesting and exciting way for physicians to be involved with FDA related matters, and contribute to the process of protecting Americans’ health and safety, by letting the medical community’s voice be heard.
One of the most significant things I learned at the FDA was the utmost importance of defining appropriate outcome assessments for clinical trials. I completed a project evaluating the literature on the use of endoscopic outcome assessments in Crohn’s Disease clinical trials, and had an opportunity to present my findings at a Division-wide meeting. My findings will hopefully be incorporated into future guidance for industry on designing appropriate outcome measures for Crohn’s clinical drug trials.
I would like to thank all of the wonderful people at the ACG and FDA for making my experience incredibly rewarding and I sincerely hope to have the opportunity for further collaboration in the future.”