Wednesday, October 09, 2013

Zeroing in on Therapies at the California Stem Cell Agency

BURLINGAME, Ca. -- Directors of the California stem cell agency today mulled over a recommendation that they focus intensely on a handful of research projects that are most likely to result in commercializing a stem cell therapy.

No decisions were made, but directors raised questions about whether such a move would mean a reduction of funding for other research efforts or affect other projects in a negative way.

The recommendation and others came from agency's new scientific advisory board(SAB), appointed by CIRM President Alan Trounson at the behest of an Institute of Medicine study. The agency received the panel's report only on Monday and cobbled together staff responses for today's directors' meeting.

The SAB proposals were bad news for the agency's shared labs program, which costs CIRM $7.5 million a year and is set to expire in 2014. The panel recommended an end to the program after that date. CIRM agency staff agreed, declaring that the original rationale was no longer valid and that the program could be wrapped into the recipient institutions' budgets, if they wished to continue with it.

The SAB, which has only one California member, said the stem cell agency should focus on six to eight projects that would lead to early stage clinical trials involving safety and proof of concept(stage one and 2A).

Discussion of the plan came after Ellen Feigal, senior vice president for research and development, briefed the directors on 70 agency grants that are moving well along the clinical development pathway. She told them, however,
“We are not going to take 70 projects forward.”
The agency currently has $600 million in uncommitted funds after handing out $1.9 billion over the last nine years. However, it could come up with more funds if it decided to “uncommit” some grant rounds conceptually approved but for which applications have not been solicited. CIRM is scheduled to run out of cash for new grants in 2017.

Feigal said that the SAB proposal could have “downstream implications” if extra money is required to intensify efforts on six to eight projects. However, she also said the agency could simply provide an “expedited pathway.”

CIRM Director Sherry Lansing noted that the agency is “trying desperately to get a win.” She suggested putting out a “do-you-need-help” RFA which would target applicants that have well-developed projects that could be moved ahead rapidly with some cash. 

Director Jeff Sheehy said the agency needs to “talk about sustaining what we have built.” He said,
 “It is not like our folks are going to graduate from our funding to NIH funding.”
The NIH is already suffering from a major cash crunch.

The recommendations from the SAB and staff reaction will be heard by the directors' Science Subcommittee, chaired by Sheehy, before the directors' December meeting. The December meeting is also expected to include a briefing on a proposal for creation of a “strategic roadmap” for future CIRM funding.

Here is the Power Point summary of the recommendations and staff responses. We have asked the agency for a copy of the original document from the SAB.

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