Wednesday, September 23, 2009

CIRM Looking for Closer Conformity on Egg Rules

SAN FRANCISCO --As part of its effort to achieve consistency with national standards, the California stem cell agency is moving towards allowing the use by CIRM researchers of embryos created through IVF that originally involved payments.

The CIRM Standards Working Group last week approved the move although specific language is yet to be worked out. Bernie Lo, co-chairman of the group and director of the medical ethics program at UC San Francisco, said the language would be narrowly focused.

Jesse Reynolds of the Center for Genetics and Society of Berkeley, Ca., said he was
“encouraged” by the CIRM direction. Earlier, the group had expressed concern that CIRM might be creeping towards possible creation of a loophole in the Prop. 71 ban on compensation for egg donors.

CIRM hopes to present specific language soon for its proposed rule to the Standards Working Group in a telephonic meeting. The proposal would then go to the CIRM board and from there into the official state regulation process.

In other matters involving the standards group, Alta Charo, a professor of law and bioethics at the University of Wisconsin, who has been a member of the group since its beginning in 2005, is leaving the panel because of her new position as a senior advisor at the FDA,

CIRM hopes to approve a replacement at the board meeting that begins Oct. 27.

Reynolds also praised CIRM staff for the early posting of background material on matters to be discussed at the meeting last week. Additional material has been posted as well on the research standards issues facing CIRM. It all can be found here. Sphere: Related Content

Thursday, September 17, 2009

Germany Added to CIRM's Stable of Partners

The California stem cell agency today announced its sixth international agreement – this one with Germany – with the hope that it will lead to joint research in stem cell transplantation and immunology.

The agreement is intended to make it easier for researchers in California and Germany to obtain joint funding. As with the other agreements, no California funds are permitted to be spent outside of the state.

CIRM already has agreements with organizations in Canada, the state of Victoria in Australia, Japan, Spain and the United Kingdom.

CIRM's news release quoted California Gov. Arnold Schwarzenegger as saying,
“There are brilliant minds all over the world, especially here in California, and with collaborations like this we can help ensure that potentially life-saving breakthroughs can come more quickly and more often.”
In response to a query, Don Gibbons, chief communications officer for CIRM, said,
“We have over $60 million in commitments from our international collaborative funding partners.... There were a total of nine collaborative applications in the Disease Teams, with Canada, Spain and the UK represented, but of course we won’t know how those nine fared among the 31 until October 28(the next CIRM board meeting). There are a number of Japanese collaborations among the Basic Biology 2 awards that have just come in and are being assessed internally now.”
The only international grants awarded so far came last spring in the early translation research round. Four collaborations were funded for a total of $29 million($24 million California and $5 million Victoria) involving Alzheimer’s disease, Parkinson’s disease and techniques for working with embryonic stem cells. Sphere: Related Content

Egg Donor Proposal Stirs Concern; CIRM Says Language is 'Placeholder'

The Center for Genetics and Society Thursday raised “serious concerns” about some of the matters to be discussed at today's meeting of the research standards group of the $3 billion California stem cell agency.

CIRM, however, said the center has “misconstrued the intent of the proposed changes.”

In a letter to CIRM, the Oakland, Ca., organization center referred to preliminary language contained in a briefing paper for the group that dealt with compensation for egg donors, which is banned by CIRM. The draft language, which is intended to conform CIRM rules to others nationally, would “limit the payment restriction to donation of oocyctes provided specifically for research purposes.”

The center said,
“We were startled to see this for two reasons. As you know, both Proposition 71 and California law prohibit paying women to provide eggs for research. This proposed policy would mean that a woman undergoing egg extraction could be compensated or receive other valuable consideration as long as research is not the specifically stated purpose of harvesting her eggs. Diverting eggs for which payments have been made from the reproductive to the research context would be contrary to Proposition 71 and state law.

“We sincerely hope that this is an oversight. We ask the Standards Working Group to reject the proposed language and to clarify that paying women for eggs that will be used for research (beyond reimbursing their expenses) is contrary to law, and will not be done in California.”
CIRM posted a response to the CGS letter on the agency's website. In the response, CIRM referred to National Academy of Sciences guidelines and said,
“The language 'specifically for research' is a placeholder taken directly from the NAS Guidelines. The SWG (standards group) has consistently drawn from the NAS guidelines to provide a model for our regulations. This example is no different. This placeholder language is designed to support policy development. Any proposed regulatory language is subject to SWG review, ICOC approval, OAL review and public comment to ensure the regulatory language is consistent with the intent of the policy.”
Our take? We think CIRM's intent is clear. However, whether the proposed regulatory language achieves that goal is another question. We suspect more artful language will be developed as these proposed changes work their way through the regulatory process during the next few months.

