Showing posts with label private funds. Show all posts
Showing posts with label private funds. Show all posts

Tuesday, October 22, 2019

Halloween Meeting Set for $3 Billion California Stem Cell Agency: Last Research Awards Expected to be Made

California's $3 billion stem cell agency next week is expected to give away the last of its funds for new research awards and hear a report on private donations that it may have received in the recent past or perhaps expects in the future. 

The donations report is something of a mystery, based on the agenda, but perhaps appropriate for the governing board's meeting, which comes on Halloween, Thursday Oct. 31. 


More details are likely to be posted online in the next week or so and reveal more clues about the direction -- over the next 12 months -- of the agency, formally known as the California Institute for Regenerative Medicine (CIRM).


The agency expects to run out of money for new awards at the end of this month unless a there is a surprise announcement that a private fund-raising effort has produced significant results. CIRM was created in 2004 by voters, who allotted it $3 billion in state bonds. No other source of cash was provided by the ballot initiative. 


In addition to consideration of applications for clinical and translation stage awards, also on next week's agenda are:

  • "Use of public funds in connection with ballot measure presentation"
  • Last week's report on the economic impact of the agenc
  • Changes in the "administrative funds donor agreement and disclosure of funds received from donors." (Those changes were not available on the agenda but are likely to be available in the next few days.)
The ballot measure discussion involves the appropriate and legal role of the agency in connection with the $5.5 billion, proposed ballot initiative to provide additional support for CIRM. The measure is now before state officials for certification prior to being circulated for the 600,000-plus signatures needed to qualify for the November 2020 ballot. 

State law prohibits the use of state funds to support ballot campaigns. The agency has been careful to adhere to the law. But it is always a touchy area. A number of gray areas exist involving the agency's additional legal requirements to respond to questions and inform the public about the conduct of the taxpayer's business.

The public can comment and recommend changes in the proposed initiative between now and Nov. 12.  Suggestions for changes will be relayed to the backers of the measure.

Regarding the currently cryptic Halloween agenda, look for more details on the California Stem Cell Report between now and Oct. 31. We will be filing fresh items as the information emerges.  

Next week's meeting will be held at CIRM's Oakland headquarters. The public can attend and also participate via the Internet. Remote telephonic locations that are open to the public can be found in La Jolla, San Diego, Fresno and San Francisco. Directions and instructions can be found on the agenda.

Wednesday, September 11, 2019

Meeting Delays and the California Stem Cell Agency: A Matter of Many Millions of Dollars

For the second time in two months, the governing board of the $3 billion California stem cell agency has postponed important meetings which had been expected to deal with its final research awards and its declining finances. 

The latest postponement involved a Sept. 25 meeting. On the table would have been redirection of tens of millions of dollars and the question of financing awards already approved by the agency's reviewers.

Last month, an Aug. 22 session involving major awards was  cancelled. As of today, the next meeting of the agency's board will not come until Oct. 31.

The governing board of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), has before it far more reviewer-recommended awards than it can fund. Agency officials hoped that funds received from cancelled research projects would help fill the gap.

CIRM is financed with $3 billion in state bonds but has no source of significant cash beyond that. It expects to run out of money for new awards -- most likely by the end of next month -- depending on how it deals with the applications in its award pipeline. Those decisions are now likely to be made at the meeting currently scheduled for Oct. 31. 

Queried about the reason for delaying this month's meeting, Maria Bonneville, executive director of the board,  replied, 
"There were some scheduling issues and, as you know, getting the whole board together isn’t easy. (The) soonest I could get a quorum was Oct 31."
CIRM's future depends on a proposed, $5.5 billion ballot measure in November 2020 that would allow it to continue at the pace of the last 14 years. The agency also has been engaged for some time in an effort to raise privately more than $200 million to bridge the funding gap between now and the 2020 election. 

No specific progress has been publicly announced concerning that effort. However, the financial plight of the agency has received more public attention in recent months. That attention may have generated the loosening of the purse strings of some potential donors. 

The agency also may well have made a pitch to California Gov. Gavin Newsom for some sort of interim funding, possibly payable back with 2020 bond proceeds. Newsom was an important supporter of the agency in 2004-05 and engineered a $17 million package to lure its then headquarters to San Francisco when he was mayor of that city.

Thursday, October 18, 2018

$144 Million California Stem Cell Research Program Set for 2019

Directors of the California stem cell agency this morning approved a $144 million research budget for next year, which could well be its last for dispensing any major cash in its search for stem cell therapies.

The amount compares to $148 million expected to be awarded this year.  At its peak, the agency was handing out close to $300 million a year in research awards, but the amount varied from year to year.

Most of the funds for the next year will be devoted to clinical stage work. The agency, formally known as the California Institute for Regenerative Medicine (CIRM), is already backing 49 clinical trials, the last stage before a therapy is approved for widespread use. But it has yet to help finance a therapy that can be used by the population at large, despite expectations of voters who approved creation of the $3 billion agency in 2004.

