Potential Death of California Stem Cell Program Hangs Over Its Performance Evaluation

The looming demise of California's $3 billion stem cell research effort dominated today's meeting of its governing board, which was told both that the agency has made "incredible progress" but needed to do better.

The occasion was the presentation of a $230,000 performance audit required by state law, a task performed by the firm of Moss Adams, one of the largest accounting and consulting firms in the world.

The firm's 38-page report targeted fund-raising, retention of staff and better utilization of board members in its recommendations for improvement and called for a more concrete plan for raising more than $200 million. Excerpts from the report can be found here and an earlier story on the audit findings here.

In its oral presentation, Moss Adams representatives had a number of good things to say about the stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). They cited the agency's "incredible progress" and said "we usually see a lot of good things here."

It was the third go-around for Moss Adams, which has performed all three of the CIRM performance audits. (See this for links to the previous audits.) Today's presentation, however, focused more on the issues surrounding the agency's end within a few years, unless ambitious fundraising plans are successful.

The agency expects to run out of cash for new awards next year unless it is successful at raising $200 million from private contributors. That would take care of the agency's needs until a possible $5 billion bond measure might be approved by California voters in 2020.

One board member, Jeff Sheehy, also a member of the San Francisco board of supervisors, raised a number of critical questions, seeking more details about the fund-raising effort. He said there seemed to be a "lot of uncertainty" about it.

Jonathan Thomas, chairman of the agency, said a fund-raising plan is in place. He is leading the effort and being assisted by two other employees. He said some board members have been engaged and he plans to consult with all 29 board members.

David Higgins, a board member from San Diego, asked Thomas about a "double-edged sword" that could come into play because of a successful fund-raising effort. Higgins said the public might be more likely to oppose to a new bond measure if the $200 million is raised, reasoning that public funding was not needed in light of private support. Thomas said he did not think that was a major problem.

The Good and the Not-So-Good: Excerpts From an Evaluation of the California Stem Cell Agency

The latest performance audit of California's $3 billion stem cell agency reports both pluses and minuses on the agency's work. Here are some excerpts from the $230,000 study, the third such audit of the California Institute for Regenerative Medicine (CIRM).

"CIRM has a collaborative, engaged, and performance-oriented culture. Managers, Board members, and staff report improved morale and a more collaborative culture since CIRM 2.0 implementation. CIRM appointed a new president in 2014 and again in 2016. Turnover is often elevated during times of leadership transitions, as noted in 2014 and 2015. However, CIRM’s turnover rate dropped to 10 percent in 2016, suggesting stability in the organization’s leadership and culture."

"CIRM’s uncertain future funding results in employee concerns related to job security. These concerns can, in turn, translate into poor employee morale and reduced organizational productivity. Employees facing potential layoffs often experience elevated stress and anxiety that can become evident in their day-to-day interactions with colleagues and grantees. Because individual employee performance and team performance impact overall organizational performance, declining employee morale can negatively impact CIRM’s ability to efficiently and effectively achieve its mission."

"CIRM’s strategic plan emphasized that CIRM is patient-centered. As such, CIRM has increased its stakeholder engagement, particularly with patient advocates. The agency hosts patient events and trainings across the State of California and has at least 1,000 patient advocates registered. Additionally, CIRM’s Science Officers now proactively search for viable projects, helping engage researchers and increase the quality of proposed grants." 

"As CIRM’s Proposition 71 funding is exhausted, the role of the Communications Department should be elevated to serve a strategic function in educating the public. It is imperative that members of the public are aware of and understand CIRM’s activities and impact while CIRM remains fact-based and objective about its role as a state agency. To achieve this, CIRM should establish metrics focused on external communication and public awareness. Examples of these metrics include: Number of posts on social media accounts, number of press mentions, follower growth on social media accounts, number of 'likes' or 'shares' on social media accounts, growth in website visitors, citations of CIRM-funded research in publications These metrics provide insight on the organization’s communications output, reach, and engagement with audiences beyond patient advocates."

"With the implementation of CIRM 2.0, the organization improved many of its processes to be more efficient and effective. Examples of key process improvements include: ... Establishing “The Wall” by developing a policy clarifying the roles and responsibilities of CIRM employees within and outside the grant review process to ensure it remains fair and impartial.  Streamlined the review summary process by reducing the time to summarize grant applications from six weeks to approximately three weeks.  Reduced grant processing time by reducing the time required to process grants from 22 months to 120 days.  Incorporated milestone-based payments in contracts by shifting the responsibility for project progress to grantees and ultimately holding them responsible for achieving research objectives."

"The ICOC is a large, statewide governing board, with 29 members located across California. There are inherent challenges to this structure: Geography limits the ability of some members to participate in Agenda Item #8 ICOC Meeting March 13th, 2018 California Institute for Regenerative Medicine FY 2016-2017 Performance Audit  17 person and interface with CIRM staff; individuals on a large board may feel less personally responsible and therefore less inclined to participate; and it is difficult for officers and committee chairs to meaningfully build relationships with and identify the best roles for such a large number of members. This is evident in committee participation; while CIRM leverages ICOC expertise through standing and ad-hoc committees, which is a best practice, some members serve on multiple committees while others serve on none. In addition to these challenges, changes to CIRM’s conflict of interest policy in 2013 eliminated the ability of institutional members to participate in grant funding votes. This has limited their overall participation, and several ICOC members reported a reluctance to participate in discussions. Both ICOC members and CIRM staff reported a decline in the engagement of institutional members in all discussions, not just those related to grants."

