WARF hESC Patent Update: Seven Years and Challenge Still Underway

Last week UC Davis stem cell researcher Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an online Q&A that touched on patents and how they can stifle research and discourage development of therapies.

Loring did not mention it in the Q&A but she is the key figure in the ongoing challenge to the WARF (Wisconsin Alumni Research Foundation) patents on human embryonic stem cells. Her effort began in 2006 but has dropped out of the news. We asked her for an update on the case.

Here is the text of what she replied,

“Dan Ravicher is the lawyer behind several big patent cases, including the recent Supreme Court case challenging human gene patenting (Myriad), and a challenge to Monsanto's restrictive enforcement of its patents on genetically modified seeds. 

“I'm lucky that he is also the lawyer working with John M. Simpson (of Consumer Watchdog) and me to challenge the WARF patents.  Currently, we are getting ready for another year of appeals and counter-appeals on the third of WARF's three patents that give them control over all human embryonic stem cells.

“This is Dan's summary of the current situation:

"'We filed challenges at the Patent Office to all three of WARF's hESC patents. During those challenges, WARF agreed to narrow all three of the patents, and they also loosened their licensing requirements. But, even though the patents were narrowed, we still think they're invalid, and thus disagree with the Patent Office's decision to re-issue them in the narrowed forms. Unfortunately, due to the age of the patents and changes in the law, we were only allowed to appeal one of the three decisions, and that appeal is now pending at the Court of Appeals in Washington. But, we expect the decision in our appeal will affect the validity of the other two patents, since they're all basically on the same technology." 

“The 'narrowing' of the patents has had an unexpected consequence.  Before the narrowing, WARF's patents would have covered iPSCs as well as hESCs. After the narrowing, they can only claim hESCs.”

In the Q&A on Knoepfler's blog, which also involved an interesting discussion of IPS research, Loring said,

“Patents on fundamental things -- genes, human embryonic stem cells, iPS cells -- allow the patent holder to have a monopoly, preventing anyone else from using whatever they’ve patented.

“Patents are supposed to stimulate investment in development.  Why, as Justice Scalia said last week, would anyone have the incentive to study a gene and, for example, develop diagnostic tests, if they couldn’t prevent everyone else from working on that gene?

“But patents also stifle competition and the advances that come from having many different groups studying the genes or cells.  One of the main reasons I returned to academia was so I could have freedom to study human ES cells without worrying about getting threatening letters from a patent holder, demanding that I either stop working on the cells or pay a steep licensing fee.

“There will inevitably be problems commercializing iPSC-based therapies and assays, because at least three institutions own patents on aspects of iPSCs.  I’m paying attention to the patent 'landscape,' but have decided to deal with those problems when they arise, and hope that the iPSC patent holders realize that the potential of these cells is too great to keep to themselves.  It would be better for all of us if the issue of stem cell patents never has to be decided in the Supreme Court.”

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

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

Robert Klein
Elie Dolgin/Nature photo

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

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

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

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

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

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

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

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

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

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

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

Asked whether the agency is concerned about the appearance of Klein's donation and the subsequent board action, McCormack replied,

“No, the two items are entirely separate with no connection. Item 1  involved Bob Klein making a donation to allow science officers to attend a critically important scientific meeting on stem cell research.  The science officers had originally planned on attending but then were told they could not because of cuts in our out-of-state travel budget – Bob Klein’s donation, without using state funds, enabled the science officers to attend.  Item 2 is an ICOC (board) decision to fund a research project that they felt had promise and was important for the people of California.”

As for the special treatment of Klein in the wake of his donation, the agency did not respond to inquiries asking for an explanation.

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

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

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

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

Klein defended the involvement of McEwen, who Klein said has contributed to the stem cell group conducting the meeting. Klein said McEwen does not engage in technical discussions and added,

“On a conceptual basis it was important for him to understand the spectrum of medical advances towards therapies. His additional contributions to Canadian non-profits could assist Canada in collaborating with California on more international research, with California only funding the research done in California and the donor helping to fund the research done in Canada. No specific grant applications were discussed. Finally, the discussion with the international partners focuses on the funding process and funding collaboration it does not discuss any individual.”

Private funding of activities by state employees has stirred up controversy over the years in California. The most recent example was Gov. Jerry Brown's much-reported trip to China this spring, which was financed by private donations. Articles in the Los Angeles Times and The Sacramento Bee both noted that private funding arrangements have plenty of critics.

Columnist George Skelton of the Times wrote,

 “It just looks unseemly — a pack of lobbyists and other favor-seekers paying big bucks to traipse after the governor, schmoozing and gaining invaluable access.”

Reporter David Siders carried a quote in The Bee from Jock O'Connell, international trade adviser for the economics consulting firm Beacon Economics, who said,

“They're donating because they want to curry favor with the incumbent administration."

Asked whether CIRM planned to accept donations for trips in the future, McCormack replied that the agency is “always open to donations from generous supporters” provided they meet the state's legal requirements.

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

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

CSCR to CIRM:

“Is CIRM concerned about the appearance created by the donation from Bob Klein to enable scientific staff to attend the ISSCR meeting in Yokohoma, coming one month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application and one month before the July Board meeting that led to the approval of the award?”(Editor's note: It was actually two months before the board meeting.)

CIRM's response:

“No, the two items are entirely separate with no connection. Item 1  involved Bob Klein making a donation to allow science officers to attend a critically important scientific meeting on stem cell research.  The science officers  had originally planned on attending but then were told they could not because of cuts in our out-of-state travel budget – Bob Klein’s donation, without using state funds, enabled the science officers to attend.  Item 2 is an ICOC decision to fund a research project that they felt had promise and was important for the people of California.”

