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.

Tracking CIRM Grants: "Thin Ice" Lurking?

Directors of the California stem cell agency today approved a $15.7 million operating budget for next fiscal year – 28 percent higher than this year's spending – and requested a report from its staff concerning its critical grants management system.

The report was sought after CIRM Director Michael Friedman, CEO of the City of Hope, said he wanted to “express in the strongest possible terms my discomfort” with the decision by CIRM staff to build a custom grants management system.

He said that “unless you are prepared to spend enormous amounts of money, you are stepping on some very thin ice.”

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

Friedman asked if any subcommittee of directors had approved the decision to go forward with a custom system. The answer was no, but that the decision had been carefully considered by CIRM staff.

At that point in the meeting, we lost the Internet connection to the CIRM audiocast. By the time it was restored , the budget discussion had concluded with approval of the spending plan. Don Gibbons, chief communicastions officer for CIRM, told us by email that the report had been requested. (We will revisit the budget discussion after the agency posts a transcript of the meeting.)

On Monday, when we reported some of the details of the budget, we noted that spending on information technology is scheduled to jump 53 percent from $817,000 to $1.2 million, an increase of about $433,000. Most of that goes for the grant system.

CIRM is trying to oversee more than $1 billion in grants to more than 300 recipients and, at the same time, hand out many hundreds of millions more in the next year or so. It is building custom programs for entire process, from applications to oversight. Currently, CIRM has a $125,000 RFP out for “systems analysis and software development services” and hopes to have a company on board next month.

The board also discussed the strategic financing report(see here and here), which will be wrapped into an external review of CIRM's strategic plan next fall. There appeared to be no clear consensus at this point whether the agency should make grants as speedily as possible or husband its resources to deal with unexpected opportunities in the fast-moving stem cell field. Related to that was a discussion of the CIRM grant portfolio. No action was needed on either item.

Comments by John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., were discussed briefly after they were read into the record. Simpson said he was “troubled” by what appears to be a lack of a level playing field for grant applicants from business and the dominance of academic institutions, who constitute a plurality on  the board.

CIRM Chairman Robert Klein said he did not think that the biotech industry agreed with Simpson's concerns about whether business grant applications were being treated fairly. Klein noted that BIO, a national biotech industry group, recently recognized him with a national award, indicating that the group valued CIRM's contributions. But Klein said more progress was needed.

Vice Chairman Art Torres indicated that he took Simpson's concerns about the seriously but said the public does not understand just how stringent are the conflict of interest standards at the agency.

Directors also approved the a concept proposal for a $45 million round of grants for basic biology research.

You can find slides from the report by CIRM President Alan Trounson here. He discussed recent stem cell research, a proposal for a CIRM online journal and upcoming CIRM workshops. The slides also include those used for the budget presentation.