"In its transition plan, CIRM leadership identified $200 million in additional required funding to continue operating at existing capacity between 2019 and the potential bond measure in 2020. This additional funding would enable the organization to maintain current annual grant awards and staffing levels. Currently, key board members are leading fundraising efforts, which have remained largely confidential. In order to secure this significant amount of funding, additional resources are likely required to demonstrate CIRM’s funding needs, seek donors of varying size and requirements, and provide overall support for fundraising efforts."

"Because the level of funding required to sustain CIRM’s operations is significant, CIRM should develop a formal fundraising plan to identify required resources, activities, and strategies. CIRM’s fundraising plan should identify additional resources and support within the organization required to help potential funders understand the benefit of their investment. For example, the role of the communications team could be expanded to develop fundraising materials that detail CIRM’s goals, plans, and successes as well as funding requirements."

"Transition plans and associated strategies should continue to be deployed as living documents that are continually updated and available to Board members, staff, and external stakeholders. Future iterations should also include organizational structure options during a potential wind-down process. For example, grant funds are currently expected to be exhausted by 2019; grant monitoring, management, clinical trials, and closeout will continue past that date; and intellectual property reporting will be required for 10 years. Eventually, some CIRM activities could be transferred to another state agency. As the transition proceeds, stakeholders and grantees should be made aware of staffing changes to help preserve continuity."

California Stem Cell Performance Audits and More: Public Has 16 Golden Opportunities to Weigh In

Californians throughout the state next week will have what appears to be a record number of opportunities to participate -- albeit remotely -- in one of the more important, regular public meetings involving the $3 billion state stem cell agency.

The occasion is the March 13 meeting of the governing board of what is known formally as the California Institute for Regenerative Medicine or CIRM. The meetings of the CIRM governing board are the single most important public events that the agency holds.

The board has 29 members. Fifteen of those members will be participating remotely in next week's session, which means that the public can participate as well from those locations in addition to the physical site of the meeting at CIRM HQ in Oakland. The remote locations range from Fresno to La Jolla  and from Riverside to Elk Grove.

And if you are in New York City, you can weigh in from there as well. One of the agency directors will be hooked up from the Big Apple.

During the meeting, the board solicits public comment on each item under consideration plus general comments as well.

The top item on the agenda is the triennial performance audit of the agency, which in the past has

Graphic by Shopify

reported checkered but improving results in the last two reports. Conflict of interest issues surfaced in the last audit(see below).  In 2012, the audit, required by state law, identified 27 areas where improvements were needed.

The actual audit for this year has not yet been posted on the CIRM web site but is likely to pop up any day now.  The audit, which is required by state law, cost the agency $230,000, bringing to $694,944 the total that the agency has spent on its three performance audits.

If you are interested in attending at the remote locations, check the addresses in advance. Sometimes not enough specificity is provided. But an email to info@cirm.ca.gov will provide full directions.

Here is a link to the 2017 CIRM request for a proposal to conduct the performance audit.

Below are excerpts and links to previous items on the two earlier performance reports. At the end is a comparison of performance audit findings to results from other studies of the agency.

SUNDAY, MAY 17, 2015

Conflict-of-Interest Failings Reported in Application Reviews at California Stem Cell Agency

Conflict-of-interest issues have dogged the $3 billion California stem cell agency since its inception, and they are surfacing once again this week in a report commissioned by the agency itself.

This time the matter is being brought up by Moss-Adams, LLP, of Seattle, a business consulting firm that is being paid $230,000 by the agency to conduct a "performance audit."

In a report to be discussed at a CIRM governing board meeting on Thursday, the firm said it discovered serious problems dealing with the reporting of the interests of the agency's blue-ribbon reviewers.

TUESDAY, MAY 19, 2015

California Stem Cell Audit: Praise for Mills but More Work Needed on IP, Conflicts of Interest

The California stem cell agency this week received good marks for changes made by its new president, but it is also being told that it needs to improve how it tracks potential royalties and how it prevents grant reviewer conflicts of interest.

SUNDAY, MAY 17, 2015

Conflict-of-Interest Failings Reported in Application Reviews at California Stem Cell Agency

Conflict-of-interest issues have dogged the $3 billion California stem cell agency since its inception, and they are surfacing once again this week in a report commissioned by the agency itself.

This time the matter is being brought up by Moss-Adams, LLP, of Seattle, a business consulting firm that is being paid $230,000 by the agency to conduct a "performance audit."

In a report to be discussed at a CIRM governing board meeting on Thursday, the firm said it discovered serious problems dealing with the reporting of the interests of the agency's blue-ribbon reviewers.

THURSDAY, MAY 24, 2012

CIRM Directors Pleased with Performance Audit Findings

The $3 billion California stem cell agency received a "very favorable" performance audit report compared to other government agencies, CIRM directors were told today.

