Friday, June 17, 2016

The California Stem Cell Agency: A Business with Scientists as Subcontractors?

The following commentary was submitted by a grantee of the California Institute for Regenerative Medicine (CIRM) in response to its $15 million award earlier this week to Quintiles, a clinical research organization. The person who wrote the item asked to remain anonymous.

Comments from readers are always welcome on the California Stem Cell Report.  They can either be filed directly on an item by clicking on "post a comment" at the end of each item or by sending them to djensen@californiastemcellreport.com. Here is the commentary on the direction of the stem cell agency.Scientis

"With the funding of Quintiles the last piece of the puzzle falls into place. Randy Mills is very proud of the fact that he transformed the company Osiris, which was research oriented, into a product-oriented company.
"Everything he has done since he became president of CIRM has been strategy to turn it into a product-oriented business.
"From start to finish, Mills is refashioning CIRM as a business. The grant applications have now become 'partnering opportunities,' and the researchers receiving those grants take on a role as subcontractors under  CIRM’s control rather than independent scientists.
"With grantees as partners and subcontractors, the next stage in commercialization is to hire a CRO (contract research organization) to funnel through all of the promising products, taking them out of the grantee’s hands.  Quintiles is a huge organization and the $15 million grant is insignificant for them -- they subcontract for drug companies to run clinical trials.  They have no stem cell experience.
"Subcontracting a CRO is a business strategy to avoid investing in employees and technologies the company needs.  The selection of grantees has also become business-oriented:  CIRM is recruiting companies outside California to fund so they can be added to its corporate profile.  Companies have also become the preferred recipients of CIRM grants, even if they are virtual companies set up by academics for the purpose of obtaining CIRM funding.
"CIRM is morphing into a corporation with centralized control, with the hope that the product pipeline will yield something that makes money.  The question is:  was this the intention of Prop. 71?  If so, why wasn’t it always a corporation?" 
(Editor's note: Prop. 71 is the ballot initiative that created the stem cell agency in 2004.)
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3 comments:

  1. There is a precedent for government granting agencies to fund businesses. The NIH, which is the largest funder of biomedical research in the US, has a specific granting program for businesses, the Small Business Innovation Research (SBIR) grant. Our SBIR grants provided a significant part of our funding for GenPharm, a start-up company I worked for in the 1990s. While SBIRs are still grounded in the quality of the science, the review criteria are different and they are reviewed together by a special review committee. If CIRM really does want to fund businesses, they could have parallel tracks and separate review committees like the NIH. I think the concern is that CIRM has from the beginning been a funding agency that supported mostly academic research and development, and the sense is that it has radically changed without specifically stating that they will now favor companies. Perhaps a bit more transparency is in order.

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  2. Anonymous11:10 AM

    It cannot really blame CIRM to switch direction to industry. CIRM has given a lot of the money to academics, most of the profs have no stem cell expertise, only produced some high profile scandal papers in top journals, that is it, money are all gone. Of course, academic profs have comfortable position and salary to rely on, failure on CIRM projects would not really matter to them.

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  3. Dear anonymous:
    I'm sorry, but I have to tell you that you are wrong.
    We have more stem cell expertise in California than any place in the world, thanks to the NIH's and CIRM's support of stem cell lab training courses over the last 12 years. My lab alone has trained 400 scientists in human pluripotent stem cell technology.

    Not a single one of the 4000 publications funded by CIRM has been a scandal.

    There are no comfortable faculty positions in stem cell research. At the Scripps Research Institute, where I work, and at the other California non-profit institutions, we must bring in grant or philanthropic funding for all of our own salary, as well as the salaries for all of our lab members and all of the supplies and instruments for our research. CIRM's infrastructure program in 2007 allowed me to purchase all of the major equipment that I still use in my lab.

    Research in academic institutions is still the best route to stem cell clinical applications. We are the ones who have invented the technologies, who have the knowledge and experience to know what is needed for a therapy. And, we work without the interference of venture capitalists whose only motivation is a 10x return on their investments, without pressure to drop ambitious projects that have temporary setbacks in favor of more trivial programs that will generate revenue.

    A very current example of the value of academic medical research is the immunotherapy that is curing leukemia patients who would have died if their treatment was limited to the therapeutic agents developed by pharmaceutical companies. The therapy was developed in academic research labs, and not until the scientists showed the efficacy of their treatment did they invite the investment from pharma companies and venture capitalists.

    CIRM invested in the researchers themselves, not companies, and while there have been failures, the successes have been spectacular in cases in which the researchers were passionate about helping patients.

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