The California stem cell agency on Wednesday completed creation of a $30 million effort to dramatically speed approval of stem cell therapies and establish the Golden State globally in the much-heralded regenerative medicine field.
Dubbed the “pitching machine,” the two-part program is designed to pick up where basic stem cell research leaves off and to accelerate it through the all-important clinical trials involving humans. Such trials are required prior to widespread use of a therapy by the public and generally take years.
With no debate, no questions and no discussion Wednesday, the governing board of the stem cell agency unanimously approved a $15 million award to QuintilesIMS in San Diego to help move basic research into clinical trials. The effective decision, however, was made Oct. 4 during a closed-door meeting of the agency’s scientific reviewers, who gave the proposal a score of 89 out of 100.
The other half of the pitching machine was an additional $15 million award to Quintiles, which formally began operations this month. Quintiles is a publicly traded, multinational firm based in Durham, N.C., that deals with “information and technology solutions” in health care.
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C. Randal Mills, president of the $3 billion stem cell agency officially known as the California Institute for Regenerative Medicine, said the pitching machine is likely to be the most significant achievement of the state’s 12-year-old research effort.
CIRM’s contracts with Quintiles call for the $30 million to be spent in California.
California voters created the state’s stem cell agency in 2004 following a ballot initiative in which voters were told that stem cell cures were nearly at hand. The agency has yet to finance research that has produced a therapy that is available for widespread use.
Quintiles’ responsibilities will include pharmacology and toxicology studies along with manufacturing stem cell and gene-modified stem cell products. The company will also provide clinical trial operations and management services as well as data management, and biostatistical and analytical services.
CIRM’s contracts with Quintiles are for five years. The effort will also feed into the agency’s Alpha Clinics, a $34 million program to intensify focus on stem cell treatments and to contribute to California’s global position in the stem cell field.
The agency said Wednesday’s action will create “the first center in the world designed specifically to overcome the unique challenge of manufacturing, safety testing and other activities needed to successfully apply” to start a stem cell clinical trial. One clinical trial that launched in 2010 required submission of 22,000 pages of information to the FDA.
CIRM said Quintiles’ expertise will create “a standardized, uniform approach that best meets the needs of the FDA, making it easier for the agency to evaluate projects in a timely manner.”
Mills said that with the $30 million Quintiles deal, “we are doing a lot more than just funding research. We have created an entire infrastructure, unique to California, that will help us increase the volume, speed and quality of projects moving into clinical trials.”
CIRM is involved in 19 active clinical trials. It is projecting its participation in about 50 more before 2020, when its funding is scheduled to run out. No additional source of funding has been secured.