Fresh Comment

"Anonymous" has posted a comment on the "CIRM PR" item, saying that he or she has added this blog to their news reader after seeing our piece on FierceBiotech.

CIRM Funding Priorities Presentation

Here is the CIRM presentation today on the agency's funding priorities. The document was provided courtesy of CIRM and its communications chief, Don Gibbons. The document is available via Scribd.
Priorities(at Rev IV) 2009PC

Publish at Scribd or explore others: Presentations Academic Work

CIRM PR on Today's Meeting

Here is a link to the CIRM news release on today's board meeting. It includes a list of the institutions receiving the training grants with links to the reviews of their proposals.

CIRM Meeting Over, More News Coming

The board of directors of the California stem cell has adjourned its meeting. We will more news coming up shortly dealing with funding priorities.

Clinic vs. Basic Research: CIRM Funding Priorities

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

The California stem cell agency today set a goal of raising roughly $240 million by privately selling state bonds over the next two years, preserving both its touted efforts to push development of therapies in the clinic and basic biological research.

CIRM Chairman Robert Klein told the board that one of those therapeutic efforts, a $210 million disease team program, is a critical piece in marketing the bonds and is unique to the agency. Without it, he said raising the funds not only will be more difficult but would turn the agency's back on its main mission.

Funding priorities came up today during the CIRM board meeting in Sacramento as a result of the financial plight of the agency, which will run out of cash next fall unless it sells bonds, virtually the only source of funding for the program.

Klein wrote the measure that created CIRM in such a fashion that it puts the agency outside the normal budget allocation processes involving the legislature and the governor.

Directors debated the virtues of funding grants for basic biology versus higher profile enterprises aimed at developing potential therapies at a more advanced stage of research.

Marie Csete(see photo), chief scientific officer for CIRM, told the board that scientists at recent hearings on CIRM's strategic plan were emphatic in stressing the importance of basic research, whose grant round sizes have already been cut.

Director Jeff Sheehy, a communications officer at UC San Francisco and a patient advocate representative, said the disease team project is already a year behind schedule. He said,

"We do not want to hamstring the disease team."

Requests for preliminary applications in that round have already gone out. It is scheduled to be awarded in September or October.

The goal set by the board of directors is just that. Klein will come back in late April with more information on his efforts to sell the bonds. The budget and funding priorities are expected to be reviewed again then.

CIRM Gives Go-Ahead on $17.5 Million Training Program, Funding Deferred on $41 Million Round

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

Directors of the financially troubled California stem cell agency today approved funding for $17.5 million in training grants for the state's community and state colleges, but delayed funding for 12 months a more advanced, $41 million training effort.

The vote followed recommendations from CIRM staff that reflected the fact that the agency will run out of cash this fall unless it can privately market state bonds, which are virtually its only source of funding.

The two rounds of training grants were approved in January but the board deferred decisions on payment timing until it had a better grasp of the agency's financial situation. The board stipulated that recipients in the $41 million round could go ahead with their programs this year and could be reimbursed later.

The motion to fund the community/state college grants was approved 9-0 and the training grants received a 8-2 go-ahead. Twenty-nine persons sit on the CIRM board, but most of them could not vote on the grants because of conflicts of interest. The conflicts also barred them taking part in the discussion.

The staff recommendation for funding the $17.5 million program was justified because the schools do not have access to other funding. Timing is also critical since the programs need to be set up soon so they are ready for the next school year.

Rollins Richmond(see photo), president of Humboldt State University, told the board,

"To back away now would place CIRM and this whole program in question."

Board members expressed confusion during the discussion of the funding issues concerning what grantees were being told about the status of funding from CIRM. CIRM President Alan Trounson said that grantees are being informed that their cash is "subject to funds being available." CIRM Chairman Robert Klein summarized the agency's position by saying, "This is a contract. The question is timing."

Klein has repeatedly emphasized that the grants are legally enforceable contracts.

Roth and Torres Chosen as Vice Chairs of CIRM

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

The board of the California stem cell agency today unanimously elected two vice chairpersons – Art Torres, who is the head of the state Democratic Party, and Duane Roth, who has biomedical industry connections.

The board also voted to approve a $75,000, halftime salary for Torres(photo on left). Roth(on right) is a current member of the board of directors and is rejecting a salary. He receives $112 a day for CIRM meetings and $14 an hour for meeting preparation.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., suggested the salary should be $90,000 although he has been critical of much higher salaries at the agency. However, Bob Klein, chairman of the agency, indicated that the vice chair deal had already been worked out. The implication of Klein's remark was that changing the terms at this point could make things come unglued.