CSCR to CIRM:

"Please explain why the agency could not finance the trip itself ."

CIRM's response:

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

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

CIRM's response:

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

The Klein Donation: Text of Robert Klein's Response re StemCells, Inc.

Here is the text of the initial response from Robert Klein, chairman of the California stem cell agency until July 2011, to questions from the California Stem Cell Report (CSCR) concerning his $21,630 donation to the agency. The questions posed by CSCR on precede the response by Klein. Here is a link to a story on the matter.

CSCR to Klein:

“Why did you give the agency the money?
“Did you place on conditions on its use?
“Did anyone connected with the agency indicate in advance  that your donation would be desired? If so who? Who did you deal with primarily on the donation -- Trounson, Thomas or...?
“The donation came one month after grant reviewers rejected StemCells Inc.'s Alzheimer's application. Do you think it was appropriate to make the donation and then ask the board twice to override its reviewers?
“Do you think the donation and subsequent action on StemCells, Inc.'s Alzheimer's application will negatively color the perception of future efforts by CIRM at private fundraising?”

Klein's response:

“In April or May of 2012 I committed approximately $20,000 as a contribution to CIRM to cover the travel expenses of staff to the International Stem Cell Society meeting in Japan. My commitment to ensure scientific staff can participate in international meetings dates back many years. In 2011 I wrote the following explanation of its importance in obtaining the knowledge to accelerate the drive of scientific research to reach patients with chronic disease.

            Leverage Leading Edge Science

            “Travel by CIRM staff members and leadership permits CIRM to stay in contact with, and understand, the leading edge advances of scientists all over the world, and to leverage those advances by creating a platform for collaborations between these leading scientists and their peers in California. Currently, CIRM has collaboration agreements with 15 foreign governments pursuant to which these governments have pledged $134,380,000 in commitments to fund the work of their scientists on join teams with California scientists to develop therapy candidates and to advance therapies to human trials. Although a significant amount of this commitment is currently pending scientific peer review and not all of it will be awarded as part of a successful application, every dollar in funding by a foreign government magnifies the scientific impact of California’s taxpayer dollars. If just $40 million is awarded each year over ten years, it would provide California with $400 million of scientific leverage.

•     It is critical to understand that there are unpublished scientific discoveries in progress in each of these nations. Often, publication may trail a scientific discovery by nine months or more.
•     The travel requested by CIRM provides a critical link for the timely transmission of valuable new information. California cannot afford to lose the opportunity to harness discoveries in other countries to advance the development of therapies in California and to capture the opportunity to advance therapies for patients instead of using California taxpayer dollars to duplicate discoveries already mastered in other countries.
•      While CIRM’s scientific staff works with scientists in other countries to capture the scientific knowledge for the benefit of California’s therapy development teams, the Chairman’s Office works with international finance ministers, the premiers of international states, and foreign funding agencies to ensure funding allocations for these bilateral funding agreements. These discussions often involve face-to-face negotiations in foreign nations and states, in addition to meetings at international conferences, all of which are supported by extensive staff work in California.
•      CIRM issued its first co-funding awards early in 2009. Over the last two years, these agreements have yielded $57 million in international funds actually approved through peer review. This $57 million represents participation by only the first five countries and one international state with which CIRM established a collaboration. Now, CIRM has agreements with nine countries and two international states and an additional three countries will be added in the near future.
•     Even if CIRM were only to obtain $30 million per year in international matching funds, the ratio of return on CIRM’s $206,920 travel expenditures would be approximately 145 to 1.
•    Proposition 71 specifically anticipated and directs CIRM to develop leverage and global leadership to capture the benefit for patients.

Keeping on the Cutting Edge of Stem Cell Science

"CIRM’s over 20 MDs and/or PhDs science officers on the grant review staff at CIRM reach out nationally and internationally through conferences that may include 10-20 meetings per day and workshops of 8-12 hours per day to grasp the leading edge of this pre-publication, dynamic revolution in medical knowledge. In order to ensure that the every research dollar is optimally deployed to advance therapies to save lives or rescue the quality of life for patients, it is critical that CIRM staff remain on the cutting edge of new discoveries. International conferences and workshops provide a critical opportunity for massive and decisive transfers of information, which ensures that California is funding the right research.

“I principally corresponded with Dr. Trounson on the issue covering the travel expenses for the staff for the reasons stated above. I had no input into the selection of scientific staff. In May and even in June when the conference occurred I had no idea that there would be any disagreement on the Alzheimer’s application of Stem Cells Inc. in August. At the Board meeting I asked that there be consideration for the fact that three other peer reviews had found the work leading up to this application to be outstanding and they had ranked it highly. In addition, the current peer review had not been briefed on the fact that they downgraded the applicant for following the directions on material points by the prior peer reviews. Finally, the standard deviation on the 2012 peer review was extremely high and the re-review by the three member committee resulted in a split decision. It is particularly appropriate with a huge standard deviation, demonstrating both strong support and opposition within the peer review group, for the Board to make its own independent decision.  Please recall that the staff recommended against approval so that they clearly were not influenced by my commitment to a contribution to the Agency, months before, for the benefit of scientific staff to be able to attend an international science conference. Additionally, Dr. Trounson, I believe, recused himself from the review of the Stem Cells Inc. application, for unrelated reasons, so he was not involved. I personally had served on the three prior peer reviews, including one in the prior year that recommended this application for a Disease Team approval. I know how strongly the scientists on those three prior peer reviews supported funding this scientific research, with the 2011 review specifically recommending this Disease Team for approval. I believe it was extremely important for me to provide a voice to those three scientific panels who disagreed with a portion of the scientists on the 2012 scientific panel. Supporting the scientific movement to human trials for Alzheimer’s has to be eventually approved by the FDA; but, this loan will move the science and the potential for clinical trials forward significantly and hopefully obtain FDA approval. I believe all three of the Board’s overrides of the peer review recommendations on the Disease Team round in 2008 are leading directly to human trials in the United States and/or United Kingdom. 92% of the all of the funds awarded by CIRM have followed the recommendations of the peer review committee; but, in those significant cases where the Board has made an independent decision, there has been an extremely high success rate particularly when there has been a high level of disagreement within the Peer Review Board that was overridden and prior peer reviews recommended and/or approved the scientific approach and concepts of the applicant.”

