IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

The $3 billion California stem cell agency is laboring under a range of problems that include protection of its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month study said yesterday.

The performance audit by the Moss Adams accounting firm of Seattle, Wash., made 27 recommendations for improvements, including more effort to ease strain connected to the agency's controversial dual executive arrangement. The study said that the nearly eight-year-old agency has many "opportunities" to "enhance performance reporting and decision making, strengthen effectiveness and efficiency, retain essential human resources and leverage technology."

In response to the report, the stem cell agency said, "(M)anagement concurs with the findings and recommendations....The recommendations are focused and constructive. CIRM is already implementing many of these recommendations, and we will be investigating the others in the coming months."

The performance audit is the first ever made of the California Institute for Regenerative Medicine. The audit is required by state law and was commissioned by the agency at a cost of $234,944. For years, the agency for years had resisted calls for a performance audit until it sought legislative approval in 2010 for removal of a 50-person cap on its staff. Originally, the performance audit legislation would have put the study in the hands of the only state body charged with oversight of the agency and its board. CIRM, however, was successful in lobbying to have that provision removed.

The 54-page report identified once again a number of issues that have troubled the stem cell agency for some years. Moss made 12 top priority recommendations, many of which dealt with information technology and grants management. Many of the recommendations focused on providing better and faster information on performance outcomes, which the audit said has been slow to come and hard to generate.

The report said,

"Key performance information is not readily available to CIRM leadership and other stakeholders on an ongoing basis. CIRM board members and senior management do not receive regularly updated, enterprise-level performance information. The ability to evaluate performance against strategic goals is critical to effective leadership and program monitoring, evaluation, and reporting."

The audit stated,

"CIRM does not effectively communicate outcome-based performance internally or externally. As such, CIRM does not focus on performance metrics as part of its (staff) meeting process."

The report additionally said,

"CIRM does not have an integrated financial information system....The use of spreadsheets results in labor intensive processes to generate reports and respond to information inquiries, since data must be pulled from multiple spreadsheets, a process that may be prone to error. ...Spreadsheets are not linked to each other or a master report. CIRM does not have a comprehensive list of spreadsheets or instructions for how to maintain the files or generate reports from them."

Moss Adams said that CIRM needed to do a better job in "bond forecasting," a reference to the California state bonds that finance virtually every aspect of the agency's operations. CIRM directors were caught by surprise a few years ago when they suddenly learned the agency was up against a major cash crunch.

Some of the recommendations will require more work from CIRM grantees and their technology transfer offices in an effort to track intellectual property and grant outcomes. The report also recommended a speed-up in CIRM's review of progress reports from grant recipients, which have been lagging completion by several months.

The dual executive arrangement, which was written into law by Prop. 71, has troubled CIRM since nearly day one. CIRM's own external review panel also identified it as problem two years ago. The executive structure is virtually impossible to change because of the political difficulty in making alterations in the ballot initiative.

Moss-Adams said,

"The working relationship between the chairman’s office and the president’s office has vastly improved over the past year, but there are still opportunities for improvement."

The performance audit recommended,

"Make every effort to manage and operate as one cohesive organization, while recognizing the varying roles, responsibilities, and authorities that exist with positions in both the chairman’s office and president’s office."

One of the top 12 recommendations involved CIRM's public relations/communications effort. CIRM Chairman J.T. Thomas told directors last June that the agency was in a "communications war."

Moss-Adams said,

"CIRM does not have a communication plan, and there is lack of clarity on how to address mission-based communication to CIRM’s various target audiences, especially the general public....The best way to facilitate results-based communications is to 1) quantify goals and outcomes in CIRM’s strategic plan and 2) report on achievement of those goals and outcomes by enhancing CIRM’s annual report with additional performance-based information."

Another performance assessment of the stem cell agency is also underway. It is being conducted by the prestigious Institute of Medicine and is costing CIRM $700,000. That report is expected this fall.

CIRM's board of directors is scheduled to consider the Moss Adams report at its meeting May 24.

Our take: While the findings and recommendations of the performance audit were delicately worded in many cases, they brought out issues that need to be addressed, many of which have been around for a great deal of time. At their meeting next week, CIRM directors should act very directly on the recommendations. They can do that by requiring a written report each month from CIRM Chairman J.T. Thomas and CIRM President Alan Trounson on the specific steps that they are taking to implement the performance audit's recommendations. Otherwise, the inevitable drift will set in.

California Budget Slashing Misses Stem Cell Agency

The $3 billion California stem cell agency dodged the governor's financial knife today.

This morning, Gov. Jerry Brown announced sweeping cuts throughout California state government as he attempted to close a new, $15.7 billion deficit. A report in the Los Angeles Times said the governor was "grabbing any spare change available." But this afternoon, in response to a query, Kevin McCormack, CIRM's spokesman, said,

"The answer is no, we won't be affected."

The question arose because California's financial picture is much bleaker than it was just four months ago. And the stem cell agency's only real source of cash is money borrowed by the state -- general obligation bonds.