Representatives of Moss Adams, which was paid $234,944 by CIRM for the study, made the comments during a presentation today to the agency's 29 directors. During their comments, CIRM executives and directors focused on the favorable aspects of the findings of the six-month study.

TUESDAY, MAY 15, 2012

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."

--

Here is a link to the California state controller's comparison of the findings of the 2012 performance audit to previous findings from a number of enterprises ranging from the National Academy of Sciences to the state's Little Hoover Commission. 

California's Stem Cell Agency Meets This Month to Award Millions, Discuss Performance Improvements

This month’s meeting of the governing board of the $3 billion California stem cell agency, already the subject of some unhappiness from patient advocates, will be staged from 12 different teleconference locations on Sept. 24.

All but one site is in California. One board member, Lauren Miller, will be logging in from Atlanta for what is expected to be about an hour-long meeting.

This month’s session was originally scheduled for San Diego, where board members and staff would have been available for face-to-face discussions with the public. But the San Francisco-based agency switched the meeting to a teleconference session because of estimates that it would last only an hour.

The move upset Parkinson’s patient advocates in San Diego, who planned to attend the session in their area to speak about the need for funding for research into a possible cure for the affliction. They already have protested delays in funding at the July meeting of the board in Oakland.

On this month’s agenda are mostly routine matters considered earlier by board subcommittees that are expected to be quickly approved. Also on the agenda is consideration of presumably multi-million dollar applications for clinical stage research proposals. The board nearly invariably rubber-stamps the actions of its blue-ribbon panel of application reviewers. No information is yet available on those applications.

Up for discussion is a plan to correct unspecified deficiencies identified in a $230,000 performance audit of the agency.  The study, commissioned by the agency and required by law, said the agency needed to improve its procedures involving conflicts of interest and grant application reviewers. Also identified as an area needing work is the tracking of potential royalties. No board action is expected to be necessary this month to implement the plan.

The agency’s president, Randy Mills, is additionally scheduled to give an update on the agency’s strategic plan, which is being reformulated. The board has roughly $1 billion left before its cash for new applications runs out in 2020.

No background information has yet been posted on the meeting agenda for any item to be discussed or acted on. The California Stem Cell Report will carry items on the material as it becomes available. If interested parties would like to submit comments to the board in advance of the meeting, they can be addressed to mbonneville@cirm.ca.gov.

The teleconference locations where the public can participate in the meeting and comment can be found on the agenda.  The session is scheduled to be audiocast on the Internet as well. Directions will be placed on the agenda. 

California Stem Cell Audit: Praise for Mills but More Work Needed on IP, Conflicts of Interest

The California stem cell agency this week received good marks for changes made by its new president, but it is also being told that it needs to improve how it tracks potential royalties and how it prevents grant reviewer conflicts of interest.

A "performance audit" by Moss-Adams, a Seattle business consulting firm, made 12 recommendations for the $3 billion research enterprise. One of the 12 was to implement the unfulfilled recommendations made by Moss-Adams three years ago.  Seven of the 24 from that audit still need more action, the firm said.

On Thursday, the agency's governing board is scheduled to discuss the latest audit at a meeting in Berkeley.  The study is required by state law every three years. The agency's scientific performance, however,  is specifically excluded from being examined. Moss-Adams is scheduled to receive $230,000 from the agency for the audit, which was for the 2013-14 year.

On Sunday, the California Stem Cell Report covered the deficiencies involving disclosures of the financial interests of grant reviewers.

Other areas of concern included the need for better tracking of intellectual property that could mean royalties for the state, more timely review of progress reports from grantees, more timely, formal evaluation of employees and keeping up-to-date on technology related to grant management and agency efficiency.

Under the subject of "commendations," Moss-Adams said that CIRM had "many strengths."  The consultant said the agency has made "significant strides" in three areas: the grant management system, grants process improvements and "organizational culture."

The grants process comment referred to CIRM 2.0, the fast-track funding program initiated by Randy Mills since he became president a year ago. The organizational culture commendation also involved Mills' efforts, but touched indirectly and delicately on the resignation of Robert Klein as chairman and the election of Jonathan Thomas to replace him in June of 2011. 

Moss-Adams reported "enhanced seamlessness" between the president's and chairman's offices. Proposition 71, which created the agency, dictated a controversial dual executive situation that has troubled the agency since its inception.

The audit found significant deficiencies involving the treatment of CIRM employees, some of which have been addressed in a positive way already by Mills. One example cited by the audit involved performance evaluations that are tied to pay increases. It said that evaluations that were scheduled to occur in 2013-14 did not actually take place until January of this year.  

Moss-Adams said the agency also needs to do better in monitoring and protecting its intellectual property (IP), which could generate royalties. Without tight tracking of the IP and inventions funded by CIRM research, the state could lose out on revenue. Backers of Proposition 71 told voters in 2004 that the state could receive more than $1 billion in royalties from CIRM research. So far, none has resulted. 

Moss-Adams said that royalties are now more possible because the agency is backing late stage research that is more likely to make it into the market place. 

Moss-Adams said more work was needed on implementing the seven recommendations from three years ago, including those involving IP, the transition plan to deal with the possible demise of the agency and a grants outcome database. 