CIRM is to be lauded for posting its 28-page briefing paper well in advance of today's meeting. That allows time for such parties as the Center for Genetics and Society and others to comment thoughtfully on the matters to be considered. It also allows time for CIRM to respond publicly in advance of the meeting. The upshot is likely to be better policy and better regulations and enhance CIRM's image as responsive to the public.

We should also note that the center's letter also raised concerns about the “prospective use for research of paid-gamete IVF embryos could create conflicts of interest for the physician attending an egg provider, and thus put her at increased risk.” Sphere: Related Content

Correction

The “Prop. 71 Minutia” item on Sept. 16 contained a quote that referred to “advice” from the Little Hoover Commission that CIRM should lower its quorum requirements. A draft of the Hoover report contained that recommendation, but it was omitted in the final version. The final report said the super-quorum requirement was “restrictive” and “problematic” but said the problem would be eased by reducing the size of the board from 29 to 15. Sphere: Related Content

Wednesday, September 16, 2009

Prop. 71 Minutia Stalls CIRM Again

SAN FRANCISCO – The board of directors of the California stem cell agency Tuesday failed to achieve a quorum and was forced to put off action on regulations tied to its ambitious, $210 million disease team grant round, the largest ever in CIRM history.

That means it will be at least another two weeks or more before the board can act on the IP rules that it needs for disease team project. The grants are scheduled to be awarded later this year.

The board has been handicapped for years by its super-quorum requirement, 65 percent of its 29 members. Tuesday, the quorum was 19 but only 18 answered the roll call during the special, teleconference meeting based here. Twenty-one had been expected. Without a quorum, the board cannot take legal action.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said today that problems with quorums are a persistent and important issue at CIRM. Simpson has followed the matter for several years. In one case in 2008, he wrote about how the board “essentially” drafted a member of the audience to raise a quorum.

Commenting today, he said,
“This clearly shows that (the board) has not resolved its nagging problem with mustering a quorum. They should have taken the Little Hoover Commission's (initial) advice and moved to make a simple majority all that is necessary to conduct business. Instead, they insist on a meaningless charade that wasted the time of 18 very busy people.”
The quorum mandate is written into state law by Prop. 71, which created the stem cell agency in 2004. It cannot be changed without a vote of the people or by the legislature. But the latter involves another super-majority requirement, 70 percent of both houses of the legislature and the signature of the governor.

The Little Hoover Commission, the state's government good government panel, earlier this year cited CIRM's problems with achieving quorums. But the CIRM board last month rejected suggestions that the quorum be reduced to 50 percent. It relied on its attorney's opinion that to do so would “undermine” the intent of the voters and would leave the board open to being captured by a minority.

However, super-majority requirements actually facilitate minority dominance of bodies such as the CIRM board. On Tuesday, the absence of one member paralyzed the board. In other cases, a few members have left CIRM board meetings and thus prevented it from taking action. Conceivably, 11 members of the board could control it by simply refusing to attend unless their wishes prevailed.

The regulations under consideration Tuesday dealt with intellectual property requirements. Initially, they appeared to be relatively non-controversial, although CIRM director Susan Bryant, vice chancellor for research, University of California, Irvine, raised anew concerns expressed last July by the University of California (statewide).

Director William R. Brody, president of the Salk Institute, also criticized some of the proposed regulations as “absurd” and suggested that language from federal IP law be adopted. However, others noted that CIRM deliberately moved away from federal law in its development of the regulations over several years.

In the absence of a quorum, CIRM Chairman Robert Klein said the proposed regulations will be taken up later after CIRM director Ed Penhoet, head of the IP Task Force and a co-founder of Chiron, has a chance to discuss them with Brody and Bryant.

The CIRM board also did not act on hiring underwriters (more than one is needed because of potential conflicts of interest) to run its $500 million biotech loan program. The effort is scheduled to begin with the disease team grant round. But the board was told that a very small number of potential borrowers are involved in that round.