Under Prop. 71, which created the agency in 2004, the bond funds flow directly to the agency without intervention by the legislature or the governor. However, Brown has been chary of additional bond sales since they create an increasing burden in the form of interest costs. Those costs must be financed out of money that otherwise might go to the University of California, K-12 schools and medical help for the poor.

Under an agreement arrived at last year, CIRM has what amounts to a $225 million line of credit with the state, which should take care of its needs until January. The cash is coming from short-term borrowing by the state instead of bonds.

The Brown Administration has cut back on bond borrowing and intends to cut more this fall. According to the state Department of Finance, the cost of borrowing has declined $173 million this fiscal year, down to $5.2 billion. CIRM's share of the debt service is more than $200,000 a day.  

Correction

The StemCells, Inc., item earlier today incorrectly stated that the disease team applications will come before the board of the California stem cell agency later this month. In fact, they are scheduled to come up at the board meeting in late July.

StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

StemCells, Inc., said today it has applied for as much as $40 million in funding from the California stem cell agency for two projects dealing with Alzheimer's disease and cervical spinal cord injury.

The announcement came in a news release dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board of the $3 billion California stem cell agency. Funding for businesses in the disease team round is expected to come through a loan.

StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two applications to the California Institute of Regenerative Medicine (CIRM) for 'Disease Team Therapy Development Research Awards,' one for Alzheimer's disease and one for cervical spinal cord injury. A research award may be up to $20 million, payable over four years, to fund preclinical and IND-enabling activities with the aim of starting human clinical trials within a four-year window."

Applications in the round were reviewed behind closed doors in April. CIRM also has a policy of not releasing the names of applicants until its board acts and then only if an applicant is approved. CIRM says it does not want to embarrass firms that do not win approval. That includes individual researcher names as well as the names of such institutions as the University of California.

During discussion of grant applications by the CIRM board, directors are not told the names of the applicants, just the number of the application. If board members have conflicts of interest on specific applications, they are barred from voting on and discussing the application. The names of applicants have occassionally slipped out. Sometimes their identities can also be discerned by information contained in the summaries of the reviews of the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.

Most companies seeking funding from CIRM do not identify themselves in advance, although they do if they appeal a negative decision by reviewers. The board has ultimate authority for approval of grants but has almost never rejected a recommendation for funding by reviewers.

StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage of Salk and David Anderson of Caltech. Weissman and Gage have won substantial grants from CIRM. 

StemCells Inc.'s stock price closed at 92 cents yesterday. Its 52-week high was $8.20, and its 52 week low was 70 cents.

Here is a link to an analyst's report on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

Correction

The "stem cell lawyers" item May 9 incorrectly stated that CIRM is expected to have six lawyers on staff in the next fiscal year. The agency expects to have a legal team of six (four lawyers and two assistants). 

$2.4 Million for State Stem Cell Lawyers: Too Much or Not Enough?

The California stem cell agency is spending $2.4 million a year on lawyers, a figure that one agency director has described as "awfully bloated."

More than one dollar out of every ten that CIRM spends on its operations goes for legal advice, and the subject came up at a meeting last month of a meeting of its directors' Finance Subcommittee. The issue triggered a sharp exchange revolving around a proposal to hire an additional attorney to deal with intellectual property issues.

In the next fiscal year, the agency expects to have legal team of six (four lawyers and two administrative assistants) on board out of a total CIRM staff of 60. It also has three outside lawyers or firms under contract at an annual cost of $1.1 million. Overall, CIRM is spending 13 percent of its $18.5 million operational budget on legal matters. Its budget for legal services will increase $50,000 next year.

CIRM's proposed budget includes a cut in external legal contracts to help finance the addition of another staff attorney. Elona Baum, CIRM's general counsel, is also advancing an additional proposal this month that would pay for another staff attorney indirectly through CIRM loans to business, thus avoiding problems with the 6 percent legal cap on the agency's budget.

At the April 2 meeting of the Finance Subcommittee April 2, Art Torres, CIRM's co-vice chairman and an attorney himself, vigorously questioned the addition of another lawyer. In an exchange with Baum, Torres said,

"Well, wait a minute. We already have you. We have Ian. We have Scott. We have James. What more do we need to add more to our legal services budget, which looks awfully bloated."

Baum and CIRM President Alan Trounson defended the addition of a staff lawyer. Both cited the need to protect intellectual property and promote commercialization of CIRM-funded inventions. Trounson and Baum said grantee institutions are failing to do so. Consequently, they said, the stem cell agency is "at risk."

In one exchange, Torres said,

"There are current counsels within the UC and Stanford and USC that ought to be taking care of this for their grantees."

According to the transcript, Trounson replied,

"Well, they're not – you know, this is not being taken care of in a way which is -- which is -- which is reasonable to the organization here. and I think it's putting the organization at risk...."

