DURHAM, N.C. – The Duke Human Vaccine Institute (DHVI) received a $16,218,499 (includes the base period and all options), seven-year (if all term options are exercised) contract to implement the Immunology Quality Assessment (IQA) Program from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to provide a resource to evaluate and enhance the ability of U.S. and non-U.S. laboratories to participate in NIAID-funded and collaborative clinical studies. The period of performance is September 30, 2021 – September 29, 2028.
The IQA program will be under the leadership of Thomas N. Denny, who has been at Duke University since 2006; and is currently the COO of the Duke Human Vaccine Institute, Director of the Immunology Virology Quality Assessment Center (IVQAC), and Associate Dean for Duke RTP Campus Administration and serves as Principal Investigator of active DHVI NIAID-funded research contracts including IQA (current award ending September 29, 2021), Nonhuman Primate Virology Laboratory for AIDS Vaccine Research and Development (NHP), External Quality Assurance Program Oversight Laboratory (EQAPOL), and Virology Quality Assurance (VQA) Program. With this award, the Denny team will have led the IQA program for 28 consecutive years.
The specific research mandate is to monitor the ability of labs to reliably perform study-specified immunological tests and cryopreserve peripheral blood mononuclear cells (PBMCs) and other human biological samples; facilitating the optimization, standardization and validation of immunological assay methodologies, with focus on laboratory-developed tests (LDTs) for implementation in NIAID-supported studies; helping labs meet Sponsor and regulatory requirements for good clinical laboratory practices (GCLP) and submission of data to regulatory agencies; and hosting and maintaining an electronic data management system and document library in support of contract activities.
Dr. Barton F. Haynes, MD and Duke University School of Medicine Frederic M. Hanes Distinguished Professor of Medicine and DHVI Director comments on the award – “Tom Denny and his team play major roles in the success of DHVI. The IQA contract is central to our success by providing quality controls for all we do. In addition, the IQA provides quality monitoring for all NIAID grants and contracts. DHVI is so fortunate to have Tom Denny and the IQA team at Duke.”
Thomas N. Denny, MSc, MPhil Duke University School of Medicine Professor in Medicine, DHVI COO and Director of the Immunology and Virology Quality Assessment Center and Associate Dean for Duke RTP Campus Administration comments on the award – “This award marks the fourth consecutive seven-year term of four that our team will administer the Immunology Quality Assessment Program for NIAID-DAIDS. It’s a privilege to have this program at Duke and the DHVI and we value the trust and confidence that NIAID-DAIDS has placed in DHVI with this award.”