Geron's Clinical Trial: Risk, Front-loading and Costs

The Vatican doesn't particularly care for the idea. "Unacceptable" was the word it used.

Over at Bioworld Today, it was "the dawn of a new era."

A reader of the New York Times warned of the danger of "front-loaded" arguments that can be detrimental to stem cell research.

What they were talking about is Geron and its re-vitalized clinical trial of an hESC therapy for spinal injuries. The FDA late this week lifted its hold on the effort. Andy Pollack of the New York Times said "cysts were discovered in some mice injected with the cells. Geron had to do another mouse study and develop better ways to check the purity of its cells."

Pollack wrote,

"Years of further testing will be required before the therapy would be proven and ready for widespread use, assuming it works."

Among the readers of Pollack's story was a person from Seattle who said,

"As in the case of most things in science, we just do not know enough to say which scientific modalities will bear fruit first if at all and when and hence multi-pronged approaches are needed. And the field of stem cell biology painfully realized a few years ago, some of these discoveries are fads that cannot be replicated by others ( I am referring to Catherine Verfaillie's assertion that adult stem cells can do most of what embryonic stem cells can do, a claim that has since been refuted/ withdrawn or generally agreed to be highly exaggerated at best). The damage done to stem cell biology from that fiasco is still evident. Hence most scientists would agree that front-loaded arguments for and against particular technologies are dangerous and can be detrimental to general scientific progress."

(Verfaillie is a CIRM grant reviewer.)

Over at UC Davis, stem cell researcher Paul Knoepfler, writing on his blog, called it a “milestone,” but noted that while the potential is high, the risk is very high as well.

Donna Young, Washington editor of Bioworld Today carried a detailed account concerning the trial. Her story began,

"The FDA's blessing Friday of the world's first clinical trial of a human embryonic stem cell (hESC) therapy has not only launched what may be 'the dawn of a new era' for medical treatment, but if successful, the therapies could alleviate much of the burdensome costs plaguing the nation's health care system, insisted Geron Corp. CEO Thomas Okarma."

Most of the news reports did not mention the seminal role of UC Irvine in the research leading to the clinical trial. You can find more details about that here on the Califoria Stem Cell Report.

Geron Go-Ahead Rouses Industry and Researchers

Geron Corp. said today that it hopes to begin within the next two months a clinical trial for an hESC therapy for spinal injuries, triggering a wave of ebullience from scientists, investors and patient advocates.

The company disclosed its plans following the lifting by the FDA of a hold on the effort.

Clive Cookson of the Financial Times of London caught the global significance. He wrote,

“The world’s first treatment based on human embryonic stem cells is set to begin a clinical trial within the next two months, in patients with acute spinal cord injury.”

For patient advocate Don Reed of Fremont, Ca., it was an emotional event. Writing on his blog, Reed said,

“The research behind this ground-breaking event was paid for a California law named after my paralyzed son, the Roman Reed Spinal Cord Injury Research Act of 1999.”
Reed continued,

“Christopher 'Superman' Reeve gave us his blessing, saying, 'One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.' Cure did not come in time for our paralyzed champion, but we still believe in that great dream.”

Shares of Geron, a firm in Menlo Park, Ca., shot up 17 percent or 83 cents to $5.63. Analysts predicted skyrocketing share prices if the clinical trial proves successful.

Rob Waters and Molly Peterson of Bloomberg News interviewed Thomas Okarma, CEO of Geron. Bloomberg said,

"The FDA action strengthens Geron’s ability to start similar trials in the future, Okarma said. It also leaves regulators with a better grasp of how to review a completely new type of therapy.

"'It’s helped both of us to get up the learning curve together,' Okarma said. 'We’ve brought the FDA to a higher level of understanding which has been very positive and mutually beneficial. And phew, it’s about time.'"

Peterson and Bloomberg continued:

"Two other U.S. companies are working with embryonic stem cells. Advanced Cell Technology;of Marlborough, Massachusetts(and Los Angeles), is awaiting FDA approval to start a clinical trial in patients with Stargardt’s macular dystrophy, an eye disorder that causes severe vision loss.

"Viacyte, formerly known as Novocell Inc., a closely held San Diego company, is working on methods of turning embryonic stem cells into insulin-secreting cells for the treatment of diabetes."

Paul Knoepfler, a stem cell researcher at UC Davis, had predicted on his blog on July 1 that the FDA hold on Geron would be lifted “very soon.” Today he said,

"The hold was placed because of a 'higher frequency of cysts.' However many of us were wondering why the serious concern (and seemingly long hold) about non-tumorigenic cysts that were somewhat unremarkable in appearance. That remains unclear except that perhaps it was the "higher frequency" part. Despite being a bit puzzled about the length of the hold, I think in the long run caution makes sense."

CIRM President Alan Trounson said in a statement,

“This is an important milestone for the whole field to have an embryonic stem cell therapeutic in clinical trials. We are looking with hope and expectation that the transplant will be safe and effective.”

Geron is expected to be one of three firms (including Advanced Cell Technology) seeking funding from the California stem cell agency in its upcoming $50 million clinical trial round. The RFA was originally scheduled for May but was rescheduled for this month. CIRM appears likely to miss that target.

Pay Proposal for Patient Advocates on CIRM Board

The California stem cell agency is proposing to pay the 10 patient advocate members on its 29-member board of directors up to $15,000 a year for work performed in connection with their responsibilities for CIRM.

The move would implement some provisions of legislation that also removes the 50 person cap on the size of the CIRM staff. That legislation (SB1064) seems likely to be enacted this year. It is up for consideration in Sacamento next Wednesday by the Assembly Appropriations Committee.

Both the cap and the problem being addressed by the patient advocate proposal stem from Prop. 71, the ballot initiative that created CIRM and also wrote variety of minutia into law. The proposition requires a super-majority (65 percent) for a CIRM governing board quorum, which is based on the number of board members eligible to vote. Since many of the board members have conflicts of interest that prevent them voting on matters before the board, the presence of patient advocates is necessary to take action – much more so than many other members of the board.

A memo by James Harrison, outside counsel to the CIRM board, said,

"As a result of the requirements in Proposition 71, the Patient Advocate members of CIRM’s Governing Board are required to devote a substantial amount of time to the review of applications for research and facilities funding and the development of the standards pursuant to which research must be conducted. The time devoted to service on the Working Groups is above and beyond the time devoted to Board, subcommittee and task force meetings. In the aggregate, this service can seriously affect members’ ability to serve while simultaneously carrying out their other responsibilities, including their current occupations.

“Under the proposed bylaw, the Board would have the authority to set a daily consulting rate to compensate Patient Advocate members of the Grants Working Group and the Vice Chairs of the Facilities and Standards Working Groups for their service on the Working Groups. The Patient Advocates would continue to be limited to a per diem of approximately $116 per day for their service on the Board, Board subcommittees, and task forces. The proposed bylaw also addresses concerns that SB 1064 imposes no cap on the daily consulting rate the Board could set for Patient Advocate members of the Working Groups. Thus, it would impose a $15,000 annual cap and it would limit the daily rate to no more than 75% of the rate paid to scientific members of the Grants Working Group. In addition, the bylaw would require the Board to find that service on the Working Groups requires an extraordinary commitment of time.”

The CIRM directors' Governance Subcommittee will take up the pay plan at its meeting next Tuesday. Also on tap for the session are changes in outside contracting procedures. The agency is heavily reliant on contractors because of the 50 person staff limit.

The panel is additionally slated to discuss CIRM's grants management system, which has been a critical issue for the agency since 2007. A number of directors expressed concern at their June meeting about the staff decision to build a custom system, declaring that such efforts often have unfortunate outcomes. The staff report on the matter is not yet available to the public.

The public can take part in the subcommittee meeting at a number of teleconference locations throughout the state. The specific addresses can be found on the agenda.