Baum cited an "a very in-depth" memo that she said justified hiring an additional attorney. Following the meeting, the California Stem Cell Report asked for a copy of the memo.

It consisted of a one-page job description. Dated March 5, it was written by Baum and directed to Trounson. It described the duties of the new lawyer but not the justification for hiring the person. In addition to IP work, duties including 350 hours of work to "provide increased certainty of commercialization rights," 250 hours for due diligence in the grant award process, 200 hours of work on genomics and reprogrammed adult stem cell efforts. The memo calls for 690 hours on business transactions including 150 hours to administer the loan program and 200 hours on agreements with companies seeking to relocate to California.

Much of the committee discussion focused on the need for legal expertise on IP issues, which Baum said the agency lacked.

CIRM first took a crack at hiring an IP attorney in 2008, seeking both a consultant and a fulltime staff attorney. A fulltime staffer was never hired. However, Nancy Koch was hired as an IP consultant for six months at $150,000 and has been with the agency since. Koch was deputy general counsel of Chiron Corp. and its successor Novartis Vaccines and Diagnostics, Inc. During 11 years at Chiron/Novartis, Koch was responsible for a wide range of intellectual property matters including litigation and licensing. Her current contract is for $250,000 for a year but would be reduced to help provide cash for a staff attorney. Baum said last month that Koch is primarily involved now with collaborative arrangements with other countries.

Our take? It is commonplace to be critical of lawyers, their profession and their numbers. CIRM, however, is an unprecedented agency operating in uncharted scientific waters with an enormous reponsibilility for generating a return for the state. It is engaged with firms that will be negotiating aggressively to cut the most beneficial deal possible for themselves – not for California taxpayers, who are paying the freight. CIRM must protect the state's interests. And first-rate IP lawyers do not come cheap. In 2008, the agency was lowballing when it offered $150 an hour. If CIRM fails to generate a financial return for the state, critics are sure to say that it was overmatched legally when it dealt with the private sector. On the other hand, the agency is sure to be battered by contemporary critics for its battalion of barristers.

The issue of a new hire went unresolved last month, and it was turned back to a handful of directors and staff to solve. CIRM directors will deal with it again at their meeting later this month.

A final footnote: Philip Pizzo, a CIRM director and dean of the Stanford medical school, was part of the meeting during which Trounson identified Stanford as failing to take of care of some of its IP responsibilities. Pizzo said towards the end of the meeting, "If Stanford is going to be referenced, we ought to be clear that we've got all the facts correct about what Stanford does or doesn't do."

Pizzo said Stanford does a "great job."

(An earlier version of this item said incorrectly said that CIRM would have six lawyers on staff next year.)

Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

The California stem cell agency is in the midst of making significant changes in its lending regulations, but says it is not part of an effort to transfer a $25 million loan to Geron to another company.

That does not mean, however, that the agency is not going to transfer the loan at some point. CIRM says it already has the authority to do so.

Talk has surfaced from time to time at CIRM meetings about the likelihood of helping to continue with the hESC clinical trial that Geron abruptly abandoned last fall. The surprise termination of Geron's hESC program came only a few months after CIRM and Geron signed a $25 million loan agreement in August. Geron is trying to sell off its hESC business, although Geron's hESC team has already left the company, according to industry reports.

Modification of the CIRM loan regulations has been underway for some time. Tomorrow the CIRM directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.

Some of the changes deal with relinquishment and transfer of loans. The modifications explicitly give CIRM President Alan Trounson the ability to transfer a loan without having to go through additional reviews or seek board approval. Other changes are also designed to clarify and remove ambiguities in the transfer arrangement, which may well be necessary in order to make a transfer acceptable to a buyer of the Geron assets.

Geron paid off the loan last fall but it is not clear whether that action would preclude a transfer. At one point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is currently involved. Geron has hired  Stifel Nicolaus & Co. to help peddle the hESC business.

CIRM's loan changes are complex. The agency has not yet put together in one place a straightforward rationale and explanation of all the modifications. Nonetheless, biotech and stem cell firms should pay close attention to the proposals. They could mean the difference between the infusion or loss of millions for a company's research.

The proposals are expected to go before the full CIRM board later this month. Then they will be subject to the state's administrative law process, including a period for public comment.

Tomorrow's meeting has public teleconference locations in San Francisco, Los Angeles, La Jolla and two in Irvine. Specific addresses can be found on the agenda.

Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency

A "special advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a firm that is sharing in a $14.5 million grant from the state research enterprise.

She is Saira Ramasastry, managing partner of Life Sciences Advisory, LLC, of Emerald Lake Hills, Ca., and who also has worked as a consultant to Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010, when she served as a consultant for the panel that CIRM hired to review its operations. The panel strongly recommended that CIRM engage industry more warmly. Since then Ramasastry's contracts with CIRM have totalled $65,000. Her current $25,000 contract describes her work for CIRM as "industry analysis and consultation."