(Editor's note:  The applications in this round were reviewed once in April 2012 by CIRM's full grant review group. StemCells, Inc.'s application was subject to a reevaluation after Klein's appeal in July 2012 and rejected again, but it was not a full review.  Klein may be referring also an earlier round that provided grants for planning to apply for the full $20 million.) 

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

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

CSCR to Klein:

"I have sent the following to CIRM asking for their response and am offering the same opportunity to you. Here is what I sent the agency:
'The documents that I have received so far show that after Klein gave CIRM $21,000 the agency instructed six of its science officers to give him special access to their activities and apparently did not object to additional instructions from another member of the public, Melissa King, to provide Klein and her with written summaries about their activities at the ISSCR convention and “details” about their work at CIRM. Email addresses of the six were also provided to Klein, who may have additionally received their cell phone numbers although that is not entirely clear. The CIRM documents show that the six were told to engage in one-on-one sessions with Klein, which actually included a third person, a wealthy Canadian mining company executive. One document indicates that the science officers should assist in fundraising for CIRM by identifying areas of “special importance” to Klein and 'other donors.'
"'Additionally, Alan Trounson, at Klein's request, invited the mining executive to a closed door session involving the agency's international partners, a session at which presumably valuable, little known scientific information would be discussed and future directions charted. Trounson specifically told the executive that it was Klein who asked that executive be invited to the session, adding to Klein's clout in any business or other dealings that Klein might have with the executive.'

My questions to CIRM deal with the special treatment that was provided in connection with your donation. I would ask you if you think that state agencies should provide this sort of extraordinary treatment for individuals who donate to the agency. At the very least, doesn't this raise questions about the integrity of the agency and doubts in the public mind about whether it can be fair and even-handed in its activities?

Klein's response:

"In April or May of 2012 I committed to contribute a charitable donation to CIRM to cover the travel costs for 5-7 additional science officers to attend the International Stem Cell Conference in Japan.  It is important to CIRM that their science officers understand the cutting edge research being developed around the world so that CIRM does not fund redundant research; but, to the contrary, the science officers understand how to create networks between California scientists and scientists in other foreign countries who are doing complementary research that can potentially accelerate the advancements of therapies for patients. I do not hold any financial interest in biotech companies. I have historically been involved in encouraging international collaboration to advance medical therapies; for patients, every day of delay in the development of a therapy is a delay they cannot afford. To conceptually document the value of additional scientists traveling to these meetings, it was discussed that there should be conceptual, bullet point summaries about the value for CIRM obtained through the scientists discussions at the international conference.  The idea was to create bullet points of information about a few of the most meaningful scientific concepts and contacts the science officers benefitted from each day of attendance at the conference. I did not participate in the selection of the science officers who attended and I did not play any part in determining what activities they participated in. There were two fundamental goals to the very short one-on-one sessions that were arranged at "down time" that would not conflict with their other activities. The first goal was to conceptually understand if each of the science officers believed that the benefit to the agency was sufficient to justify the cost of their attending, when considering the learning and contacts they had gained which might accelerate research and therapies for patients. The second goal was to assist universities and non-profits, principally in Canada - a research partner of CIRM - in advancing their contributions from an existing donor or donors.

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

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

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

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

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

hESC Research Totals $458 Million out of $1.8 Billion from California Stem Cell Agency

The California stem cell agency today said that it has awarded $458 million to fund research involving human embryonic stem cells (hESC) out of a total of $1.8 billion it has given away during the past eight years.

The amount is of some interest because the key reason that the agency now exists is the perceived need in 2004 to fund hESC research in the wake of the Bush Administration restrictions on federal funding in that area. The restrictions created a national uproar in the scientific and patient advocate community, which feared that promising therapies would never be developed.

The $35 million ballot campaign to create the agency focused hard on hESC research to the virtual exclusion of any mention of adult stem cell research. Opposing the effort were such forces as the anti-abortion movement and the Catholic church. But this month LifeNews.com carried a mildly approving item that pointed to the agency's turn towards adult stem cell research.

When the Obama administration lifted the Bush restrictions, some questions were raised about the need for the California effort, which is costing state taxpayers $6 billion, including interest. But those concerns received little public attention and quickly died out.

Funding for the agency comes through state bonds. Cash for new awards is scheduled to run out in 2017. The agency is looking at developing a public-private effort for thefuture that would need a $50 to $200 million “public investment” and major private funding.

Amy Adams, CIRM's communications manager, provided the $458 million figure following publication of this item yesterday on the California Stem Cell Report.

'Praise' for California Stem Cell Agency from Unlikely Corner

The California stem cell agency this month received what some might consider a gesture of approval from a longtime foe – LifeNews.com.

LifeNews is a site devoted to anti-abortion efforts and information and is sharply opposed to research involving human embryonic stem cells.

So it was with some surprise that we read a tacit endorsement of recent CIRM activities in an April 22 piece written by Gene Tame out of Sacramento. It said the most recent $32 million grant round from CIRM “demonstrates – again – where the future of stem cell reserch lies.”