Managing More than 300 Grants: CIRM's Thin Ice Question

A key panel of directors of the California stem cell agency on Tuesday will wrestle with ongoing issues involving its critical grants management system and consider changes in its policies concerning the many outside contractors CIRM is forced to rely on.

The agency has already posted some background information for the Governance Subcommittee meeting including a list of current contracts and the proposed changes in contracting. However, still missing is a report on the grants management system, which stirred strong concern from directors at their June meeting.

One director, Michael Friedman, CEO of the City of Hope, warned that CIRM was skating on “thin ice” with its plans to create its own software to monitor and track grants. Friedman said,

“Everybody has seen horrible examples of custom-designed systems that go bad.”

He continued,

“I have to express in the strongest possible terms my discomfort” with the CIRM staff decision to build a custom system.

Friedman's probing led CIRM directors to seek the report on the grants system for next week's meeting. CIRM plans to use the system for the entire grant process from application to termination. CIRM has awarded more than 300 grants involving more than $1 billion. It plans to hand out another $2 billion over the next seven years or so.

The grants management effort has a long history, dating back to 2007 when directors were told it would cost only $757,000. By our count, the agency has spent $1.2 million so far, not including staff time, with much more coming this year. CIRM has not publicly provided its own total nor has it forecast how much more will needed to be spent until the system is fully developed. Also missing are projected annual maintenance and service costs following that point.

For the current fiscal year, the CIRM budget forecasts that spending on information technology will jump by 53 percent, from $817,000 to $1.2 million, an increase of about $433,000. Most of that goes for the grant system.

Also on tap Tuesday are unspecified changes in the bylaws for the CIRM governing board.

Tuesday's meeting will have teleconference locations in San Francisco, Los Angeles, Sacramento, La Jolla, Irvine and Palo Alto. If you would like to attend any of those sessions, you should check the agenda for specific addresses. In some cases, you will need to call CIRM because it has not provided enough information on the agenda to let the public know exactly where the meetings will be held.

Jonny and His Stem Cell Breakdown

We all owe a debt of gratitude to the reader who posted an anonymous comment yesterday concerning the reality of life in stem cell labs.

The commentator poor-mouthed his brief note as “bit light.” But we think it is just what the field needs – a well-seasoned researcher engaged in educating the unwashed – sort of.

The matter involves Jonathan Garlick of Tufts. A light-hearted fellow, he is given to using an unusual method to discuss science. In this case, stem cell science.

Known as Dr. Jonny Cool J, Garlick has put together a six-minute rap on the virtues of the field. It has been viewed nearly 22,000 times.

“This Guy RULEEEES!!!” said one viewer. And now, here's Jonny.

Despite New CEO Job, Alan Lewis to Continue to Consult for CIRM

The California stem cell agency said this morning that Alan Lewis will continue to work as a consultant to the agency although he has what appears to be a full-time job as the new CEO of Ambit Biosciences of San Diego.

In the wake of the announcement of the new job, we queried CIRM earlier today about Lewis' status as the interim vice president for research and development for the $3 billion stem cell agency, an arrangement that began only on June 21.

Don Gibbons, CIRM's chief of communications, replied via a comment filed on our item that reported that Lewis had a new job. Gibbons said,

“CIRM's president was informed of Mr. Lewis' new position Friday. From the outset the $250,000 salary was to be prorated based on days actually worked with the full amount assuming a five-day week. With his new position Mr. Lewis will scale back his time with CIRM from a planned two to three days a week to 2 to 3 days a month, and the salary will be prorated accordingly, while we continue the search for a VP for R&D. “

Gibbons did not mention whether Lewis would continue to hold the title of interim vice president. Ambit and Lewis have not yet responded to our queries concerning his job with CIRM.

CIRM's New Interim VP for Research Takes Job with San Diego Firm

Only a little more than a month into his $250,000, six-month contract with CIRM, Alan Lewis has taken a job as CEO of the Ambit Biosciences of San Diego.

An anonymous reader alerted us this morning to Lewis' new post. (See the reader's comment to the left of this item under the heading “recent comments” or via the comments function on the “$250,000 Contract” item.) The reader makes the reasonable assumption that Lewis, former head of Novocell, will no longer be working part-time with the California stem cell agency. However, the full press release on Lewis' sort-of-new job does not mention the CIRM contract. We are asking both Lewis and the stem cell agency to clarify his status.

Lewis has served as executive chairman of Ambit since March, a fact not mentioned by CIRM when it announced his appointment as interim vice president of research and development. (Lewis told us that his executive chairmanship began in May. Today's Ambit news release says March.)

The anonymous reader also makes a good point concerning the amounts paid to CIRM contractors. The best talent costs money. But failing to effectively manage a $3 billion investment costs a lot more. Also readers should understand that the figures paid to independent contractors should be discounted by 35 to 50 percent if they are to be compared to conventional salaries. Standard pay figures do not include the cost of fringe benefits paid by employers, such as health insurance, retirement contributions, Social Security payments, etc. Depending on the company or government, those fringe benefits can run to 35 to 50 percent. In the case of individual contractors with CIRM, they must pay for those benefits themselves.

But regardless of the justification for spending large sums for outside contractors, California voters can be outraged by the amounts. Their reaction is visceral and emotional, a phenomena we discussed in this item. You can see examples of it on this blog on items dealing with salaries at CIRM and some outside contracts.

We also want to extend our personal thanks to the anonymous reader who brought Lewis' new job to our attention and that of our readers. We encourage comments from all readers, especially those bring fresh information to California stem cell matters.

A Matter for CIRM to Ponder: California's Visceral Reaction to High Salaries for Public Servants

Lavish government or quasi-government salaries are an anathema to California voters.

They reacted predictably with outrage last week when news surfaced about what they considered egregious greed. Jail time was urged. “Nauseating” was another word that was used.

The response is something to be considered by directors of the California stem cell agency, which has its own set of generous executive salaries. What is important here is what the voters perceive as lavish or greedy – not the perceptions of recipients or the perceptions of those who approve the pay.

One non-CIRM instance involved the city of Bell, a tiny, not particularly well-off enclave not too far south of downtown Los Angeles. It was there that the city manager resigned after it was disclosed by the Los Angeles Times that he was earning $800,000 a year. And that left him with a pension estimated at $600,000, going on $700,000. Times columnist Steve Lopez wrote,

“The sad reality, dear Californian, is that depending on where you live, you may be personally contributing to the insultingly fat pension of ousted Bell city administrator Robert "Ratso" Rizzo.”

The other instance involved the executive director of the non-profit California School Boards Association, which is based in Sacramento and supported by tax dollars that are paid to the association by school boards. The executive, who is mostly a lobbyist, retired after Sacramento television station KCRA disclosed that he made more than $540,000 two years ago, the most recent figure available.

“Piggies,” “unconscionable,” “retire him to the county jail” were some of the 129 comments filed on a Sacramento Bee story about the matter.

The salary scale at the $3 billion California stem cell agency tops out at more than $500,000. Amounts paid to its top executives have triggered harsh comments from a handful of observers. CIRM's contracts with outsiders have also been targeted. But the pay and contracts have received no widespread notice.

A good case can be made that the salaries at the highest levels of the stem cell agency are necessary and appropriate. But that makes little difference to citizens struggling with layoffs, cutbacks and wage roll backs. Even before the current dismal economic climate, they would froth and foam reflexively at what they regarded as excessive pay for public servants.

As CIRM aims at another pitch to the voters for billions more for research, its directors and executives should be preparing for a visceral and emotional outburst from citizens concerning its executives' pay.

CIRM Defends Legality of Barring Public From Marriott Meeting

The California stem cell agency says it did not violate state open meeting laws when it barred two members of the public from a meeting in June at a San Francisco hotel.

In an unsolicited note earlier this month to the California Stem Cell Report, Ian Sweedler, deputy legal counsel for CIRM, said,

“The Bagley-Keene Open Meeting Act applies to multimember boards or commissions, like the ICOC (CIRM directors) and its subcommittees, not to agency staff, or to other meetings that staff attend or organize in the operation of the agency, including the SCNT workshop.  We are always mindful of Bagley-Keene, and careful to follow it when it applies.”

