Since early 2013, SRI Biosciences, with support from the Michigan Economic Development Corporation, has been gearing up to establish a Phase 1 clinical trial facility in Plymouth, Michigan, located squarely in the state’s “Life Sciences Corridor.” The facility will meet an important translational need for government and industry clients and partners, particularly small biotech companies that need early-stage human clinical trial services. The coordinated activities of team members and organizations on multiple fronts have been productive, and we are looking forward to moving in to our new 9,400-square-foot clinical trial unit that will be located in the Michigan Life Science Innovation Center.
Hiring is actively under way, and several critical positions have already been filled, while promising candidates have been identified for other key spots. We have been joined by Gloria Chou as our clinical research operations manager and Ligi Mathews as investigational study pharmacist and clinical pharmacologist. Gloria brings with her highly relevant experience in clinical trials and will manage a study coordinator, regulatory support staff, and a laboratory research associate. Ligi has extensive experience in clinical trials, management, and pharmacy-related work. The research pharmacy will be equipped to handle a wide range of oral and injected investigational products.
SRI Biosciences’ new Phase 1 unit will enable researchers to conduct early clinical trials in healthy volunteers and patients across all medical areas. Researchers will perform single and multiple ascending dose studies, Phase 1b proof-of-concept trials leveraging our expertise in biomarker development, food effects, bioequivalence, drug-drug interaction studies, and evaluation of medical devices. Overall, these critical early clinical evaluations will focus on safety, tolerability, pharmacokinetics (i.e., blood levels achieved after dosing) and, in Phase 1b trials involving patients, preliminary evidence of mechanistic or clinical activity.
The unit’s leadership team will enable efficient and innovative clinical trial design that will help refine development strategies for emergent biotechnology and medical device start-ups. The latter serves as a vital differentiator for SRI within the early-phase clinical trials space.
This is an exhilarating time for SRI Biosciences, as we extend our translational capabilities from discovery and preclinical development to the next major milestone—clinical trials—in bringing new drugs, biologics, devices, and other biomedical product candidates into the clinic.
David Sahner, M.D., is senior director of clinical translation in SRI Biosciences’ Pharmaceutical Development Section.