UB awarded multi-million dollar NIH funding to continue innovative HIV drug development

BUFFALO, N.Y. – The University at Buffalo School of Pharmacy and Pharmaceutical Sciences has received three grants totaling $3.85 million from the National Institutes of Health (NIH) for the Translational Pharmacology Research Core and its HIV Clinical Pharmacology Research Program.

The awards represent a competitive renewal through 2020 of the AIDS Clinical Trials Group (ACTG) Pharmacology Specialty Laboratory (PSL) located in the UB Center of Excellence in Bioinformatics and Life Sciences (CBLS).

Gene D. Morse, PharmD, professor of pharmacy practice and principal investigator on the grant, says the PSL is one of six such labs globally. Morse also is the director of the ACTG Laboratory Network, Clinical Pharmacology Laboratory Core.

“The UB laboratory receives funding toward developmental pharmacology initiatives in HIV clinical pharmacology and hepatitis C virus (HCV) drug development research,” says Morse, “as well as continued coordination of a national pharmacoinformatics and drug interactions database project.”

Initially funded in 1987 as one of the ACTG’s first HIV Clinical PSLs, the UB program has had sustained NIH support since the original award. Morse, who has been the research program’s principal investigator and director, is also a member of the ACTG Viral Hepatitis Transformative Science Group and chairs the ACTG Clinical Pharmacology Advisory Group.

The UB PSL operates a bioanalytical laboratory that develops and validates drug assays using innovative applications of liquid chromatography and mass spectrometry. It also contributes to clinical pharmacology studies that investigate new drug treatments and drug interactions research during drug development programs.

The PSL collaborates in ACTG research with pharmaceutical companies that include U.S.-based AbbVie (Chicago), Bristol Myers Squibb (New Jersey) and Merck Inc. (Philadelphia).

UB’s HIV Clinical Pharmacology Laboratory, an internationally recognized drug bioanalysis research facility, contributes to multicenter trials that investigate new treatments for HIV, HCV, TB and chronic inflammation.

During the recent NIH competitive renewal process for HIV Clinical Trials Units (CTUs), Andrew Talal, MD, MPH, joined Morse in the University of Rochester (UR) AIDS Clinical Trials Unit application, which was awarded and resulted in a subcontract to UB earlier this year.

Talal is a UB professor in the Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, School of Medicine and Biological Sciences, whose specialty is hepatology with extensive experience in drug development for HCV infection and an interest in intrahepatic drug measurement.

Morse says HCV is a common co-infection among HIV patients as they share a common route of transmission via exposure to infected blood. Because of this connection, the hepatology program and the clinical pharmacology program are working together to provide a novel multidisciplinary research effort that is now a component of the UR CTU.

Talal was also elected to the ACTG Viral Hepatitis Transformative Science Group earlier this year and is vice chair of an ACTG protocol that will assess HCV RNA decline and intrahepatic drug concentration in HCV-infected patients treated with novel combinations of antiviral medications.

Talal and his team direct a comprehensive liver clinic on the Buffalo Niagara Medical Campus and have initiated clinical trials for a variety of liver disease indications.

Funding from the grant also supports continuing the UB PSL Precautionary and Prohibited Medications Database, a pharmacoinformatics database that identifies new clinical pharmacology studies of drug interactions among HIV, HCV and tuberculosis (TB) drugs during drug development, and integrates new research data with an informatics utility that is based in the CBLS’ Translational Pharmacology Research Core.

This utility is used by NIH investigators for developing new treatment protocols that access the most current drug interaction data available; this also promotes the safety and protection of subjects who participate in these clinical studies.

With all of the research across disciplines and cross-unit collaborations bringing academic minds together with industry, Morse hopes to discover new interdisciplinary approaches to drug development.

“We hope to develop approaches that characterize drug distribution into different body tissues and fluids and combine that with analysis of gastrointestinal and liver drug metabolism,” he says. “The UB PSL studies HIV and HCV drugs in the liver and brain and is investigating the link between pharmacokinetics and pharmacogenomics.”