We asked him to clarify his response, including whether CIRM's actions in this case violated recent changes in the California Constitution that guarantee the public a broadly construed right to information about the taxpayer's business.

Sweedler said,

“Sorry if I wasn’t clear.  Yes, I am stating, without qualification, that the SCNT workshop did not violate Bagley-Keene or Proposition 59(the change in the state Constitution), or any other law that I am aware of.  You had stated that a specific CIRM activity violated a specific law, and I thought it was important to correct that.  Thanks.”

We understand and respect Sweedler's opinion. However, it would take a court decision to determine whether he is correct. Our research indicates that a strong case can be made that such meetings must be open. Additionally, the state's open meeting laws were written well before CIRM, an agency unlike any other in state history, came into being. They must be reinterpreted not only in the wake of the Prop. 71 but also in the wake of a new, much broader constitutional guarantee of right of public access. The most important point, however, is that CIRM has pledged to go beyond the mere compliance with open meeting laws. As we noted earlier,

“Legalities aside, it is not in CIRM's best interest to bar persons from any of its sessions – not to mention that it is not in the best interests of the people of California. CIRM needs to do more than meet the minimum standards of the state's sunshine laws. To fail to do so will create a record that will surely harm CIRM's public support and hamper its efforts to secure more funding after it runs out of the $2 billion it has left to spend.”

As to whether CIRM adhered to the law, Sweedler confirmed that the meeting in question included the attendance of at least one alternate for a CIRM director, Jeannie Fontana. We also understand that some persons were in attendance who had not been invited directly by CIRM.

Those facts have an impact on whether the ban on the public is strictly legal. The First Amendment Coalition of California watches over the application of sunshine laws in California. The group says,

“California law doesn’t exactly ban deal-making by politicians in smoke-filled rooms, but it comes close to doing that at the local level (under the Brown Act) and among state agencies (under the Bagley-Keene Act). The fundamental idea behind these statutes is that the full process of political deliberating and decision-making—justly likened to the making of sausage—should be conducted in the open, in public meetings for all to see. Although the laws allow for certain matters to be considered in 'executive session,' they are the rare exception (in theory, at any rate).”

The coalition's Web site discusses cases (see here, here and here) that have application concerning the incident at the Marriott Hotel. They deal with the presence of a board member (or alternate in this case) at meetings such as those held by CIRM, as well as the possibility that they could lead to an illegal “serial meeting” of the CIRM board of directors even if only CIRM staffers were involved at the initial meeting.

In one case involving local open meeting laws, the First Amendment Coalition quoted the state attorney general as saying,

“In construing these terms, one should be mindful of the ultimate purposes of the Act — to provide the public with an opportunity to monitor and participate in decision-making processes of boards and commissions.  Conversations which advance or clarify a member’s understanding of an issue, or facilitate an agreement or compromise among members, or advance the ultimate resolution of an issue, are all examples of communications which contribute to the development of a concurrence as to action to be taken by the legislative body.”

In other words, such meetings should be open to the public.

Sweedler's statements go beyond CIRM's earlier comments. The stem cell agency previously contended that the meeting was closed to protect proprietary information, but failed to argue that open meeting laws did not apply. Don Gibbons, CIRM communications chief, said the meeting was designed “to gather information for critical decisions regarding the direction our funding should take.” To us, that sounds like something the public should have access to.

CIRM has virtually nothing to gain by barring the public. It is not as if hoards will descend on the sessions. Even full CIRM board meetings rarely attract more than 10 members of the public. Indeed, the agency is likely to benefit from comments that come from a different angle.

Correction

In two recent items, we misspelled the last name of a Duke University researcher. The correct spelling is Rob Wechsler-Reya. We had it incorrectly as Weschler.

Questions and Commentary on Stem Cell Reprogramming

The California stem cell agency and a UC Davis stem cell researcher are blogging on the implications of research that indicates that reprogrammed adult stem cells may not be the magic bullet that avoids the problems associated with human embryonic stem cells.

You can find a summary of some of the research and discussion from CIRM's Amy Adams here. Paul Knoepfler of UC Davis said,

"So if iPS cells are not that similar to ESC, what does this mean?

"First, it is not the end of the world. Many of us had assumed that iPS cells are similar to ESC in some ways, but distinct in others. These studies simply validate that notion.

"Second, iPS cells are still very useful even if they are not quite so close siblings of ESC. In fact, iPS cells do not need to be extremely similar to ESC to be useful. The pluripotency and self-renewal of iPS cells makes them a powerful tool regardless.

"Third, iPS cells are a distinct type of stem cell from ESC and should be considered as such.

"Fourth, these studies also highlight that every iPS cell line made is distinct from the others made. The heterogeneity amongst iPS cell lines is probably more substantial than the differences between ESC lines, but ESC lines also vary between each other quite a lot as well.

"Finally, the tumorigenicity of iPS cells is a serious concern. A remaining open question is how prone iPS cells are to form malignant tumors (although don't forget that teratoma can be malignant!). We predict that iPS cells are dramatically more prone to produce malignant tumors compared to ESC."

(Editor's note: An earlier version of this item contained typos in the material that was inserted from Knoepfler's original post. He corrected those typos on his blog, and we have altered his quote above to reflect those changes.)

Day 153 of the Wechsler-Reya Affair: Near Silence from All Quarters

California's $6 million, long-running courtship of a pair of Duke Blue Devils has apparently not been consummated.

But, like many other consummations, it is not easy to tell. Silence is the watchword on the part of those who know.

Last April, the California stem cell agency offered a $6 million signing bonus to Robert Wechsler-Reya, a researcher at Duke University, to move to La Jolla's Sanford-Burnham Institute. The award is part of a two-year, $44 million taxpayer-financed effort to help recruit scientists to California.

Sanford-Burnham is also providing “an extremely generous commitment of laboratory space, matching funds for equipment, additional support for relocation and research, and access to excellent core facilities,” CIRM grant reviewers said.

But the multimillion dollar enticement did not make the Duke pair jump with alacrity. Wechsler-Reya told the California Stem Cell Report last spring he had not made a decision. That situation seems to be unchanged today.

On Monday, we queried Wechsler-Reya about whether he and his wife, Tannishtha Reya, also a stem cell researcher, will take their work to Sanford-Burnham. So far he has not responded. CIRM remains mum as well, failing to answer our questions from Monday.

Andrea Moser, vice president for communications at Sanford-Burnham, however, did say something.

“At the current time, we do not have an update on the Wechsler-Reya recruitment.”

In April, the $3 billion stem cell agency tried to impose a June 30 deadline on the courtship. CIRM President Alan Trounson told directors that Sanford-Burnham had assured him the deal would be done by then.

One reason that directors wanted the matter settled was competition for more of the signing bonus cash. If the Duke researcher was not coming to California, more money would be available to help other institutions lure scientists to the Golden State. CIRM reviewers held a closed-door session last week to make decisions on those applications, but no news was forthcoming from that event.

So we are now into Day 153 of the Wechsler-Reya Affair. Stay tuned for all the developments.

(Editor's note: We started counting the days beginning with the Feb. 18 application deadline for the grant.)

(Wechsler-Reya photo)

Stem Cell Directors Postpone Action on Troubled Appeals Process

Directors of the California stem cell agency today delayed action on moves to reshape the “broken” grant appeal process at CIRM.

In response to a query about the outcome of the directors' Science Subcommittee, Don Gibbons, chief of CIRM communications, said,

“A lengthy discussion resulted in agreement to continue the discussion rather than take action at this time. It was generally agreed that any re-scoring request from the board should be a rarely used option.”

CIRM's board of directors has been bedeviled by problems with the appeals process for 2 1/2 years. The directors' new Science Subcommittee began to address the issue late in May.

More details on the directors' thinking on the problem will have to await the unveiling of the meeting transcript in about two weeks.

