California's $3 billion stem cell research effort today garnered a handsome dollop of favorable national news coverage– a lengthy piece in Fortune magazine that spoke of looming stem cell cures and the leading role of the state stem cell agency.
The article led the Fortune web page online at one point this morning and likely will be read by tens of thousands of persons, although it was not the cover story on the print product.
"To be clear, the earliest stem cell therapies are almost certainly years from distribution. But so much progress has been made at venerable research institutions that it now seems possible to honestly discuss the possibility of a new medical paradigm emerging within a generation. Working primarily with rodents in preclinical trials, MDs and Ph.D.s are making the paralyzed walk and the impotent virile. A stem cell therapy for two types of macular degeneration recently restored the vision of two women. Once they were blind. Now they see!
As for the California stem cell agency itself, the article contained remarks from its Chairman J.T.Thomas, President Alan Trounson and former chairman Robert Klein about the origins and progress of the California Institute for Regenerative Medicine (CIRM).
O'Brien interviewed a several prominent businessmen who have contributed tens of millions of dollars to stem cell research "about the prospects of a legitimate industry emerging." One was "bond genius" Bill Gross, who has contributed to UC Irvine. Gross replied.
While the Fortune article has its negative points about stem cell research, it is about as laudatory as it is going to get at this point for the California stem cell agency. The piece recognizes and even celebrates much of the work of the agency. The article clearly details the void in financing for commercialization of stem cell research, bolstering support for efforts like those in California. Importantly, it also helps to push the activities of the stem cell agency more fully into the national discussion of stem cell research and its future. That should pay off again and again in future news coverage and also benefit the stem cell agency as it explores the possibility of additional funding – either private or public – after the cash for new awards runs out in 2017.
The $700,000 study of the $3 billion California stem cell agency is nearly concluded and is expected to be released sometime in November.
A draft of the report has been sent out for "peer review" and no additional public meetings are scheduled, according to a spokeswoman for the Institute of Medicine(IOM), which is conducting the study. The IOM did not respond to questions from the California Stem Cell Report about the number of peer reviewers or how they were selected.
The study began last year under a contract with the stem cell agency, which commissioned the effort, in part, because agency directors hoped the findings by the blue-ribbon panel would bolster efforts to win voter approval of another multi-billion dollar state bond issue. More recently the agency has explored the possibility of private financing to continue operations.
The agency is expected to run out of funds for new awards in 2017. It currently has something in the neighborhood of $700 million for awards that is not already committed in one fashion or another.
The location of the October meeting of the governing board of the California stem cell agency has been changed from Irvine to Burlingame, near San Francisco International Airport, in an effort to save travel costs.
CIRM Chairman J.T. Thomas said the one-day meeting is being moved because the session will require the attendance of a large number of CIRM staffers who are based in the agency's San Francisco headquarters. They will be involved in presentations involving the agency's new strategic partnership fund and other matters.
The date of the meeting remains unchanged – Oct. 25. Look for posting of the agenda on the CIRM web site on Oct. 15. The site of the meeting is the Hilton Bayfront Hotel, 600 Airport Blvd.
The "online session" item Sept. 24, 2012, incorrectly identified the author of the CIRM webinar piece as Cynthia Adams. Her correct name is Cynthia Schaffer.
One of the lesser known activities of the California stem cell agency is webinars that put researchers together with the folks who make the federal decisions about whether stem cell research will be turned into therapies.
One of those sessions is coming up on Thursday, and it is not too late for scientists and other interested parties to get on board.
Writing on the stem cell agency's blog, Cynthia Schaffer, CIRM's contract administrator and compliance officer had this to say today about the webinars.
"The FDA very graciously donates their time to speak on these webinars because they too have pledged to maintain an active dialogue with the industry and provide education on their regulatory expectations for product development in the regenerative medicine field. CIRM science officer Kevin Whittlesey recently wrote a paper with Celia Witten of the FDA about the role of the FDA in reaching out to regenerative medicine community, including webinars such as these.
