Monday, October 31, 2011

IOM and California Stem Cell Agency: Study Lacks Key Perspective

The prestigious Institute of Medicine earlier this month kicked off its $700,000 study of the California stem cell agency minus an important perspective – the view directly from California.

None of the persons on the 13-member panel evaluating the performance of the $3 billion enterprise comes from California. The reasons for that are not clear. The IOM is all but mum on the matter.

One could argue that it is not necessary to be geographically located in California to determine whether CIRM is working at peak performance. However, some conditions do exist in California that are difficult for many others to grasp. They include its state budget crisis that has now placed the once Golden State at the bottom of the heap in terms of its credit. Some even liken it to Greece. Obviously that situation can be understood in the abstract by reading The Sacramento Bee and the Los Angeles Times. But the intensity and emotion surrounding that issue and others are difficult to comprehend for many folks living in more blessed states.

Count among the other volatile issues the cutbacks in the state's once vaunted higher education system, including the University of California, which showed its back to students by increasing tuition by nearly 18 percent this fall. Couple that with a visceral antipathy -- and that is putting it mildly -- among some Californians to what they regard as execessive state salaries, including those at the stem cell agency.

What does all this have to with financing stem cell research through an agency that was supposed to have a guaranteed stream of income isolated from mischief that could be wreaked by the governor or legislature. It turns out that CIRM's cash flow is not as guaranteed as its backers believed. Instead of issuing bonds, the state is going to finance the agency over the next 18 months with commercial paper, if necessary. That's because Gov. Jerry Brown wants to reduce the interest costs on state borrowing, which have risen sharply and now consume 8 percent of the state budget along with funds that could otherwise go to educate California's children, among other things.

Brown's parsimony is famous. During his first term in office, he denied pay raises to state college professors, saying they are amply rewarded through "psychic income." More recently, he objected to out-of-state travel by CIRM staff. Too much "lollygagging in London on the taxpayer's dime," a Brown spokesman said. CIRM Chairman Jonathan Thomas promptly cut travel in the chairman's office by 50 percent and asked CIRM President Alan Trounson to do the same for the rest of the staff.

It is an environment that can be difficult to navigate under the best of circumstances. It places limitations on the stem cell agency and tends to focus its operations and funding in different directions than might be the case if California's economic climate were rosier.

The IOM has no real response to the question of why no Californian is on the panel. The California Stem Cell Report last week asked the institute whether an overt decision had been made to exclude persons from California. The IOM did not answer directly. Instead it referred to a generic description of how panel members are selected. The institute's unwillingness to address the specific question does not speak well for the openness and transparency of the IOM examination of CIRM.

Currently the IOM does have a comment period available on the selection of the panel members, who will not become official for another three days. Interested parties can make their views known to the IOM by using this link.

A Californian or two on the IOM panel would help to bring a valuable, broader perspective to this important study, which is sure to affect the future of the state's stem cell research and voter approval of another possible multibillion dollar bond issue in the next few years.

Friday, October 28, 2011

Deadline Next Week for Comments on IOM Panelists Examining California Stem Cell Agency

If you have any comments on or objections to the members of the Institute of Medicine panel examining the $3 billion California stem cell agency, only six days remain to file them with the IOM.

The panel has just begun its review of CIRM's performance, which is being paid for by the agency itself in a $700.000 contract. The study is expected to be completed in November of next year and is expected contain recommendations for changes at CIRM.

In a posting on its web site, the IOM said,
"No appointment shall be considered final until we have evaluated relevant information bearing on the committee's composition and balance. This information will include the confidential written disclosures to The National Academies by each member-designate concerning potential sources of bias and conflict of interest pertaining to his or her service on the committee; information from discussion of the committee's composition and balance that is conducted in closed session at its first meeting and again whenever its membership changes; and any public comments that we have received on the membership during the 20-calendar day formal public comment period."
The procedure for filing comments on the members of the panel can be found at the bottom of the page found here.



http://www8.nationalacademies.org/cp/CommitteeView.aspx?key=49397

Wednesday, October 26, 2011

California Stem Cell Agency Approves $68 Million in New Funding

In a matter of a few minutes this afternoon, directors of the California stem cell agency approved $68 million in new financing rounds, including a $30 million business-friendly effort to speed development of clinical therapies.

