Written By: James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
Nearly 40 graduate students from the MS in Regulatory Science program at the School of Pharmacy had an opportunity to visit the Food and Drug Administration (FDA) in White Oak, Md., and met with top scientists in the Division of Cardiovascular and Renal Products (DCaRP) on March 28. Norman Stockbridge, MD, PhD, director of the Office of Drug Evaluation I in DCaRP; Michael Monteleone, MS, associate director for labeling in DCaRP; Edward Fromm, RPh, chief of project management staff in DCaRP; Thomas Papoian, PhD, supervisory pharmacologist in DCaRP; Senatore Fortunato, MD, medical officer in DCaRP; and Lori Wachter, RN, BSN, safety regulatory project manager in DCaRP, spent more than 90 minutes engaged in a panel discussion with students, answering questions about a wide range of topics, such as:
- Drug safety assessment
- New preclinical models
- Areas of dialogue between FDA and sponsors
Devi Kozeli, a current student in the MS in Regulatory Science program and senior regulatory health project manager and consumer safety officer at the FDA, organized the panel discussion. “I am thrilled that I was able to help my classmates gain a better understanding about how FDA teams represent the disciplines that we study in class. Scientists with backgrounds in clinical research, pharmacology/toxicology, post-marketing safety, labeling, and regulatory management all work together to review new drugs,” he said.
Following the panel discussion, I had an opportunity to debrief with students and ask their thoughts about the experience. In addition to expressing their appreciation to the FDA for granting our program this unique opportunity, the students shared their thoughts about the aspects of the experience that they found most enjoyable.
“It was fascinating to learn how the FDA review process is a truly collaborative one that involves scientific exchange among numerous reviewers with different perspectives,” said Laura Murphy, MT, MPH, manager of pharmacovigilance at C.B. Fleet Company and recipient of the School’s Ellen H. Yankellow Scholarship. “A common theme that seemed present throughout the panel discussion was the application of basic science in problem solving. I particularly enjoyed how Dr. Papoian emphasized this concept, as there isn’t always a simple checklist that we can run through to solve these real-world problems.”
“I learned so much from this experience,” added Grishma Patel, MS, quality assurance specialist at Tishcon Corporation. “Safety and efficacy are topics that we discuss every day at work. While classes in the MS in Regulatory Science program address a wide range of approaches that we can use to evaluate efficacy and safety, it was wonderful to gain some additional understanding and learn that the tools currently available to measure safety are not necessarily the same tools that you would use to measure efficacy. Safety evaluation seems much more heuristic than the evaluation of efficacy.”
Keisha Hines-Harris, quality analyst specialist II at Leidos Biomedical and the National Cancer Institute, also noted, “I enjoyed listening to the individual perspectives of each reviewer, which sometimes differ from the general consensus, even though both share the common goal to protect the public health. I also enjoyed the opportunity to meet my classmates, which is rare for programs based exclusively online.”
Visit this webpage for more information about the Division of Cardiovascular and Renal Products at the FDA. More information about the MS in Regulatory Science program is available on the School of Pharmacy’s website.