Wednesday, October 06, 2010

The Biotech Industry and the California Stem Cell Agency: An Unhappy Relationship

Late last June, the chairman of the California stem cell agency, Robert Klein, dismissed concerns that biotech firms are not getting a fair shake at the agency's $3 billion in research awards. That's not what he has heard, he told CIRM directors. In fact, Klein said, he had just received an award from a national industry group.

Two months later, leaders of the Northern California biotech industry sat down with Klein at private dinner at a tony San Francisco peninsula restaurant and told him that he was simply wrong.

They showed him the numbers. In the five years that CIRM has been operational, businesses have received only 3 percent of the more than $1 billion awarded so far. If CIRM really wants to produce therapies that can be used, Klein was told, it can only do so by helping to finance enterprises that actually create medical products.

One executive in attendance at the Aug. 25 dinner at the Marche restaurant in Menlo Park had harsh words for the agency. He later told the California Stem Cell Report that CIRM is “completely misaligned and mismanaged.” He said the agency is dominated by the academics on its board, whose institutions have received nearly all of the funding. The executive said the academic institutions are not going to deliver on CIRM's mission of “turning stem cells into cures.”

However, June's message of concern came from an unlikely, non-industry source. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., called for a major effort by CIRM to deal with the matter. The issues he addressed have been simmering for some time, largely in private because of CIRM's enormous funding clout. No one wants to be on the agency's bad side.

In a statement to CIRM directors, Simpson said,
“When Consumer Watchdog began its stem cell project almost five years ago, I na├»vely expressed concerns that the program would be hijacked by the biotech industry. That has -- at least so far -- not happened; rather, it has been dominated by academic research institutions, whose representatives hold the largest number of seats on the board.”
He recommended that CIRM take a number of steps, including a public task force, to remedy the situation.

According to the meeting transcript, Klein replied in part,
“I don't think the biotech industry at large has feelings that are reflected in that statement. As some of you may know, I received a reward from biointernational conference (BIO) this year, their humanitarian award.”
The August meeting, however, that Klein attended included top executives from Geron, iPierian, Vistagen, StemCells, Inc., Cellerant and others. “All the major players,” we were told. The dinner was organized with the support of BayBio, the biotech industry organization in Northern California, and the Orrick law firm of San Francisco, which serves as bond counsel to the state of Californa. From CIRM came – in addition to Klein – Director Ted Love and Patricia Olson, the agency's executive director of scientific activities . Missing was CIRM President Alan Trounson. No reason was given for his absence.

A BayBio briefing paper for the meeting, said,
“CIRM has a perception of not being friendly to industry. Private companies with strong track records of receiving NIH funding are frequently unsuccessful in getting grant funding from CIRM. Conversely, in comparison to CIRM for-profit companies have sporadic success rate at best with CIRM grants. CIRM’s contention on this is that the non-profit applicants that are received they tend to come from well-established and research –intensive institutions, as opposed to the less known and established for-profit companies.”
The paper said,
“CIRM’s current grant review policies and practices do not track with the stated goals of RFAs and favor funding academic applications thus reducing funding opportunities for industry and discouraging future company participation.”
CIRM's leadership, including Klein, also came under criticism for a lack of understanding about what is needed bring a stem cell therapy to the clinic. “Everybody is enamored of Klein,” said the source at the meeting. The deans on the board have no knowledge of product development, he continued.

CIRM directors are not unaware of business concerns, but the situation has remained nearly unchanged over the years. Only on rare occasions has a biotech executive publicly voiced concern. One of the issues that has been raised involves the lack of grant reviewers with business backgrounds, a situation that has existed since CIRM's inception. Directors have discussed the need for improvement. Some  have said there is tilt towards basic science among reviewers that manifests itself in a lack of interest in the relatively more pedestrian research needed to produce a product.

The BayBio paper said,
“Currently there are no scientific experts from industry on the grants review group and only six (out of 89) are alternates.”
The briefing paper made three recommendations:
“BayBio and industry need clarification on CIRM IP and public access requirements to increase private sector comfort with CIRM programs and encourage more companies to participate in the program.
“Changes are needed to the grants application and approval process to increase the success rate of companies applying for CIRM funding.
“There needs to be more transparency all around with respect to the process and final decision making.”
The CIRM officials took notes on the August discussion and said they would get back to the participants.

Next week, the stem cell agency will hold a two-day, closed-door review – with the exception of one hour -- of its strategic plan. The “external review” is the most comprehensive examination ever of CIRM's direction. However, the fair treatment of business grant applications is not one of the specific subjects listed on the agenda for the blue-ribbon, international panel.

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