The vote came after several board members noted that the men bring different, high level skills that will enhance what CIRM is attempting to do.

Director Sherry Lansing, former head of a Hollywood film studio, said the agency had a "high class problem" when the two men were nominated. She electing both will total more than two – more like five.

Lansing is co-chair of the CIRM Governance Subcommittee. She and her co-chair, Claire Pomeroy, dean of the UC Davis School of Medicine, were the key players in putting together the dual vice chair plan.

CIRM Going With Taxable Bonds on its Private Sales Plan

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

The California stem cell agency is planning to offer taxable state bonds, as opposed to tax exempt instruments, in its effort to shore up its critical financial situation and avoid running out of cash next fall.

Normally the state issues tax exempt general obligation bonds, which would carry lower interest rates than taxable bonds. The interest is a cost to the state.

However, CIRM Chairman Robert Klein said that he did not believe that the state would lose out financially because of the use of taxable bonds. He said CIRM will be dealing with individual purchasers as opposed to a broader market. He said the bonds will also meet program needs of potential purchasers such as charitable foundations.

In fact, Klein said, "We may well have less than a market rate interest."

He estimated that the bonds would have an interest rate of 5 to 5.5 percent, a figure that is attractive under current market conditions. He also said that the bonds could be repackaged in a few years, taking out the tax exempt projects and reissuing bonds for them separately.

Klein said that "going taxable saves us time" and avoids possible legal challenges, plus they can be sold to a larger range of customers.

Klein's statements on the use of taxable bonds came in response to a question from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca.

Simpson also asked about the size of the legal fees involved in the sale of the bonds for CIRM. His question came after Klein said that CIRM's efforts have involved a goodly number of lawyers from other state agencies as well as CIRM and will continue to do so.

Klein said he plans to have a workup of costs associated with the private placement plan ready for the April meeting of the board. He said it is hard to estimate because the private placement plan is "unprecedented" in "our lifetimes."
Klein is a lawyer, but said he does not practice law and has no financial interest in any law firms.

In other matters, Klein acknowledged the presence of Art Torres at the Sacramento meeting. Torres is one of the candidates for the vice chair's job. Duane Roth, a current board member, is the other candidate.

The board is now in executive session.

Listening in on the CIRM Cash Woes, Vice Chair Election

Here is the latest information from the California stem cell agency on its audiocast Thursday of its board meeting during which its financial situation will be reviewed and vice chairs will be elected.

To hear the audiocast by telephone, dial (866) 254-5934 with an access code of 991416.

To hear it on the Internet, use this URL: http://65.197.1.15/att/confcast
Enter conference ID # 991416 then click go. No password is needed.

Do not use a period after the end of the URL

The meeting is scheduled to begin at 8:30 a.m. PDT but usually starts late, so you may not hear anything immediately unless ATT has made arrangements for some sort of recorded message.

The audiocast does not provide for public participation. But public participation is possible at remote teleconference locations at the City of Hope in Duarte, UCLA and the office of Jonathan Shestack in Los Angeles. Another location is at Toyon Farm in Napa, a horse training operation and vineyard owned by Camille and Ed Penhoet, who was the last vice chairman of CIRM and who remains on the board. Specific addresses are on the agenda.

Zach Hall on Monday Morning at the White House

Zach Hall, the first president of the California stem cell agency and now a director of the New York Stem Cell Foundation, attended the ceremonies at the White House on Monday. Here is his account of the event and some of its implications. Our thanks to Hall (pictured at left) for providing the article.

----

On a soft spring morning, a distinguished and festive group gathered at the East Entrance to the White House. It was a gathering of the tribe of embryonic stem cell research supporters – scientists, Washington officials, patients, and patient advocates, many of whom had been working for years for the day when the Presidential restrictions on stem cell research would be lifted. As we waited, we greeted colleagues, shared our excitement about the event, and began the first round of picture-taking. California was well-represented, with stem cell scientists Irv Weissman and Renee Reijo-Pera from Stanford; Bob Klein, Chairman of CIRM and author of Proposition 71; and CEO Tom Okarma from Geron. Leading stem cell scientists Jamie Thomson from Wisconsin, Shinya Yamanaka from the Gladstone Institute and Japan, John Gearhart from Pennsylvania and George Daley from Harvard were there, as were several Nobel Prize winners (Mike Bishop from UCSF, Steven Chu, the new Secretary of Energy, Robert Horvitz, Eric Kandel, Harold Varmus, Peter Agre) and other scientific notables (Bruce Alberts, Eric Lander, Francis Collins). Among the California patient advocates were long-time stem cell advocates, Roman Reed and his parents, Gloria and Don, and Katie Hood of the Michael J. Fox Foundation. A number of those present (Alta Charo, Clive Svenson, John Wagner, Janet Rowland) are well-known to CIRM as members of its Working Groups.