Ramasastry's website says she serves as "a special advisor to CIRM in industry engagement initiatives and strategic projects." Her firm also offers expertise to life sciences firms in "strategic alternatives advisory, strategic options analysis, tailored business development solutions and innovative financing strategies."

In a news release April 30 announcing her nomination, Sangamo said Ramasastry has worked as a consultant to the Richmond, Ca., company. William Ringo, chairman of Sangamo's board of directors, said,

 "Saira's extensive experience in global healthcare investment banking and strategic advisory consulting will bring valuable financial, commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing in a $14.5 million, four-year grant from CIRM with the City of Hope in Los Angeles dealing with an AIDS- related lymphoma therapy. The grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice president for research and development, said the effort is due for an evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

Sangamo's board is scheduled to vote on Ramasastry's nomination on June 21. 

The California Stem Cell Report has asked Ramasastry if she has any comment for publication. We are also querying CIRM and Sangamo. Their comments will be carried verbatim when we receive them.

Our take? Ramasastry's consulting work with both CIRM and Sangamo demonstrates again the tiny size of the world of stem cell science. It also raises questions about conflicts of interest involving CIRM and industry. Can a consultant in such a position serve two masters and serve them both equally well? CIRM's interests are not necessarily the same as Sangamo's, which is a publicly traded firm working diligently to generate profit and financial returns for its shareholders. To do that, it needs capital from its financial "backers," including CIRM. The stem cell agency, however, is in the business of getting the results that it wants from Sangamo. If not, the grant can be cancelled. Working for both the stem cell agency, whose paramount obligation is to the people of California, and a recipient of the agency's millions is incompatible.

Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure

A key panel of directors of the $3 billion California stem cell agency yesterday voted unanimously to retain full public disclosure of the financial interests of its directors and top executives.

The director's Governance Subcommittee bypassed a proposal that would have substantially weakened disclosure at a time when the agency is moving closer to industry in an effort to develop cures.

"Because of CIRM's unique mission and the agency's longstanding commitment to transparency," said Kevin McCormack, the agency's spokesman, "they believed that CIRM should continue to set an example by requiring the broadest disclosure of members of the board and high level staff."

Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the rejected changes, disclosures would have instead been required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." 

The proposed changes would also have relieved CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.

The subcommittee's action will go before the full CIRM board later this month, where it is expected to be ratified. 

Our take? The Governance Subcommittee took the right action and is to be commended for going beyond the letter of the law. The integrity and credibility of CIRM are paramount. As the California Stem Cell Report wrote last week, narrowing disclosure would only have engendered suspicion and unnecessarily raised questions about the conduct of the agency as it embarks on an aggressive push for stem cell cures.

Researcher Alert: First Look at Proposed Rules for California's Stem Cell Bank

The California stem cell agency today unveiled initial details of how it plans to run its $30 million bank of reprogrammed adult stem cells.

The proposed regulations are the first step this year in the $3 billion agency's project to make IPS cells available worldwide at low cost. It is part of an effort to stimulate the science and develop commercial cures by removing research roadblocks.

As Amy Adams, CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system for stem cells – except we don’t want the cells back."

The agency expects to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by the CIRM board no later than Feburary of next year.

To clear the way for the first round, CIRM plans to revise its IP regulations to ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors' IP/Industry Subcommittee next Tuesday. The six-member panel is co-chaired by co-chaired by Stephen Juelsgaard, former executive vice president of Genentech, and Duane Roth, CEO of Connect in San Diego, a nonprofit that supports tech and life sciences entrepreneuers. Sites where the public can participate in the meeting will be available in San Francisco, La Jolla, Los Angeles and two in Irvine.

Under the new IP rules, CIRM will retain ownership of the cells in its bank instead of the grantee, as the current IP rules state.

In a memo to directors, Elona Baum, general counsel for the agency, said,

"This permits CIRM to have complete control of this valuable resource and is consistent with the practice of NIH’s Center for Regenerative Medicine which is also creating a repository for iPSC lines and derived materials."

Baum also said,

"The (current) IP regulations were drafted to address conventional drug discovery activities and did not contemplate creation of a comprehensive repository of cell lines intended for broad distribution. As a result, the IP regulations contain a number of provisions which are either not applicable or worse could impede the success of the hiPSC bank. For instance, IP regulations permit the exclusive licensing of CIRM funded inventions and technology. This would be counterproductive to the goals of the hiPSC repository which are predicated on wide spread access."

Baum provided the following summary of the $30 million banking initiative:

"These lines will serve as valuable tools in drug discovery and will be available to researchers worldwide. The Tissue Collection RFA No. 12-02 will fund clinicians and other scientists to identify, recruit and consent sufficient numbers of affected individuals within a disease population so as to effectively represent the disease’s manifestations. Tissues will be collected and appropriate clinical, medical or diagnostic information, will be obtained to enable informed discovery of disease-related phenotypes and drug development activities using hiPSC-based models. These tissue samples will be provided (without charge) to the recipient of the CIRM hiPSC Derivation Award (RFA No. 12-03) for the production of the hiPSC lines. Once derived, characterized and released, the lines will be deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses for the public meeting locations can be found on the agenda.

