Tuesday, September 02, 2014

California's New $200 Million Stem Cell Spark

Directors of the $3 billion California stem cell agency this month will attempt to supercharge some of their major research programs and push stem cell therapies more rapidly into the marketplace and the clinic.

Sir John Bell
Academy of Medical Sciences photo
The move is part of a $200 million effort approved only last December and was recommended by the agency’s blue-ribbon scientific advisory board, chaired by Sir John Bell of the University of Oxford in the United Kingdom. 

Awards in the first phase of the program – dubbed an “Accelerated Development Pathway” -- will range up to $25 million each. The effort will also involve more assistance and streamlined procedures from the California Institute of Regenerative Medicine (CIRM), as the agency is formally known.

The awards are scheduled to be approved publicly on Sept. 10 at the directors’ meeting at the Claremont Hotel in Berkeley, Ca. Winners will be culled from a select group of researchers already funded by the agency.

The number of applicants was not immediately available from CIRM, but they were limited to individuals and institutions that have already received the agency’s signature disease team or strategic partnership awards. Also unknown was whether any businesses were among the applicants. Applicants rejected in next week’s round will have a chance to apply in upcoming, new “pathway” rounds.

According to the request for applications (RFA) on the CIRM Web site, the agency is seeking “high potential” research that can achieve “clinical demonstration of an acceptable safety profile and proof of concept during or before 2017.”

The RFA continued,
“For example, a team could propose additions to an ongoing CIRM-funded clinical trial that would accelerate development decisions such as including the testing of a biomarker they identified in correlated research work or adding a patient group based on data from an unblinded safety study. Other examples of accelerating activities could include changes in manufacturing processes or delivery devices, based on novel ideas that emerged from the activities of the initial award or related research that could require comparability studies to facilitate development of the candidate therapeutic. In addition, the Accelerated Development Pathway would also consider the possibility of funding a future clinical trial to demonstrate clinical proof of concept in the approved therapeutic indication, ‘subject to satisfaction of milestones and conditions.’”
The “pathway” program was approved by CIRM directors after its new Scientific Advisory Board recommended its creation. The advisors said the agency should move “at speed” to turn research into treatments.

Creation of the panel of advisors was recommended by the Institute of Medicine (IOM) in a $700,000 study funded by CIRM. The IOM report said the panel would be invaluable in helping the agency to “make fundamental decisions about dealing with challenges that cut across particular diseases, decide which discoveries should progress toward the clinic and determine how best to engage industry partners in developing new therapies.”

(See here for the names of the members of the advisory panel. The full text of their report can be found at the end of this link.)

The panel has held only one meeting, and that was behind closed doors.

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