After passing through security, we entered the White House and, after a brief wait, streamed into the East Room where we were joined by a Congressional delegation including Speaker Nancy Pelosi, Senator Diane Feinstein and Representative Henry Waxman from California, Senators Tom Harkin and Orrin Hatch, and Representatives Mike Castle and Diana DeGette. One entire wall was packed with TV cameramen, journalists and photographers, whose presence was made evident throughout the event by the constant chorus of camera clicks.

The ceremony began with the entry of seven distinguished scientists, Nobelists and others, who would stand behind President Obama as he signed the Executive Order for embryonic stem cell research and the Memorandum on scientific integrity, their presence a clear signal of the importance of science to his administration.

The President entered, bounding onto the stage to a prolonged standing ovation. His first words were: “Well, I’m excited, too.” His speech was firm, clear and thoughtful, with the eloquence that we have come to expect from him. He was enthusiastic, but appropriately cautious about the promise of stem cell research, recognizing that “there is no finish line in the work of science.” He acknowledged and expressed respect for those who oppose the research, but cited the strong majority of Americans who believe the research should go forward. President Obama then adroitly tied the reversal of the presidential restrictions on human embryonic stem cell research to his effort to restore scientific integrity to government, to listen to scientists even when (“especially when,” as he added) it is inconvenient, and to “make scientific decisions based on facts, not ideology.” Needless to say, these words were warmly received by those present. The President ended with a tribute to Christopher and Dana Reeve and to the many people who have worked tirelessly on behalf of embryonic stem cell research.

The President then moved to the desk and signed the documents using multiple pens, as is the custom. “I’ve learned to extend my signature,” he said. After shaking the hands of those near the front (I was delighted to be one of them), the President left. Still excited and savoring the moment, the group lingered, reluctant to leave, until White House attendants pointed us to the door.

The President’s remarks, as well as the stem cell document itself, contained several small surprises. The general expectation among the stem cell community was that the Executive Order would permit federal funding of research on stem cell lines as long as they were made from surplus IVF embryos using money from private or state sources. The Executive Order, however, makes no specific mention of what can and cannot be funded, but directs the NIH to provide guidance on that point within 120 days, in light of “widely recognized guidelines.” This leaves open the possibility that the NIH could fund research on embryonic stem cell lines made by other means, including somatic cell nuclear transfer, as long as federal money was not used to make the lines. The use of federal funds to actually make stem cell lines is, in any case, illegal under the Dickey-Wicker amendment which prohibits any research that results in harm or destruction of a human embryo.

The second issue concerns whether or not legislation is desirable. The White House had indicated previously that this was a matter for the Congress to decide, but in his speech he suggested that his former colleagues “still have plenty of work to do.” Presumably this is encouragement to pass a new version of the Castle-DeGette bill, which allows federal funding for new lines made from IVF embryos, but might be taken as a reference to the Dickey-Wicker amendment. A legislative battle over Dickey-Wicker would be much more difficult and more polarizing than a revised Castle-DeGette bill.

In the end, one can only admire the President’s eagerness to engage the scientific community in solving the many problems that the nation faces, the use of stem cells among them. To be there as a scientist, among so many distinguished colleagues and supporters of biomedical research, and to see the President demonstrate his commitment to our shared enterprise, both in word and deed, was truly inspiring. I felt privileged to be at the White House on this historic occasion.

Fresh Comment

“David” has posted a fresh comment on the “Dual Vice Chairs” item, pointing out that other state constitutional officers nominated Art Torres for vice chair of CIRM in addition to state Treasurer Bill Lockyer.

Audiocast Available for CIRM Board Session Thursday

Here is a reminder that Thursday's CIRM board meeting can be heard by dialing in 866-254-5934 or using this Internet address – http://65.197.1.15/att/confcast The access code is 991416. The audiocasts do not provide for participation, however.

The public can hear AND participate in the Sacramento meeting at teleconference locations in Southern California, including the City of Hope, the Salk Institute and two in Los Angeles, one at UCLA and one at the office of CIRM director Jonathan Shestack. Specific addresses can be found on the agenda.

Dual Vice Chairs Coming Up for CIRM -- One From the World of Politics, One From Business

With less than 24 hours remaining before Thursday's meeting of the CIRM board of directors, the agency has begun unveiling a plan aimed at keeping two big dogs of California politics quite happy.