Biopolitical Times Questions Rationale for Future CIRM Funding

The case that California stem cell Chairman Robert Klein is trying to make for more funding for the $3 billion research effort rings hollow, according to the Center for Genetics and Society.

Writing on the group's Biopolitical Times blog, Jesse Reynolds, the Berkeley center's project director on biotechnology accountability, said that another ballot measure for stem cell research would fail. He said,

“...(I)nstead of the promised cures of the Proposition 71 campaign, reality-based voters see dramatic cuts in the state's essential services, liberalized federal funding of embryonic stem cell research, and a potential alternative in cellular reprogramming.”

Reynolds made his comments in the wake of a cover story in the San Francisco Examiner about the state of CIRM. Reynolds wrote that Klein “unsurprisingly defends its continued funding.”

Reynolds continued,

“But Klein’s arguments ring hollow. First, he cites an economic study that concludes the program has generated significant tax revenue. But that study's conclusions were controversial, and in any case $100 million is far less than the billion dollars the CIRM has already spent. The program is certainly not paying for itself, as he suggests now and as he claimed before the vote on Proposition 71.

“Second, Klein cites reduced health care costs. He goes so far as to say, 'First of all, we’re saving lives.' While I sincerely hope that embryonic stem cell research leads to therapies, that is not yet the case. Clinical trials are yet to begin. (Maybe next year?) Until there are genuine therapies, such savings remain hypothetical.”

CIRM Seeks Communications Coordinator

The California stem cell agency is still looking for a “communications outreach coordinator” to help beef up its public relations efforts.

The agency has re-posted the RFP for the $85,000, 12-month job after apparently not being satisfied with the earlier round of applicants. The part-time position also includes a $10,000 travel budget. The winning applicant will be expected to work 20 to 30 hours a week.

Among the responsibilities for the position are three CIRM town forums, Stem Cell Awareness Day, relations with patient advocacy groups and assistance in developing material for use in advocacy group meetings.

Deadline for applications is July 30.

UC Davis Scientist Praises CIRM Appeals Change

A stem cell researcher at UC Davis today said a change in the CIRM grant appeals procedure makes “a lot of sense.”

Writing on his blog in regard to "extraordinary petitions," Paul Knoepfler said,

“I think the proposed change makes a lot of sense and would greatly improve the process. Sometimes the reasons in the petitions are clearly not meritorious and as it now stands, they end up wasting CIRM's time. The last time CIRM received 9 petitions as well, which represented a remarkably large fraction of the total applications. A stricter process would discourage the submission of large numbers of petitions, an important issue given that the number of petitions received by CIRM continues to grow.

“As someone who has submitted dozens of grant applications over the years to many different funding agencies, I know how it feels to get applications unfunded and receive critiques I may not agree with. It is not fun. It is especially difficult when one is near but below the funding cutoff. However, it happens all the time.

“I think CIRM might consider a bit stronger language in their policy on appeals making it clear that appeals should only be filed in very limited circumstances and that appeals found to be without merit will be frowned upon.

“In other words, don't file an appeal simply because the rules theoretically allow you to and/or you are grumpy about how your grant application was received. Such frivolous appeals may affect your reputation.”

Knoepfler also received a comment from Jeff Sheehy, chairman of the CIRM Science Subcommittee, which will be considering the changes. Sheehy said,

“One thing that I think confuses folks is the lack of control we have over what comes to the Board.  As a public body, we're governed by State open government-Bagley-Keene rules (which I strongly support, btw).

“On any matter under consideration by the Board, any member of the public can speak to the matter or provide documents to Boardmembers.  Within that legal reality, we can only channel and not reject 'extraordinary petitions.'”

Whither Wechsler-Reya? A $6 Million Stem Cell Tale

Is a high-flying stem cell researcher from Duke coming to California to claim his $6 million grant from the state's $3 billion stem cell agency?

Can the prestigious Sanford-Burnham Institute in tony La Jolla, Ca., lure him and his wife away from their spots at the Gothic Wonderland, as Duke University is sometimes known?

The answers to these and other questions are still a mystery despite a quasi-deadline for the giveaway imposed by the 29 directors of the Californa Institute for Regenerative Medicine.

The will-they or won't-they matter involves Robert Wechsler-Reya and Tannishtha Reya, another Duke researcher.

The couple is being or has been recruited by Sanford-Burnham with the help of the multimillion dollar grant from California taxpayers. Directors of the state stem cell agency approved the award in April.

At the time, directors appeared to be initially unaware that the deal was not done. Wechsler-Reya told the California Stem Cell Report that he had not made up his mind on whether he would become a latter-day California argonaut.

According to the transcript of the April 29 CIRM board meeting, Chairman Robert Klein said he wanted a “definitive time” for conclusion of the Wechsler-Reya recruitment. CIRM President Alan Trounson said that Sanford-Burnham said it would be finished by the end of June. He told directors,

“We're reassured that that will be the case.”

Sanford-Burnham has announced other hires this month, but did not mention the Duke researchers. Earlier this month, we asked CIRM about the situation.

Amy Adams, communications manager for the agency, replied on July 1,

“The deadline in the RFA is for funding to start within six months after ICOC approval. At the ICOC meeting, there was agreement that it would be desirable to know Dr. Wechsler-Reya's decision before the next review so that we know how many slots remain, and the hiring institution agreed that would be reasonable. It was also stated that we hoped to have the recruitment resolved by the end of June, which has not happened.”

Wechsler-Reya has not responded to a request for comment. We are asking both him and CIRM again about the matter.

CIRM Finally Discloses Grant Appeal Proposals

The California stem cell agency early today belatedly posted a two-page memo on proposed changes in how it will deal with appeals by scientists whose grant applications have been rejected by reviewers.

The information comes only one business day before a meeting of the CIRM directors' Science Subcommittee to consider alterations in the appeals process. The changes deal with an issue that has been publicly troubling the CIRM board for 2 1/2 years. Many CIRM directors are unhappy with a situation that finds researchers publicly appearing before the board to press their cases. One director has described the process as “broken,” a description that others would likely use.

One proposed change provides for “re-scoring” of applications when directors are unable to make an "informed decision" at the board meeting at which an application is considered. The re-scoring would occur when “a material dispute of fact exists or when new information that is not available at the time of the initial review has come to light.”

The staff memo said,

“Programmatic issues, such as whether the agency’s portfolio is well-balanced among diseases, should not be a justification for re-scoring, nor should clear errors in the review of an application that have been identified by staff and presented to the board.”

Other changes would stipulate that CIRM staff would not respond in writing to the board on “extraordinary petitions” unless they believe the petition has merit.

Applicants would be advised that they may submit a petition – which is tantamount to an appeal – five days before the CIRM board is to consider their application “if they believe a material error or omission in the review of their application may have affected the recommendation made by the Grants Working Group to the board.”

Staff summaries of reviewers' recommendations would also cover the “majority views and the minority views, when there is a major difference of scientific opinion between large blocks of reviewers (e.g. eight speaking against and five in favor).”

As we have noted, it is a dismal commentary on CIRM that it has taken the agency until now to post the two-page document on the proposed changes. The agency cannot expect well-considered comments or questions from the hundreds of affected California scientists when it discloses information only one business day prior to the meeting at which a matter is to be considered. Indeed, we suspect that most California stem cell researchers are not even aware that CIRM is considering changes tomorrow that could affect their livelihood and work. That is not to mention that CIRM's belated posting does not come close to meeting the pledge of CIRM Chairman Robert Klein that the $3 billion research effort will adhere to the highest standards of openness and transparency.

Sticky, Troubling Appeals by Rejected Researchers Targeted by Stem Cell Agency

A key step in the process for awarding billions of dollars in research grants is “broken,” according to many directors of the California stem cell agency, and major changes are looming that will affect hundreds of scientists.

Just what those changes are likely to be is unclear. The stem cell agency has not made available to the public any drafts of likely proposals or other related material for a meeting on the matter that begins in only one business day. The only information on the agenda for the directors' Science Subcommittee says: “consideration of changes to extraordinary petition and grant administration appeals processes.”