The proposals received almost no discussion as four board members scurried for flights or to return home. Their departure left the 29-member board without the 19-member quorum needed to act legally. The board was already short of a full contingent of members.

In addition to the business loan program, the board approved a $35 million basic biology round and a $3 million program to provide internships for high school students at research labs. The funding goes to the labs, which then pick the students.

Action on the items came swiftly after CIRM Chairman Jonathan Thomas told directors they had only 20 minutes to approve them before the quorum was lost.

Here is the CIRM press release on the plans.

CIRM Directors Adjourn

Directors of the California stem cell agency adjourned their meeting early this afternoon after hastily acting on a number of multimillion dollar items.

Four members of the board left to catch planes or return home, leaving the 29-member board without sufficient members to act legally. The board has a super-majority requirement written into state law, courtesy of Prop. 71, the measure that created CIRM. Loss of quorums has been a problem for CIRM since its inception.

The board had been scheduled to meet until 5 p.m. PDT today. The board adjourned at 2:39 p.m.

Board member Bert Lubin, president of Childrens Hospital of Oakland, told remaining board members that all board members should stay for the entire scheduled meeting. He suggested to CIRM Chairman Jonathan Thomas that he write a letter to the board to that effect.

The hasty departure of the board members followed a lengthy discussion earlier in the day about CIRM's shaky public image and ways to improve it.

Two minor items were put off until December. We will have more on board actions in the next couple of hours.

Stem Cell Board Racing Through Agenda

California stem cell agency directors are hurrying through their agenda in Irvine this afternoon as four directors will be leaving to catch planes.

That will leave the board shy of its super-majority quorum requirement. The 29-member board needs 19 members present to legally act. Maintaining a quorum has been a problem since day one of the organization. The quorum requirement was written into state law by Prop. 71.

Stem Cell Directors OK New PR Push to Improve CIRM Image

Directors of the $3 billion California stem cell agency today approved a new PR/communications initiative aimed at bolstering the image of the research effort and moving it closer to winning voter approval of additional billions of dollars within the next few years.

Without additional funding, the seven-year-old agency will not be able make additional grants beyond about 2017. It has only $1.2 billion left for research spending, an amount that does not go far when some grant rounds are topping $200 million.

CIRM directors approved the plan on a unanimous voice vote following a brief discussion. Chairman Jonathan Thomas described the plan as ambitious. It will be administered by a new director of communications who is expected to be hired soon. CIRM already has three persons working in communications. A fourth is likely to be added under the plan.

The board's action followed presentation of a $20,000 study of its PR efforts by the political and PR consulting firm of Townsend Raimundo Besler and Usher of Sacramento. The firm said CIRM's PR efforts have produced "less than satisfactory results," damaged its own public image, failed to stay abreast of the need to communicate with many different audiences and led to organizational "dysfunction."

Townsend recommended "rebranding" the California Institute for Regenerative Medicine, the official name of the agency, as the "Stem Cell Institute." Townsend's report said the agency's formal name "has proven not particularly effective in helping the public" understand its work.

Townsend recommended centralizing communications management, reorganizing existing communcations staff, creating an annual communications/PR plan and developing a set of messages that will generate public support. Also recommended were polling and focus groups to help formulate needed strategies along with specific ways of measuring the success of CIRM's communications plans. 

New Collaborative Agreement Announced Between California Stem Cell Agency and NIH

The California stem cell agency and the NIH today announced a collaborative agreement aimed at accelerating the transformation of basic research into cures.

The agreement came up several times during this morning's discussion of changes in CIRM's strategic plan in the context of leveraging the agency's efforts. Some directors indicated that the agreement could mean that CIRM could spend less on costly translational grant rounds. Here are some excerpts from the agency's press release.
"The memorandum of understanding signed by CIRM President Alan Trounson and Michael Gottesman, Deputy Director for Intramural Research at NIH, is a pilot project of these partnerships in clinical and translational research. This MOU establishes a framework to advance the complementary and synergistic goals of CIRM and the NIH to 'help NIH and CIRM researchers work together to bring their special talents in stem cell and regenerative medicine research to bear upon prevention, diagnosis, and treatment of various diseases.'"