Conflict-of-Interest Failings Reported in Application Reviews at California Stem Cell Agency

Conflict-of-interest issues have dogged the $3 billion California stem cell agency since its inception, and they are surfacing once again this week in a report commissioned by the agency itself.

This time the matter is being brought up by Moss-Adams, LLP, of Seattle, a business consulting firm that is being paid $230,000 by the agency to conduct a "performance audit."

In a report to be discussed at a CIRM governing board meeting on Thursday, the firm said it discovered serious problems dealing with the reporting of the interests of the agency's blue-ribbon reviewers.

The reviewers make the de facto decisions on the applications from researchers for millions of dollars from California taxpayers.  Their reviews are conducted behind closed doors. The identities of the specific reviewers and applicants are not publicly disclosed.

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, requires the reviewers to fill out forms about their financial and professional interests as part of the review process.

However, those disclosures are withheld from the public and from applicants whose proposals are being assessed.  The agency's basic position has been to say "trust us" to monitor the conflicts.

Moss-Adams said, however, it "found that CIRM did not fully meet its compliance requirements regarding financial disclosures" during 2013-14. It also said that it could not verify that CIRM staff had actually checked for unreported conflicts.

Moss-Adams examined 40 applications and pre-applications and did not mention specific instances, such as the 2013 case involving a reknown scientist from Washington state, Lee Hood, and Stanford researcher Irv Weissman.  The matter was first reported by the California Stem Cell Report.

The audit said,

"Specifically, we found that of the 25 pre-applications we tested, three reviewers were missing Financial Interest Disclosure Forms in connection with the review of applications submitted in response to a particular RFA. These three reviewers participated in the review of four of the 25 pre-applications. Similarly, for the 15 applications we tested, which related to five different RFAs, we found that Financial Disclosure Forms were missing for eight different reviewers. For each of the 15 applications, we found that CIRM was missing a Financial Disclosure form for one or more reviewers who participated in the application review process for a particular RFA. In each of these cases, however, the reviewers completed their Conflict of Interest Form for that review."

The audit, which is required by state law, continued,

"Unlike the Conflict of Interest Form, which had already become an integrated element in the GMS (grant management system) in fiscal year 2013-14, no system restrictions were in place to prevent participation in reviews prior to the receipt of Financial Interest Disclosure Forms. Without these system restrictions, compliance with this requirement lapsed and reviewers with missing Financial Interest Disclosure Forms were allowed to review and score pre-applications and applications."

Moss-Adams said the agency took steps to correct the situation in July of last year. However, it told CIRM that  it should continue those procedures to ensure compliance on conflict of interest matters.

The audit also said it could not verify that CIRM had actually followed its process for determining whether unreported conflict of interests existed on the part of reviewers.

The audit said,

"Currently, there are no written policies or procedures outlining this process. While CIRM regulations define what constitutes a financial conflict of interest, the Grants Review Staff does
not have additional written guidance to follow when performing these reviews. Moreover, because the Grants Review Staff does not document the performance of these reviews, we could
not verify that these reviews were performed or assess the manner in which they were performed. Without procedures that formalize this process or internal records that document
the performance of these reviews, CIRM cannot fully demonstrate its performance of due diligence to ensure the financial independence of reviewers."

Moss-Adams told the agency that it should develop detailed procedures for examining the disclosure forms and document the work via the automated grants management system.

The agency's response to the concerns raised in the audit, which covered a wide range of issues beyond conflicts, did not specifically mention the disclosure and conflict matters.

The California Stem Cell Report will have more on the findings of the audit during the next few days. Specifically excluded from the audit is the performance of the agency's scientific portfolio.

Fast-Track Stem Cell Grants and Big Boost in California Stem Cell Agency Budget

Directors of the California stem cell agency will meet May 21 to make their first award under the agency's new, fast-track grant program and to approve an $18.7 million operational budget, up $2.8 million from this year's estimated spending.

The award will come in Randy Mills' CIRM 2.0 program as he begins his second year as president of the $3 billion state research effort. He initiated the program with intention of dramatically speeding cash to researchers.

The agenda for the directors' meeting in Berkeley does not specify how many awards are likely to be considered, but the number is expected to be very small. More details are likely to be posted on the agenda prior to the meeting.

Mills plans to extend the CIRM 2.0 speed-up to all of CIRM's award cycles, including basic research.

Also expected to be approved is the operational  budget proposed by Mills for the fiscal year that begins July 1. The spending plan is up substantially from actual spending for the current fiscal year largely because of increases in personnel costs. Mills expects to fill a number of high-level slots in the organization that will help boost employee costs from $11.3 million this year to $12.7 million. The agency is expected to be $815,000 under budget for employee expenses for the current fiscal year because positions were not filled.

Mills also plans to update the agency's strategic plan during the next few months. A discussion of that effort is on the meeting agenda. Such matters as spending on basic research vs. clinical funding are the sort of topic for strategic planning. A few years ago, a shift away from basic research triggered some public concerns among researchers, who said the field was too young to push heavily on the more costly clinical funding.

The agency has committed $1.9 billion so far and estimates it will run out of cash in 2020 for new awards.

No plans for public input concerning the strategic plan have been announced, but they have been a component of previous efforts.

