FDA Awards $4.35 Million in Contracts to College of Pharmacy
At the end of 2015, the US Food and Drug Administration (FDA) funded three separate contracts to Drs. Amidon, Schwendeman, and Sun, all in the Department of Pharmaceutical Sciences in the University of Michigan College of Pharmacy. These contracts are funded as part of the agency’s Broad Agency Announcement (BAA) with an initial commitment of $4,348,178. Additional options would reach $14,766,472 in total funding if approved by the agency.
These projects seek to answer fundamental questions of drug delivery related to generic drug development and regulation. The funds will support basic mechanistic bench work, theoretical calculation confirmations, animal studies that simulate conditions relevant to human administration, and potential studies in human subjects for further proof of concept. These funded projects serve as a testament to both the quality of the department’s research as well as U-M’s long-standing commitment to support high impact pharmaceutical science that helps shape FDA’s national strategy to guide companies through the complex drug development process to achieve safe and effective innovator (brand-name) and generic drug products.
“The goal of my project is to design a wireless pharmaceutical analysis device (WPAD) to obtain gastrointestinal (GI) fluids and track locations in GI tract for determination of drug dissolution and drug transit in the human GI tract,” explains Duxin Sun, PhD’02, William I. Higuchi Collegiate Professor of Pharmaceutical Sciences. “We are excited for this project because it’s truly a collaborative effort between College of Pharmacy, College of Engineering, and FDA. Once device development is completed, the device will be tested in human subjects, and the use of validated software tool kits will help distinguish meaningful product differences and evaluate bioequivalence (BE) potential for generic drug products,” concludes Dr. Sun. “These goals align with objectives of FDA regulatory science: to revolutionize the drug approval process, design drug products to distinguish meaningful product differences in humans, and ensure BE.”
“My FDA-funded pharmaceutical product focused research project will develop innovative new pharmaceutical drug product testing standards that will ensure all approved pharmaceutical products on the U.S. market are safe and effective. The research will utilize the recently developed and most advanced MRI technology for study of the human GI tract,” notes Gordon Amidon, PhD’71, Charles R. Walgreen Jr. Professor of Pharmacy and Pharmaceutical Sciences. “The goal of the project is to provide dramatically improved, more universally applicable, and less expensive methods that can be used for regulation of pharmaceutical products for both innovator and generic products. We will have mechanistically based drug product testing methods that are applicable to all patients for the first time.” The project is a collaboration between the University of Michigan College of Pharmacy, the University of Michigan Department of Gastroenterology and the MRI department at the University of Nottingham UK. This is a truly internationally collaborative scientific project focused on advancing and applying the most innovative scientific methods available today to ensure the efficacy of pharmaceutical drug products available to patients throughout the world.
"My project is focused on bridging the fundamental scientific knowledge gap between manufacturing conditions and performance of long-acting release dosage forms (LARs) when administered to patients," says Steven Schwendeman, PhD’92, Chair and Ara G. Paul Professor of Pharmaceutical Sciences, College of Pharmacy. “My research group and I are very proud to be a part of this U-M effort together with the teams led by my colleagues, Professors Gordon Amidon and Duxin Sun, to respond successfully to this important initiative of the FDA.”
For more information, visit the Department of Pharmaceutical Sciences homepage.