"The NIH, through its trans-NIH Center for Regenerative Medicine (NIH CRM), the NIH Clinical Center, and the newly established NIH Center for Translational Therapeutics (NCTT), will foster these interactions. The NIH Clinical Center is the world’s largest hospital dedicated entirely to clinical research. The Center houses basic, translational and clinical research efforts of the NIH intramural research community, including the recently established NIH CRM funded through the NIH Common Fund."
The press release also mentioned possible opportunities for collaboration. It said,
"One relates to the current round of applications for CIRM’s Disease Team Therapy Development Research awards. During the planning phase of these awards, California teams could develop collaborations with researchers at the NIH Clinical Center on various aspects of a preclinical, Phase I, Phase I/II or Phase II clinical trial. Another option is to enable California researchers with the opportunity to take part in NIH Clinical Center visiting fellowship or clinical investigator training programs. A third is to access unique resources they could apply to use that may not be available at their home institution."

CIRM Directors Break for Lunch; PR Plan Up Next

Directors of the California stem cell agency have concluded their discussion of possible changes in their strategic plans for the next five years and adjourned for lunch and a closed-door personnel session.

They plan to return at about 15 minutes after the hour. The directors plan to take up a new communications/PR plan at that time.

No votes were taken during the discussion of the strategic plan. We will have more on what directors had to say later.

Stem Cell Meeting Resumes

CIRM directors have resumed their meeting today, beginning a discussion of possible changes in the agency's strategic plan as it determines the priorities for its remaining $1.2 billion.

CIRM Directors on Break

Directors of the stem cell agency are currently are on a short break and should be back in session at seven or eight minutes after the hour, if they keep to their schedule. A discussion of the strategic plan moderated by a consultant will begin when directors return.

Stem Cell Directors Discuss Changes in Strategic Plan

California stem cell agency directors are in the midst of a discussion of changes in their strategic planto focus more heavily on driving reseach into treatments.

Ellen Feigal, vice president of research and development, introduced the discussion and noted that the agency does not plan to abandon basic research, a touchy subject for many researchers. She also said the directors should examine the proportion of  expenditures devoted to basic research and translational research.

CIRM Directors Meeting Underway

Directors of the California stem cell agency have begun their meeting today in Irvine. CIRM President Alan Trounson is in the midst of a presentation.

Conflicting Start Times for CIRM Board Meeting

The agenda for today's meeting of the board of the California stem cell agency says that it will start at 9 a.m. PDT. However, the audiocast schedule says 9:30. We have queried CIRM concerning the discrepancy.

If our WiFi connection, provided free by the Panamanian government to the entire country, can hold up, we will bring live coverage of the meeting when it begins. It is struggling mightily right now , and we may move to another location, which will mean a delay in our coverage.

Tuesday, October 25, 2011

CIRM's Next Six Years: Stem Cell Agency Re-examines Its Priorities

The California stem cell agency is taking a fresh look at its strategic plan as it drives more aggressively to develop therapies that can actually be used in the clinic. The re-examination is likely to have an impact on business and academic researchers alike.

The first public session is in Los Angeles today. Tomorrow the 29 members of the CIRM board of directors tackle the subject in Irvine. On Halloween, another session is scheduled for the public in San Francisco.

Little fresh information is being provided for the Los Angeles and San Francisco meetings. But directors will have a document prepared by Ellen Feigal, CIRM's vice president for research and development.

One goal of tomorrow's discussion is to deal with priorities for the six next years, which may well be the agency's last. CIRM is scheduled to run out of funds in 2017 unless it receives more bond funding from the state or cash from other sources. Also on the table are possible changes in CIRM operations, ranging from grant review criteria to RFA content.

Feigal's document, the best we have seen on the strategic plan since the first version in 2006, asks the question: "What would success look like?" The purpose is to trigger responses from the CIRM board members.