ACT and CIRM Together on Eye Research Webinar

Executives of Advanced Cell Technology, which has been repeatedly rejected for funding by the $3 billion California stem cell agency, will participate this week in the agency's Internet "webinar" on research involving the human eye.

ACT, which is engaged in the only hESC clinical trial in the nation, was held up earlier this month (see here and here) at an Institute of Medicine hearing as a prime example of the California's agency's failure to fund the stem cell industry in any significant way.

Gary Rabin, CEO of ACT

Nonetheless, three ACT execs are scheduled to be online for the CIRM session on Wednesday: Gary Rabin, the CEO of ACT; Matthew Vincent, director of business development, and Edmund Mickunas, vice president of regulatory affairs. The webinar will deal with regulatory issues with the FDA and clinical trials involving the eye.

Also on the panel are Samuel Barone, medical officer with the FDA, and Mark Humayun, professor of opthamology at USC, who is the PI on a $16 million macular degeneration grant from CIRM.

So what is the significance of ACT's participation in the CIRM event? If the relationship between ACT and CIRM has been touchy, this sort of cooperation is probably a good sign for both. For one, CIRM could have hardly staged the webinar without ACT, given the subject matter. But if the agency did not want to engage ACT, it could have simply done nothing about setting up a webinar in which the firm would participate.

Does this mean that ACT is going to receive a handsome grant or loan from CIRM? CIRM has established procedures (RFAs, peer review, etc.) for approval of funding, and ACT would have to go through that process unless CIRM does something very unusual.

Wednesday's event is aimed at researchers and is likely to be technical. Persons interested in taking part must register in advance.

California Stem Cell Agency Wants to Weaken Financial Disclosure for Execs and Board

The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.

The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort's existence.  CIRM's dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.

The proposed changes will be considered next Thursday by the CIRM directors' Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.

Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." CIRM offered no explanation of what it means by "of the type to receive" funds from the agency.

The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM's changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.

The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that "all" investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative's intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.

The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research. While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point

Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM's new senior director of public communications and patient advocate outreach, replied that the changes were "proposed" by the state Fair Political Practices Commission, which oversees state disclosure laws.

He said the FPPC says agencies "should tailor their disclosure categories to type of work performed by the agency." McCormack cited as examples the State Board of Education and the state retirement system.

As for the specific changes in CIRM's code, McCormack said,

"Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate."

McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)

The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM's new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.

Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.

Text of CIRM Response on the Weakening of Financial Disclosure Requirements

On April 24, the California Stem Cell Report asked the state stem cell agency about its proposed changes in its requirements for financial disclosures from its officials. Here are the key elements from that query with the stem cell agency's response following.

The agency was invited to respond to the following: "The new code appears to give discretion to the employee to determine what enterprise is 'the type to receive grants or other monies' from CIRM. Additionally, it would not appear to require disclosure of an investment with or income from, for example, Kleiner Perkins, which is a major investor in iPierian, which holds $7 million in CIRM grants and could well be a future applicant...(T)he weakening of the code comes at a time when the agency is moving to cozy up to industry and looking to raise funds to continue its existence, all of which raises even greater conflict of interest issues than earlier in CIRM's existence."

Here is the text of the response April 25 from Kevin McCormack, CIRM's new senior director for public communications and patient advocate outreach.

"In answer to your question, we are proposing changes to the Conflict of Interest Code based upon recommendations from the California Fair Political Practices Commission (FPPC). The Political Reform Act requires state agencies like CIRM to review their Conflict of Interest Codes every two years.  The FPPC, which is charged with enforcing the Political Reform Act, is responsible for reviewing and approving CIRM's Conflict of Interest Code.  In preparation for this review, CIRM's counsel met with the FPPC staff who suggested the proposed amendments which are the subject of the upcoming Governance Subcommittee meeting.  The proposed amendments to CIRM's Conflict of Interest Code are consistent with the FPPC's position that agencies should tailor their disclosure categories to type of work performed by the agency.  For example, CalPERS's conflict of interest code requires CalPERS officials to disclose investments in, and income from, entities that are of the type with which CalPERS contracts and entities in which funds administered by CalPERS could be invested.  Likewise, the State Board of Education requires its members to disclose investments, business positions, and income from a publisher, manufacturer, or vendor of instructional materials, or services offered to educational institutions in the State of California and investments, positions of management and income from any private school in the State of California.  Similar to these codes, the FPPC proposed that CIRM's Code be tailored to the nature of CIRM's work.  Thus, the FPPC proposed that CIRM require its board members and high-level employees to disclose investments in, and income from, entities that are of the type with which CIRM would contract or from which CIRM could procure goods or services as well as investments in, and income from, biotech and pharmaceutical companies.  Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate.  It is important to remember, however, that this is a preliminary proposal.  CIRM will seek input from the Governance Subcommittee, the Board, and members of the public before seeking approval of the amendments."