Here is the full text of comments made by the California stem cell agency, Joe Mathews, co-author of "California Crack-Up" and Bob Stern, former president of the Center for Governmental Studies and co-author of the California Political Reform Act, in connection with the Sept. 23, 2012, article in The Sacramento Bee headlined "Stem Cell Cash Mostly Aids Directors' Interests." The comments were abbreviated for publication in The Bee because of newspaper space constraints.
"To make sure we do the best job of managing taxpayer's money it's natural that we turn to people who know most about stem cells and stem cell research. In fact, as the state's own Little Hoover Commission reported in its analysis of CIRM: "The fact that CIRM funding has gone largely to prestigious California universities and research institutes is hardly surprising and should be expected, given the goals of Proposition 71 and the considerable expertise resident in these research centers." But in recruiting the best minds, we also adopt best practices to ensure that there is no conflict of interest. Every board member has to recuse themselves from voting on, or even being part of a discussion on anything to do with their own institution, or to an institution or company that they have any connections to. All this is done in meetings that are open to the public. CIRM's conflict of interest rules have been subject to multiple reviews – by the Bureau of State Audits, the Little Hoover Commission and the Controller – and there is no evidence that any of CIRM's funding decisions have been driven by conflicts of interest. Indeed, CIRM rigorously enforces its conflict of interest rules at each stage of the funding process to ensure that all decisions are made on the merits of the proposal for funding and not as a result of any conflicts of interest.
"California ballot initiatives are a terrible way to make public policy. And they are even worse as a method for making scientific policy.
"It's not merely that this initiative was drafted in such a way as to benefit the enterprises of its directors. It's that, under this initiative's own provisions and the California constitution, it's so hard to change Proposition 71 and fix what ails CIRM. Effectively, these provisions are baked in, and nothing short of another vote of people can really make the change. (Yes, there are provisions, as you know, that permit the legislature by super-majority to do things, but supermajorities are effectively out of reach in California).
"Sadly, initiatives like Proposition 71 are not uncommon. Many measures are drafted to benefit the people who would support the measure, or oversee the program established. This has been very common with bonds. Essentially, to win the support of various groups whose money and backing is important to passage of a bond, a sponsor of an initiative bond will set up rules and include money specifically intended for each group. This is a form of pay-to-play. Agree to back the initiative and you're in. And it happens because there's no rule against it and because passing initiatives in California require difficult, expensive campaigns.
The California stem cell agency faces no easy task in trying to translate basic research findings into something that can be used to treat patients and be sold commercially.
Even clinical trials, which only begin long after the basic research is done and which involve more ordinary therapeutic treatments than stem cells, fail at an astonishing rate. Only one out of five that enter the clinical trial gauntlet successfully finish the second stage, according to industry data cited last spring by Pat Olson, executive director of scientific activities at the stem cell agency. And then come even more challenges.
But at a much earlier stage of research there is the "problem of irreproducible results," in the words of writer Monya Baker of the journal Nature. Baker last month reported on moves by a firm called Science Exchange in Palo Alto, Ca., to do something to ease the problem and speed up preclinical research. The effort is called the Reproducibility Initiative and also involves PLOS and figshare, an open science Internet project.
The California Stem Cell Report earlier this week asked Iorns for her thoughts on the implications for the California stem cell agency, whose motto is "Turning stem cells into cures." Here is the full text of her response.
Looking for a good job at an enterprise that is on the cutting edge of biotechnology?
Nine positions are open at the $3 billion California stem cell agency, headquartered in San Francisco. Some of them could pay more than $200,000 a year.
Several of the new jobs are closely aligned with the agency's fresh focus on commercializing stem cell research and driving therapies into the clinic. Scientists and lawyers are being recruited along with a business development officer. For some of the positions, travel is required.
One new, high-level position is described as a senior development officer. The job posting calls for "expertise in product development for stem cell therapies." The person would "directly interact with investigators on CIRM's clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives." An M.D. or Ph.D. degree in a biomedical science is required. Pay tops out at $232,891. This person would report to Ellen Feigal, senior vice president for research and development.
