Wednesday, June 15, 2016

California Stem Cell Agency Awards $15 Million to Quintiles to Accelerate Stem Cell Therapies

BERKELEY, Ca. -- The California stem cell agency today awarded $15 million to a North Carolina firm to create an organization that would be a key in making California the global leader in clinical application of stem cell therapies.

The five-year contract will go to Quintiles, a publicly traded firm that specializes in shepherding research through clinical trials and over federal regulatory hurdles. The governing board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, voted 13-0 to approve the award.

Randy Mills, president of CIRM, said that the plan to create the operation specializing in stem cells in San Diego would speed development of commercial therapies for widespread use. Mills said that effort "may be the best thing that CIRM does." He said it will give the state a "big competitive advantage."

The award requires that Quintiles begin its work on what CIRM calls an "accelerating center" within 45 days. The company expects to base its effort at its existing facility in San Diego.  It said it will scale up employee levels as needed.

Quintiles, headquartered in Research Triangle Park, N.C., is a Fortune 500 firm with 35,000 employees around the world. According to Wikipedia, it is "the largest provider of biopharmaceutical development and commercial outsourcing services."

No stem cell therapies have yet been approved by the Food and Drug Administration. Mills said that novel nature of the therapies means longer review periods of potential therapies that can run into years. Unforeseen issues also surface in the process of testing stem therapies.

Avi Kulkarni, senior vice president of Quintiles, made an unusual public presentation to the CIRM board prior to action by directors. Applicants are almost never allowed to make lengthy public presentations to the board. Three other unidentifed enterprises applied for the award but failed to be recommended by reviewers.

Kulkarni said the goal of his clinical research organization is to improve the probability of success in developing therapies.  He said the stem cell market is poised for "significant growth." But he said the existing models for therapy development do not serve the market well.

Queried  by Anne Marie Duliege, a CIRM board member, Adrian McKemey, also a senior vice president of Quintiles, said that Quintiles has been involved in 10 to 20 clinical trials related to regenerative medicine.  About half of those deal with stem cells, he said.

The board did not discuss concerns by grant reviewers about what they described as Quintiles lack of stem cell experience and their questions involving the top management of CIRM/Quintiles contract.
CIRM grant recipients will be the first beneficiaries of the Quintiles arrangement and will receive discounts on its services that Mills estimated will total $22.5 million.

The Quintiles executives said they expect to be involved with researchers even prior to formally filing applications. They also said Quintiles will assist in bringing additional stem cell efforts into California.

Here is a link to the CIRM press release on the contract.

(An earlier version of this item, based on incorrect information supplied by a Google search, incorrectly identified Quantiles as headquartered in Colorado.)
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