Frontage Laboratories and Frontage Clinical Services have unveiled plans to provide full service human radiolabeled Absorption, Metabolism, and Excretion (hAME) study capabilities, subject to receipt of required regulatory approvals.
 
Building on over 20 years of experience in early phase clinical research study conduct, data management and biometric services, Frontage Clinical Services is expanding study conduct capabilities to include human AME studies. This service complements the existing key components of hAME studies, including Quantitative Whole-Body Autoradiography (QWBA)/dosimetry, mass balance, and metabolite identification/profiling studies which have been provided routinely by Frontage Laboratories for the last several years, resulting in a comprehensive hAME service offering.
 
Following fulfillment of federal and state radioactive material licensing requirements, Frontage plans to begin healthy volunteer recruitment and study conduct, including radiolabeled dosage preparation, at its 160-bed Phase 1 unit in Secaucus, NJ. It anticipates receiving regulatory clearance to begin studies in the first half of 2021.
 
“Having all required services for a human AME study available through the Frontage company is consistent with our stated strategy and ultimate goal to expand the range of Frontage services with more integrated solutions for our biotech and pharmaceutical clients,” said Dr. Song Li, chief executive officer, Frontage Laboratories.
 
Dr. Lisa Diamond, president, Frontage Clinical Services, said, “Alignment of Frontage Labs DMPK strengths with Frontage Clinical Services expanded capabilities presents the opportunity to offer our clients end-to-end hAME services, ensuring efficient sample analysis and a seamless service experience.”