Tame wrote,

“CIRM has been steadily moving away from its original mission to give preferential treatment to funding for human embryonic stem cell research (hESCR). Instead, after adopting a renewed emphasis on translating research into clinical trials, CIRM has more and more shifted the bulk of its grants towards funding research utilizing adult stem cells and other alternatives to hESCR, such as induced pluripotent stem cells (iPSCs).”

Tame continued,

“(T)he lack, once again, of funding for hESCR only serves to highlight how old and dated that approach to finding treatments and cures increasingly seems.”

Tame is correct in his assertion that the stem cell agency has moved a considerable distance from its reason for being – research involving human embryonic stem cells. In 2004, the ballot campaign to create the agency pitched voters hard on hESC research and made no real mention of adult stem cells. Instead, it focused on the threat from the Bush Administration with its restrictions on hESC research, which have been lifted by the Obama Administration. .

In 2010, a study by a Georgia Tech academic, Aaron Levine, reported that through 2009 only 18 percent of California's dollars went for grants that were "clearly" not eligible for federal funding under the Bush restrictions. 

At the date of the study, CIRM had not publicly disclosed statistics on its funding of hESC research.

Today, however, its web site shows that only about 240 of the 595 awards that it has handed out are going for hESC research. CIRM has not made public the dollar value of those 240 awards, but it has given away a total of $1.8 billion. (Following publication of this item, the agency told the California Stem Report that it has funded $458 million in hESC research.) 

A footnote: Levine was a member of the blue-ribbon Institute of Medicine panel that recommended sweeping changes at CIRM.  

California Stem Cell Agency Seeks Lobbyist Bids

The California stem cell agency has put out a bid for a private lobbyist to watch out for its interests in Sacramento, perhaps severing a longtime relationship with one of the Capitol's more prestigious power brokers.

The $3 billion agency has had a contract since 2005 with Nielsen Merksamer Parrinello Gross & Leoni LLP of Sacramento, which reported lobbying revenue last year of more than $5 million. That made it one of the top revenue producers among California lobbyists.

The agency's contract is tiny, however. It started at $49,900 for five months in 2005 on a no-bid contract with Nielsen, although the annual figure is now $49,999.  The agency's request this month for bids calls for a boost to $65,000 annually.

Nielsen Merksamer is very active in health care lobbying. Its biotech/pharmaceutical clients have included Genentech, Merck & Co. and Pfizer. The firm also played a role in the drafting of and campaign for Proposition 71 in 2004. In 2009, at the behest of Robert Klein, then chairman of the agency, it produced a legal memo that Klein used to help box in the agency governing board on taking a position on the Little Hoover Commission report recommending major changes at the enterprise.

The stem cell agency is one of the few agencies that hires a private lobbyist, which has raised some eyebrows. Nearly all agencies handle legislative relations internally.

Deadline for bids is May 3.

Stem Cell Agency Provides More Cost Detail on Future Plans

The California stem cell agency today clarified the size of the assumed "public investment" in its rough outline of its plan for future activities. 

In response to a query from the California Stem Cell Report, Don Gibbons, a spokesman for the agency, said,

"This hypothetical range of public investment ($50 million to $200 million) is thought of as a one-time investment, with hope of private investments in multiples of that with the fund recharging to some extent based on revenue."

Gibbons also said the agency did not want to indicate what it was prepared to pay for the study.  He said, 

 "We have not wanted to post the budget range because we want honest estimates of what folks think the budget should be rather than having them penciling estimates that max out the budget."

Deadline This October: California Stem Cell Agency Seeking Detailed Public-Private Plan for its Future

The $3 billion California stem cell agency, which is currently scheduled to go out of business in a few years, hopes to come up with a detailed plan by this fall for a novel public-private arrangement that would extend its life.

The rough outlines of the proposal assume $50 to $200 million in “public investment,” although it is not clear whether that would be a one-time figure or an annual amount from presumably the state budget or perhaps another state bond measure. The concept includes additional private funding of a yet-to-be-determined nature. (The agency later said that the public investment figures would be a one-time event.)

The broad sketch of the agency's latest thinking about how to regenerate itself was found in an RFP posted four days ago on its website.

CIRM is seeking a consultant who would flesh out the general concepts that it has offered. Work would begin in mid June and be completed in four months, close to the ninth anniversary of the agency, formally known as the California Institute for Regenerative Medicine. The RFP did not contain a figure for the cost of the study, but said that the price would be part of the criteria for evaluating bids.

CIRM was created in November 2004 when California voters approved Proposition 71, a ballot initiative. Since then it has awarded $1.8 billion to 595 recipients. It is funded by money borrowed by the state (bonds), but cash for new grants is scheduled to run out in 2017. Interests costs on the bonds raise the total cost of the agency to roughly $6 billion.

CIRM said in the RFP that the plan for its future should provide

“...an in-depth analysis of various public-private funding models with potential to attract private sector investment to, and facilitate further development of the most promising CIRM-supported research projects; and recommend a single preferred approach for achieving this goal, complete with details relating to the recommended structure and an operational plan.”

The RFP also contained a just-released, $31,750 study by CBT Advisors of Cambridge, Mass, that examined mechanisms for financing translational research, which is the key focus nowadays at the stem cell agency. Such research is aimed at pushing laboratory findings into the marketplace.

Among other things, the CBT report, whose lead author was Steve Dickman, said,

“The nature of CIRM as a state agency is perhaps the biggest weak point (and) has to be addressed politically and cleared up as soon as possible or raising money will be unnecessarily challenging.”

The CBT study did not address how that might be done, which could be a considerable task. Proposition 71 modified the state constitution and state law and can be altered only by a super, super majority vote of the legislature or by another ballot initiative.

California is the first state to provide billions for stem cell research by using borrowed money. It also is unique in California state government in that its funding flows directly to the agency and cannot be altered by the governor or the legislature.