CIRM expects to run out of cash for new awards next year. Possibilities exist for continued funding of research in 2020, but the agency is budgeting conservatively. CIRM Chairman Jonathan Thomas is attempting to raise privately $220 million to maintain the agency's funding. Thomas briefed directors today on that effort but notably did not report that specific additional funding had been secured.

CIRM also expects to recover possibly as much as $30 million in 2019 from projects that do not meet their milestones and possibly use the funds for awards next year or in 2020.

The agency is pinning its hopes for ultimate survival on a yet-to-be-written $5 billion bond measure on the November 2020 ballot.

Thursday, December 14, 2017

$5 Billion Bond Measure: California Stem Cell Agency Sets a Course to Secure Its Financial Future

CIRM spending plan for next year and beyond. 
Educ refers to educational  grants. Discovery 
refers to basic research. Tran refers to translational, 
and Clin refers to clinical trial related awards. 
CIRM spent $213 million this year on Clin awards. 
OAKLAND, Ca. -- Directors of the California stem cell agency today virtually endorsed a plan to stave off its financial death, pinning their hopes on a possible $5 billion bond measure and a private fundraising effort to bring in an additional $222 million.

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, expects to run out of cash for new awards in late 2019 because of limits in the ballot measure that created it in 2004.

Robert Klein, who led the 2004 initiative campaign, appeared before the governing board meeting and touted the new bond proposal. The Palo Alto real estate investment banker told directors that California had a "moral imperative" to continue its stem cell work. He said,
"This is California’s contribution to the future of medicine....This is the bridge to the future of health care."
No vote was taken on endorsement of a ballot measure that has yet to be written or qualified for the ballot. But no objection was raised by board members to moving forward on what Thomas called the best option.

Under that scenario, Klein would lead a new, $5 billion initiative that would require hundreds of thousands of voter signature to qualify for the November 2020 ballot. Then it would require raising roughly $50 million to run a successful campaign, Klein told the California Stem Cell Report last month.

The $222 million fundraising effort is already underway and would continue until the end of 2019, with the expectation that it would provide bridge funding until voter approval of the new, multibillion dollar bond measure.

Klein told directors that 70 percent of California voters favor continuing funding of the agency. However, last month he declined a request by the California Stem Cell Report for a copy of the poll or the name of the firm that conducted it.

The 2004 campaign led voters to believe that miraculous stem cell cures were right around the corner. The agency has yet to help finance a treatment that is in widespread use. But it has currently invested $300 million in 26 clinical trials, the last stage before a proposed therapy can be certified for general use. Trials, however, can take years.

The agency is funded by money that the state borrows -- bonds. The authority to issue those bonds is expiring, and the agency is down to its last $269 million.

A fallback funding scenario would involve asking the legislature to place a bond measure on the ballot. There was no discussion of that today but it would involve negotiating with lawmakers and possibly making major changes in the way CIRM operates.

Prior to discussion of the bond measure, directors approved $68 million in cuts to the size of awards so that more awards could be made over the next two years. They also approved spending $270 million on awards next year, including $130 million on awards related to clinical trials, $30 million for research bridging the gap between the clinic and basic research and $10 million for basic research.

Wednesday, December 02, 2015

California's New $105 Million Stem Cell Surge: The Creation of an Industrial Powerhouse


Highlights
National biotech interest likely
$75 million alone for public-private effort
High risk, high reward
More support for Alpha clinics

California is hoping to fire up the state’s stem cell industry this month with $105 million aimed at creation of an unprecedented, “industrial stem cell therapeutic powerhouse” on the nation’s West Coast. 

The money is coming from the state’s stem cell agency, which has already spent $2 billion on stem cell research in the last decade. The agency is now on its last $900 million and pushing hard to translate stem cells into therapies and cures. It is expected to run out of money for new awards in 2020.

Earlier this week, a key panel of the agency’s governing board approved the $105 million surge, a decision that is certain to be ratified by the full board at a meeting Dec. 17 in Los Angeles. The action will initiate a 2016 competition for the cash, which is likely to draw national interest, although the money can be spent only within the state.

The largest component of the $105 million is $75 million for a program that the agency has dubbed the “Accelerating Therapies through Public-Private Partnership” or ATP3. The award would be one of the largest ever made by the agency, which is formally known as the California Institute for Regenerative Medicine (CIRM).

Also approved was a $15 million round for an "accelerating center" and another $15 million round for a "translating center." All of the awards are scheduled to be made by late 2016. 

Under the ATP3 public-private round, the recipient would be required to match the $75 million from California taxpayers. The program would bundle together for continued CIRM funding the most promising current CIRM projects. Those projects -- a “portfolio of  ‘high risk’ but high reward projects” -- would be selected by the recipient for development for commercialization, the agency said in a memo.