California Stem Cell Agency Launches $30 Million Plan to Lure Industry

Just one week after the $3 billion California stem cell agency was sharply criticized for its failure to adequately support biotech firms, the agency formally kicked off a $30 million effort to engage industry more closely.

The initiative, in the works since the middle of last year, was heralded as the beginning of a "new era" for CIRM, which is moving to transform into cures the stem cell research it has funded over the last seven years. The agency has scheduled a webinar for April 25 for prospective applicants.

CIRM's press release, crafted by the agency's new PR/communications director, Kevin McCormack, yesterday quoted CIRM President Alan Trounson as saying,

"This initiative is a major new development in the progress towards providing new medical treatments for patients by engaging the most effective global industry partners."

Elona Baum, the agency's s general counsel and vice president of business development, said the program "represents a new era for CIRM."

Under the RFA, the agency will award up to $10 million each for three grants or loans. The program, however, is not limited to businesses. Non-profits may apply as well. Representatives from industry have complained about a strong tilt on the part of CIRM towards academic and non-profit research enterprises. The CIRM board is dominated by representatives from those two sectors.

The program grew out of recommendations in November 2010 from an "external review" panel put together by CIRM that said the agency needed to do better with business. The refrain was heard again directly from stem cell firms at last week's hearing by the Institute of Medicine on the stem cell agency's performance. According to CIRM's figures, businesses have received $54 million in grants and loans since 2005, the first year the CIRM board approved grants, out of a total of $1.3 billion.

Only one news outlet has written a story so far about the posting of the RFA and the press release, as far as can be determined.

Ron Leuty of the San Francisco Business Times said,

"The most likely candidates to attract industry funding would be CIRM’s 'disease team' grant winners, who face a deadline of 2014 to bring a project to the point of first-in-human clinical trials. CIRM has weighed options for pushing those projects — there are 13 of them now — deeper into the FDA approval process."

CIRM said in the RFA material,

"The intent of the initiative is to create incentives and processes that will: (i) enhance the likelihood that CIRM funded projects will obtain funding for Phase III clinical trials (e.g. follow-on financing), (ii) provide a source of co-funding in the earlier stages of clinical development, and (iii) enable CIRM funded projects to access expertise within pharmaceutical and large biotechnology partners in the areas of discovery, preclinical, regulatory, clinical trial design and manufacturing process development.

"This initiative requires applicants to show evidence of either having the financial capacity to move the project through development or of being able to attract the capital to do so. This may be evidenced by, for example, (i) significant investment by venture capital firms, large biotechnology or pharmaceutical companies and/or disease foundations; or (ii) a licensing and development agreement with a large biotechnology or pharmaceutical company or a commitment to enter into such an agreement executed prior to the disbursement of CIRM funding.

"The objective of the first call under this initiative, the Strategic Partnership I Awards, is to achieve, in 4 years or less, the completion of a clinical trial under an Investigational New Drug (IND) application filed with the Food and Drug Administration (FDA)."

CIRM has scheduled a webinar on the RFA for prospective applicants for next Wednesday, April 25. It is asking for registration and questions in advance.



(Editor's note: An earlier version of this article did not contain the sentence about businesses receiving $54 million out of $1.3 billion awarded by CIRM.)

CEO of Biotime's Comments on Stem Cell Agency and Development of Therapies

Michael West, CEO of Biotime, Inc.of Alameda, Ca., has published the text of his prepared remarks to the Institute of Medicine panel examining the performance of the $3 billion California stem cell agency.

Here is one excerpt from the statement by West, who was also CEO at Advanced Cell Technology and founded Geron.

"To put it simply, stem cell research by itself will not lead to cures. Research and DEVELOPMENT leads to cures. In my opinion, if CIRM fails to deliver on its goal to deliver cures, it will not be a result of internal governance issues. Instead, it will be a result of inefficient capital allocation. A graphic way of visualizing my point is to say that CIRM has historically funded primarily research, and little product development, i.e. large “R” little “d”. Approximately 5% of CIRM’s expenditures have been allocated to biotechnology and health science entities whose expertise is product development, and 95% has been allocated to nonprofit institutions in the state for basic research. Human therapeutic product development in the United States requires a very intense and expensive process for approval that is primarily focused on development side of the equation. In this respect, therapeutic approvals differ significantly from the discovery and development of silicon-based technologies that have been so successfully commercialized in California."

Here is a link to the full text of what West posted on the Biotime web site.

Correction: ACT Not Rejected 15 Times by California Stem Cell Agency

A venture capitalist who said earlier this week that the California stem cell agency rejected 15 grant applications from Advanced Cell Technology this afternoon retracted the statement, which he said was incorrect.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, said in an email,

"Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the principal investigator was substantially below 15."