Translating all that into some sort of public-private arrangement would be novel among state government departments and could well require legislative or voter approval.

The California Stem Cell Report has queried the agency concerning the frequency of the assumed “public investment” and CIRM's budget for the RFP. We will report that information when we receive it.  (The agency later declined to disclose what it was prepared to pay for the study.)

California Stem Cell Agency Budget Up 4.6 Percent, Topping $17 Million

During the past couple of years, the California stem cell agency has vastly improved the way it budgets the relatively tiny amount it spends on operational expenses.

At one point a few years back, its operational budget was often all but incoherent to the public and to at least some members of its governing board. (See here, here and here.) But times have changed. The process for its operational budget, which amounts to about $17 million for the 2013-14 fiscal year, is now more transparent and better organized.

The long overdue improvements can be credited to the hiring of Matt Plunkett in December 2011 as its first chief financial officer in its eight-year history, as well as the efforts of CIRM directors Michael Goldberg and Marcy Feit. Goldberg, a venture capitalist, is chairman of the board's Finance Subcommittee and Feit, CEO of Valley Healthcare in Pleasanton, Ca., is vice chair. Plunkett, however, left the agency suddenly last summer and the agency has no plans to replace him. CIRM Chairman J.T. Thomas says Plunkett put new financial systems in place that can be operated without a CFO.

Interested readers can get a glimpse of what is upcoming for CIRM spending beginning in July in documents prepared for the Monday meeting of the governing board's Finance Subcommittee meeting. The agenda, however, lacks a much-needed explanation and justification for the spending. All that is presented now for the public are raw numbers and a PowerPoint presentation, which is no substitute for a nuanced, written overview.

Nonetheless, here are the basics. The budget proposed for 2013-14 stands at $17.4 million, up 4.6 percent, according to California Stem Cell Report calculations, or $771,000 from forecast expenditures for the current year. The budget represents the cost of overseeing $1.8 billion in grants and loans and preparing new proposals and reviews of applications for hundreds of millions of dollars in additional awards.

The largest budget component is for personnel – $12.1 million, up from $10.7 million. Second largest is outside contracting at $2 million, down from $2.9 million for the current year, continuing a trend away from outside contracts, which once were burgeoning.

One interesting area includes “reviews, meetings and workshops,”- which are expected to cost $1.8 million this year. Next year, they are budgeted for $2 million. Some might look askance at those sorts of expenditures for “meetings.” However, that includes the fees and expenses for scientific reviewers for multi-day meetings in the San Francisco area, which is a high cost area, and other large gatherings. However, the figure does not include travel for reviewers, who come from out of the state and even from overseas.

Examples of the meeting costs include a three-day grant review session last September at the Claremont Hotel in Oakland that cost $44,019. A two-day meeting at the same hotel for the 29-member CIRM governing board cost $34,424. (These figures and others involving outside contracts can be found on the agenda of the board's Governance Subcommittee meeting April 10.)

The agency also dissected the budget from different perspectives on expenditures. The spending plan includes $2.0 million for the office of Chairman Thomas and $1.6 million for the office of President Alan Trounson. Comparable figures for actual spending this fiscal year were not provided, however, by CIRM for the Finance Subcommittee meeting. The size of the chairman's budget reflects the controversial dual executive nature of management at CIRM, which has come under repeated criticism, including from the recent blue-ribbon report by the Institute of Medicine.. However, the arrangement is locked into state law as the result of the ballot measure, Proposition 71, that created the stem cell agency in 2004.

Legal expenses are budgeted at $2.2 million with public relations and communications running slightly more than $1 million. The scientific office, as one might expect, consumes much larger amounts, with basic research, translational research, grants review and grants administration budgeted at $4.7 million. The development side of the scientific office, which focuses on pre–clinical and clinical research, is slated for $3.4 million. The agency did not offer comparable figures for the current year.

Under Proposition 71, the agency can legally spend only 6 percent of its $3 billion in bond funding for operational expenses. At one time the agency had a 50-person staff cap, but that was altered several years ago by the legislature. The most recent figures show it has 54 employees. However, this month's budget documents did not list the number of staff for this year or next.

The stem cell agency also reported that it expects to spend an additional $1 million a year for rent beginning in 2015, when a free rent deal provided through the city of San Francisco expires. The city put together a $18 million package to attract the CIRM headquarters in a bidding war with other California cities. The agency has never produced a public accounting of whether it has received full value on the package.

The proposed budget is likely to be approved by the Finance panel next week without significant changes and then by the full board late in May.

The public can participate in the Finance meeting at two locations in San Francisco one each in Irvine, Pleasanton, La Jolla and Berkeley. Specific locations can be found onthe agenda.

Meager California Biotech Representation in Governor's China Trip

California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

Some 90 persons were involved in the governor's delegation, but representation was meager from California's renown biotech sector and none at all from the $3 billion California stem cell agency, which has a collaboration underway with Chinese scientists. It may have been the only state agency with a formal collaboration agreement with China prior to Brown's visit.

According to many reports, the Chinese government regards growth of its biotech industry as one of its core economic efforts. Within that sector, biomedicine ranks as the most important and fastest growing, according to an Italian Trade Commission report. Stem cell research is especially important, according to this Canadian study. Indeed, some scientists in China are eyeing a Nobel Prize in the field (See here or here.)

California would seem to be well placed to take advantage of that situation, given its substantial biotech industry and community, which is only rivaled by Massachusetts. Add to that the existence of the unique California stem cell agency, which has funded a $1.5 million study by Holger Willenbring at UC San Francisco that also involves research by Lijian Hui at the Shanghai Institutes for Biological Sciences, which is separately funded by that country to the tune of nearly $1 million.

