January 14, 2015 – Michael Cohen-Wolkowiez, MD, PhD, will serve as principal investigator for the DCRI, which could potentially receive up to $90 million over the span of the 10-year contract.
The DCRI will become one of three national sites to run early clinical trials of new anti-infection therapies under a contract announced by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The 10-year contract establishes the DCRI as a Phase I Clinical Trial Unit for Therapeutics, a project NIAID began in 2008 to more quickly find promising therapies for diseases such as influenza, Methicillin-resistant Staphylococcus aureus, and drug-resistant tuberculosis.
The DCRI could launch and manage up to four early-phase clinical trials a year, and potentially receive $90 million over the life of the contract, depending on the length and complexity of the different trials.
“The DCRI is the only academic medical center to be awarded this contract,” said principal investigator Michael Cohen-Wolkowiez, MD, PhD, director of pharmacometrics and assistant director of the Duke Pediatric Clinical Research Unit at the DCRI. “We bring an outstanding operations team and unique expertise, including a state-of-the-art clinical research unit, analytical support at our pharmacometrics center, and access to healthy volunteers and patients through the medical center.”
Cohen-Wolkowiez said the first clinical trials at Duke will likely start later this year, after infrastructure is established. The trials will be first-in-human studies, with the goal of identifying appropriate doses prior to continuing the drug development process.
“We look forward to participating in this important federal effort to speed development of new drugs and therapies for infectious diseases,” Cohen-Wolkowiez said. “As these diseases are increasingly resistant to current treatments, they pose a significant public health risk and highlight the urgent need for this work.”