$7.6 Million Contract Establishes International HIV/AIDS Clinical Pharmacology Quality Assurance and Quality Control Program and Lab at UB

BUFFALO, N.Y. -- A $7.6 million, seven-year contract awarded to the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo will provide the funds to train in-country laboratory specialists where HIV/AIDS infection rates are highest globally, test their proficiency and conduct quality control analysis of HIV/AIDS clinical trials.

Funded by the National Institute of Allergy and Infectious Diseases, the award establishes a Clinical Pharmacology Quality Assurance (PQA) program and laboratory in the UB Pharmacotherapy Research Center on UB's North (Amherst) Campus and at the Translational Pharmacology Research Core in the New York State Center of Excellence in Bioinformatics and Life Sciences in downtown Buffalo (CoE).

The UB PQA program and laboratory, the only one of its type in the world, will assure that AIDS researchers in developing countries conduct the highest quality clinical trials. An estimated 33 million adults and children are living with HIV worldwide, according to the World Health Organization. The UB program and lab will be integrated with global research networks to target some of the regions where the infection rate is highest.

Gene D. Morse, Pharm.D., professor and associate dean for clinical and translational research, is principal investigator on the award.

"We are excited about this opportunity to use our expertise and facilities to help fight the global AIDS epidemic," said Morse. "This award highlights our expertise in this critical area."

Conducting research in developing countries can be challenging, noted Morse, because of a lack of clinical scientists, insufficient laboratory facilities to conduct HIV research and the lack of clinics to provide care to HIV-infected patients.

"These difficulties are often compounded by problems such as HIV co-infection with TB and malaria, variable nutritional status among patients, extensive use of traditional and herbal medicines producing unknown drug interactions and counterfeit drugs," he said.

"Building on our extensive experience, our group has been selected to provide a broad-based PQA that will consider each of these factors and guide the growth of HIV/AIDS treatment by facilitating the ability of the pharmacology research laboratories to conduct high-quality research."

The funding represents a significant "next step" in the growth of the UB School of Pharmacy and Pharmaceutical Sciences' clinical research program, said Wayne K. Anderson, dean of the UB pharmacy school. "It is consistent with the UB 2020 vision for the growth of biomedical research collaborations at the Center of Excellence. Professor Morse and other faculty and staff have made a significant commitment to ensure success at the CoE."

Bruce A. Holm, Ph.D., UB senior vice provost and executive director of the CoE, said of the award: "This international contract initiative with National Institutes of Health is another positive outcome of the close collaboration between the CoE and the School of Pharmacy. Dr. Morse's program offers great opportunity for further expansion of our viral disease efforts at UB."

Sen. Hillary Rodham Clinton praised the university for its work to improve clinical trial capacity in developing countries.

"The University at Buffalo is a world leader in cutting edge research and this contract will only enhance its well earned reputation for excellence," she said. "The training UB will lead will make a critical contribution to efforts around the world to stop and reverse the spread of HIV and AIDS. I applaud the university for its contributions to AIDS research and I congratulate them on this well earned award."

HIV/AIDS global efforts currently are focused on increasing antiretroviral access to countries with few resources and conducting clinical trials of new antiretrovirals and combination treatments within their borders. Antiretroviral drugs inhibit the replication of HIV. When antiretroviral drugs are given in combination, HIV replication and immune deterioration can be delayed, and survival and quality of life improved.

Clinical trials of approved and potential new therapies to fight the global AIDS epidemic need to be conducted where the infection rate is highest, but most of those regions are in countries where clinical pharmacology facilities and trained specialists are scarce.

The UB PQA will establish a reference laboratory for antiretroviral bioanalysis that will coordinate key aspects of clinical pharmacology research, including assay development and transfer, global proficiency testing for antiretroviral assays, testing method validation reporting, analytical powder procurement and inter-laboratory quality control.

PQA 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, PQA personnel will conduct on-site audits, disseminate data across HIV/AIDS research networks and establish a centralized Web site that will integrate the components of the PQA program and provide global information access.

Many of the new drugs developed for HIV have complex pharmacology.

"When patients take the FDA-approved antiretrovirals in fixed doses, they often have variation in individual characteristics such as age, body size, genetic makeup and diet, as well as the occurrence of many drug interactions," said Morse. "When patients take similar doses of these antivirals, we see great variation in drug exposure from patient to patient. Consequently, clinical pharmacokinetics is a common component of early clinical drug development and later in comparative clinical trials."

Clinical pharmacokinetics involves measuring drug concentrations in patients' blood samples (and other body fluids) to determine the extent of drug exposure and then correlating drug exposure with drug effects (pharmacodynamics) and genetic variation (pharmacogenomics).

"Because measuring clinical drug concentrations in patients who participate in clinical trials is an important aspect of HIV/AIDS drug development and translational research, having pharmacology laboratories that conduct high-quality analysis is essential," said Morse.

"Establishing these laboratories requires extensive training. Personnel need to develop research skills, learn how to conduct critical review of drug assays, do external auditing of laboratory activities, conduct proficiency testing, do quality assessments of the reagents used in the assays and disseminate appropriate information to ensure the best quality research will be conducted."

Specialists will train through an online tutorial. Two hundred clinical researchers are expected to complete the tutorial annually, said Morse. UB personnel will conduct antiretroviral proficiency testing twice a year at 10 laboratories the first year, and have options to add one new site each year for the duration of the contract.

Buffalo-based Frontier Science Technology Research Foundation will be responsible for data management and statistical analysis.

Morse said he sees the potential for long term growth in this area. "In the future, the PQA lab may conduct pharmacology quality assurance for cancer, diabetes and other trials, and could attract companies involved in IT and analytical technology."

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research – at the National Institutes of Health, throughout the United States and worldwide – to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these illnesses.

The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system that is its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.