CIRM’s plan for the project said,

“The aggregation of a basket of otherwise unpartnered CIRM projects offers the successful applicant ‘multiple shots on goal.’ This increases the probability of successfully developing and commercializing a stem cell treatment and makes significant industry investment in stem cell technology more attractive.”

The agency said in a presentation that industry is “beginning to show interest” in stem cell therapies but only 8 percent of CIRM’s 71 active therapeutic programs have industry partners.

CIRM’s presentation said the awardee must have a “top-tier” track record and “could be an established company, a spin-off or a new company with a team formed by Pharma, biotechnology or by an investor.”

CIRM said Californians would benefit from "creation of an industrial stem cell therapeutic powerhouse that increases the likelihood of the commercialization of stem cell treatments for patients with unmet medical needs."

The other CIRM award rounds that are up for ratification later this month aim also at bringing stem cell therapies into widespread use.

The $15 million accelerating center round, which is open to non-California-based organizations, would fund the following activities:
  • “Regulatory management services (including IND preparation and submission)
  • “Clinical trial planning and management, including site selection, contracting, and clinical site management (e.g., patient recruitment and operational and logistical support)
  • “ Data management, biostatical and analytical services
  • “Provision of services to (CIRM’s) Alpha Clinics Network, CIRM-funded investigators and sponsors with translational and clinical stage projects, and clinical sites seeking to join the Alpha Clinics Network”
The translating center would fund the following activities:
  • “Project planning in coordination with CIRM and the Accelerating Center.
  • “Project management for pre-clinical IND-enabling development programs, including pivotal pharmacology and toxicology studies.
  • “Process development and product manufacturing activities suitable for production of cell products under good manufacturing practices (GMP).
  • “Assembly and authorship of documents to support IND submissions and FDA interactions.
  • “Development and execution of a business plan to sustain operations beyond CIRM funding.”

Thursday, May 16, 2013

The Klein Donation: Top Stem Cell Agency Execs, Lawyers Aware of Gift but Fail to Report It

A number of top level executives, in addition to six lawyers, at the California stem cell agency knew of Robert Klein's $21,630 donation in May of last year although they failed to report it to the agency's board as required by agency regulations.

As a result, the 29 directors were not aware of the gift when Klein, former chairman of the agency, appeared before them two months later and successfully asked them to override a grant reviewer decision rejecting a $20 million award to StemCells, Inc., of  Newark, Ca. It was the first time in the eight year history of the agency that its board had approved an application rejected twice by its scientific reviewers. The proposal had been given a score of 61 out of 100. The board rejected higher scoring applications in that particular round.

According to a person familiar with the agency, members of its executive committee, some of whom are lawyers, were aware of the Klein donation in May. Other lawyers not on the executive committee knew as well. Previously, it was not known that the donation was known so widely among CIRM executives and lawyers. It also was not clear that they knew that Klein intended to appear before the board in July. At the time of his donation, reviewers had already rejected the StemCells, Inc., application but it was not supposed to be publicly known.

Most of the CIRM executives and lawyers aware of the gift were also present at a public meeting of the CIRM board in May as well as July but did not alert the board to board to the donation.

Last week, an agency spokesman said the failure to report the Klein gift was  “due to the lack of additional donations, a transition in CIRM’s finance office and an oversight."

The board will be formally told of the gift at next week's board meeting, more than a year after it was made.

The donation by Klein, a Palo Alto, Ca., real estate investment banker, financed a trip by six CIRM science officers to Japan for an international stem cell conference. CIRM President Alan Trounson subsequently directed the officers to give special access to Klein, among other favors Trounson granted Klein. Two of the officers were heavily involved in the grant round that included the StemCells, Inc., application. The science officers participate in the application of the closed-door review process but do not vote on proposals. Trounson excused himself from participation in public discussion of the StemCells, Inc., application because of his relationship with the company's founder, researcher Irv Weissman of Stanford University. 

The board vote approving the application was a narrow 7-5. It is not clear whether the vote would have changed if the board had been informed publicly about Klein's gift. But it would have heightened concerns that Klein was using his six-year service as chairman of the agency plus the donation to sway the board, which rarely overturns the decisions of its scientific reviewers. CIRM directors go along with reviewer decisions on 98 percent of applications, according to agency calculations.

One of the votes in favor of Klein's position came from Art Torres, one of two vice chairman of the agency. Torres' state-required economic disclosure statements show that he received at least $31,000 from firms controlled by Klein during 2012 and 2011. Torres works four days a week for the agency, earning an annual salary of $225,000. Torres told the California Stem Cell Report that his vote had no connection to the consulting work he did for Klein's real estate firms.

Klein has denied any impropriety in connection with his donation. He has not responded to questions involving Torres.