Bonfiglio made the assertion Tuesday at a meeting of the Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency, which has been criticized for its lack of funding of biotech firms.

Here is more of what Bonfiglio had to say in his email this afternoon,

"Unfortunately, your California Stem Cell Report posting on April 11 contains some inaccurate information, for which I appear to have been the source.  As you will recall, I stated during the IOM Panel that Advanced Cell Technology had submitted multiple applications for funding from CIRM, but had been unsuccessful in obtaining any funding from CIRM.  I also stated that ACT had been involved in “15 grant applications” to CIRM.   You highlighted that number in your April 11 California Stem Cell Report posting.   Unfortunately, that number is not accurate.  Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the Principal Investigator was substantially below 15.   The number I quoted in the IOM Meeting on April 10 included applications in which ACT had some involvement, but was not the lead principal Investigator.  ACT has filed several applications for CIRM funding as the lead PI, but the number of CIRM applications in which ACT was the lead PI was far below 15.   Moreover, some of ACT’s direct applications for CIRM funding were withdrawn by ACT, rather than denied by CIRM.

"I would request that you correct this inaccuracy regarding ACT's applications for CIRM funding as soon as possible.  I'm sure you will agree that the regenerative medicine community, and the general public, have a real and significant interest in obtaining accurate information about developments at CIRM, and that the publication of inaccurate information is a tremendous disservice to all involved.  More importantly, ACT is a publicly traded company and the publication of inaccurate information regarding ACT, its technologies, or its funding could have adverse consequences for the company.   Furthermore, as an active participant in the regenerative medicine community who has spent his professional career developing a reputation for honesty, accuracy, and integrity I am very concerned that I might be the source of inaccurate information regarding developments within the field of regenerative medicine.  For these reasons, I would ask that you retract the statement in your April 11 Blog posting that ACT was 'rejected 15 times for funding' by CIRM, and that you refrain from making any other statements to that effect.

"I appreciate your cooperation in this regard, and I would request that you move quickly to correct the inaccuracy in your April 11 Blog posting.   As I am sure you are aware, information in blog postings is sometimes picked up by more traditional media, and I would not want any republication of this inaccurate information regarding ACT’s grant applications to CIRM."

At the time Bonfiglio made his comments concerning ACT, top officials of the stem cell agency were in the room, but did not make any statement concerning his assertion. On the morning of April 11 prior to publication of the item, the California Stem Cell Report asked ACT for comment .

No response has been received from ACT about the figure. CIRM also has not commented since the item appeared.

California Stem Cell Agency Cited for Improvements in Transparency

IRVINE, Ca. – The $3 billion California stem cell agency was praised this week for making progress in accountability and transparency during the last year.

The comments came from a representative of California state Controlller John Chiang, the state's top fiscal officer and who also chairs the only state entity specifically charged with financial oversight of the stem cell agency and its board.

Ruth Holton-Hodson, deputy state controller, told the blue-ribbon Institute of Medicine panel examining the performance of the stem cell agency that the controller's office "would like to acknowledge the progress the new leadership has made in the last year towards making CIRM a far more transparent and accountable agency than it has been in the past."

CIRM has a new chairman, J.T. Thomas, a Los Angeles financier, who has been in place since the beginning of last July. He succeeded Bob Klein, who was the initial agency chairman and who took office in 2004.

In her testimony at the IOM hearing here on Tuesday, Holton-Hodson discussed previous problems that CIRM had with the transparency of its budget. She said,

"We are very pleased that CIRM’s new leadership recognized this as a problem and quickly adopted a much more transparent budget format which is broken down by function. To make CIRM’s expenditures as transparent as possible, we have also recommended that they post the annual budget on the website. Again, we’re pleased to say that the new leadership has agreed to do this."

She also said,

"At our most recent meeting (of the Citizens Financial Accountability and Oversight Committee), we also recommended that CIRM post all of its private donations and they have agreed to do this."

Holton-Hodson criticized the dual executive arrangement at CIRM that is written into law by Proposition 71. She said,

"It is difficult to uphold the appearance of accountability and objectivity when the board chair has direct line authority over some CIRM staff positions. In essence under the current model, the chair is responsible for evaluating and approving some of the work of the chair.

"While this issue is still outstanding, it is important to acknowledge that the current leadership has made significant progress in more clearly delineating the responsibilities of the chair and the president."

Here is the full text of Holton-Hodson's remarks.Statement from California state controller's office to IOM-CIRM panel April 10, 2012

California Stem Cell Agency Nixes ACT Grant Applications 15 Times

(Editor's note: The assertion in this item that 15 applications by ACT were rejected by the California stem cell agency is incorrect, according to the venture capitalist who made the statement. He retracted it on the afternoon of April 12. His explanation can be found here. )


IRVINE, Ca. --The only firm in the nation conducting an ongoing hESC clinical trial has been rejected 15 times for funding by California's $3 billion stem cell agency.

