Friday, October 08, 2010

Parsing Statistics vs. the Reality of Biotech Concerns About CIRM

The California stem cell agency is missing the essential point of complaints from the biotech industry concerning CIRM's record on funding commercial research.

In its response to the biotech concerns, CIRM parsed statistics compiled by BayBio, the biotech industry group in Northern California, but ignored the reason for the private dinner meeting in August between top executives of the $3 billion agency and the area's stem cell firms.

Industry is less than happy with the California Institute of Regenerative Medicine. BayBio and the Orrick law firm did not bring together all those CEOs in August to pat CIRM on the back.

The industry concerns are not new. They have been around for several years. They have been acknowledged more than once by CIRM directors, some of whom have spoken pointedly about the need to funnel more cash to stem cell businesses. It is not just a matter of spreading money around equally. It is a matter of actually creating usable medical products, something that Stanford, the University of California and nonprofits are not going to do.

Director Jeff Sheehy, a patient advocate member of the CIRM board who works at UC San Francisco, said at the August CIRM board meeting,
“From the minute I've been on this agency I've heard...(at)all the industry meetings -- I've heard (that) we've got products waiting for money.”
According to the transcript of the meeting, CIRM Chairman Robert Klein, a real estate investment banker, acknowledged that CIRM does not have a “big supply” of grant reviewers with industry expenence – one of the problems cited by BayBio for the lack of grants to business. Finding them is “difficult,” Klein said.

Director Philip Pizzo, dean of the Stanford School of Medicine, additionally raised a question about CIRM's outreach to business.
“If industry has got things in the pipeline...are there ways that we could seed this to happen in more novel manners?

“Have we had, for example, as part of our strategic planning effort, an off-the-record kind of think tank between industry leaders, academic, venture capitalists in the same room at the same time, not separate -- would you buy into this ...approach -- but really coming together and say if we could create the world differently, how might we think about novel ways of approaching these kinds of both research and translation efforts?”
The question went unanswered at the board meeting. The strategic plan, however, comes up next week at CIRM headquarters in San Francisco when a blue-ribbon panel of external reviewers will conduct a closed-door examination of CIRM and its performance. The meeting's agenda, however, does not mention the stem cell industry's concerns.

Industry executives have been reluctant to go public with their issues, understandably wary of offending a financially powerful organization. Privately, they are more frank. We have heard bitterness and frustration from a number of them.

The industry found an unusual ally, at least on this issue, in Consumer Watchdog's John M. Simpson, who worked closely with some firms during CIRM hearings on its IP policy. He came up with a constructive proposal in June to deal with business issues that was brushed off by Klein.

But, as on any matter, there is not complete unanimity within the industry about CIRM. Funded firms are not likely to complain much.

CIRM has an additional $5 billion reason to move concretely to deal with biotech's concerns. Klein is touting for the ballot a CIRM bond measure of that magnitude, possibly in two years. The electoral campaign that created CIRM six years ago cost $30 million. Another ballot measure will run upwards of that amount, which means raising buckets of cash. And the only likely major donors will come from the biotech industry and its investors.

(A footnote: CIRM disputes statistics produced by BayBio on the percentage of awards given to business. We suspect the industry's figures were based on earlier grant numbers published by CIRM. The agency's totals change each time it approves another grant round every month or so. The presumably old percentages probably indicate that BayBio has been stewing over this issue for quite some time. BayBio has also filed a comment on an earlier item on this subject. Its carefully worded remarks said the August meeting created “a renewed sense of collaboration and areas to address.” BayBio did not speak to CIRM's criticism of its statistics.)


  1. Anonymous5:06 AM

    Not being able to find people with industry experience to serve as reviewers is bull. Granted there are not legions out there, but they do exist. Cell therapy has been around for 30 years for heaven's sake. The issues of safety and efficacy really haven't changed, just the hurdles of using a different cell source. The problem may once again be conflict of interest, however the NIH SBIR folks deal with it and manage to put together interdisciplinary teams of expert reviewers to review industry grants. Perhaps CIRM should look to the NIH for some guidance -- if they are really interested.

  2. Anonymous7:46 AM

    Good comment, Anonymous. Glad to see others reviewing CIRM's comments using basic logic. You're right, cell therapy has been around for 30+ years! Filling the need for reviewers "difficult"? Hey CIRM, just write a de-facto job description into the next legislation! Candidates don't necessarily have to have any medical degree, any medical related degree, or even any medical research related degree! And, if it passes, fill it according to that criteria and presto-finito, reviewer slots filled overnight!