|Why is this man smiling? Jonathan Thomas, Chair of the CIRM Board|
Finding new ways to do the same thing is never easy, particularly when the goal you are aiming for is to try and get the most promising therapies out of the lab and into clinical trials and patients. But yesterday our governing Board found some new ways to try and reach that goal.
The Board, more formally known as the Independent Citizens Oversight Committee, approved a new $40 million initiative called the Preclinical Development Award. The award is designed to support projects that the agency is already funding, to help them with all the development activities needed to get a therapy ready for approval by the Food and Drug Administration (FDA). This includes developing plans to manufacture the stem cell-based products needed for the therapy and doing the studies to show that these cells function as expected. The award also allows for researchers not yet funded by the agency to apply for the award as well, as long as they meet certain conditions.
In a news release the stem cell agency’s President, Alan Trounson, Ph.D., talked about the importance of this new award:
“If a researcher or company has already identified a therapy or approach that shows potential in battling disease, we want to help them in every way we can. By working with them to develop plans on manufacturing the therapy and how to ensure the quality of the product and what the best dosage will be we can really give them the tools they need to get this to the FDA and ultimately to patients in as short a time as possible.”
The Board also approved the fourth round of our Strategic Partnership initiative, approving another $32 million to increase our engagement with industry and help them move their most promising projects into patients as fast as possible.
But perhaps the easiest vote of the day was over the issue that just one year ago was a source of real contention, namely changes to the way we operate in the wake of the Institute of Medicine (IOM) report.
As a brief refresher, the IOM report praised us as a “bold social initiative” but also raised questions about some of our procedures saying they raised the potential for a perception of a conflict of interest. They didn’t say there had been any conflicts only that there was a potential for that perception. Even so, we took their recommendations seriously and introduced some fairly sweeping changes to the way our Board votes on funding issues including:
• The 13 Board members appointed from institutions eligible for funding from the stem cell agency, such as those in the University of California system, no longer vote on any grants brought before the Board but would instead abstain
• All members of the Board are able to participate in discussions on applications but only patient advocates and independent members of the Board can vote on funding issues (members will continue to refrain from any discussion of specific applications from their institutions)
The Board voted to introduce the changes and come back in one year to assess how they are working. Yesterday they clearly thought they were working well and, without any debate or argument, voted unanimously to make them permanent. Chairman Jonathan Thomas was clearly pleased at the result:
“The vote today shows the changes we introduced one year ago, though difficult, have succeeded in protecting the integrity of the Board and the integrity of the work we do and the way we do it,”
For those of you who just can’t get enough in-depth information about policy and process you can find all the details of those changes on the Board page on our website.