(Editor's note: Hours after this item was posted, CIRM added material to its agenda that outlined the proposed changes. You can find more on the plan here.)

Nonetheless, specific proposals are virtually certain to come out of the session. Those would then go to the full board meeting on Aug. 18 for ratification and perhaps modification.

Many CIRM directors have long been uncomfortable dealing with public appeals by applicants rejected by the agency's grant review group. On the first such occasion in January 2008, Gerald Levey, a CIRM director and then dean of the UCLA Medical School, said, "I don't think we can run a board this way. If we do, it would be chaos."

Eight months later, directors approved the use of “extraordinary petitions” by applicants. However, that has not eased the situation. Last month directors were hit with a record nine petitions and overturned negative decisions by reviewers on four grants, also a record.

The Science Subcommittee first dealt with the appeals process on May 25. According to the transcript, the panel's chairman, Jeff Sheehy, a patient advocate and communications manager at UC San Francisco, said during the brief discussion,

“This is a broken process. I think almost everybody on the board would agree that it is.”

Duane Roth, co-vice chairman of the CIRM board and a San Diego businessman, said,

"This is one that I think really needs to be rethought completely because what we have right now doesn't seem to be working. Even the extraordinary petitions, I think with the exception potentially of one which we responded to, we agreed with the reviewers. And then in the board meetings turned around and disagreed with our own disagreement. And I think we just don't want to do that.

"Second, I think we're inviting very bad precedent behavior by opening ourselves up to the kinds of things that we went through at the last meeting. We just invite people to continue to do that. I'd like to see us find a solution for grievances on the reviews that everybody can get behind and endorse and embrace."

Among the suggestions in May was one from Sheehy to create a “re-review” option. Facing an appeal, directors could send an application back to the review group for re-evaluation in the light of comments from an applicant. CIRM directors almost certainly already have that authority although it has never been used or formally articulated. Prop. 71 makes the CIRM board the final arbiter on applications. Directors can do anything they want with an application. In practice, however, the grant review group makes the de facto decisions with the board intervening in only a tiny percentage of cases.

Sheehy, who is also a member of the grants review group, additionally said he would like the bifurcated appeal process consolidated. Currently, an “appeal” can only be made on the grounds of a conflict of interest. However, those reviews are done behind closed doors and applicants do not know the identity of reviewers charged with close evaluation of their proposals. Conflict appeals are handled privately by CIRM staff and do not normally come before the full board. Extraordinary petitions are technically not appeals, according to CIRM, but in reality serve that purpose.

Complicating the whole matter is the fact that any scientist or member of the public can speak directly to the board at its meetings on any matter, including rejection of applications. They can also write or email the directors. That is a matter of law and cannot be changed by CIRM rules.

At the May subcommittee meeting, CIRM President Alan Trounson discussed the public appearances of researchers. He said,

"It makes it very difficult on the spot to try and provide the board with the kind of information that they need."

Trounson also said the schedule for petitions is tight and comes only days before a board meeting, making it difficult for CIRM staff to evaluate the issues that are raised. However, some petitions are being presented to the board even though they have not met the deadline for submission.

Art Torres, co-vice chairman of the board and a former state lawmaker, suggested that applicants sign a document stating that they have read the rules for filing petitions. CIRM Chairman Robert Klein concurred with that suggestion.

Whatever comes out of Tuesday's meeting, it is a dismal commentary on CIRM that it cannot or will not provide timely information to the public and its stakeholders about how it plans to handle this portion of $3 billion in taxpayers' business.

Here is a link to a reading list, prepared by the California Stem Cell Report, of articles and CIRM documents on appeals and extraordinary petitions.

New CIRM VP Lewis and Ambit Biosciences

The new, part-time interim vice president for research and development at the California stem cell agency, Alan Lewis, also is executive chairman of Ambit Biosciences, a privately held biotech firm in San Diego. That information was not included in CIRM 's news release on his role at the agency.

We asked Lewis by email about his work at Ambit and told him we would carry his responses verbatim. He responded directly and quickly. Here are the questions and his answers.

California Stem Cell Report (CSCR): When did you become executive chairman of Ambit?
Lewis: “Approx May, 2010."

CSCR: What responsibilities does that entail?
Lewis: “It is similar to being board chair except Ambit is seeking a new CEO so I am the 'sign off' person who speaks once a week to three key staff. Also responsible for helping to create board agendas, and I am a member of the compensation committee.”

CSCR:Is the position compensated? If so, how much?
Lewis: “Typical of biotech boards--approx $25k/year. This consists of an annual fee plus board meeting fee.”

CSCR: Do you plan to continue as executive chairman while you are serving as interim VP at CIRM?
Lewis: “Yes. It involves approx five meetings per year in San Diego, and will have less responsibility as soon as the new CEO joins, probably mid-later July this year.”

CSCR: Do you see any conflicts of interest of any sort involving CIRM and your role at Ambit?
Lewis: "No. Ambit has no interest in regenerative medicines or cancer stem cells. They are focused on kinase inhibitors for cancer and inflammatatory diseases.”

CSCR: Were you a candidate for the VP position as a fulltime employee at CIRM?
Lewis: “No.”

CSCR: Do you plan to seek any other position at CIRM or on the CIRM board in the future?
Lewis: “Not given this any thought – probably not.”

Correction

On July 2, we incorrectly reported that the consulting contract CIRM has with Alan Lewis was not mentioned at the June meeting of the governing board of the California stem cell agency. Our apologies to CIRM President Alan Trounson for getting this wrong. In fact, Trounson announced that Lewis would serve as a consultant two or three days a week.

Here is the text of what Trounson told the board, according to the transcript.

“We're having difficulties in that area(selection of a vice president for research and development), difficulties in attracting someone because of the high salaries of these very competent people in the industry to join us. So we're still in research mode at the moment, but I should let you know that Alan Lewis, who just stepped down from the Junior Diabetes Research Foundation, is going to join us as a consultant to work two or three days to help us with the clinical, preclinical programs. He's a terrific guy. I think most of you would know him. And he's agreed to become a consultant for the time being while we're still in search mode.”

Appeals on Stem Cell Grant Applications: CIRM's Upcoming Re-examination

If researchers want to be successful at winning some of California's stem cell billions, they should set aside time this month to consider or comment on likely changes in policies that will affect their livelihoods.

The California stem cell agency is re-examining the process by which scientists can appeal negative decisions by reviewers on their applications for grants and loan. This reaches beyond academia and affects business applicants.

Little is known at this point about exactly what the agency is proposing to do. The July 20 meeting of the directors' new Science Subcommittee was just announced this weekend, and no background information has been posted. CIRM has two processes involving appeals: extraordinary petitions and “normal” appeals, which are based only conflict of interest issues.

CIRM directors have long expressed exasperation with the appeals process. In fact, they created the extraordinary petition procedure to deal with the issue. A host of articles dealing with the appeals process can be found on the California Stem Cell Report by searching on the terms “extraordinary petitions” and “appeals.”

If researchers or the public cannot make it to the teleconference locations for the meeting, they can send their comments by email to the agency (mking@cirm.ca.gov).

Also on the agenda is consideration of commissioning an Institute of Medicine study of CIRM and a plan to add funds to the new clinical trials grant round, now slated for $50 million. The clinical trials RFA is scheduled to be posted this month and is likely to involve a firm whose financial backers pumped nearly $6 million into Prop. 71, which created the stem cell grant program.

Teleconference locations for the meeting can be found in San Francisco(2), Duarte, Irvine (2), Healdsburg, Stanford, Palo Alto and Pleasanton. Specific addresses are on the agenda.

Klein Defends Burgeoning CIRM Budget

The San Francisco Examiner today published a couple of stories focusing on how the $3 billion California stem cell agency is immune to the budget pressures that face the rest of the financially troubled state.