Feigal writes that "stem cell-based therapies are the core of CIRM's mission."
"Getting treatments in clinical trials that evolved from stem cell research, we plan to do this in the following ways:
"Show great strides getting game-changing, innovative therapies into clinical trials that would not have happened without CIRM
"Transform public thought about science and medicine so the public better understands the dynamic connection between basic research and clinical development"
Feigal proposes that CIRM work to establish California as the "Stem Cell State" and stimulate its biotech industry.

She identifies some weaknesses at CIRM including relations with industry and communications. She suggests that scientific reviewers need to have a broader view of the agency's work. And she cites the need for prioritizing activities. She said CIRM needs to be "cautious about the 'let a thousand flowers bloom' approach.

The last round on strategic planning triggered a sharp discussion involving fears that CIRM would give short shrift to basic science. This latest proposal is likely stir that pot again as basic researchers become concerned that less grant money will flow to their projects.

Feigal's document came late to the public and was posted only last Friday, three business days before the CIRM board meeting tomorrow. It was one of two major subjects before directors that lacked background until very recently. The other is the communications proposal that dovetails with the strategic plan.

CIRM's timetable for completing the latest revision of the strategic plan calls for final approval by the CIRM board of directors in March 2012.

Live Coverage of CIRM Board Meeting

The California Stem Cell Report will provide live coverage tomorrow of CIRM's board meeting at UC Irvine in California. We will be listening to the Internet audiocast from our post aboard our sailboat-home anchored off Panama City in the Republic of Panama. For those who wish to follow along, directions for the audiocast can be found on the meeting agenda, which also contains the addresses of three remote locations in California. Those locations provide the ability to make comments and actually participate in the proceedings. The meeting is scheduled to begin at 9 a.m. PDT.

Monday, October 24, 2011

Stem Cell Agency PR/Communications Not Up to Snuff, CIRM-funded Report Says

The communications/public relations efforts of the $3 billion California stem cell agency have fallen short, damaged its own public image and led to organizational "dysfunction," according to a CIRM-commissioned study.

The report by the Sacramento firm of Townsend Raimundo Besler and Usher cited "less than satisfactory results" and CIRM's failure to keep pace with the need to communicate with many different audiences. The political consulting and PR firm wrote,
"(A) lack of coordination and systematic organization has led at times to dysfunction, and, while the Institute may be respected and well-known in the scientific world, it is far less of either among other critical audiences."
(Disclosure note: The author of this item on the California Stem Cell Report and Jeff Raimundo, one of the principals of the Townsend firm, worked together at The Sacramento Bee two decades ago.)

The report, to be acted on tomorrow night and on Wednesday by CIRM directors, cited some measureable PR successes. But it said CIRM "lives in two worlds – the high-level domain of advanced scientific research and the secular world of politics and public opinion."

The Townsend firm recommended a number of changes to improve matters, including "rebranding" the California Institute for Regenerative Medicine, the official name of the agency, as the "Stem Cell Institute." Townsend said the agency's formal name "has proven not particularly effective in helping the public" understand its work.

Townsend also recommended centralizing communications management, reorganizing existing communcations staff, creating an annual communications/PR plan and developing a set of messages that will generate public support. Also recommended were polling and focus groups to help formulate needed strategies along with specific ways of measuring the success of CIRM's communications plans.

Townsend cited the need to go beyond traditional scientific as well as mainstream media. The report said that the while public has traditionally "gotten their information from mainstream news media, that is no longer true. Much of the flow of information to the public is through interactive and electronic media today, particularly blogs and websites."

The report indirectly referred to former Chairman Robert Klein, who stepped down in June. Townsend said,
"Virtually since its inception and until recently, the Institute has been led by a high-profile, articulate and charismatic individual who assumed much of the responsibility for communicating with many if not most of CIRM's audiences. Although that situation helped keep messages simple and focused, it did not keep pace with the demands of the Institute to communicate at many different levels and with many different audiences."
CIRM commissioned the study following the June election of Jonathan Thomas, a Los Angeles bond financier, to replace Klein, who is a Palo Alto real estate investment banker.