The matter involves the election of a vice chairperson for the CIRM board as well as the wishes of Republican Gov. Arnold Schwarzenegger and Democratic State Treasurer Bill Lockyer. While the scheme may satisfy those two, it was called “ridiculous” by one longtime CIRM observer.

The governor has nominated Duane Roth, a current member of the CIRM board of directors and an executive with close ties to the biomedical industry, for the vice chair slot. Lockyer has nominated state Democratic Party Chairman Art Torres, a friend and former state legislator.

The governor has been a good ally for CIRM and loaned it $150 million in state funds a few years ago during the agency's first financial crunch. Lockyer controls the issuance of state bonds, which are the only significant source of funds for CIRM. He is a key player in the agency's current plans to market state bonds privately.

The CIRM board is set to elect both men to vice chair positions at its meeting Thursday in Sacramento. That became clear this morning when the agency posted proposed changes in bylaws that create a “statutory” vice chair and a “bylaws” vice chair.

It appears that Torres will be elected to the statutory slot because it carries a salary, which he said he needs. Roth has declined a salary.

The CIRM board is also scheduled to reduce the salary for the vice chair from its current range of $180,000 to $332,000 a year. The agency has not yet posted information on its plan, but we believe the new range to be roughly $75,000 to $90,000. CIRM Chairman Robert Klein is paid $150,000 for his halftime position. It is not clear at this point whether Torres will be designated halftime.

In response to a query, John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, said,

“This is a ridiculous attempt to try and please both the governor and the treasurer. It’s also an insult to the candidates who were originally nominated and faced a real election when the (CIRM board) was first organized. Suppose next time there are four different candidates for chair. Do they create a 'statutory' chair and three bylaws co-chairs? I’ve got a modest proposal: Really please everyone and name 28 'bylaws' vice chairs.”

We are reserving comment on the deal at this point. But the bylaws changes were posted extremely late. They contain no explanation, context, justification or further details. The result is that the public and interested parties are effectively denied the right to comment intelligently or register their comments in the presence of the CIRM board of directors. Failure to provide details about the plan in a timely fashion is certainly a violation of the spirit of the California state Constitution, which guarantees a broadly construed right of access to information about issues before government agencies.

Fresh Comments

John M. Simpson of Consumer Watchdog has filed a comment on the “Shifting Sands” item. “Realtor in Toronto” has filed a comment on the “Obama Snippets” item.

The NY Times, CIRM and Shifting Sands

The financial woes at the California stem cell agency vaulted today onto the pages of the august New York Times. It was not a story that necessarily will find favor at CIRM.

Written by Andrew Pollack, the piece said that President Obama's actions “could cause state governments and philanthropists to pull back on billions of dollars they have pledged for such work.”

Pollack discussed the California research effort as a case study in how the shifting sands of science are moving in one major arena.

Pollack said Obama's action has removed the original reason for the creation of CIRM. He reported as well that hard economic times have hammered foundations and the wealthy donors, now not so wealthy.

Pollack covered familiar ground for this blog's readers on CIRM's financial plight as well as its plans to privately market $400 million in state bonds so that it does not run out of money late this year.

He noted that CIRM is turning towards the biotech industry, a move that came under fire last week at a hearing on the CIRM stategic plan at the City of Hope. Its CEO, Michael Friedman, sits on the CIRM board. Pollack quoted Linda Iverson, a neuroscientist at the City of Hope, as saying at the hearing.

“To use taxpayer money essentially as venture capital money is beyond the pale.”

Pollack continued,

“Alan Trounson, CIRM’s president, responded by saying Californians had approved the $3 billion effort to develop therapies, 'not just to get the work in scientific journals.'“

Pollack concluded,

“In the meantime, 'a lot of people are running on fumes in their labs,' said Jeanne F. Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute in San Diego.

Even with the federal financing restrictions lifted, Dr. Loring said, “We need CIRM.”

Pollack's story was measured and fair, but by raising at a national level questions about CIRM, it adds to the burden that the agency faces while it tries to sell bonds.

With the exception of reports by Terri Somers at the San Diego Union-Tribune, no daily California newspaper has written in such detail about CIRM finances. It goes without saying that a total vacuum exists on television and radio.

The NY Times story may trigger some additional coverage. But given the gloomy state of the newspaper business, the tales of CIRM and its travails are likely to vanish once again into a media black hole in the near future.

Snippets from Obama Stem Cell Media Coverage

Here are some tidbits from the vast coverage of President Obama's stem cell ceremony on Monday.