A look at the list of those traveling to China with the governor showed two representatives who could be considered from biotech: Joe Panetta, head of BioCom, a life science industry organization in Southern California, and Michel Baudry, dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences in Pomona, Ca..

We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

(Following the posting of this item, Ron Leuty of the San Francisco Business Times gave us a heads up on the latest on the site. He reported in March that Joinn Laboratories, a Chinese contract research organization, purchased the site. Leuty said that its plans are vague about future development, but that it may lease some of the space.)

StemCells, Inc., Nails Down Controversial, $19 Million Award from California Stem Cell Agency

The stock price of StemCells, Inc., price today jumped as much as 9 percent after the company disclosed it had finally concluded an agreement with the California stem cell agency for a $19.3 million forgivable loan for research twice rejected by the agency's scientific reviewers..

The stem cell agency governing board seven months ago approved the loan to the Newark, Ca., firm. But the cash was withheld until the financially strapped company could demonstrate that it could match the size of the loan, as promised in its application.

The StemCells, Inc., (SCI) application was nixed two times in 2012 by the agency's scientific reviewers who gave it a score of 61. In a controversial move, the 29-member board approved the award in early September on a 7-5 vote after former agency chairman Robert Klein intervened publicly on behalf of the firm. It was the first time that Klein had lobbied the board publicly on behalf of an application. It was also the first time that the board approved an application that was rejected twice by its reviewers, a panel of internationally recognized stem cell scientists.

In a press release, Martin McGlynn, CEO of StemCells, Inc., said,

"With CIRM's support, we are now able to lay the groundwork that could result in the world's first neural stem cell trial in Alzheimer's patients."

Both the company and the $3 billion state research agency were tight-lipped about the nature of the matching funds from the company, which reported losses of $28.5 million in 2012 on revenues of $1.4 million.

In a brief response to questions from the California Stem Cell Report, McGlynn said, 

 “At this time, we do not intend to elaborate any further on the contents of our press releases or public filings pertaining to the SVB (Silicon Valley Bank) or CIRM(the stem cell agency) loans.”

Earlier this week, the company reported receiving a $10 million loan from Silicon Valley Bank. Both McGlynn and the stem cell agency did not answer a question about whether those funds are being used to back the award from California taxpayers.

The agency confirmed that the firm was providing $19.3 million in matching resources. But Kevin McCormack, senior director of public communications, did not provide any specifics on the nature of the match. He only said,

“The matching  requires them to demonstrate they have enough funds necessary to fund SCI’s share going forward as well as their own operations and other commitments.”

The award was originally for $20 million. We have queried the agency about the smaller figure announced today.

The company's stock price rose as high as $1.87 earlier today after closing at $1.71 yesterday. It stood at $1.77 at the time of this writing. Its 52 week high is $2.67, and its 52 week low is $0.59. The loan from Silicon Valley Bank gives the bank warrants to purchase 293,531 shares of the company at $1.70 over the next 10 years.

The 10-year loan from CIRM is low risk for the company, which said its “obligation to repay the loan will be contingent upon the success” of the research. If a product is developed, it will take years before it could hit the market.

The award to StemCells, Inc., put the stem cell agency in a touchy situation involving the company's decision last month to reject an additional $20 million award from the agency.( It was the first time a recipient has rejected an award.) Neither the company nor the agency would give a reason for the rejection of the loan for a spinal injury project . However, the award also required a $20 million match, which undoubtedly tested the company's resources.

The spinal injury application was scored at 79 by agency reviewers and was routinely approved by the board. With its withdrawal by the company, the agency, which prides itself on funding only the best science, was left supporting research (StemCells, Inc.'s Alzheimer's project) judged significantly inferior by reviewers with its score of 61.

In response to a question about that situation, CIRM's McCormack said,

“Our goal is to always fund the best, most promising science. This is not the first time that our board has voted to fund a project that the Grants Review Group had not recommended (this has happened in around 2% of cases) The board did so for a number of reasons, not the least of which is that this was the first disease team application that had a goal of  moving a promising stem cell therapy for Alzheimer's towards clinical trials.”

The round in question, however, had another application dealing with Alzheimer's which was scored at 63, two points higher than the one from StemCells, Inc. Reviewers also did not recommend funding that application.

The action last September by the agency board came only after it publicly said the funds would not be distributed until the StemCells, Inc., could show it could provide the match, still another first for the agency.

The award triggered a column in the Los Angeles Times by Pulitzer Prize winning writer Michael Hiltzik, who said in October that  the process was “redolent of cronyism.” He said a “charmed relationship” existed among StemCells, Inc., its “powerful friends” and the stem cell agency.

StemCells, Inc., was founded by Stanford researcher Irv Weissman, who was a major fundraiser for Proposition 71, which created the stem cell agency in 2004. Klein headed the ballot campaign, which spent more than $30 million to win voter approval. Weissman sits on board of directors of StemCells, Inc., and holds 124,608 shares in the firm, including 8,630 he reported this month receiving.

Modest Approval from Long-time Stem Cell Agency Critic

Of all California's newspapers, The Sacramento Bee, the only daily paper in the state capital, has long been the most critical – editorially – of the Golden State's $3 billion stem cell research agency.

Today, however, the newspaper gave a modest nod of approval to the agency's modest efforts to clean up its built-in conflicts of interest, which have been cited as a major flaw by the prestigious Institute of Medicine.

The headline on the Bee's editorial today said,

“Stem cell agency finally addresses potential for conflicts”

The piece said that Jonathan Thomas, chairman of the agency, “has taken important steps in reducing the potential for conflicts within this agency.”

The editorial continued,

 “He hasn't gone as far as we would like, or that independent outside reviewers have recommended....But he's achieved what's possible, at least for now, and the board may empower him to go further.”