Instead of hiring two or more underwriters, John Robson, CIRM vice president for operations, said the lending effort can begin with a pilot project involving one underwriter. He said that it will help the agency develop a better underwriting effort for the directors to approve next year. Following the meeting, Robson said he hopes to conclude a pilot agreement within days.

You can read more on quorum problems, as discussed by Simpson, here, here, here, here and here.

(Editor's note: In an earlier version of this item, the quotation from John M. Simpson did not contain the word "initial" in parentheses.) Sphere: Related Content

Tuesday, September 15, 2009

Eggs, Donors, NIH Rules and More This Week

For those of you interested in research standards and rules, the California stem cell agency has posted 28 pages of background material for its meeting in San Francisco this Thursday and Friday.

On the agenda is New York's policy that permits compensation for human eggs to be used for research. CIRM does not permit compensation(valuable consideration), but the agency plans to make some changes in its rules to conform to national standards.

Also available via the CIRM web site is briefing material on proposed changes for donor consent requirements and an update on the NIH rules for human embryonic stem cell research, plus more. Sphere: Related Content

CIRM CEO To Gain More Power in Grant Reviews

The president of the California stem cell agency would wield more power in the agency's grant review process under a proposal that was approved by CIRM's Grant Working Group earlier this month.

The proposal, which will probably go before the CIRM board of directors in October, would give CIRM CEO Alan Trounson the authority to pick an “acting” chairman to preside over each grant review session.

Currently responsibility for the reviews lies with the existing position of chairman, which will be eliminated in its current form. That post has been vacant for nearly a year.

Instead two types of chairs will be created. An “administrative” chair would be named to handle chores other than grant application reviews, which are the chief function of the Grants Working Group. The acting chairs would handle the review sessions. The board of directors would retain authority to approve the administrative chair.

The grants group makes the de facto decisions on CIRM grants, which are expected to total $1 billion by the end of the year. Sphere: Related Content

Correction

The “More Clout” item on Sept. 8 incorrectly stated that the CIRM president will have the ability to appoint an administrative chairman for the Grants Working Group under proposed changes in the group's bylaws. In response to a query, CIRM spokesman Don Gibbons said the current responsibilities of the existing chair are being split between an administrative chair and various acting chairs. Sphere: Related Content

Thursday, September 10, 2009

CIRM Airs Powerful Patient Video

With some regularity, the board of the California stem cell agency hears directly from some of those afflicted with diseases and conditions that are among the targets of its $3 billion in research.

All of their stories are emotional, sometimes heart-rending.

The CIRM staff recently captured on video one of the more powerful presentations at its meeting in San Diego last June. Called “Spotlight on Leukemia,” it is now available via CIRM's YouTube site.

The video is a fine piece of work that tells a strong human story and well supports CIRM's mission.

Don Gibbons
, CIRM's chief communications officer, aired the video at last month's CIRM board meeting. He said,
Amy Adams led the story direction and Todd Dubnicoff did the amazing video editing.”
It is narrated by Geoff Lomax, senior officer for the CIRM Standards Working Group. Sphere: Related Content

Wednesday, September 09, 2009

CIRM Nearing Agreement on Underwriters for $500 Million Biotech Loan Program

The board of the California stem cell agency will hold a special, teleconference meeting next Tuesday to consider hiring a bank or two to run its new and ambitious $500 million biotech lending program.

Also on the agenda are revised IP rules dealing with affordable access to taxpayer-financed stem cell therapies, although there appears to be no controversy about the rules at this point.

CIRM had hoped to have the bank underwriters in place by now for its $210 million disease team program, the largest research round ever for CIRM. Applications for that program are being reviewed behind closed doors today through Friday in San Francisco by the CIRM Grants Working Group.

Three banks were under consideration to run the biotech loan effort. They were Comerica, Square One and Silicon Valley Bank. The first two provided the lowest cost estimates, with Comerica coming in at $71,000 for handling a $20 million, six-year loan. More than one bank is expected to be hired because of the potential for conflicts of interest.

At the August CIRM board meeting, John Robson, vice president for CIRM operations, said that once the agency had some sort of initial agreement in place with Comerica and Square One, negotiations would follow with Silicon Valley Bank.