Wednesday, May 15, 2013

Klein, StemCells, Inc., and $31,000 in Consulting Fees for Torres

The Robert Klein-StemCells, Inc., affair has taken another turn with the disclosure that a vice chairman of the California stem cell agency was paid at least $31,000 over a two-year period by Klein and also voted on behalf of Klein's effort to win approval of a $20 million award for StemCells, Inc.

Art Torres received what he reported were consulting fees during 2011 and 2012 from firms controlled by Klein, former chairman of the agency. In 2012, Torres backed Klein's efforts to override grant reviewers' rejection of the $20 million application from the Newark, Ca., publicly traded firm.

Art Torres, center, with Bob Klein, left, at Klein's last meeting in
2011 as chairman of the California stem cell agency.
 Incoming chairman Jonathan Thomas is at right. 
The 29-member board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, narrowly voted 7-5 last September for the award. It was the first time that the board has approved an application rejected twice by its scientific reviewers. It was also the first time that Klein has lobbied the board on behalf of a specific application since stepping down in June 2011. He was elected chairman in 2005 as the agency was just beginning its work and is an iconic figure to many in the California stem cell community.

Asked for comment last week by the California Stem Cell Report, Torres said,
"My decision to support an award to StemCells, Inc. to explore the use of neural stem cell transplantation to treat Alzheimer's disease was based on the merits of the application and the hope it offers to patients who suffer from Alzheimer's, a disease that affects millions, including Bob Klein's late mother. I have no financial interest in StemCells, Inc. nor does Bob Klein, and my decision to support the award has no connection whatsoever to the work I do with Bob Klein."
Kevin McCormack, senior director for public communications at CIRM, said that Torres' statement would be the only comment on the matter from the agency.

Klein did not respond to questions, declaring that personal issues were occupying his time.

The California Stem Cell Report's questions to all three dealt with the propriety of Torres' employment by both CIRM and Klein while Klein was asking the board to award a business $20 million. The governing board has a code of conduct that declares members should “maintain the highest standards of integrity and professionalism.” However, it does not speak to questions of appropriate employment by CIRM directors outside of the agency.

In January 2012, Torres authored a document discussing CIRM's conflict of interest rules. He said they are intended “to eliminate even the appearance of impropriety.” He also referred to CIRM's policy on “incompatible activities” for employees. It deals with activities that could “discredit” the agency or that are “inimical” to it. However, it does not specifically deal with the type of situation involving Torres and Klein, who is a real estate investment banker and attorney. The policy additionally does not address cases where a governing board member is also an employee of the agency.

Torres' economic disclosure statements, which are required by state law, contain only broad ranges for compensation, and the amount could be significantly higher than $31,000. Torres reported that in 2011 he was paid between $10,001 and $100,000 by both Klein Financial Corp. and K CP Cal, which share the same address as Klein's offices in Palo Alto. In 2012, Torres reported receiving between $10,001 and $100,000 from K CP Cal and between $1,001 and $10,000 from Klein Ventures LLC, which also has the same address.

Torres reported that the payments were consulting fees and that the firms dealt with real estate. He did not respond to requests for more details.

Torres earns $225,000 a year in his part-time role as one of two vice chairmen for the agency. Under the arrangement, he works four days a week.

Torres was chairman of the state Democratic Party and a longtime state legislator. He was nominated for vice chairman in 2009 by state Treasurer Bill Lockyer, among others.

Last week, another financial arrangement involving Klein surfaced in connection with the StemCells, Inc., application. Klein gave the agency $21,000 last May,two months before he pitched the board on the StemCells, Inc.,application. The donation was not reported to the board prior to Klein's appearances before the panel. The agency's regulations require such gifts to be reported to the board but do not specify a time frame. Following inquiries from the California Stem Cell Report, the agency said it would report the donation at the agency board meeting next week.

Klein's donation financed a trip by six CIRM science officers to Japan for an international stem cell conference. The agency directed the officers to give special access to Klein. Two of the officers were heavily involved in the grant round that included the StemCells, Inc., application, which scientific reviewers scored at 61 on a scale of 100.