The Bee referred to action last month in which the agency's governing board decided, among other things, that 13 of the 15 board members linked to recipient institutions could not vote on any grants, although they could participate in discussion of applications. Twenty-nine persons sit on the board. In a $700,000 report commissioned by the agency, the Institute of Medicine recommended a fully independent board.

The Sacramento newspaper said, 

“We think Thomas and the oversight board should go further and adopt the Institute of Medicine recommendations. But that is politically unlikely. As is now obvious, it will be up to the Legislature to fully remove representatives of funding-eligible institutions from being involved in decisions about grants that could come back to them.

“Thomas, to his credit, recognizes that his compromise may not be the perfect solution. He wants to test out the new policy for a year, and see how it works. There's a lot riding on the outcome. CIRM is expected to run out of funds in 2017, and while philanthropy and foundation money could extend that for a few years, supporters of California stem cell research clearly want to go back to the ballot to seek additional funding. To make that case, CIRM supporters can't afford any more scandals about insider dealing. The next year will reveal whether it is on the right track.”

StemCells, Inc., Rejects $20 Million from California Stem Cell Agency

When does a financially struggling biotech company turn down a $20 million “forgivable loan?”

When it is StemCells, Inc., of Newark, Ca., and the cash is being offered by the $3 billion California stem cell agency. The research program has handed out nearly 600 awards, and it is the first time that a recipient has rejected funding.

That's the latest development in a stem cell saga that began publicly last July and that involved unusual personal lobbying by the former chairman of the Golden State's stem cell research agency. The high point of the saga may have come in September when the agency's governing board finished awarding StemCells, Inc., $40 million in two different awards. But there was a catch. StemCells Inc., had to match that figure with $40 million of its own.

Late last month, StemCells, Inc., threw in the towel on the $20 million awarded on its cervical spinal cord injury application. In comments to analysts March 21, Rodney Young, chief financial officer of the publicly traded company, said:

“The funding would have been in the form of a forgivable loan, however, we have elected not to borrow these funds from CIRM(the stem cell agency).”

According to the Seeking Alpha transcript of the conference call with analysts, Young said,

“You may also recall that last September, CIRM approved a separate application under the same disease team program for Alzheimer's disease, which was also for up to $20 million in the form of a loan. We remain in confidential negotiations with CIRM regarding the terms and conditions that would attach to this loan.”

The company provided no explanation for rejecting the cash, either in the conference call transcript or in its press release.

During the conference call, StemCells, Inc., reported continuing losses. For 2012, net losses totaled $28.5 million compared to $21.3 million in 2011. Revenue for 2012 was $1.4 million compared to $1.2 million in the previous year.

The awards last year to StemCells, Inc., founded by Stanford's eminent researcher Irv Weissman, stirred up a bit of a ruckus. The spinal injury award was handed out routinely in July. Scientific reviewers gave it a score of 79 and recommended funding. It was another matter on the Alzheimer's application. It was scored at 61. Reviewers said it did not merit funding. But the company publicly appealed to the full board, which sent the application back for more examination. It was rejected again. Nonetheless, in September, the 29-member board approved the award on a 7-5 vote, bypassing a rival Alzheimer's application scored at 63. It was the first time in the eight-year-history of the agency that its board approved an application that was rejected twice by reviewers.

Approval came only after strong lobbying by Robert Klein, former chairman of the board. Klein was also chairman of the ballot campaign that created the agency, and Weissman, who holds stock in StemCells, Inc., and sits on its board, was a major fundraiser for the campaign. 

The Los Angeles Times' Pulitzer Prize-winning columnist, Michael Hiltzik, wrote in October that  the process was “redolent of cronyism.” He said a “charmed relationship” existed among StemCells, Inc., its “powerful friends” and the stem cell agency.

As for the remaining $20 million award, Martin McGlynn, CEO of StemCells, Inc., expects “quick” action on finally securing the cash.

Here is an exchange that came during the March conference call between McGlynn and analyst Kaey Nakae of Ascendiant Capital Markets.

Nakae: “Okay. Just 2 more questions. I guess the first one, as it relates to CIRM. In deciding to decline the funding for spinal cord yet continuing to pursue the funding for Alzheimer's, is there a difference in what you're getting from them in terms of potential terms and conditions that allow you to proceed on one and not the other, or is it the fact that you're already in human with -- in spine, and still very preclinical with Alzheimer's?”

McGlynn: :”I think you're very definitely -- you're getting at some important criteria when one considers how to fund programs whether you use debt or equity, etcetera. So I wouldn't disagree with anything that you've outlined or surmised. But I just would pray your indulgence until we're finished, the negotiations with CIRM, which are coming to a close and we expect those to resolve pretty quickly with regards to the Alzheimer's program. And then quite frankly, we can be way more forthcoming and way more disclosive with regards not only to our decisions, but to our thinking.”

StemCells, Inc., was trading at about $1.65 at the time of this writing, down slightly from the previous day. Its 52-week high is $2.67 and its 52-week low $0.59.

Gone Sailing

The California Stem Cell Report will go dark for a couple of weeks or so as we make our way across the bounding main to Mexico. As many of you know, yours truly lives on a sailboat (15 years come June 1) that shuttles about the Pacific south of the American border. We have spent nearly two years in Panama and are now working our way back to Mexico where the chiles are hot and the frijoles “rico.” Look for fresh coverage either late this month or early April.  

Cyberspace Makeover at California Stem Cell Agency

California's $3 billion stem cell agency has performed a well-done makeover on its most important public face – its web site, which is chock-a-block full of useful information for researchers and the unwashed alike.