At the time of Thomas' election, he told directors that the agency is in a "communications war." He said the world is focused on "internal issues" at CIRM instead of "the grand, big picture. "  He also discussed CIRM's financial situation. Its bond funding will run out in roughly 2017. And prior to his departure, Klein expressed the need to seek another multibillion dollar bond measure sometime in the next few years. Such a ballot measure would seem certain to be rejected today, given the state's current financial crisis and the lack of the cures that were touted in the 2004 election campaign that created CIRM and that was headed by Klein.

Earlier this year, directors approved an organizational change that created a senior level director of public communications in the office of the CIRM chairman to market the stem cell agency to the public. The agency is currently in the process of hiring that person. However, the three-person communications staff remains within the president's office.

Accompanying the Townsend report was a document from CIRM President Alan Trounson detailing responsibilities for the new hire and declaring that he "fully supports" the new communications effort. Under Trounson's structure, the PR chief would report to Art Torres, the co-vice chairman of CIRM, and Ellen Feigal, vice president for research and development. Trounson's statement does not specifically delineate who reports to the new PR person but places responsibility for virtually all of the agency's communications efforts in the hands of that person.

The Townsend study also says that CIRM is understaffed for its communications tasks although it did not specifically recommend new hires.

The Townsend report was posted on the CIRM website sometime during the weekend, only two business days before it is to be considered, making it nearly impossible for the public or interested parties to prepare thoughtful comments.

The California Stem Cell Report asked CIRM earlier for the cost of the Townsend report as well as a copy of the contract, both of which are a public record. Neither piece of information has been forthcoming.

Stem Cell Agency Strikes New Financial Deal with State of California

The $3 billion California stem cell agency has worked out a creative, new financial arrangement with the Brown Administration and the state treasurer that assures the agency of cash at least until 2013.

CIRM was on track to run out of funds late next spring because of the earlier suspension of the sale of state bonds, the agency's only real source of money. When the sales resumed last week, it received only $50.8 million, which is well short of meeting CIRM's obligations to grant and loan recipients.

But new CIRM Chairman Jonathan Thomas said late Friday that CIRM now has what amounts to a $225 million line of credit with the state and assurances of a loan should additional cash be needed. In a telephone interview with the California Stem Cell Report, he said,
"We are in really good shape."
The arrangement appears to eliminate the likelihood that CIRM could run out of funds if the financially troubled state of California suspends bond sales again early next year. The state's current budget is built on optimistic revenue projections, which are not being met. If those fall short, severe, automatic budget cuts will be triggered in January. Under less dire conditions last year, the state suspended bond sales. Gov. Jerry Brown, who last week touted the $50.7 million in stem cell borrowing, has also deplored the state's debt load. Bond interest costs have risen from 3.4 percent of the state budget in 2003-04 to nearly 8 percent this year. That amounts to $2,542 per person, compared with the national median of $1,066, according to The Sacramento Bee.

CIRM's new deal with the state minimizes interest costs through the possible use of commercial paper, which is a form of very short term borrowing with low interest rates.

Here is how the new arrangement works, according to Thomas, who is a Los Angeles bond financier. Currently CIRM has $190 million on hand. The addition of the $50.8 million will carry it through June, which is the end of the current fiscal year. If CIRM has additional financial needs, the treasurer's office will provide up to $75 million through the use of commercial paper, which CIRM would ultimately have to repay.

If the state sells more bonds in the first part of 2012, CIRM will receive an additional allotment that will carry it into the 2012-13 fiscal year. If no bond sales occur, the treasurer's office will provide an additional $150 million via commercial paper over a six-month period. Should CIRM need cash beyond that, the state would provide a loan in much the same way that former Gov. Arnold Schwarzenegger did during CIRM's early days. The chief advantage to the state is that the arrangement helps to avoid the issuance of more bonds this year with their ongoing interest costs. The financial arrangement is subject to a review every six months.