Directors are additionally expected to hear a report on a "performance audit" of the agency. The agency commissioned the $230,000 audit, which is required by state law. The last such audit in 2013 made 27 recommendations for improvements at the agency. An evaluation of the agency´s scientific portfolio was specifically not included in the audit.

Look for more details on matters to be considered by the agency on the California Stem Cell Report over the next 10 days as more information becomes available.

California Stem Cell Agency: Comparing the Critiques

State Controller John Chiang has posted a useful, side-by-side comparison of critiques of the $3 billion California stem cell agency, including the Institute of Medicine(IOM) study, along with the responses from the agency.

Chiang, the state's top fiscal officer, has additionally posted the initial remarks Jan. 23 by CIRM Chairman Jonathan Thomas before the stem cell agency governing board on his plan to deal with the sweeping recommendations of the IOM.

Regardless of one's opinion of the board's response to the IOM, Thomas adroitly handled the discussion and vote, not a small accomplishment given the size of the board (29 members) and the legal restrictions involving public meetings. Under state law, Thomas could not lobby significant numbers of the board in advance of the meeting. He was restricted to engineering the approval in a public session, which can easily take on a life of its own given the unwieldy size of the board and the necessity for public comment.

As for the documents posted by Chiang, he is chairman of the Citizens Financial Accountability and Oversight Committee, the only state body specifically charged with oversight of the agency and its board. The web site for the committee is the only location on the Internet where Thomas' prepared remarks and the comparison can be found.

Chiang's comparison chart includes not only the IOM study, but last year's performance audit and the Little Hoover Commission study in 2009. Missing, however, is the state auditor's report in 2007 and its recommendation that the agency seek an attorney general's opinion on whether scientific grant reviewers must file a public financial disclosure form.

Here are links to the various documents: Thomas' prepared comments, Power Point chart used by Thomas, comparison chart of various studies and the transcript of the Jan. 23 meeting during which the governing board approved its response.

$80 Million in Grants, Money for Viacyte and Blue-Ribbon Report on California Stem Cell Agency

Directors of the California stem cell agency are expected to give away $80 million next week to 20 fortunate researchers in addition to exploring a “commercialization and industry engagement plan.”

The subjects are on tap for the Dec. 12 meeting in Los Angeles of the governing board of the $3 billion research effort.

The $80 million grant round is aimed at “career development of physician scientists working in translational stem cell research.”

The RFA said

“This award will fund promising physician scientists in the critical early stages of their careers as independent investigators and faculty members establishing their own laboratories and programs.” 

Summaries of the grant reviewers comments and application scores should be available sometime this week. The bare-bones agenda lacked elaboration on the commercialization plan.

Directors are additionally scheduled to hear a presentation on the blue-ribbon report by the Institute of Medicine for which the agency is paying $700,000. The report has been 17 months in the making and is scheduled to be released this Thursday.

Other interesting matters are on the table, although the agency has yet to produce background material laying out any details. The subjects include:

• More money – no amount yet specified – for Viacyte, Inc, of San Diego, which has received more than $36 million from CIRM.
• An update of the agency's response to the only performance audit conducted at the agency. The audit identified 27 areas where improvement is needed, but the governing board has not discussed the results publicly since they were disclosed last May.
• Approval of the concept plan for another round of basic biology grants and adoption of conflict of interest code changes.

Interested parties will be able to take part at the meeting location in Los Angeles and teleconference locations in La Jolla, Oakland and UCSF. If you are interested in the teleconference locations, you will need to contact the agency for more specific directions than are provided on the agenda.

California Stem Cell Agency Shy This Week on Openness

In the past year, since J.T. Thomas has served as chairman of the California stem cell agency, the $3 billion enterprise has done well in providing the public with important information about matters that come before its governing board – a welcome change from the grievously deficient past performance.

However, that new, high standard for openness and transparency is coming up short this month.

With less than three days remaining before Thursday's meeting of the governing board, important information remains missing on significant matters scheduled to be discussed later this week in Burlingame.

At the top of the list is the response by CIRM President Alan Trounson to the first-ever performance audit of the nearly eight-year-old agency. The $234,944 study said the agency is laboring under a host of problems, ranging from protection of its intellectual property and management of its nearly 500 grants to an inadequate ability to track its own performance. Trounson's response could have come much earlier than this week, even last May when the results were unveiled publicly, although the agency had been briefed privately on them still earlier.

Also missing from the agenda is an important update on what Thomas has called a “communications war” – shorthand for the efforts by CIRM to generate more and favorable news coverage of the agency along with solidifying support among its constituent groups. The agency's weak PR effort, which is now improving, has troubled many directors for some time. The CIRM story is critical to the agency's financial future as it looks to private funding to continue its life beyond 2017 when its money runs out.

Also not be found is an explanation of an item before the directors' Science Subcommittee on Wednesday evening that appears to have interesting implications, given CIRM efforts to embrace the biotech industry more warmly. The proposal calls for  establishing “responsible budgeting as a criterion for evaluating applications for funding.” No further information is available. But one wonders whether the proposal could reflect CIRM's unfortunate experience with Geron, which signed a $25 million loan agreement with CIRM last summer only to dump its hESC program a little more than three months later. Geron cited financial reasons. One also wonders whether the need to focus on “responsible budgeting” reflects problems with some researchers or whether it is intended to help businesses pick up a larger share of awards.

