SRI Biosciences, a division of SRI International, a California-based independent nonprofit research institute, has completed construction of an early-phase clinical trial facility in Plymouth, Mich. The 9,400-square-foot unit, located in the Michigan Life Science Innovation Center, now is open and fully equipped for early-stage human research studies of new medicines and medical devices.
The new purpose-built facility includes 13 beds and three infusion chairs, a state-of-the-art investigational pharmacy with the capacity to prepare sterile infusions, a laboratory for sample processing, amenities to accommodate extended overnight stays for research participants and equipment to monitor and protect the safety of these volunteers.
The staff offers strategic development support to biotech and device companies, academic investigators and other collaborators. SRI Biosciences will help innovators with limited development infrastructure refine target product profiles that address specific unmet medical needs and optimize development strategy to maximize efficiency and minimize risk.
"Our core focus will be translational medicine research—that important stage when scientific breakthroughs move from the lab to the clinic and where their potential to improve human health can be initially evaluated," said David Sahner, M.D., senior director of clinical translation, SRI Biosciences. "When done well, early-phase clinical trials can provide critical insights—into safety, tolerability, absorption, distribution and elimination of drugs and biologics, as well as early assessment of mechanistic and therapeutic effects—that help reduce drug development risk, pave the way for future regulatory and commercial success, and get new medicines to patients who need them more quickly."
The SRI unit is equipped to perform studies involving healthy volunteers and patients with a variety of underlying diseases. SRI will leverage its extensive organizational capabilities in biomedical research, including core competencies in biomarker assay development and validation and clinical-trial product manufacturing, to facilitate the design and completion of clinical projects. SRI Biosciences also will develop its own compounds at the new facility.
In 2012 and 2013, the Michigan Strategic Fund approved a $5 million grant through the Centers of Innovation program and an $800,000 Michigan Business Development Program performance-based grant to support the project.