Tuesday, May 14, 2013

Patient Advocate Reed Defends Klein Donation to Stem Cell Agency

The California Stem Cell Report today received the following email from Don Reed, a patient advocate, who has long been involved in California stem cell agency affairs. Reed is vice president of public policy for Americans for Cures Foundation, a position he has held for some years. Americans for Cures is the personal lobbying organization created by Robert Klein, former chairman of the California stem cell agency. Reed said his opinions below are his own and may or may not reflect those of the foundation.
“I must take issue with your entry, 'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May 05, 2013.
“When Bob Klein donated $21,630 to the California stem cell program (to allow scientists to attend a research conference in Japan) he was doing exactly what he always does: advancing research to ease suffering and save lives.  The scientists needed a way to attend a top-level conference. Believing in the benefits of researchers sharing thoughts, Bob paid for their trip.
“Unfortunately, your article appears to imply corrupt motivations.
“'A seemingly innocuous…gift…generated a wave of special favors for (Klein) that stretched out to include a gold mining multimillionaire from Canada.'.
A 'wave of special favors?'  The article states that 'Klein wanted to meet with the six science officers…'  and to get their impressions on the conference.
“Is that not natural? First, would it not be helpful to hear from the scientists if the trip was worth the time and expense? Second, Bob Klein works in real estate, a full-time job. He does not have the scientist’s automatic involvement to keep him up to speed on everything new in regenerative research. But he wants to know the latest: what is working, what is not. He is always eager for a chance to speak one-on-one with an expert.
“He met with a Canadian millionaire? Why is this shocking? The millionaire supports stem cell research; so does Bob. California is working closely with Canada on several projects; they pay their scientists, we pay ours; more bang for the buck. If there is a person with the resources and will to advance Canadian research, it is natural that Bob would want to develop a deeper interest in the shared research.
“And why should Klein be criticized for supporting a research project attempting to alleviate Alzheimer’s? He saw his own mother die of the disease, after losing the ability  to recognize her own son.  I am familiar with that particular Alzheimer’s project, and it had some amazing results, restoring memory to laboratory rats. This was a water maze test, and the rats recovered the memory of a pathway out of the water, which they had forgotten. To the best of my knowledge, no one else in the world had achieved memory return, and the project deserved the most serious consideration.  Yes, the board of directors voted against the Grants Working Group; it is not only their right but their responsibility to exercise judgment, and not merely be a rubber stamp for the GWG.
“There is also the matter of free speech. Anybody else in California can come to the meetings of the program and voice their opinion—why should Klein be denied the right to voice his opinion?
“Bob Klein owns no stem cell stock, no biomedical enterprises. Financially, supporting stem cell research has cost him a great deal. This is the man who led the fight to build the California stem cell program, donating roughly six million dollars, taking out loans on his house to help finance Proposition 71. And, for six years (without salary) he worked full-time as Chair of the Board of the oversight committee. Physically and emotionally, it has been an exhausting decade for him. He has not profited in any way, except to see the advancement of research for cure.
“Passing a $3 billion stem cell program in the midst of a recession was like relocating Mount Everest—seemingly impossible, but he did it anyway. He moved the mountain. Thousands of people helped, but one man made it possible. Without Bob Klein, California would not have the greatest stem cell program in the world: challenging diseases considered incurable since the dawn of time. That he should continue to support it, with his dollars, time, energy and creativity, is commendable.
“Sometimes a good deed is just that: no sinister motivations, no secret agendas-- just a positive action which benefits all.”  

Sunday, May 05, 2013

Cash and Favors: Robert Klein Gives $21,630 to the California Stem Cell Agency

A seemingly innocuous $21,630 gift to the California stem cell agency has kicked up new questions about a controversial $20 million research award and generated a wave of special favors for the donor that stretched out to include a gold mining multimillionaire from Canada.

Robert Klein
Elie Dolgin/Nature photo
The gift was made last May by Robert Klein, chairman of the stem cell agency from 2004 to July 2011, but has never been publicly reported to the agency's governing board as required by its own regulations. 

In July, two months after he donated the cash, Klein made an unusual appearance before his old board and  pitched it to override rejection by scientific grant reviewers of a $20 million application by StemCells, Inc., of  Newark, Ca.  The board subsequently asked for a reevaluation of the proposal, which was again rejected by reviewers. Klein persisted at a September meeting, and the 29-member board decided, on a 7-5 vote,  to go along with him. It was the first time in its eight-year history that the board has approved an application that was rejected twice by its scientific reviewers, who scored the proposal at 61 out of 100. 

Klein's donation to the agency, formally known as the California Institute for Regenerative Medicine (CIRM), included more than the cash, which financed trips to a prestigious stem cell conference in Japan for six of the agency's science officers in June 2012. He also arranged the waiver of roughly $3000 to $4000 for their registration fees for the annual meeting of the International Society for Stem Cell Research. Nine agency executives and other staffers were already attending at taxpayer expense, but the six could not attend because of travel budget cuts at the $3 billion agency. (The total of 15 amounted nearly one-third of the agency's staff.)

Klein's donation triggered a number of special favors from the agency, according to documents provided by CIRM to the California Stem Cell Report under a state Public Records Act request.  Klein wanted to meet with the six science officers, who have a wide range of responsibilities, including managing and developing grant and loan programs, participating in reviews of applications and evaluating research progress. CIRM President Alan Trounson obliged. At the meeting in Japan, the six science officers received a memo approved by Trounson instructing them to meet privately “one-on-one” with their benefactor and to give him special access to their activities. The meetings were actually scheduled to also include a third person, Rob McEwen,  who is one of the 100 richest persons in Canada, a $20 million donor to a stem cell center in Toronto and CEO of the gold mining company bearing his name.

