‘Handshake meeting’ kicks off SOP collaboration with FDA


Wednesday, August 16th, 2017
By: Cynthia McMullen

 

Among the VCU School of Pharmacy faculty working to establish an MOU with the FDA are (from left) David Holdford, Aron Lichtman, Patty Slattum, Doug Sweet and Jürgen Venitz.

Leadership from the U.S. Food and Drug Administration Office of Clinical Pharmacology and VCU School of Pharmacy recently met to discuss opportunities for development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships.

This meeting was subsequent to a memorandum of understanding into which FDA and the SOP entered last August. School of Pharmacy professor Patty Slattum (B.S.‘85, Pharm.D./Ph.D.‘92) was a key player in presenting SOP research and collaborative interests.

Multiple collaborations were discussed, including an initial opportunity to develop a model for Advanced Pharmacy Practice Experiences (rotations) and internships at FDA OCP for students enrolled in Pharm.D. and graduate programs. Future opportunities — such as research; access to facilities for educational and scientific endeavors; and participation in joint fellowship programs, advisory boards, personnel exchanges and joint meetings for education and research — also were discussed.

The school has had longstanding relationships on various levels with the FDA, which also employs several of its alumni, including Joseph Grillo (Pharm.D.’93), associate director for labeling and health communication, and Kellie Schoolar Reynolds (Pharm.D.’92), deputy director of the Division of Clinical Pharmacology IV, both with FDA OCP.

In addition, Slattum serves on the FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, and pharmaceutics professor Jürgen Venitz is in his fourth year as chairman of the FDA Pharmacy Compounding Advisory Committee. A former resident, Mongthuong Tran, now works as a pharmacist with the OCP. And School of Pharmacy alumnus Omar Hassan (Pharm.D. ’17) recently completed an ORISE (Oak Ridge Institute for Science and Education) summer fellowship at the FDA and has returned to VCU to begin graduate work.

Representing the School of Pharmacy during initial talks with the FDA, in addition to Slattum and Venitz, were professor David Holdford, Department of Pharmacotherapy and Outcomes Sciences; professor Aron Lichtman, associate dean for research and graduate studies; and professor Doug Sweet, chairman of the Department of Pharmaceutics. Presenting on behalf of specific research areas at the handshake meeting were Slattum, pharmacotherapy; Sweet, pharmaceutics; and Holdford, pharmacoeconomics and health outcomes.

“We are among a strong group of universities that have MOUs with the FDA,” notes Slattum. Among them are University of Maryland, University of Florida, Virginia Tech, Howard University, Duke University, Stanford University, Johns Hopkins University, Harvard University, Massachusetts Institute of Technology and Georgetown University.

The Office of Clinical Pharmacology is a multidisciplinary organization of more than 200 clinical pharmacologists, pharmacists, researchers, project managers and administrative staff with diverse skills within the FDA’s Office of Translational Sciences. OCP is an integral part of the Center for Drug Evaluation and Research’s review, policy and regulatory science core that bridges pharmacology and clinical medicine to improve public health. Its mission is to accomplish that goal by building and translating knowledge of drug response into patient-centered regulatory decisions of the highest quality.