Katie Worth wrote,

“...(N)ary a paper cut has injured the budget of the state-funded California Institute for Regenerative Medicine.

“In fact, last month, the 5-year-old agency’s largest operating budget ever was approved. Its out-of-state travel budget will more than double this year. Later this year, agency leaders hope to receive a legislative OK to expand the staff beyond the voter-mandated limit of 50 employees. The agency just hired a new vice president on a part-time basis: He will work about 24 hours a week for six months, and be paid $250,000.

“The agency chairman (Robert Klein) said all of these expenditures are justified because the research the agency has funded is well on its way to saving lives. In fact, he said once the current unbroken flow of cash begins to slow, the agency will be able to make a strong case to voters that they should fund even more research.”

SF Lawyer Urges Openness at Stem Cell Agency

Writing in connection with an incident in which two persons were barred from a CIRM meeting, a San Francisco attorney this week called on the California stem cell agency “to return to its commitment to an open and public process.”

Justine Durrell, who is involved in issues dealing with biotech and women's health, made the comment in a three-page letter to the 29 members of the board of directors of the $3 billion research effort. Her letter referred to the item last month in the California Stem Cell Report describing the incident at a San Francisco hotel.

Durrell raised a series of question in connection with the meeting and its implications for procurement of human eggs. Among them were the absence of public notification about the meetings, the justification for exclusion of the public and CIRM's lack of funding for research into the health consequences on women who provide eggs for research.

She wrote,

“Additionally, I emphasize the importance of CIRM's return to its commitment to an open and public process. In the end, openness and transparency will better serve all Californians. Please obviously post in advance all meeting times and locations, the agenda, whether they are open or closed (the justification therefore), and the transcripts/minutes/reports following the meeting.”

You can read Durrell's entire letter here.

Open Meeting Letter -- Justine Durrell to Stem Cell Board

Campaign Contributors, iPierian and the California Stem Cell Agency

Major contributors to the Prop. 71 campaign are pumping more of their own cash into a South San Francisco stem cell firm that has received $1.5 million from the state agency that they helped to create in 2004.

The firm, iPierian, Inc., also has plans to seek additional millions in the near future from the California stem cell agency. The new venture capital funding round announced by the firm today may well be tied to that application.

Ipierian's news release additionally disclosed major new support from another enterprise tied to a Prop. 71 campaign contributor. Ipierian said Google Ventures had joined the firm's backers in the $22 million funding round. Google Ventures will get a seat on the iPierian board as a result of its investment in the company. Sergey Brin, co-founder of Google, made a $100,000 contribution to the Prop. 71 campaign in 2004. (For more on that subject, see the last few paragraphs of this item. )

Other investors in iPierian, including John Doerr of Kleiner Perkins Caufield & Byers of Menlo Park, contributed nearly $6 million to the campaign for Prop. 71. The figure was 25 percent of the total contributed to the campaign, which was run by CIRM Chairman Robert Klein. The Kleiner firm also took part in today's new funding round for iPierian.

During the campaign, opponents said that Prop. 71 was little more than seed money for the venture capital community.

CIRM says no connection exists between the contributions and the CIRM award to iPierian. The company and Kleiner have not responded to requests for comments. We are asking again and will carry their remarks verbatim if we receive them.

Ipierian has said it plans to seek CIRM funding in the upcoming $50 million clinical trial round. It is expected to be one of only three companies applying. Today's announcement said the new financing “will allow the company to drive its programs into the clinic, while securing pharmaceutical partnerships.” In March, when CIRM directors approved the concept for the clinical trial round, they were told it would require substantial matching funds from applicants.

The RFA for the round was originally scheduled for April or May but has not yet been posted. On June 7,  we asked Don Gibbons, CIRM's communications chief, why the RFA was delayed. Gibbons has not replied, but one reason for the delay in posting could be that potential applicants needed more time to arrange for matching funds. The RFA is now targeted for posting this month.

Today's announcement from iPierian also said that John Walker was leaving as CEO, a job he has held since February 2009. He is being replaced by Michael Venuti, who was president and chief scientific officer. Venuti praised Walker for his leadership, including securing grants from CIRM.

CIRM Improving Web Site, Easier to Navigate, Better Organized

The California stem cell agency has made some improvements in its Web site aimed at making it easier to use and more helpful to the public.

One good change deals with the way it presents the information concerning the meetings of the agency, improving the organization and making it more intuitive. The new presentation should be more useful to the public and also save time for CIRM. You can find upcoming meetings, transcripts and agendas, complete with background material on the meetings pages.

Other changes involve the disease and governing board pages. The disease pages help people interested in stem cell research and particular diseases. Amy Adams, CIRM's communications manager,  said they now “include resource links, info about grants we've funded in those disease, and links to videos and outside resources. I think these pages are an excellent resource for the community. We'll be adding to these over time.”

The governing board pages provide a better entry point for finding information on the 29 directors of the $3 billion enterprise.

The CIRM has also tried to make it easier for folks around the globe looking for stem cell information. They are optimizing the site to make it easier for “strangers” to CIRM to find the location through Google, Bing, Yahoo and other search engines.

Adams says more changes are in the works. One that we would like to see is a major improvement in the internal search engine – the one that is used to come up with facts and figures actually on the site.

The CIRM Web site has a huge amount of information on it. More is to come. Good organization and navigation tools make it even more useful to the public and CIRM's special constituencies.

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.

CIRM's Self Interest Demands More Openness

Cobbling together a $3 billion research program from scratch is no simple task. No chairs, no phones, no computers, no payroll system but no employees either or, for that matter, an office – that was picture more than five years ago when the California stem cell agency launched its unprecedented enterprise.

Adding to CIRM's teething problems were the state's “sunshine” laws. They require the agency's meetings and its records to be open to the public. On top of that was a newly minted change in the state Constitution, also in 2004, that for the first time in state history guaranteed the public the right to access to the people's business.

Some adamant advocates of sunshine laws seem to believe that compliance with all that openness is an easy matter that has little organizational impact. But even the state Department of Justice, in its guide to open meeting laws, acknowledges that the sunshine requirements place an “unnatural” burden on state endeavors. “Frustrating” and “inefficient” were a couple of other terms applied to the “sunshine” law.

It is much easier to sit down in a quiet, private room – away from the great unwashed – and organize a complex enterprise that, in the case of the stem cell agency, is to this day still trying to work out the kinks.

Nonetheless, a “higher value” exists, according to the Department of Justice. A seat must be reserved at the table for the public.

Which brings us to the “Incident at the Marriott” last month. That's when CIRM barred two academics from a meeting that CIRM said was aimed at gathering information for “critical decisions regarding the direction our funding should take.” Certainly a topic of considerable public interest since CIRM's costs (all cash borrowed by the state) run to $6 billion, including interest.

Since that we wrote that item, the barred academics have sent us a copy of the agenda for the meeting that they were originally seeking to attend. Among the matters to be discussed was the sensitive subject of "reimbursement" of human egg donors.

However, a scientist in attendance at a related workshop that day said we were off base when we deplored CIRM's flouting of state law.

The researcher, who must remain anonymous, said in an email,

"This meeting was about sharing the scientific details of the work of the few researchers who have been able to get SCNT to work in animals. There was a scientific discussion about the feasibility of human SCNT, and about what the scientific community would learn if SCNT were to be successful in humans. The goal was to share information about the science. Since so little is published about this field, the scientists were given a safe environment to frankly discuss their unpublished work and their failures. This was a landmark meeting, and it was all about science. It would have never accomplished its goal of scientific communication if the public had been invited. There will be a public report. If the ethics of egg donation are to be the main topic, then there should be another meeting, because that is an entirely different subject."

We respect that point of view and acknowledge that some scientists could have been reluctant to be forthright. But warnings about the possibility of the withholding of information have been common in the decades that I have been connected with state government issues. The reality is that interested parties usually become quite candid when cash is at stake – especially the potential loss of funding.