CIRM Chairman Robert Klein, who originated the concept for the biotech lending program, stressed the importance of moving forward with Silicon Valley Bank. He said,
“Given the tight time frame, moving forward with Silicon Valley Bank is going to be important, if feasible, so that the board really has the full choice and the cost differences in front of them when they are asked to approve the delegated underwriters. With a prototype process, we will and have run into some issues with these banking institutions as they've -- their legal departments have understood the complexity of dealing with the state. So we need to bring forward, to the extent we can, all three opportunities for the board so the board can make a decision.”
CIRM is seeking to hire a bank to run the program because the agency does not have the expertise or the staff to do the work. The banks would perform an analysis of business applicants, assess their operations and management and make recommendations.

CIRM plans to lend money to risky enterprises that otherwise could not secure financing. Loan failure rates of up to 50 percent in the program have been predicted by CIRM.

The first loans are scheduled to go out following formal approval later this year of winners in the disease team program.

The IP rules that are also under consideration next week stirred a flap at one point. The board, however, last month rescinded the controversial proposed changes.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., and who raised the earlier concerns, says he is satisfied with the current proposed changes.

The public can listen to and participate in the board meeting at a number of locations throughout the state. Their specific addresses can be found on the agenda.

A transcript of last month's brief discussion of the biotech loan program can be found here. Sphere: Related Content

Correction

Based on incorrect information on the CIRM Web site, we stated in the “CIRM President to Gain More Clout” item that Stuart Orkin was chairman of the stem cell agency's Grants Working Group. Orkin says he resigned as chairman last November and is no longer on the panel. According to CIRM, Rainer Storb of the Fred Hutchinson Cancer Research Center served as acting chair at the last meeting of the group and is presiding over the meeting underway today in San Francisco. CIRM has also corrected the information on its Web site. Sphere: Related Content

Tuesday, September 08, 2009

Advisory/Correction

Based on incorrect information on the CIRM Web site, the item below states that Stuart Orkin is currently chairman of the CIRM Grants Working Group. However, he told us in an email that he resigned last November and is no longer on the panel. We are querying CIRM concerning the current status of the chairman's position. Sphere: Related Content

CIRM President to Gain More Clout in Competition for Millions in Grants

The California stem cell agency is moving to strengthen the hand of its president in the review of applications for hundreds of millions of dollars in grants.

The proposal comes before the agency's Grants Working Group tomorrow morning at a two-day meeting in San Francisco to consider applications for its ambitious $210 million disease team program, the largest single research grant round in CIRM history.

The grants group makes the de facto decisions on CIRM grants, which will total about $1 billion by the end of this year.

The group operates behind closed doors for review of applications, but the move to alter CIRM's review process will be considered and voted on in public.

According to a staff memo, the new procedures would allow CIRM President Alan Trounson to pick “acting” chairs to head each grant review session. The selection would be made from either regular or alternate members of the grants group.

It was not clear what responsibilities would remain in the hands of the existing chair position. The exact language of the proposed changes in the group's bylaws was not available on the CIRM Web site at the time of this writing.

Currently the grants review chairman is appointed by the CIRM board of directors and has sole authority to preside over scientific evaluation of grants. The position of chairman has been vacant since last November.

The CIRM staff memo said changes are called for because the $3 billion agency is broadening its research to include translational, preclinical and clinical trial programs.

CIRM said,
“Consequently, there is an important need to have chairs of CIRM review panels with the expertise and seniority that is complementary to the type of RFA being considered.”
The agency also said it is impractical to have one person lead the five to seven review meetings in San Francisco each year. CIRM said similar NIH review groups rarely meet more than twice a year.

The proposal follows CIRM board approval of changes last month in compensation for review group members that could provide perhaps $4,500 or so per grant round per scientist, depending on payment decisions by CIRM staff.

(Editor's note: Based on inaccurate information on the CIRM Web site, an earlier version of this item incorrectly stated that Stuart Orkin was chairman of the Grants Working Group. Orkin says he resigned as chairman last November and is no longer on the panel. At the time of this posting, CIRM said that the position remains vacant and has been filled over the last 10 months by others on an "acting" basis. CIRM has also corrected the information on its Web site.

(The earlier item also incorrectly stated that Trounson would appoint the administrative chair. That responsibility will remain with the CIRM board. ) Sphere: Related Content