Posting details on issues to be decided by directors -- in a timely fashion -- should be a routine matter for the agency. It is also key to engaging the public, industry and researchers – not to mention that it is good policy, good management and good government. Without adequate notice, it is impossible for interested parties to comment on proposals or make well-considered suggestions. Given the agency's improved performance during the past year, this month's slippage may only be an aberration. We hope so.

CIRM Directors Pleased with Performance Audit Findings

The $3 billion California stem cell agency received a "very favorable" performance audit report compared to other government agencies, CIRM directors were told today.

Representatives of Moss Adams, which was paid $234,944 by CIRM for the study, made the comments during a presentation today to the agency's 29 directors. During their comments, CIRM executives and directors focused on the favorable aspects of the findings of the six-month study.

CIRM Chairman J.T. Thomas said the report showed that CIRM is "doing better than being on the right track." Co-vice chairman Art Torres said,

 "Comparatively we have done very well."

The report praised the professionalism of the CIRM staff – "a high caliber group" – and noted the seven-year-old agency is both "ramping up and ramping down" at the same time – a reference to the end of state bond funding for CIRM in 2017.

Prior to the presentation, CIRM President Alan Trounson said the staff would review the findings and come up with a plan for the board at its July meeting. The agency is already implementing some of the recommendations.

The audit was required by a recent state law that also allowed CIRM to hire more than 50 persons, a cap imposed by Proposition 71, which created the agency. The audit found a need for improvement in 27 areas and made recommendations. Of the 20 recommendations with the highest priority, half involved how CIRM manages its information, much of which is needed for good decision-making. The audit did not assess the scientific performance of the agency.

The Moss Adams report, performed by the Seattle firm's San Francisco office, said,

"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. CIRM does not currently have a formal performance reporting program."

In addition to decision-making information, Moss Adams called for improvements in the agency's long-troubled grants management system, better grant outcome tracking, development of a results-based communications plan, creation of a comprehensive, formal business development plan, formulation of a comprehensive information technology plan that would include steps to establish clear responsibility for CIRM's website and improved monitoring of invention disclosure forms from grantee institutions.

Last week, in a long overdue move, the agency hired a director for information technology, who is expected to solve many of the problems cited in the audit.

State law requires another performance audit in a few years. 

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.

$250,000 Stem Cell Agency Performance Audit to Skip its Scientific Performance

When is a "performance audit" not a performance audit? Answer: When the California stem cell agency commissions it.

Under a new law, the $3 billion state research effort is required to conduct its first-ever "performance" audit this year and again every three years. Under the law, CIRM could have stipulated that the audit would include scientific performance, but it has chosen not to do so.

Instead, the audit will primarily examine "policies and procedures" for issuing contracts, grants and treatment of intellectual property to determine how well the agency is doing.

Admirable goals but certainly not even close to a full measure of CIRM's performance. Most would agree that the paramount measure is whether the agency has made good on the promises of the 2004 election campaign that created it. To do that would require an examination of CIRM's scientific program and the results it has generated.

The agency plans to pay $250,000 for the audit, selecting a bidder next month. The deadline for firms to present their bids is Friday. At least 10 firms have expressed an interest in the contract. They include Teeb Lead Project Management Solutions, Capital Partnerships Inc. (also dba The Resources Company), Crowe Horwath LLP, KPMG LLP, IntelliBridge Partners, Moss Adams LLP, Level 4 Ventures, Inc., Thompson, Cobb, Bazilio& Associates, PC; Moss Adams LLP, Strategica, Inc., and Sjoberg Evashenk Consulting, Inc.

The requirement for the audit was contained in legislation authored by State Sen. Elaine Alquist, D-San Jose. When she introduced her bill last year, she said CIRM is "essentially accountable to no one."

Alquist initially would have placed the performance audit in the hands of an independent, third party, the state controller, instead of CIRM itself. The controller, the state's top fiscal officer, is chairman of the only state body, the Citizens Financial Accountability Oversight Committee, specifically charged with evaluating the performance of the stem cell agency and its board. Introduction of the legislation came after Controller John Chiang and the committee unanimously called for more accountability at CIRM.

The legislation  also originally provided that the audit would include CIRM's strategic policies and plans, which would have brought scientific matters under scrutiny.

But as the bill moved through the legislature, CIRM was successful in amending it to remove the "strategic policies and plans" language. Also inserted was language that the audit did not need to cover scientific performance, which gave CIRM more control of the scope of the audit.

However, CIRM took the matter further this summer. In its RFP for the audit, the agency misstated the statute, telling potential bidders that the law bars an examination of scientific performance, when in fact it does not.

Here is CIRM's language from the RFP:

"The statute specifically excludes scientific performance from the scope of the audit."

Here is the language from the law:

"The performance audit shall not be required to include a review of scientific performance."

Asked for a comment, CIRM defended the RFP characterization. Melissa King, executive director of the CIRM board, said in an email,

"The statement is correct because it is intended to convey that a scientific review is expressly excluded from the required audit areas. Furthermore, most government accounting firms do not have the expertise to conduct a scientific review. That is one of the reasons we have asked the IOM (Institute of Medicine) to conduct a study."