The memo indicated that the science officers – all California state employees – should be helpful by identifying areas of “special importance” to Klein and “other donors.” The CIRM documents show no objection from the agency to instructions from another member of the public -- Klein aide Melissa King -- to provide her and Klein with written summaries about the science officers' activities at the convention along with “details” about their work at CIRM. Email addresses of the six were also provided to Klein, who may have additionally received their cell phone numbers although that is not entirely clear.

At Klein's request, Trounson also invited McEwen to a closed-door session in Japan involving the agency's international partners, a session at which presumably valuable, little known scientific information might be mentioned and future directions charted. Trounson specifically told McEwen in an email that it was Klein who asked that the executive be invited to the session.

Both the agency and Klein deny any wrongdoing in connection with the donation, which was the only private contribution to CIRM in the 2011-12 fiscal year. Both say there was no connection between the donation last May 16 and the StemCells, Inc., application, which was rejected by reviewers one month earlier during closed-door meetings April 18-20, 2012.

CIRM's gift regulations bar donations from persons who have applied for funding or who intend to apply for funding, but the rules do not speak to gifts from persons who lobby on behalf of funding for others. The rules require that the governing board of the agency be informed at a public meeting of gifts accepted by Trounson on behalf of CIRM. Trounson is required to identify the donor and conditions imposed by acceptance of the gift. Trounson did neither prior to Klein's appearance last July on behalf of StemCells, Inc.

At the July meeting, Trounson recused himself from public discussions of the StemCells, Inc., application, although he did not offer an explanation. However, his action was connected to his relationship with stem cell scientist Irv Weissman of Stanford University, who founded the publicly traded company, currently sits on its board and holds 124,608 shares of the firm. Trounson was a guest once at Weissman's ranch for four days in July 2011, CIRM said in response to a question this week.

In the wake of the California Stem Cell Report's inquiries, Kevin McCormack, the agency's senior director for public communications, said last week that the agency plans to report the donation to the governing board at its meeting in the San Francisco Bay Area later this month.

McCormack said the failure to report the donation prior to the board's consideration of StemCells, Inc.'s, application was “due to the lack of additional donations, a transition in CIRM’s finance office and an oversight."(See thefull text of McCormack's statement here.) 

Asked whether the agency is concerned about the appearance of Klein's donation and the subsequent board action, McCormack replied,
“No, the two items are entirely separate with no connection. Item 1  involved Bob Klein making a donation to allow science officers to attend a critically important scientific meeting on stem cell research.  The science officers had originally planned on attending but then were told they could not because of cuts in our out-of-state travel budget – Bob Klein’s donation, without using state funds, enabled the science officers to attend.  Item 2 is an ICOC (board) decision to fund a research project that they felt had promise and was important for the people of California.”
As for the special treatment of Klein in the wake of his donation, the agency did not respond to inquiries asking for an explanation.

Klein said in an email that his donation was not connected to StemCells, Inc. He said that as late as June he had “no idea” that the its application had been rejected by reviewers. Klein said that he committed to the donation in “April or May.”  (The full text of Klein's comments re the application can be found here and here.)

Prior to leaving CIRM in 2011, Klein was a non-voting  member of the CIRM grant review committee, which consists of out-of-state scientists and seven CIRM board members. His service on the committee included the period when it approved a planning grant for StemCells, Inc., to prepare its application for the $20 million.

Klein noted that he did not pick the six science officers for the Japan trip. One of them was the lead science officer on the award round involving StemCells, Inc. A second was also heavily involved, according to  the transcript of the July 2012 board meeting. Science officers, however, do not vote on or score applications. Klein characterized the CIRM staff as recommending against approval of the grant so “they were clearly not influenced” by his donation.

Klein said his meetings with the six science officers were aimed at determining whether they believed the cost of attending the stem cell convention justified what they learned at the meeting. He said a second goal was to aid universities and other researchers, mainly in Canada, “in advancing their contributions from an existing donor or donors.” Canada is one of CIRM's research partners.

Klein defended the involvement of McEwen, who Klein said has contributed to the stem cell group conducting the meeting. Klein said McEwen does not engage in technical discussions and added,
“On a conceptual basis it was important for him to understand the spectrum of medical advances towards therapies. His additional contributions to Canadian non-profits could assist Canada in collaborating with California on more international research, with California only funding the research done in California and the donor helping to fund the research done in Canada. No specific grant applications were discussed. Finally, the discussion with the international partners focuses on the funding process and funding collaboration it does not discuss any individual.”
Private funding of activities by state employees has stirred up controversy over the years in California. The most recent example was Gov. Jerry Brown's much-reported trip to China this spring, which was financed by private donations. Articles in the Los Angeles Times and The Sacramento Bee both noted that private funding arrangements have plenty of critics.