The figure was reported yesterday at a hearing by the blue-ribbon Institute of Medicine panel looking into the performance of the stem cell agency, which has been sharply criticized in recent years for its paucity of industry funding.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, a stem cell venture capital firm in Portola Valley, Ca., disclosed the grant attempts by Advanced Cell Technology, whose nominal headquarters are in Santa Monica, Ca. Bonfiglio indicated that it was a high profile example of how CIRM is not taking the necessary steps to fulfill its goal of developing therapies that actually reach the clinic.

He noted that ACT received national attention in January when it posted favorable findings for its clinical trial at UCLA dealing with blindness but that the firm was still unable to win a CIRM grant over the last several years.

ACT had moved much of its operations to California in the wake of passage of Proposition 71, the measure that created the state's stem cell research effort in 2004. It has since re-centered its operations in Massachusetts.

The California Stem Cell Report has queried ACT on its grant efforts and will carry its response verbatim when it is received.

Another firm, which cannot be identified, said privately yesterday that it was rejected 14 times.

According to our calculations based on figures this morning on the CIRM web site, businesses have received only $54.3 million in grants and loans during the last seven years, 4 percent of the $1.3 billion awarded. However, the CIRM list slightly understates the industry total. At least two other firms are sharing in two $20 million grants involving academic institutions, but are not noted on the list.

Yesterday's IOM meeting was the second and final California public session for the CIRM inquiry. Most of the day was occupied by a variety of critiques of the organization. The panel has already heard extensively from the agency itself and beneficiaries of its grants. The IOM report is expected in November.

Harold Shapiro, chairman of the panel and former president of Princeton University, described yesterday afternoon's panel involving stem cell business executives as "one of the more interesting" of the day.

One of the speakers was Michael West, CEO of Biotime in Alameda, which has received $4.7 million from CIRM. West, the founder of Geron, was also head of ACT when it moved it to California. He said CIRM had several "blind spots," including misconceptions about how products are made. For example, West said, CIRM's performance indicates that it does not fully understand that development leads directly to cures -- not research.

West said that if the high tech industry had to rely on CIRM-type funding years ago, laptops and iPads would still be in the lab instead of the marketplace.

The business industry representatives said that creation of CIRM has been beneficial for stem cell  research, but cited a number of deficiencies in connection with industry applications.

In some ways, their comments echoed past remarks by several CIRM board members, who have expressed concern about the lack of funding for industry, as well as those of the agency's own external review panel. One issue raised by those CIRM directors has been the lack of grant reviewers with product development and industry expertise.

At yesterday's hearing, Gabriel Nistor, vice president of research and development at California Stem Cell in Irvine, said, it is "exceedingly rare to find academics (grant reviewers) that understand the complexities" involving industry. Nistor said his firm has applied for a "few" CIRM grants. None have been awarded.

Also speaking was Allan Robins, CEO of Viacyte in San Diego, who said his firm has done well with CIRM funding. It has received $26.2 million, nearly all of it in the form of a loan. But he said companies develop products – not academia.

Center for Genetics and Society: 'Wrong' to Ask for More Billions for Stem Cell Agency

IRVINE, Ca. – The Center for Genetics and Society today said it would "wrong" to ask the people of California for more money to continue financing stem cell research at state expense.

Marcy Darnovsky, associate executive director of the Berkeley, Ca., non-profit group, addressed a blue-ribbon Institute of Medicine panel evaluating the performance of the $3 billion California stem cell agency, which is financed by money borrowed by the state. The agency is expected to run out of cash in about five years.

Darnovsky said,

"In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding 'would be premature at this time,' but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important."

Representatives of the stem cell agency were present at today's hearing on the UC Irvine campus, but did not speak publicly at today's session. CIRM officials, however, have testified before the panel on two other days of public hearings. The agency is paying the IOM $700,000 to conduct the study. Its results and recommendations are expected to be published in November.

Darnovsky and others testifying at the morning session were critical of the agency's lack of accountability, built-in conflicts of interest and immunity from normal government oversight (see here and here).

Darnovsky said, "

The requirement for 70% super-majorities (to change the law regarding CIRM) means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

"Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues."

Here is the full text of Darnovsky's comments.
Center for Genetics and Society statement to IOM-CIRM panel, April 10 2012

The Search for Stem Cell Cures: Can California's $3 Billion Agency Move Audaciously?

IRVINE, Ca.-- California's unprecedented stem cell research effort faces a tight timetable for making major progress in fulfilling promises to voters seven years ago, complicated by potential conflicts of interest, a blue-ribbon panel was told this morning.

David Jensen, editor of the California Stem Cell Report, made the comments to the Institute of Medicine panel looking into the performance of the $3 billion California Institute of Regenerative Medicine.

The panel's inquiry comes as the agency is re-evaluating its strategies as it faces loss of funding in about 2017.

Here is the full text of Jensen's statement.
Statement to IOM-CIRM Panel by California Stem Cell Report April 9, 2012


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