A second, high-level position reporting to Feigal is senior medical officer, who would manage the agency's portfolio aimed at commercialization of stem cell research, specifically "focused on IND enabling and clinical development projects." This also requires an M.D. or Ph.D. and substantial professional experience in development of biomedical research and products. Pay also could run as high $232.891 annually.
A third new job at CIRM is business development officer. That person would help generate "outside investment in stem cell research in California for both CIRM-funded and not currently CIRM-funded programs by biopharmaceutical strategic partners; equity investors (venture capital and others); and disease foundations." The salary range hits $216,270 annually. It wouldn't be surprising if the person in this job also became involved in developing a funding mechanism for CIRM after it runs out of state cash in 2017 or so.
This position reports to Elona Baum, general counsel and vice president, business development.
And yet another new position is called director of alliance management. The job deals with the agency's extensive collaborative funding partnerships, many of which are abroad. CIRM wants somebody with a law degree, experience in intellectual property and business law along with strong negotiating skills. The pay range for the post tops out at $232,891 annually. This position reports to CIRM President Alan Trounson.
Other open positions include: deputy general counsel, two science officers and office manager.
StemCells, Inc., said yesterday that it will come up with the $40 million needed to match loans from the California stem cell agency through "existing infrastructure and overhead" and will not be issuing stocks or warrants to the agency.
In a statement to shareholders, Martin McGlynn, CEO of the publicly traded firm, discussed the $40 million in loans awarded by agency this summer, including $20 million last week. The stem cell agency's governing board, after it emerged from an executive session on the matter, last Wednesday night adopted a motion requiring the company to demonstrate that it has the matching funds.
CIRM Chairman J.T. Thomas, a Los Angeles bond financier, said that concerns were expressed during the executive session that the agency "would account for such a large part of the assets of the company." At his suggestion, the board approved the loan on the condition that "it show it has access" to the $20 million in matching funds that company offered during the application process. StemCells, Inc., also offered a $20 million match on another loan approved in July by CIRM.
The latest financial reports from StemCells, Inc., which is based in Newark, Ca., show that it had assets of $17 million as of June 30 and liabilities of $11.6 million. The company reported net income for the second quarter of $833,522 compared to a loss of $4 million for the same period a year ago.
"Under this particular CIRM program (RFA 10-05), funding for companies will be in the form of unsecured, non-recourse, interest-bearing, term loans, which will be forgivable in the event the funded research fails to result in a commercialized product. On the other hand, should the product be successfully commercialized, CIRM would earn milestone payments depending on how successful the product becomes. Because CIRM shares the downside risk, and could participate handsomely on the upside, the structure makes the loan about as close to 'equity' as one could, without having to dilute existing shareholders in order to gain access to significant amounts of capital. The company will not issue stock, warrants or other equity to CIRM in connection with these awards.
According to CIRM, the awards in the strategic partner round will be approved either next month or in December.
StemCells, Inc. stock was trading at $1.85 at the time of this writing. Last week, it rose to $2.43. During the last 12 months, its high was $2.67 and its low was 59 cents.
Most of them came during the July and September meetings of its 29-member governing board and were related to strenuous efforts by researchers to win approval of awards of up to $20 million each. Several firsts involved the agency's former chairman, Robert Klein, who could be considered the father of the state's stem cell research effort.
So here is the California Stem Cell Report's list of firsts at the California Institute of Regenerative Medicine (as CIRM, the stem cell agency, is formally known) for the summer of 2012.
It was the first time that a single company – in this case, StemCells, Inc. , of Newark, Ca. – received two awards in the same round.
It was the first time any company has been awarded as much as $40 million. Again, StemCells, Inc.
It was the first time that Klein has lobbied his former board (see here and here) on behalf of a particular grant application. That occurred in both July and September with one of StemCells, Inc.'s application.
It was the first time that the board has approved an application that has been rejected twice by reviewers, again the StemCells, Inc., proposal backed by Klein.