At cirm.ca.gov, one can find the very words of its directors as they wrestle with everything from grant approvals to conflicts of interest. Scientists can be seen telling the story of their accomplishments. Money can be followed, and summaries of reviews of grant applications read, both those approved and those that did not pass muster.

The web site of the California Institute of Regenerative Medicine (the formal name of the agency) is the place where the stem cell program really meets the public. News stories are important, but infrequent. Day to day, however, thousands of interested persons seek out information that the folks at CIRM HQ, just a long throw from the San Francisco Giants ballpark, bring to cyberspace.

Each month, said Amy Adams, major domo of the web site, 15,000 to 17,000 “unique viewers” visit online. She told the California Stem Cell Report in an email,

“We're up about 25 percent year over year in unique viewers to the site. A lot of that growth comes from search, and the rest is from traffic driven through our blog and Facebook.” 

The numbers are not huge compared to those chalked up by major media sites. But they are significant given that there are only a few thousand people worldwide who are deeply and regularly interested in stem cell research. Many more, however, are stimulated to look into the subject from time to time, either because of news stories, personal, disease-related concerns or simple interest in cutting edge science. Engaging those readers, who can spread the CIRM story, and winning their approval is critical for the agency as it faces the need to raise more millions as it money runs out in the next few years.

CIRM has mounted much information online over its short life. So much that good tools are needed to navigate the site. Decisions about what should go on the home page are critical. With the makeover, the agency now has a long-needed, home-page link to its meetings , especially those of its governing board, which are the single most important events at the agency.

The redesign is crisp and clean. The new, white background makes it easier to read and is comfortable for readers long conditioned to the black-on-white print of the books, newspapers and magazines. The video image on the home page is larger, which helps attract viewers. The site has long had a carload of videos, some of which contain powerful and emotional stories from patients.

Adams used CIRM staffers to test the new features. She reported,

“I've had people inside CIRM (who have been beta testing this site) tell me that they are finding content they'd never seen before because the site is so much easier to navigate.”

Adams and the CIRM communications team also have pulled together important information on each grant on a single page, including progress reports. You can find a sample here on a $1 million grant to Stanford's Helen Blau.

Adams said,

 “Now people can not only read about what our grantees are hoping to accomplish, they can read about what has actually been accomplished with our funding.”

Adams said another new feature is downloadable spread sheets of information that can be manipulated by readers offline. She said,

“Most places on the site where you see tables, you can now download those tables to Excel. You'll notice the small Excel icon at the lower left of the table. This feature has long been available for the searchable grants table. Now you'll see it on all the tables of review reports (see here for example http://www.cirm.ca.gov/application-reviews/10877) on the disease fact sheets (see here http://www.cirm.ca.gov/about-stem-cells/alzheimers-disease-fact-sheet) and other places throughout the site. This is part of an effort to make our funding records more publicly available.”

CIRM's search engine for its web site still needs work. A search using the term “CIRM budget 2012-2013” did not produce a budget document on the first two pages of the search results. A search on the term “Proposition 71,” the ballot initiative that created CIRM, did not provide a direct link to its text on the first two pages of search results.

Also missing from the web site, as far as I can tell, is a list of the persons who appointed the past and present board members as well as the dates of the board members' terms of office. The biographies on some of the 29 governing board members come up short. In the case of Susan Bryant, her bio does not mention that she is interim executive vice chancellor and provost at UC Irvine. Links also could be added to board members statements of economic interest. A list of CIRM staff members (only slightly more than 50 persons) and their titles could be added.

As for CIRM's count of visitors, CIRM uses Google Analytics tools. Adams said,

“A unique visitor is Google's definition (it's one of the metrics they provide). It's a visit from a unique IP (internet protocol) address. So, if you visit our site multiple times from one IP address during a day, you count as a single unique visitor. (Editor's note: It is possible to have more than one visitor from the same IP address.)

“We get ~23,000-25,000 visits per month, or ~16,000-18,000 unique visitors. Page views are on the order of 65,000 a month.”

Our take: The redesign of the web site is a worthy effort and enhances CIRM's relationships with all those who come looking for information. The agency is to be commended and should continue its work to improve the site and its connections with the public.

California Stem Cell Directors to Finalize IOM Response Next Week

Directors of the California stem cell agency will meet March 19 in Burlingame to complete action on their response to blue-ribbon recommendations for sweeping changes at the eight-year-old research enterprise.

CIRM Chairman J.T. Thomas last week told the San Diego U-T editorial board that he regarded approval as “largely ministerial.”

Thomas has been visiting newspaper editorial boards around the state, touting his plan, which was initially approved by the board in January. The main focus has been on its provisions dealing with conflicts of interest, which would have 13 of the 29 governing board members voluntarily remove themselves from voting on any grant applications. The 13 are linked to recipient institutions. Two other board members linked to recipient institutions also sit on the board.

About 90 percent of the $1.8 billion that has been awarded by the CIRM board has gone to institutions linked to past and present members of the board.

In December, the Institute of Medicine cited major problems with conflicts at the stem cell agency. It recommended creation of a new, independent majority on the board, which would mean that some members would lose their seats. The IOM report also recommended a host of additional changes that have become eclipsed by the controversy about conflicts, which were built into the board by Proposition 71, the ballot measure that created it in 2004.

An analysis in January by the California Stem Cell Report of the IOM report, which CIRM commissioned at a cost of $700,000, showed that agency's response fell far short of what the IOM proposed to improve the agency's performance.

Also on the agenda for the March 19 is approval of applications in a $30 million effort by the agency involving reprogrammed adult stem cells. The agency said the goal of the initiative is “to generate and ensure the availability of high quality disease-specific hiPSC resources for disease modeling, target discovery and drug discovery and development for prevalent, genetically complex diseases.”