Columnist George Skelton of the Times wrote,
 “It just looks unseemly — a pack of lobbyists and other favor-seekers paying big bucks to traipse after the governor, schmoozing and gaining invaluable access.”
Reporter David Siders carried a quote in The Bee from Jock O'Connell, international trade adviser for the economics consulting firm Beacon Economics, who said,
“They're donating because they want to curry favor with the incumbent administration."
Asked whether CIRM planned to accept donations for trips in the future, McCormack replied that the agency is “always open to donations from generous supporters” provided they meet the state's legal requirements.


The Klein Donation: Text of Stem Cell Agency's Key Responses

Here is the text of the key comments from the California stem cell agency in response to questions from the California Stem Cell Report (CSCR) concerning the $21,630 contribution by Robert Klein. Here is a link to the full story on the matter.

CSCR to CIRM:
“Is CIRM concerned about the appearance created by the donation from Bob Klein to enable scientific staff to attend the ISSCR meeting in Yokohoma, coming one month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application and one month before the July Board meeting that led to the approval of the award?”(Editor's note: It was actually two months before the board meeting.)
CIRM's response:
“No, the two items are entirely separate with no connection. Item 1  involved Bob Klein making a donation to allow science officers to attend a critically important scientific meeting on stem cell research.  The science officers  had originally planned on attending but then were told they could not because of cuts in our out-of-state travel budget – Bob Klein’s donation, without using state funds, enabled the science officers to attend.  Item 2 is an ICOC decision to fund a research project that they felt had promise and was important for the people of California.”

CSCR to CIRM:
"Please explain why the agency could not finance the trip itself ."

CIRM's response:
"During the financial year 2011/12  the Governor's Office issued an Executive Order requiring state agencies, under the Governor's direct authority, to reduce out-of-state travel.  Although CIRM was not required to participate, we nevertheless imposed restrictions on out-of-state travel to meet the intent/spirit of the Governor's request.  Accordingly, we made a decision to reduce the number of our science staff who would be attending the  conference.  Bob Klein's donation made it possible for those staff to go." 

CSCR asked several questions re the failure to report the Klein donation to the board as required by agency rules.

CIRM's response:
“Under the Gift Policy, the President had the authority to accept Mr. Klein’s generous offer as a 'Direct payment or reimbursement by third parties for the costs of general operation or grant management administrative activities.' (Gift Policy, Sec. III(A)(2).)  Because CIRM receives gifts only infrequently, CIRM staff determined that it would be more efficient to report gifts to the Board on a semi-annual basis.  Mr. Klein’s donation was the first gift CIRM had received in some years.  Due to the lack of additional donations, a transition in CIRM’s finance office, and an oversight, CIRM staff has not yet presented a report including Mr. Klein’s gift.  Staff plans to report Mr. Klein’s gift as part of the finance report at the May Board meeting.  Because the President had the authority to accept the gift pursuant to section III(A)(2) of the Gift Policy, it did not require a commitment letter.  (See Gift Policy, Sec. III(C)(1) ['A Commitment Letter is not required for gifts described under III.A.2., 3. and 4.'].)  However, consistent with the policy, Dr. Trounson sent Mr. Klein a letter of appreciation, a copy of which we have already provided you.”

The Klein Donation: Text of Robert Klein's Comments on Special Treatment by CIRM

Here is the text of comments from Robert Klein, former chairman of the California stem cell agency, concerning his $21,630 donation to the agency and subsequent actions by the agency. Klein's comments May 1 came in response to questions from the California Stem Cell Report(CSCR) on April 30. The text of the inquiry from CSCR precedes Klein's response. Here is a link to the story on the matter.

