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California research institutions collaborate to bridge gap in drug development

MENLO PARK, CALIF., Aug. 1, 2003 -- In an unprecedented collaboration called PharmaSTART, world-leading research organizations are joining forces to accelerate the translation of breakthrough new drugs from discovery into clinical use.

PharmaSTART (BioPharmaceutical Support for Translating and Advancing Research and Technology) is a consortium led by SRI International, a nonprofit independent research institute, with four leading California research organizations as founding members: Stanford University; the University of California, San Diego (UCSD); the University of California, San Francisco (UCSF); and the UCSF campus of the California Institute for Quantitative Biomedical Research (QB3).

PharmaSTART offers drug development and consultation services to help translate the vast unrealized research investments in new molecular targets made by California-based universities, research institutes, and small biotech companies into potentially life-saving drugs. Even though a novel drug candidate may show great promise based upon early research, it is often judged to be too risky for traditional investment through venture capital or pharmaceutical companies. However, once a drug shows safety and preliminary efficacy in patients, it becomes highly marketable and valuable to future commercial partners and outside investment.

"Billions of government dollars have been invested in drug discovery research, including large genomics, proteomics, and molecular-targeted basic research initiatives. Yet there is still a major gap in the translation of these discoveries into new drugs. Universities are not equipped to perform the necessary Food and Drug Administration-compliant development tasks required to start clinical trials. Thus, breakthrough drugs fail to reach the clinic and the marketplace where society benefits," said Glenn Rice, Ph.D., vice president of SRI's Biosciences Division. "We expect that PharmaSTART will catalyze the emergence of new collaborations, new drug development initiatives, and new funding sources."

PharmaSTART was conceptualized during the kick-off meeting of California Governor Gray Davis' s California Life Sciences Initiative hosted by SRI in December 2002, which attracted more than 150 of the Bay Area's leaders in the life science industry. Additional meetings have been held San Diego and Los Angeles.

Governor Davis said, "We created the California Life Sciences Initiative to identify and implement strategies to strengthen California's competitive position as the center of global life sciences research, manufacturing and drug commercialization. PharmaSTART will accelerate the process of drug development that will ultimately lead to new drugs and new companies, and improve the quality of life of those afflicted with life-threatening diseases."

For PharmaSTART's university investigators and their spin-off companies, SRI provides consulting services to create drug development plans, which identify all of the steps required to bring the specific drugs into the clinic efficiently following Food and Drug Administration guidelines. Detailed plans include the steps of drug lead optimization, medicinal chemistry, process development, recombinant protein expression, manufacturing, formulation, toxicology, pharmacokinetics, assay and biomarker development, and validation and regulatory affairs. The resulting comprehensive drug development plan also provides a detailed timeline and budget.

Since SRI's founding more than 55 years ago, the institute's mission has been discovery and the application of science and technology for public benefit. To help fulfill this mission and launch PharmaSTART, SRI is committing an initial half-million dollars and more than a thousand hours of consulting time.

SRI will leverage its experience as one of the leading National Institutes of Health (NIH) drug development contractors to team with investigators applying for NIH and other government-directed grants and contracts, in the role of a contractor for preclinical development services. SRI will help principal investigators access potential funding programs that facilitate drug development and navigate the web of government procurement regulations and procedures. SRI will also use the resources of its Washington D.C. offices to assist these investigators.

A major goal of PharmaSTART is to promote collaborations between the member organizations, including funding initiatives. The consortium will seek private and public funding, including from the State of California and federal funding agencies.

"PharmaSTART is a first-of-its-kind drug translation consortium," said Jerrold Olefsky, M.D., UCSD professor of medicine, division head for endocrinology, and a member of the PharmaSTART steering committee. "UCSD's faculty will benefit from this program, and we look forward to leveraging this new collaboration into large and productive inter-institutional drug development initiatives."

"PharmaSTART will provide additional resources and guidance to Stanford's faculty investigators who seek to develop new medicines for important and unmet human diseases, including so-called 'orphan' diseases," said Harry Greenberg, M.D., senior associate dean for research at the Stanford University School of Medicine.

Through PharmaSTART, principal investigators at member organizations also have access to SRI's pre-clinical development services, which include technical and regulatory planning, Investigational New Drug Application-directed contract research, manufacturing, networking and resource sharing to help bring a drug candidate to clinical use. These services will assist investigators to efficiently traverse the complex path of translating a new disease target or drug lead from initial discovery into clinical development.    

Posted: August 2003