Nicholas Wade of the New York Times wrote:

“Members of Congress and advocates for fighting diseases have long spoken of human embryonic stem cell research as if it were a sure avenue to quick cures for intractable afflictions. Scientists have not publicly objected to such high-flown hopes, which have helped fuel new sources of grant money like the $3 billion initiative in California for stem cell research.

“In private, however, many researchers have projected much more modest goals for embryonic stem cells. Their chief interest is to derive embryonic stem cell lines from patients with specific diseases, and by tracking the cells in the test tube to develop basic knowledge about how the disease develops.

“...(M)any scientists believe that putting stem-cell-derived tissues into patients lies a long way off. Embryonic stem cells have their drawbacks. They cause tumors, and the adult cells derived from them may be rejected by the patient’s immune system. Furthermore, whatever disease process caused the patients’ tissue cells to die is likely to kill introduced cells as well. All these problems may be solvable, but so far none have been solved.”

Rob Stein of the Washington Post wrote about the job facing the NIH.

“The task of deciding what kinds of studies will be supported now falls to the National Institutes of Health, which finds itself confronting far more extensive questions than its officials were contemplating. It has 120 days to do the job.

“Among other things, officials will have to decide whether to endorse studies on cells obtained from much more contentious sources, such as embryos created specifically for research or by means of cloning techniques. “

Lynn Sweet of the Chicago Sun-Times carried, on her blog, a list of guests at the Obama ceremony. They included Zach Hall, first president of CIRM, and other Californians tied to the state's stem cell agency. The list did not include CIRM Chairman Robert Klein, but other stories indicated that he attended. The current CIRM president, Alan Trounson, was invited but did not attend.

Reporter Terri Somers of the San Diego Union-Tribune reported that Klein was at the ceremony and reported that he said the door is now open for more collaboration between California scientists and those in other states.

Somers also wrote:

“At a 'Free the Stem Cells' breakfast at the home of researcher Jeanne Loring of The Scripps Research Institute, scientists gathered to watch the event and toast Obama. Some were moved to tears, Loring said, because the president's actions validated research to which they have dedicated their careers.”

Fresh Comment

“Anonymous” has filed another comment on the “CIRM calendar” item.

The remarks include the following, which is hard to disagree with:

“This calendar project may be an example of exactly the types of expenditures (multiplied over and over) which create the state's budget shortfall in the first place. State agencies should not spend money just because they can; government at CIRM, and at all other levels, have a responsibility to look at each expenditure with a critical eye toward whether the expense is fundamentally necessary and if so, insure the State's statutes governing the acquisition of goods and services are being complied with. CIRM is not a private enterprise, instead it should always be mindful that it is funded with real taxpayer dollars.”

Fresh Comment

“Anonymous” has filed comment on the “CIRM calendar” item asking about state bidding procedures and public records. We have filed a response.

Fresh Comment

“VoicedUp” has left a comment on the “Obama Chapter 5” item.

Waiting for Obama, Chapter 5 -- Be Careful What You Wish For

Some of the California reaction today to President Obama's action on stem cell research indirectly highlighted potential side effects that might make the state's stem cell agency uneasy – not to mention the biotech industry.

With the feds back in the game, they may not look kindly on wildcat activities out in fringy California and elsewhere. Turf does, in fact, matter. Moreover, with Congress now back in the stem cell legislation business, to borrow from one oldtime political commentator, no one is safe.

Consider the comment from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca. He issued a call for the feds to act to ensure that taxpayers share in any profit generated by stem cell therapies developed with government funds.

In a letter to President Obama, Consumer Watchdog cited the profit-sharing model at CIRM and said,

“Celebrating the change in policy is not enough, however. It is now necessary, more than ever, to examine the regulations governing the way federal funds are distributed to researchers. A change in those rules is needed and we call on you to work with Congress to implement reform of the Bayh-Dole Act.”

Businesses in California have taken issue with CIRM's profit-sharing rules, but the state agency has now broken the Bayh-Dole ice. The precedent in California will help fuel efforts to make changes in the federal law.

From Oakland, Ca., came another call for federal action that could have an impact on CIRM. Marcy Darnovsky, associate executive director of the Center for Genetics and Society, said the national government should enact enforceable rules for all stem cell research, public and private. Such rules would supersede those in California.

Jesse Reynolds, policy director of the center, said,

"We've seen what happens with inadequate regulation and oversight in the financial sector. The human biotechnology sector also needs effective public policy."

The Dickey-Wicker amendment is already on the table in Congress. It could become the vehicle for a host of challenges to the established order in the biotech business.