Thursday, February 08, 2018

California: Stem Cell Capital of the World? The Perspective from Oakland

The California Stem Cell Report recently spent an hour chatting with Maria Millan, the president and chief executive officer of the $3 billion California Institute for Regenerative Medicine (CIRM), as the 13-year-old, state stem cell agency is formally known. 
Maria Millan, CIRM photo

The session at CIRM headquarters in Oakland, Ca., covered a wide range of topics as the agency was releasing its annual report. One question raised by this publication was whether the Golden State has reached the sort of critical mass that would make it "the stem cell capital of the world."

Here are some lightly edited excerpts of Millan's response to that question.

"I don't know if we've reached the critical mass, but I think we are probably the furthest to (it). I remember joining (the agency)....and actually some of our programs were geared toward how can we bring in more business into California. What I'm seeing right now is a lot of players who don't actually need to come to California.  They're fine. They've got funding. They've got trials. They already have a plan to bring their products to market in the U.S., but they're coming to California, so that's telling."

"California is expensive, so we have to think about that piece of it. These cell therapies are manufacturing intensive. One of the things we are setting up is the translating center (a $15 million project at Quintiles -- now IQVIA -- in San Diego) to address that need because the process and the manufacturing have to occur close to the site of delivery, and the scientists are here, the developers are here.

"It would be great if there was a way that we could continue to help the field to address this need because that is what's going to be required in terms of getting these therapies really to patients and (meeting) the manufacturing challenges. 

"We're doing what we can with the expertise and what we currently have in place. We need to do that in partnership with other entities, so there's a lot of interest in that. The NIH and the FDA at a regenerative medicine forum identified this as a clear need -- standardization in manufacturing...."

"Another thing that is important in terms of recognition, the space of stem cell regenerative medicine does not follow the classical pharma model of drug development at all. Even the CAR-T therapies and the SPARC, those were all developed in academia, they were spun out to smaller, nimble organizations. These projects are highly risky. The de-risking role that CIRM has is critical, (reflecting) a recognition that there's now probably a new dance that occurs to getting these types of treatments developed and out there and commercialized....

"We have played a critical role in being kind of not just a funder, not just a match-maker, but an active participant in connecting the dots and bringing this conversation forward."

(Look for more on the California Stem Cell Report from Millan's additional comments throughout the month.)

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