CSCR to Klein:
"I have sent the following to CIRM asking for their response and am offering the same opportunity to you. Here is what I sent the agency:
'The documents that I have received so far show that after Klein gave CIRM $21,000 the agency instructed six of its science officers to give him special access to their activities and apparently did not object to additional instructions from another member of the public, Melissa King, to provide Klein and her with written summaries about their activities at the ISSCR convention and “details” about their work at CIRM. Email addresses of the six were also provided to Klein, who may have additionally received their cell phone numbers although that is not entirely clear. The CIRM documents show that the six were told to engage in one-on-one sessions with Klein, which actually included a third person, a wealthy Canadian mining company executive. One document indicates that the science officers should assist in fundraising for CIRM by identifying areas of “special importance” to Klein and 'other donors.'
"'Additionally, Alan Trounson, at Klein's request, invited the mining executive to a closed door session involving the agency's international partners, a session at which presumably valuable, little known scientific information would be discussed and future directions charted. Trounson specifically told the executive that it was Klein who asked that executive be invited to the session, adding to Klein's clout in any business or other dealings that Klein might have with the executive.'
My questions to CIRM deal with the special treatment that was provided in connection with your donation. I would ask you if you think that state agencies should provide this sort of extraordinary treatment for individuals who donate to the agency. At the very least, doesn't this raise questions about the integrity of the agency and doubts in the public mind about whether it can be fair and even-handed in its activities?
Klein's response:
"In April or May of 2012 I committed to contribute a charitable donation to CIRM to cover the travel costs for 5-7 additional science officers to attend the International Stem Cell Conference in Japan.  It is important to CIRM that their science officers understand the cutting edge research being developed around the world so that CIRM does not fund redundant research; but, to the contrary, the science officers understand how to create networks between California scientists and scientists in other foreign countries who are doing complementary research that can potentially accelerate the advancements of therapies for patients. I do not hold any financial interest in biotech companies. I have historically been involved in encouraging international collaboration to advance medical therapies; for patients, every day of delay in the development of a therapy is a delay they cannot afford. To conceptually document the value of additional scientists traveling to these meetings, it was discussed that there should be conceptual, bullet point summaries about the value for CIRM obtained through the scientists discussions at the international conference.  The idea was to create bullet points of information about a few of the most meaningful scientific concepts and contacts the science officers benefitted from each day of attendance at the conference. I did not participate in the selection of the science officers who attended and I did not play any part in determining what activities they participated in. There were two fundamental goals to the very short one-on-one sessions that were arranged at "down time" that would not conflict with their other activities. The first goal was to conceptually understand if each of the science officers believed that the benefit to the agency was sufficient to justify the cost of their attending, when considering the learning and contacts they had gained which might accelerate research and therapies for patients. The second goal was to assist universities and non-profits, principally in Canada - a research partner of CIRM - in advancing their contributions from an existing donor or donors.

"The Canadian mining executive had an important history in contributing to the International Stem Cell Society and to Canadian non-profit research institutions. This individual has an expert background in mining and a passionate personal commitment to medical research; but, he does not engage in technical discussions of research. On a conceptual basis it was important for him to understand the spectrum of medical advances towards therapies. His additional contributions to Canadian non-profits could assist Canada in collaborating with California on more international research, with California only funding the research done in California and the donor helping to fund the research done in Canada. No specific grant applications were discussed. Finally, the discussion with the international partners focuses on the funding process and funding collaboration it does not discuss any individual grants. The value of international collaboration and the benefits of collaborating with new international partners is discussed. Scientific theories and individual grants are not discussed and new scientific information is not presented. I attended this session of international partners to support international collaboration; again, I do not hold any financial interest in any biotech organizations. Additionally, I do not have any business or financial relationship with the Canadian mining executive. The Canadian executive, based upon family and friends who have had chronic disease, is a significant donor to non-profit research institutions in Canada. All of my activities, the donation and the encouragement to develop information to validate the future benefits of science officers traveling to international stem cell conferences were focused on benefitting California patients with chronic illness or injury and the agency formed through Proposition 71."

The Klein Donation: Trounson's Memo Instructing Six Staffers to Meet with Klein and Canadian Gold Mining Executive

Here is a copy of the memo that CIRM President Alan Trounson sent to six stem cell agency science officers after Robert Klein gave the agency $21,630.  The SO abbreviation refers to science officers.
CFP refers to collaborative funding partner, which are international partners with CIRM. Here is a link to a story on the matter.

The Klein Donation: Memo from Klein Aide to Six Stem Cell Agency Science Officers

Here is the email that Melissa King, an aide to Robert Klein, sent to the six science officers from the California stem cell agency. King was executive director of the CIRM governing board when Klein was chairman of the agency from 2004 to July 2011. Here is link to the story involving Klein's $21,630 gift to the agency.



Wednesday, July 06, 2011

Minimal Donor Restrictions on Use of Funds by CIRM

Reader Jim Fossett today raised a good point in connection with the use of donated funds by the California stem cell agency, some of which is going to pay the new chairman's salary.

Fossett said in a comment that donors may place restrictions on the use of their donations, which do not amount to a great deal of money relative to CIRM's $3 billion. (Fossett's full comment can be found at the end of the "private money" item.) The agency currently has about $2.8 million in donor funds on hand, but has committed $700,000 of that for an Institute of Medicine study of CIRM and $250,000 annually for the chairman's salary.

We asked CIRM's outside counsel, James Harrison, whether any donors had placed restrictions on the funds.

Harrison promptly replied,
"Some of the donors placed restrictions on the use of their funds. For example, donations from private foundations include a restriction on the use of funds for lobbying purposes. I don't recall any other restrictions."
The reason for the restriction on lobbying expenditures? Some nonprofits can endanger their nonprofit status if they engage in lobbying activities.

On another donated fund note, Nature magazine on June 29 carried a statement from Jonathan Thomas, the CIRM board's new chair, saying,
"CIRM has received close to $900 million in private donations above and beyond the money from private-bond proceeds."
We asked CIRM Communications Chief Don Gibbons about that figure. He replied,
"He(Thomas) was referring to the $880 million in donor and other leveraged funds that our 12 major facilities attracted. So, those were not donations to CIRM, rather donations to CIRM-backed projects that benefitted the state."

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