The paramount consideration in all this is the public nature of the stem cell research effort. When the supporters of Prop. 71 went to the people asking for the money, they implicitly acknowledged that public concerns come first – not scientific sensibilities. And without the public involvement, there would be no California stem cell agency.

By operating under a cloak of quasi-secrecy, CIRM ill serves its own interests. It lays down a record that will fuel opponents, much to their glee, a few years from now when CIRM has its hand out for more state cash, a move that CIRM Chairman Robert Klein is already discussing.

The law, the state Constitution and agency's self-interest are clear. CIRM should maximize its openness and welcome involvement by the public – not to mention its special constituencies in industry and academia.


(Editor's note: Some readers are interested in directly raising their concerns about the lack of openness at CIRM. They can send an email to mking@cirm.ca.gov and ask that it be distributed to directors. If you wish, you can send a copy to us at djensen@californiastemcellreport.com and we will reprint it. Even if it is on the other side of this matter.)

The Agenda from the Incident at the Marriott

CIRM barred two academics from a meeting last month in what appears to be a violation of the state open meeting laws. Below is the agenda, as provided by the two, for the meeting that they were attempting to attend.

A scientist from New York and one from Australia were on the panel at the meeting, whose topics included the level of reimbursement for human egg donors, a subject that readily moves into cash-for-eggs questions. The agenda provides no clear indication of a need to protect proprietary information, as contended by CIRM.

Tina Stevens of San Francisco State University, one of the two persons barred by CIRM, said of the CIRM meeting agenda,

“Please note that the proposed discussion questions following the agenda items concern, in part, paying women for their eggs for research -- something that California has clearly prohibited. Why does CIRM think it is or should be empowered to consider, make, skirt, or change policies that impact women's health without broad public awareness, input, and debate?”

Here is our original item on the “Incident at the Marriott” and a follow-up item. Here is the agenda from the June meeting.

“Session 6. Procurement of human oocytes:

“What has been the experience to date?

“15 minute talks / 30 minute discussion

“Chair Renee Reijo-Pera, Stanford University

“11:10 am Jeffrey Janus, International Stem Cell Corporation

Procurement of human oocytes in California and Russia: five years experience of International Stem Cell Corporation.

“11:25 am Scott Noggle, NYSCF

“11:40 am Bernie Tuch, Sydney, Australia

“11:55 am Aaron Hsueh, Stanford University

“12:10 pm Discussion

“Questions to consider for presenters and for discussion

“What levels of donor reimbursement are necessary to support research? (Is it feasible for CIRM to support SCNT research without allowing reimbursement)

“Are there reasons for donors to prefer research donation over reproductive use of oocytes?

“What is the experience of research donors with regard to OHSS or other adverse outcomes?

“Are research donation programs being evaluated for donor satisfaction?”

Comment on Lewis' $250,000 Contract

An anonymous comment was filed this morning on the “$250,000 Lewis” item. We are publishing it here instead of the usual posting as a “comment.” The reason being that, as filed, the post contained a personal remark about Alan Trounson, one that could be considered potentially libelous. We encourage all those posting comments to avoid personal remarks about all individuals. Comments about how individuals perform their jobs are acceptable and may be extremely forceful.

Here is the comment as edited. We substituted “wildly” for the originally phrase in the comment.

“Interesting..first the budget fiasco and now the stealth hiring of Lewis with a contract number just below one requiring governing board scrutiny. Methinks Trounson believes he is a law unto himself and that he need not seek approval for any activity or spending. While state workers get minimum wage, Trounson spends (wildly).”

$250,000, Six-Month Contract for CIRM's Lewis

The new interim vice president for research and development at the California stem cell agency holds a $250,000, six-month contract that calls for him to push hard to develop clinical applications that CIRM hopes will demonstrate the success of its $3 billion effort.

The hiring -- as a consultant -- of Alan Lewis (at right), onetime head of ViaCyte, Inc. of San Diego (formerly Novocell) and the Juvenile Diabetes Research Foundation,  brings at least a temporary halt to the search to fill the new VP post that was created after Marie Csete resigned suddenly as chief scientific officer. The CIRM Web site no longer lists the VP position as available.

CIRM President Alan Trounson sought unsuccessfully for a nearly a year to fill the job. This spring he appeared to have run afoul of resistance to his plans for compensation for the post, which would normally top out at $332,000 annually if the position were filled by a regular CIRM employee.

Under the terms of Lewis' contract, he is expected to work about 24 hours a week and meet with CIRM officials at least once a week at the agency's San Francisco headquarters. (CIRM provided an unsigned copy of the contract, which is a public document, at the request of the California Stem Cell Report.)

Lewis is the third top executive of CIRM to be working on a part-time, paid basis. The others are CIRM Chairman Robert Klein, who receives $150,000 for half-time work, and co-Vice Chairman Art Torres, who is paid $225,000 for four days a week. By way of contrast, CIRM President Alan Trounson receives $490,008 annually for fulltime work.

Lewis' agreement runs from June 21 through the end of this year at a rate of $2,500 a day, “with pro-ration (sic) for less than four hours.” The contract is capped at $250,000 not including travel expenses.

On June 23, Trounson told the CIRM governing board that Lewis would be serving as a consultant two or three days a week "to help us with the clinical, preclinical programs." Trounson did not mention that Lewis would carry the title of interim vice president for research and development nor did he mention the size of the contract. If it had been above $250,000, it would have required director approval.   

Lewis is expected to travel widely and possibly internationally. Trips from his home in Solana Beach near San Diego in Southern California to CIRM's headquarters will be paid for by CIRM.

Lewis has had a long business career, which raises questions about possible conflicts of interest. In addition to Novocell, he worked for Signal Pharmaceuticals and Celgene in the San Diego area. He left Novocell in 2008 to work for the diabetes group. The CIRM contract said Lewis affirmed that “there exists no actual or potential conflict between the consultant's family, business or financial interest and the services provided under this agreement.”

ViaCyte is the recipient of more than $26 million in awards from CIRM.

Lewis must file a statement of economic interests that is required of most state officials. We have asked CIRM for a copy of that document.

Here is how the contract describes Lewis' responsibilities:

“• Consult Senior Management on biotechnology, pharmaceutical and investment sectors to enable and enhance the development of clinical applications in CIRM’s scientific portfolio.
“• Consult on the preclinical and clinical development phases of CIRM’s programs and projects involving not-for-profit and for-profit teams, including assembling and working closely with CIRM advisory committees to provide oversight of these programs and make go/no go recommendations to the President for continuation of CIRM support.
“• Work in close collaboration with the Executive Director of Scientific Activities.
“• Integrate basic discoveries where possible into the translational and preclinical pipeline and identifies gaps in CIRM’s scientific program for delivery of cell therapies and related products.
“• Develop and implements strategies to aid clinical applications such as in the critical areas of manufacturing, drug and cell product safety and efficacy.
“• Consult Senior Management regarding interface approaches with national and international regulatory organizations”

The contract differs somewhat from the CIRM news release on Lewis. It said that he would “take direction” from the executive director of scientific affairs – not work in collaboration. This is of significance because their duties overlap and could be a source of friction if not carefully managed.

(Photo from San Diego Union-Tribune)

(Editor's note: An earlier version of this item incorrectly said that Lewis' contract was not mentioned by Trounson at the June CIRM board meeting.)

Alan Lewis Joins CIRM as VP for Research and Development

The California stem cell agency today confirmed that that Alan Lewis, formerly of head of Novocell and the Juvenile Diabetes Research Foundation, will be joining its small band in in San Francisco.

Lewis was named interim vice president for research and development. He will be working two to three days a week and focus on  “identifying strategic opportunities and developing action plans to fulfill the mission of the Institute.”

In the CIRM news release, Patricia Olson, executive director of scientific activities for CIRM, said,

“His many years of experience in developing therapies for patient benefit in both for-profit and non-profit organizations will be valuable to CIRM as we expand our program to include clinical projects.”

The announcement from CIRM said Lewis will take direction from President Alan Trounson and Olson.