The $700,000 IOM study is more far-reaching, but has also been commissioned by CIRM. The IOM has a reputation for independence. However, any examination that is paid for by the agency that is the subject of the scrutiny will always face questions about its objectivity. It goes to the old saying about he who pays the piper, calls the tune.

Both the performance review and the IOM study are certain to become election campaign documents in a couple of years. CIRM survives only on money that the state borrows – bonds. And the agency is aiming for voter approval of another multibillion dollar bond measure to continue its operations beyond about 2017. To win support, CIRM and its backers undoubtedly will ballyhoo what it presumes will be favorable findings to bolster its bid for more cash.

When viewed in the context of a ballot campaign, CIRM efforts to limit the scope and shape the findings of either the performance audit or the IOM study will also undoubtedly damage their credibility.

$1 Million Evaluation of Stem Cell Agency Comes Up Next Week

Directors of the California stem cell agency appear ready to commission a $1 million “gold standard” study of its operations with the hope that it will pave the way for voter approval of billions more for stem cell research, perhaps as early as November 2012.

The proposal is scheduled to be voted on at the CIRM board meeting next Wednesday and Thursday meeting at Stanford. However, few details of the latest version of the plan are currently available on the CIRM Web site.

Nonetheless, some information can be gleaned from the transcripts of the directors' Science Subcommittee meetings in May and July, when the proposed study was discussed.

Here is what we have been able to extract. The study would be performed by the prestigous Institute of Medicine(IOM). The cost would be in the $1 million range. CIRM Chairman Robert Klein is proposing that about half of the amount would come from private donors. In July, Klein referred to a 15-month timetable, which might be quite speedy for the Institute of Medicine, which moves slowly, according to the transcripts. If work begins in January, the study could be completed in time for the presidential election in the fall of 2012. Politically speaking, that is the likely to be the best time to seek approval of another multibillion dollar bond measure, given the larger voter turnout in presidential elections. Klein, however, did not mention a specific election timetable.

During the two subcommittee meetings, no CIRM director raised the possibility that the study would identify serious flaws in the agency's $3 billion operation. Klein predicted that the study “would be a solid milestone.”

Jeff Sheehy, chairman of the Science Subcommittee and a communications manager at UC San Francisco, said the IOM would provide a “gold standard objective evaluation.”

Sheehy continued,

“I certainly don't want to go off the board in two years without this report being finished. I don't think I could go to any member of the public, any editorial board, any member of the legislature, the governor, any elected official without some sort of external review of what's gone on with a billion dollars of the taxpayers money, especially in the middle of this horrible recession.”

Sheehy noted that the IOM is less than a household word. In May, he provided this description,

“The Institute of Medicine is an independent nonprofit organization that works outside government to provide unbiased and authoritative advice to decision makers and the public. established in 1870, theIOM is the health arm of the National Academy of Sciences, which was chartered under President Abraham Lincoln. The IOM asks and answers the nation's most pressing questions about health and healthcare. And the aim is to help those in government and the private sector make informed health decisions by providing evidence upon which they can rely.”

During the Science Subcommittee meetings, CIRM directors often referred to the IOM's vaunted independence, which they implicitly did not think would be affected by a $1 million contract. There also was no discussion of limitations that CIRM might impose on the scope of the study before signing a contract. In the case of a current $300,000 contract to assess the economic impact of the agency, CIRM specified that its economic consultants must “execute a vibrant and aggressive strategy” supporting CIRM, a requirement that fundamentally damages the credibility of whatever the their report says.

At subcommittee meeting in July, CIRM Director Philip Pizzo, dean of the Stanford School of Medicine and a member of the Institute of Medicine, said,

“Of any organization that I'm familiar with on a national level, there isn't any other that carries the weight of independence and critical review (of) the IOM and the National Academy of Sciences.”

Klein, who ran the 2004 Prop. 71 campaign that created the organization he now chairs, repeatedly framed the study in the context of a ballot campaign. He said he wanted it “finished in time that the public can analyze it before we go back and put forth the question about whether we're entitled to more bonds.”

Klein did not publicly identify potential donors to help pay for the study. A question could be raised about whether he or others intend to solicit funds from persons who have financial ties to enterprises that would stand to benefit from CIRM funding.

Directors acknowledged that the $1 million price tag appears steep. However, it is a tiny amount when compared to the $6 billion cost (including interest) of the stem cell research effort.

Klein's support for an IOM study seems to be in some contrast to his previous complaints about the amount of scrutiny (audits and otherwise) that CIRM has received from various sources. This spring, the agency also successfully stripped out of pending legislation a requirement that the state controller, who chairs a Prop. 71-created panel to oversee CIRM finances, commission an independent performance audit. Instead, the now CIRM-backed legislation (SB1064) places that audit squarely in the hands of the stem cell agency.

At the July meeting, Klein mentioned a proposal from the IOM. We have asked CIRM for a copy of that document.

Watered-Down Reform Bill Moving Ahead; CIRM Looking at Boosting Staff to as High as 60

The California stem cell agency almost certainly will be able to hire a small platoon of additional employees next year as state lawmakers appear ready to remove a voter-imposed staffing cap.

