University of Maryland and University of Michigan Receive $5 Million Grant from FDA for Center to Address Generic Drug Access and Safety
The University of Maryland School of Pharmacy (UMSOP) and the University of Michigan College of Pharmacy (U-M) have received a 5-year, $5 million grant from the US Food and Drug Administration (FDA) to establish a joint Center for Research on Complex Generics (CRCG).
The mission of CRCG is to increase access to safe and effective generic drugs through collaborative research, training, and information exchange. The center will facilitate communication and information sharing between FDA, academia, and generic drug companies.
“Complex generic drugs are, in general, more difficult to develop due to complex formulation or mode of delivery, resulting in fewer complex generics on the market,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “By awarding this grant, our goal is to support research and development of these products so they can be made available to patients in a more timely way. By supporting increased competition in the generic market, we can help provide more options for Americans and potentially bring down prices on these important therapies.”
A team of 24 interdisciplinary investigators at UMSOP and U-M will allow the center to offer broad research capabilities from formulation development and analytical characterization to in-silico models and animal testing to clinical trials and post-market assessment of patient data. Multiple collaborators from other universities, industry, and research organizations are involved with CRCG.
U-M and UMSOP faculty have a wealth of experience in multiple facets of the complex generics field, such as formulation and evaluation of complex drugs, as well as exceptional laboratory and training space to facilitate development and characterization of complex generics. Maryland and Michigan have a long track record of completing FDA-sponsored research projects, with a focus on formulation design and performance.
The center is co-directed by Anna Schwendeman, PhD, associate professor of pharmaceutical sciences at U-M Pharmacy, and James E. Polli, PhD, professor and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at UMSOP, located at the University of Maryland, Baltimore (UMB). A 1993 graduate of U-M with a PhD in Pharmaceutics, Polli’s research focuses on oral drug formulation and pharmacokinetics. Schwendeman’s research focuses on evaluation of injectable complex generic nanoparticle and peptide products. She spent 12 years in the pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics.
Funding from the grant will support three main activities: create a dynamic and adaptable infrastructure and think tank to facilitate effective communication between stakeholders, promote education and training, and conduct collaborative research and technique development.
“The education mission of the center is key,” explains Schwendeman. “We will hold workshops for generic industry scientists, including live demonstrations. We aim to engage and educate those with an interest in complex generics research.”
“Our last pillar is our research mission,” adds Polli. “The center will facilitate collaborative projects by established researchers within the industry and the FDA, and will host a Visiting Scientists Program for fellows from the FDA’s Office of Generic Drugs and the generics industry.”
Ultimately, Schwendeman and Polli hope the center will make complex analytical assays and pharmaceutical development expertise accessible to the generic industry and eventually lead to more rapid approval of high quality and accessible generic products.
For more information on the Center for Research on Complex Generics, visit www.complexgenerics.org.