Thomas, who was nominated for his post by both Brown and state Treasurer Bill Lockyer, said the arrangement makes it clear that the California stem cell agency is one of the state's priorities. He said,
"We got everything we want."
We asked Thomas who came up with the idea for the use of commercial paper. He said he could not remember specifically but said it popped up during discussions with the state Department of Finance staff, himself and CIRM co-vice chair Art Torres, a former state legislator and former head of the state Democratic Party. Ultimately the plan was approved in a meeting with Thomas, Torres, CIRM's outside counsel James Harrison and state Finance Director Ana Matosantos.

CIRM's cash needs are increasing as it more aggressively pursues development of clinical therapies. Next spring it is slated to mount a $240 million grant round. The agency has roughly $1.4 billion left, but a good chunk of that will go for operational costs, which are currently $18.5 million a year and are likely to increase. CIRM has projected that it will run out of its bond funding in about 2017.

Friday, October 21, 2011

Gov. Jerry Brown on Borrowing to Finance Stem Cell Research

Here is what California Gov. Jerry Brown had to say yesterday about the $50.8 million in taxable bond proceeds that are going to the $3 billion California stem cell agency. It was a part of a press release touting the virtues of the financially troubled state's most recent borrowing.

Much of the language in Brown's statement appears to have originated with the stem cell agency, which campaigned with the Brown administration for a share of the bond proceeds.

The stem cell agency has not yet responded to our inquiries concerning the amount of money that was provided.

Brown's statement follows:
"CIRM’s approximately $190 million in existing proceeds, plus the additional $50 million, will be used to fund the following program activities:

"• The first Food and Drug Administration-approved clinical trial for a human embryonic stem cell therapy (for spinal cord injury). CIRM’s $25 million commitment to this project has been matched by a $29 million commitment of private funds.
"• 14 Disease Research Teams that are proceeding towards clinical trials of therapies to treat diseases ranging from HIV/AIDS to dry macular degeneration (a common cause of blindness) to neurological diseases such as ALS. One of these awards is a $20 million loan which has generated approximately $20 million in additional funds by the company receiving the CIRM award.
"• Training and internship awards to fund the training of almost 900 promising new scientists and technical staff at the University of California, California State University, California Community Colleges and other institutions in California.
"• CIRM-funded research and related matching funds are expected to create or retain approximately 5,000 jobs per year and more than $60 million in new state and local tax revenues.
"• The current portfolio of stem cell research at CIRM, including the grant programs scheduled through June 2012, have resulted in over 100 scientists and 1,000 other highly-trained researchers being recruited to the state. The Stanford Stem Cell Institute estimates that each of these researchers will bring an average of $1.5 million in research funding to California, for a total of $150 million of additional research funding and associated jobs."

Thursday, October 20, 2011

Stem Cell Agency To Receive $50.8 Million in Additional Funding

The California stem cell agency, which was slated to run out of cash next June, will receive $50.8 million from yesterday's sale of state bonds, the state treasurer's office said today.

Under normal circumstances, the agency could be entitled to as much as $350 million annually in bond proceeds. We have queried CIRM concerning its perspective on the impact of this week's funding.

The state of California is in the midst of a severe budget crunch. In January, California is likely to be hit by a wave of automatic, severe budget cuts. They will be triggered if the revenue projections for the current fiscal year (2011-12) are not met. Currently the state is falling short of the projections.

The state is not scheduling any further bond sales this calendar year. It is unclear whether bond sales will resume in 2012. At the beginning of 2011, the state suspended bond sales because of budgetary concerns.

More on CIRM's Restriction of Info on Biotech Applicants

The California stem cell agency says its brief statement this week on restriction of information involving biotech companies was generated in an effort to offer a public explanation of its policy.

In response to a query about what led to the statement, Maria Bonneville, executive director of the CIRM board, said,
"In light of CIRM's efforts to work with companies to develop new therapies, we felt it was important to offer a public explanation regarding CIRM's efforts to balance its obligation to provide information to the public with the need to protect the proprietary information of applicants for therapy development projects."
The California Stem Cell Report will have more on this subject in the next week, including a discussion of how it relates to the state's constitution, which states that the public has as "broadly construed" right to information about state government activities.

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