Frontage Laboratories and Frontage Clinical Services have developed the capability to perform full-service human Absorption, Metabolism, and Excretion (hAME) studies with radiolabeled compounds at our clinical site in Secaucus, NJ. It has obtained the full approval of the NJ Department of Environmental Protection to conduct such studies evaluating radiolabeled drug candidates in humans. Frontage Clinical Services, which has over 20 years of experience conducting early phase clinical research studies, plans to begin healthy volunteer recruitment and study conduct in the second quarter of 2021.
 
The ability to execute in-life hAME studies at its 160-bed Phase 1 clinic in Secaucus, NJ complements Frontage’s experience in conducting radiolabeled studies, including Quantitative Whole-Body Autoradiography (QWBA)/dosimetry, mass balance, and metabolite identification/profiling.
 
“Human radiolabeled studies are an essential component of successful NDA filing for new therapeutic agents,” said Song Li, CEO of Frontage Laboratories. “Today’s announcement is yet another example of Frontage’s ongoing expansion to become a global leader providing a full range of high-quality services under one roof.”
 
Lisa Diamond, president of Frontage Clinical Services, said, “The achievement of this important milestone is significant, as it allows us to offer our clients comprehensive hAME services, and enables us to provide an expanded portfolio of integrated solutions to the biotech and pharmaceutical industry.”
 
“In the past, we have conducted mass balance and metabolite profiling studies for clients, but did not perform related in-life hAME services. We now have the ability to conduct entire hAME studies, including QWBA, right here in our facilities, allowing us to efficiently provide comprehensive hAME packages to clients in a very timely manner,” said Abdul Mutlib, executive vice president of Frontage Global DMPK Services.