The National Institutes of Health has awarded $12 million to the University at Buffalo School of Pharmacy and Pharmaceutical Sciences to lead a comprehensive quality assurance program in NIH-funded labs conducting HIV/AIDS and related clinical research programs worldwide.
“We are very excited that our expertise continues to be recognized as a valued contributor to the global effort to end the HIV epidemic,” said Gene D. Morse, PharmD, principal investigator on the grant, SUNY Distinguished Professor at UB and associate director of UB’s New York State Center of Excellence in Bioinformatics and Life Sciences (CBLS).
“This award highlights our established role in this critical area that contributes to global HIV clinical pharmacology research efforts,” Morse continued. “Building on our extensive experience, our group has been selected to provide a broad-based quality assurance program that will facilitate global HIV/AIDS treatment research by collaborating with university-based pharmacology laboratories that are engaged in these research efforts.”
The Clinical and Pharmacology Quality Assurance (CPQA) contract (identified by the NIH as HHSN272201500006C) runs for seven years.
The UB researchers will conduct quality assurance on clinical pharmacology research, including HIV prevention, HIV cure and eradication, antiretroviral treatment strategies, viral hepatitis drug development, tuberculosis treatment and therapeutic interventions for HIV end-organ diseases and chronic inflammation.
UB’s CPQA coordinates key aspects of clinical pharmacology research, including assay development and transfer, global proficiency testing for antiretroviral assays, analytical method validations, analytical powder procurement and inter-laboratory quality control. CPQA program personnel will provide clinical pharmacology training for clinical research site personnel who conduct clinical and translational studies to assess a drug’s effectiveness and its interactions with other HIV medications.
In addition, CPQA personnel conduct on-site assessments of clinical pharmacology laboratories, disseminate data across HIV/AIDS research networks, and support a centralized website that integrates the components of the CPQA program and provides global information access.
“HIV research has now broadened to include prevention strategies, latent virus eradication approaches, treatment of co-infections, new drug development and novel formulations of approved drugs,” said Morse. “With this grant, the UB Clinical Pharmacology Quality Assurance program is developing a coordinated approach to global clinical pharmacology, which this broadened research agenda now requires.”
Initially awarded for a seven-year contract period, which began in 2008, the CPQA program includes National Institute of Allergy and Infectious Diseases-designated clinical pharmacology laboratories that participate in the Division of AIDS’ supported HIV research networks as well as clinical research staff at NIAID Clinical Trials Units who are responsible for conducting clinical pharmacology research protocols.
The CPQA works with clinical pharmacology laboratories that determine drug concentrations in plasma and other tissues and cells used in pharmacokinetic analysis and compartmental drug concentration measurements. The individual components of the program include an international proficiency testing program; blinded, peer-review of drug assay validation reports and standard operating procedures; acquisition, characterization, storage, documentation and disbursement of quality control materials; technical guidance and assistance for clinical research staff and pharmacology laboratory technologists; and laboratory site assessments. The project also includes a computerized data management system, project management, administrative and technical support.
Part of UB’s Translational Pharmacology Research Core, the CPQA subcontracts with Frontier Science and Technology Research Foundation, a Western New York company co-located in the CBLS.
Additional UB faculty working on the grant include Robin DiFrancesco, scientific manager and research assistant professor, Department of Pharmacy Practice; Richard W. Browne, PhD, associate professor, Department of Biotechnical and Clinical Laboratory Sciences, School of Medicine and Biomedical Sciences; and Troy D. Wood, PhD, associate professor, Department of Chemistry, College of Arts and Sciences.