Program Overview
CPQA operates under a contract with the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID). The goal of CPQA is to provide quality assurance programs and training for CPQA Participating Laboratories (CPLs).
The CPQA Program is organized into several committees and units.
History
UB CPQA was initially funded in 2008 through the first contract RFP from NIAID/DAIDS. UB CPQA has successfully recompeted for this contract on two subsequent occasions with the most recent renewal in 2022.
Adaptation
UB CPQA has evolved with emerging patterns of HIV therapeutics research, adapted to include new antiretrovirals in the Proficiency Testing Program, provided training programs to new clinical research sites, and included new pharmacology testing laboratories within the program.
HIV
Since its inception, UB CPQA has focused on strengthening HIV Clinical Pharmacology and Therapeutics research by educating the clinical research staff that conduct clinical pharmacology studies and working with CPLs to assure the highest quality pharmacology data emanate from these sites.
TB Drug Development
TB drug development research has gained momentum and created a pipeline of potential therapeutics that will be used to create potent regimens that can be administered for a shorter duration of time. To address this emerging area of HIV and co-infection research, a TB Clinical Pharmacology Advisory Working Group was implemented and planning is underway for a TB PT program Development.
Monoclonal Antibodies
HIV-1 broadly neutralizing antibodies (bNAbs) are currently under investigation for HIV prevention, treatment and cure. The UB CPQA R&D Laboratory is investigating novel approaches to utilizing mass spectrometry to analyze clinical samples from ongoing protocols. Early results are encouraging and have been presented at recent scientific conferences.
Biomatrices
As alternatives to plasma samples are included in new research protocols, CPQA designs pilot projects to assess bioanalytical questions in their application to protocols. Prior projects have included peripheral blood mononuclear cells, and ongoing projects include dried blood spots, cerebrospinal fluid and urine.
Key Organizations
University at Buffalo: The University at Buffalo is the largest campus in the State University of New York system and New York’s leading public center for graduate and professional education. More than 29,000 students pursue their academic interests through more than 400 undergraduate, graduate and professional degree programs. Founded in 1846, UB is a member of the Association of American Universities.
Frontier Science: Frontier Science provides data management, statistical support, application development, and proficiency testing reports for the CPQA program. With over 40 years of experience, Frontier Science is a not-for-profit corporation that is known internationally as a highly capable data management and statistical center, collaborating with research networks, pharmaceutical companies, and others in the design, conduct, and execution of clinical trials and long-term observational studies.
HANC: The Office of HIV/AIDS Network Coordination (HANC) works with the HIV/AIDS clinical trials networks funded by the Division of AIDS (DAIDS) of the U.S. National Institutes of Health (NIH) with the intent of creating a more integrated, collaborative, and flexible research structure. The networks are an affiliated group of national and international medical research institutions and investigators that conduct clinical HIV/AIDS research to develop safe and effective drugs, prevention strategies, and HIV vaccines.
NIAID/DAIDS: The Division of AIDS (DAIDS), part of the National Institute of Allergy and Infectious Diseases (NIAID), was formed to develop and implement the national research agenda to address the HIV/AIDS epidemic. DAIDS supports global research for HIV/AIDS and related infections.
Key People
CPQA Leadership
Gene Morse, PharmD
CPQA Principal Investigator
University at Buffalo
Robin DiFrancesco, MBA
Program Manager
University at Buffalo
Sue Siminski, MS, MBA
Statistical and Data Management Center (SDMC) PI
Frontier Science
Ray Cha, PharmD
Assistant CPQA Program Director
University at Buffalo
Troy Wood, PhD
CPQA Laboratories Director
University at Buffalo
Heather Sprenger, MS
CPQA Project Director
Frontier Science
CPQA Staff
| Name | Role | Affiliation |
|---|---|---|
| Brandon Salazar | Technical Support | University at Buffalo |
| Charlene Taylor | Internal/External Quality Assurance | University at Buffalo |
| David Vlieg | Laboratory Data Manager | Frontier Science |
| Diala Ghazal | Technical Support | University at Buffalo |
| Elizabeth Sturniolo | Administrative Support | University at Buffalo |
| Ian Wetzel | Technical Writer | Frontier Science |
| Jill Hochreiter | Method Development and Validation | University at Buffalo |
| Kyle Whitson, MA | Lead Laboratory Data Manager | Frontier Science |
| Lauren Hill | Technical Support | University at Buffalo |
| Linda Hale | Technical Support | University at Buffalo |
| Madiha Quraishi | Research Contract Administrator | University at Buffalo |
| Melynda Cotten, MA | Statistical Programmer | Frontier Science |
| Mona Farhad | Senior Statistician | Frontier Science |
| Philip Lindhorst | Technical Support | University at Buffalo |
| Staci Scherrer | CPQA Laboratory Supervisor | University at Buffalo |
| Sue Rosenkranz, PhD | Research Scientist | Frontier Science |
| Yoninah Cramer | Biostatistician | Frontier Science |