That, however, may sound more troubling than the reality. The agency still has a 6 percent limit on operational spending, which makes the cap of 50 employees both redundant and a bit foolish. CIRM has labored for some time with what amounts to a staff the size of a 24/7 Burger King, and CIRM President Alan Trounson has warned that the quality of work could suffer.

The agency, with only 45 employees, is trying to oversee more than $1 billion in awards to more than 300 researchers and institutions. At the same time, it is attempting to award another $2 billion in increasingly complex grant rounds that reach into clinical trials and involvement with corporate biotech.

Earlier this year, CIRM said it might hire as many as 15 additional employees. Beyond that, it would run into space problems in its existing offices. Hiring additional employees would also “shorten the life span” of the cash available under the 6 per cent limit, which refers to the $3 billion in bond funding.

The bill removing the cap is headed for placement on what is known as the consent calendar. Items in that category are supposed to be noncontroversial (but there are exceptions) and are voted on as a block with no discussion.

The legislation, SB 1064 by Sen. Elaine Kontominas Alquist, D-San Jose, is currently in the Assembly Appropriations Committee after winning approval in the Health Committee, 19-0, on June 30. After passage by the full Assembly, it will return to the Senate for concurrence in Assembly amendments before it goes to the governor. It would take effect at the beginning of 2011.

Given CIRM's support, the first time ever for such legislation, the bill seems certain to be approved. However, approval requires a rare, super, super-majority vote – 70 percent – of both houses, so it only takes a few legislatiors to bring the bill to a halt.

The stem cell agency backed the bill in a compromise that significantly watered down the legislation. Gone are many reforms recommended by the Little Hoover Commission, the state's good government agency, along with provisions sought by the state's top fiscal officer, Controller John Chiang.

They include elimination of a performance audit by a special Prop. 71-created, financial oversight committee chaired by Chiang. Instead CIRM itself would pay ($400,000 plus) for the audit and control its scope. CIRM already has written into the bill a stipulation that the audit does not have to include “a review of scientific performance.”

Excluding a scientific review gives cover for the agency if it wants to isolate problems it does not want examined. Exclusion also avoids outside review of many of CIRM's key assumptions. However, a detailed scientific review may well be beyond the capability of most auditing enterprises, although they could presumably hire a panel of experts.

But perhaps more important is the fact that the agency would pay the audit firm for the work. If CIRM pays the piper, it calls the tune. Just ask Enron, World.com and others. Any audit paid for by CIRM can be fairly criticized for not being objective. It will mean $400,000 or more for the successful bidder. CIRM has already demonstrated it wants its contractors to be cheerleaders. That was a key criteria for selection of the firm that is now evaluating the economic impact of the agency.

Also gone are revisions in the role and election of the chairman, along with other reforms. The previous provisions would have eliminated the conflicting roles of the chairman, who now has executive management responsibilities, and the president. Problems with the dual executive arrangement at CIRM have arisen in the past and are likely to come up again. Also eliminated are provisions that would have given the board more control over selection of its own chairman.

IOM Study of CIRM to Come Before Stem Cell Directors in August

Directors of the California stem cell agency are moving forward with a proposal to commission a blue-ribbon study of their $3 billion effort by the Institute of Medicine.

The directors' new Science Subcommittee on Tuesday voted to bring the proposal, which is now connected to legislation to remove the CIRM staff cap, to the full board in August, said a spokesman for CIRM.

In response to an email query, Don Gibbons, chief communications officer for CIRM, said the panel directed the staff to “work with the leadership of the committee to develop the full scope of work for any IOM(Institute of Medicine)study.”

Gibbons also said that CIRM is seeking to verify that “this scope of work could qualify for the audit required” by SB1064 by Sen. Elaine Kontominas Alquist, D-San Jose. The bill is now on the Senate floor, clearing the Appropriations Committee Thursday on a 10-0 vote.

CIRM and Alquist negotiated a compromise on the legislation that has won the approval of the CIRM board, the first time it has endorsed legislation that would alter the agency's activities. CIRM needs passage of the bill to remove the 50-person cap on CIRM staff.

During the negotiations, proposals for independent performance audits were stripped from the bill – ones that would be conducted under the auspices of the Citizens Financial Accountability Committee, a sister panel to CIRM. As it now stands, a performance audit would be required, but it would be commissioned and paid for by the agency itself. CIRM has made it clear that it is not interested in addressing the accountability concerns raised by the citizens committee.

The bill specifies that use of the state auditor would be acceptable. However, that agency might have difficulty with evaluating the science side of CIRM's performance. The state auditor could presumably hire a consultant to assist in that area. Instead of the state auditor, the stem cell agency could contract with a private firm, which is more likely to be susceptible to suggestions from CIRM about the conduct of the performance audit.

The Institute of Medicine may well tilt to the science side of CIRM's activities with a lesser focus on whether the people of California are getting a good return on their $6 billion (including interest) investment. The institute may also be less interested in CIRM's accountability and openness than would be the case with an audit done for the Citizens Financial Accountability Oversight Committee.

Still to be determined is the cost of the performance audit and timetable. Costs in the neighborhood of $400,000 have been mentioned for a performance audit. An IOM study could run more. To be useful, an audit should be done as quickly as possible. However, it is certain to take many months or more to complete.