Wednesday, April 29, 2009

CIRM Debates Federal Legislation; $60 Million Grant Approvals Scheduled for Today

LOS ANGELES -- The board of the California stem cell agency last night backed away from endorsing industry-supported federal legislation dealing with biosimiliars, which would be copies of original biotechnological drugs following expiration of patent protection.

The board did not go along with its Legislative Subcommittee recommendation to support HR 1548 by Rep. Anna Eshoo, D-Palo Alto, which is favored by the Biotechnology Industry Organization. The subcommittee took no position on a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles, which BIO opposes.

Instead of endorsing the Eshoo measure, the board voted to seek development of a statement of principles that it would like to see in any such legislation. That statement could come up before the full board during a telephonic meeting May 12.

Robert Price, who sits on the board as an alternate for UC Berkeley Chancellor Robert Birgeneau, questioned the value of CIRM taking any position at all on the legislation.

Price, who is associate vice chancellor for research at UC Berkeley, asked,
"Do we really matter that much? I think we don't. Let's not engage in hubris here."
A number of other members of the board spoke both on behalf of the legislation and the need to protect businesses that put up the cash to develop new drugs.

Board member Ed Penhoet, former president of Chiron and a member of the National Academcy Sciences Board on Science, Technoloogy and Economic Policy, said the two pieces of legislation deal with the balance between the cost of therapies and the cost of innovation. He said it was "the most important issue in health care today."

Board member Sherry Lansing, the former head of a Hollywood film studio and a University of California regent, said,
"There will be no drugs unless we protect the people who take the risk."
As for the argument over high costs denying access to drugs, CIRM Vice Chairman Art Torres, former chairman of the California state Democratic Party, said,
"You can't have accessibility unless you have something to access."
John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., characterized the push for CIRM to become a player in Congress as a "little bit of mission creep."

In other business, CIRM communications chief Don Gibbons previewed the agency's new website, which he said should be up in a few days. He said it was designed to offer more information that will be better organized and accessible.

CIRM officials also officially confirmed for board members the news on the California Stem Cell Report that the agency's financial woes are over for some time. The agency will receive $505 million from the recent state bond sale. However, cash will get tight again by the end of 2010 unless CIRM raises more funds through the sale of state bonds.

In light of the good financial news, the board indicated that it wanted to reconsider its one-year delay in a training grant program. That topic is expected to come up in June. Additionally put off was an update on CIRM grantee progress report monitoring. Earlier a CIRM official had said said grants would be pulled because of a lack of progress, but he did not say when that would be announced.

Also on the board agenda last night were applications for $60 million in grants, including four petitions to overturn negative recommendations from reviewers. However, that was put off until this morning along with a request for $200,000 to co-sponsor the annual convention of the International Society for Stem Cell Research.

Another item scheduled to be acted on today is the performance evaluation process for the Chairman Robert Klein, President Alan Trounson and Vice Chairs Torres and Duane Roth. It is the first time the CIRM board has officially promulgated publicly an evaluation procedure for the positions. But until recently the chair and vice chairs did not receive compensation. Roth has declined a salary, but Torres is receiving one.

This morning's meeting can be heard via the Internet. Details for the Web access are here. Teleconference locations for listening and participating are available in Sacramento, Pleasanton and at Stanford. Specific addresses can be found here.

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