MENLO PARK, Calif. -- SRI Biosciences, a division of SRI International, has completed construction of an early-phase clinical trial facility in Plymouth, Michigan. The 9,400-square foot unit, located in the Michigan Life Science Innovation Center, is now open and fully equipped for early-stage human research studies of new medicines and medical devices.
"SRI International's newest facility in Michigan means great news ahead—groundbreaking discoveries, biotech startups, and new jobs that will result here," Governor Rick Snyder said. "SRI's decision to locate here validates Michigan's standing as a global biosciences leader and speaks well of our state's R&D capabilities, strong universities, and high-tech workforce."
The new purpose-built facility includes 13 beds and 3 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.
"We are grateful for the support provided by the Michigan Economic Development Corporation, which enabled us to establish this state-of-the-art clinical trial facility in a central location with a highly educated biomedical work force," said Walter H. Moos, Ph.D., vice president of SRI Biosciences. "We have tapped into the deep regional talent pool and now look forward to applying our world-class drug-development expertise to assist government and industry clients and partners in Michigan and throughout the world."
The mission of the drug development and clinical research experts in the new unit is to provide efficient, flawless clinical study capabilities that meet U.S. Food and Drug Administration (FDA) requirements. The staff also 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 will also 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 $800,000Michigan Business Development Program performance-based grant to support the project.
About SRI Biosciences
SRI Biosciences carries out basic research, drug discovery, and drug development. SRI has all of the resources necessary to take R&D from initial discoveries to clinical trials. SRI's product pipeline has yielded marketed drugs, therapeutics currently in human testing, and additional programs at earlier stages. SRI Biosciences offers a wide range of contract research organization (CRO) services, helping government and industry clients and partners advance drugs and other biomedical products toward commercialization. SRI is also working to create the next generation of technologies in areas such as diagnostics, drug delivery, medical devices, and systems biology.
About SRI International
Innovations from SRI International have created new industries, billions of dollars of marketplace value, and lasting benefits to society—touching our lives every day. SRI, a nonprofit research and development institute based in Silicon Valley, brings its innovations to the marketplace through technology licensing, new products, and spin-off ventures. Government and business clients come to SRI for pioneering R&D and solutions in computing and communications, chemistry and materials, education, energy, health and pharmaceuticals, national defense, robotics, sensing, and more.