Trounson, who has been seeking to fill the VP slot for about a year, was not quoted in the release nor was CIRM Chairman Robert Klein.

CIRM did not immediately disclose Lewis' compensation. The VP position has a salary range that tops at $332,000. The news release did not say whether Lewis would be an employee or an outside contractor. However, a CIRM insider told us he would be a contractor. The agency is heavily reliant on outside contractors because it is limited by law to 50 staffers. Currently it has about 45 employees.

Lewis' old firm, now known as ViaCyte, has $26.3 million in awards from CIRM.

The California Stem Cell Report first reported Lewis' link-up with CIRM on Monday.

Escape Therapeutics: The Latest Business to Win a CIRM Grant

A firm founded by a part-time, but award-winning poet was the only company to receive a grant in last week's round from the $3 billion California stem cell agency.

The firm is Escape Therapeutics of Palo Alto, Ca. The principal investigator on the $1.5 million CIRM grant is Basil Hantash(see photo), founder of the firm and an Illinois native who held a biodesign fellowship in 2006-07 at Stanford.

Only one other company filed an application in the $25 million immunology round, originally budgeted for $30 million. That firm's name was withheld by CIRM, which is their general policy concerning unsuccessful applicants.

CIRM reviewers gave Hantash's application a 72 score. The review summary cited some weakneses in the application, but said it was “worthwhile and achievable.”  In the words of the reviewers, the research was “well designed, logical and an interesting approach to pursue.”

Founded in 2006, Escape does not have a Web site. But, according to a company document provided by Hantash, Escape is an early stage, privately held biotech firm “focused on accelerating the commercial availability of allogeneic stem cell therapies by solving the key translational hurdle preventing their clinical utility – immune mismatch and subsequent donor rejection.”

The information continued,

"Invented by Escape’s founder Dr. Hantash while at Stanford University, the company’s platform technology represents a significant potential breakthrough that can revolutionize the treatment of blood-borne disorders such as leukemia, type I diabetes, and autoimmune diseases. Escape’s innovative technology allows for the creation of the world’s first allogeneic, 'off-the-shelf' therapy capable of being used in any patient irrespective of their HLA profile."

In addition to the last week's grant, searches on the Web showed that Escape has other ties to CIRM. It is one of four internship sites for a CIRM training program run by San Jose State University. Asked for comment, Hantash said,

"Escape focuses the training process on translational stem cell research skills, rather than pure academic basic science research. Our interns were the first to publish out of all the interns in the program, so we feel they gain commercialization experience while retaining the rigor of academics. This is a marriage of a Stanford-like focus on entrepreneurship and an industry eye on developing life-saving products to alleviate patient suffering."

Hantash was a partner from 2007 to 2009 at Proteus Venture Partners, a San Francisco Bay Area investment and advisory firm focusing on regenerative medicine. Proteus was heavily involved in CIRM proceedings concerning the agency's $500 million biotech loan effort. Hantash said his responsibilities included fund-raising and deal sourcing and evaluation.

A number of references on the Internet refer to Hantash as an award-winning poet. We asked him to provide a sample of his work. It can be found here.

(Photo of Hantash from Proteus web site)

"Seduction" -- A Poem by a Stem Cell Scientist

At the request of the California Stem Cell Report, Basil Hantash, CEO of Escape Therapeutics, Inc., of Palo Alto, Ca., sent us this sample of the poetry he writes while not working on stem cell research.

(On Aug. 11, 2010, Hantash emailed us, asking us that the poem in this item be removed from the Web site. He said tended "to agree with the anonymous comment that it may not be an appropriate venue."
As a courtesy to him, we have removed the poem.

(We heartedly disagree with the anonymous comment. A narrow-minded focus hampers all of us -- not only scientist and policy wonks.)

Former Novocell/JDRF Chief Hooking Up With CIRM

Alan Lewis, the fomer head of Novocell (now ViaCyte, Inc.) and the Juvenile Diabetes Research Foundation, will be joining the $3 billion California stem cell agency shortly, the California Stem Cell Report has learned.

It is not clear what his responsibilities will include or whether he will be serving as a consultant or on staff. The agency has been seeking a vice president for research and development for nearly a year.

CIRM President Alan Trounson created the vice president's position after Marie Csete resigned abruptly as CIRM's chief scientific officer about 12 months ago. Trounson said he would not fill the post of chief scientific officer. Instead, Trounson came up with the new VP position and said he would seek someone with industry experience. He seemed to have a candidate ready this spring. The CIRM board convened closed-door meetings to discuss compensation for the post, but the sessions ended with no announcement.

Lewis, however, could be filling another position either on staff or as an outside consultant. Lewis resigned as head of JDRF in May for personal reasons. He said he would be returning to Southern California to be with his family.

He joined JDRF in January 2010. He served as president of Novocell from 2006 until he left for the foundation. CIRM Chairman Robert Klein has also been involved in juvenile diabetes issues and was recognized in 2006 as “public service leader of the year” by JDRF. After Lewis left Novocell, it received a $20 million loan from the agency. ViaCyte/Novocell has received four awards from CIRM for a total of $26.3 million.

We queried CIRM concerning Lewis. The agency was noncommital. Lewis could not be reached for comment.

Top 10 Tips for Snagging Cash from CIRM

For businesses seeking clues about how to win cash from the $3 billion California stem cell agency, a UC Davis researcher is offering 10 free tips.

We took a look today at the advice offered up by Paul Knoepfler on his blog. It all makes good sense to us. But what do know? We have never received a grant from CIRM. Knoepfler has.

Here are a couple of his suggestions.

No. 3 –

“Read the RFA very carefully. Perhaps even read it 5 times. It may seem straightforward, but think about the key words being emphasized by the funding agency.”

No. 6 –

“Hire professional grant writers with experience in industry and academia. This is an investment well-spent.”

We also have a couple of our own.

Attend meetings of the CIRM board of directors, particularly those dealing with grant approval. Nothing else will inform you as well concerning the board's thinking on grants. You will also have to a chance to meet some of the very sharp people who control the purse strings.

Read all of the extraordinary petitions filed by rejected grant applicants. Read at least 50 or more of the summaries of reviewers' comments on applications, splitting the material between top-ranked grants and ones that did not make the grade.

Good luck!
 

Stem Cell Information Resource

A Silicon Valley firm has compiled a fine list of sources dealing with stem cell issues and regenerative medicine, ranging from investment info to links to reports on stem cell research in China and Singapore.

The list of resources was put up by Proteus Venture Partners. Many of the sources are familiar but the list is long and comprehensive. Sad to say, it does not include the California Stem Cell Report.

You can find the information roundup here.

NIH and Exculpation

For those of you not fully informed of the tricky byways of stem cell science, the Boston Globe carried a nuanced editorial today that laid out the significance of an arcane “exculpatory” matter last week

Arcane, that is, to folks who do not fiddle with human embryonic stem cells.

The case involved possible use in federally funded research of embryos donated some years back. The feds said no because they were given under conditions that do not meet today's ethical tests, although the donations met the standards of the day, which actually was only a decade or two ago. The Globe called the NIH action a “major blow.”

You can read all about it here.

Biopolitical Times Says More Openness Needed at CIRM

The Biopolitical Times says the public has a right to attend the meetings of advisory groups to the $3 billion California stem cell agency.

On June 23, the online publication of the Center for Genetics and Society of Berkeley, Ca., commented on our report about how CIRM barred two academics from one of its meetings. We said that the action certainly violated the spirit of a relatively new provision of state Constitution that gave the public a broadly construed right to access to government activities, and likely violated the letter of the law as well.

Jesse Reynolds, project director on biotechnology accountability at the center, agreed. He wrote that “CIRM is a public agency, and the public has a right to attend such influential deliberations.”

One of our readers, Justine Durrell, asked this week how CIRM could begin to address its problems with openness. One of the first things it could do is to be sure that such meetings are open to the public and be sure that interested parties are notified in a timely fashion in advance of the meetings.