It was the first time that board has received such a large outpouring of appeals by rejected applicants.
It was the first time that the board has received such lengthy presentations of emotional appeals by patient advocates on behalf of rejected applicants.
It was the first time that action on a grant round has been extended over three months(see here and here). The disease team round began in July. Action will not be completed until the end of October.
It was the first time that the governing board has sent so many applications back for re-review – five, six if the one to be acted on in October is included.
It was also the first time that the board has ordered a full-blown review of its grant appeal process with an eye to making making major changes in it.
Several reasons exist for the number of firsts racked up by CIRM. One is the high stakes involved in the disease team round that began in July and the low number approved by reviewers – six compared to the 12 approved by the board, as of today, out of 21 applications. Another reason involves the increasing understanding on the part of many scientists that they can appeal directly to the board when reviewers reject their applications. However, it is also clear that not all applicants grasp the full range of appeal possibilities. A third reason involves the agency's muddled appeal process, which has been a problem for years. And a fourth reason involves the board's push to drive research into the clinic and commercialization, which applicants are quickly learning how to exploit.
Readers should feel free to add their own firsts to this list. They can do so – even, anonymously – by clicking on the word "comments" at the end of this item.
Fresh from winning $40 million from the California stem cell agency, StemCells, Inc., is shooting for another, $10 million award from the state research effort.
The latest proposal comes as the publicly traded firm also faces the task of raising $40 million that it has promised the agency to match the earlier awards. That figure could well rise to $50 million given the new application.
The article did not disclose the timing on the new application.
StemCells, Inc.'s lobbying efforts with the stem cell agency were vigorously aided by the former chairman of the $3 billion California stem cell agency, Robert Klein (see here and here). And Wednesday evening, the company convinced the state agency's board to overturn two successive reviewer rejections of a $20 million proposal for Alzheimer's research. The vote was 7-5.
Klein's efforts came in a record-breaking round of appeals and emotional presentations by patient advocates, which triggered complaints from the board this week about "arm-twisting" and politicking.
StemCells, Inc., was founded by the eminent Stanford stem cell researcher Irv Weissman, who helped to raise millions for the ballot initiative that created the stem cell agency. He additionally appeared in in the campaign's TV advertising. The campaign was headed by Klein, who ultimately raised $35 million to convince voters to create the agency. Weissman is currently on the board of the StemCells, Inc. His wife is executive vice president.
In July, the stem cell agency board approved the first $20 million award to the firm for research involving spinal injury.
"We're the only company that has programs going on in all three regions of the central nervous system: the brain, the spinal cord and the eye."
Not discussed in the BioWorld article was a requirement, imposed by the CIRM board, that StemCells, Inc., show it can deliver $20 million in matching funds on the Alzheimer's award before receiving any state funds. CIRM said no such board requirement existed on the spinal award, but the firm has promised to match the $20 million on that award as well.
BioWorld described the awards as grants. In fact, they are loans. But under the terms of the loans, if the research is not successfully commercialized, it will be forgiven.
The moves followed a prolonged series of appeals on grant applications that began in July and continued through today, setting records for the number of appeals and generating hours of sometimes tearful and emotion-laden presentations from members of the public.
The board adopted changes in the appeal process for its next few meetings that are aimed at curbing its free-wheeling nature and making it more understandable to the public and applicants. The board also directed creation of a panel to make recommendations by the end of the year for more wide-ranging reforms.
Directors of the agency were clearly not happy with the appeal process this summer. However, it has been a problem since 2008 when Bert Lubin, now a director of the stem cell agency and CEO of Childrens Hospital of Oakland, Ca., was the first applicant to make a public pitch before the board to overturn reviewer rejection of his application.
The name of former board chairman, Robert Klein, was not mentioned during this afternoon's discussion. But Klein vigorously and successfully backed an appeal (see here, here and here) by StemCells, Inc., of Newark, Ca., for a $20 million application that had been rejected twice by reviewers. Last night the board approved the award on a 7-5 vote. It was the first time the board has approved an award that was rejected twice by its reviewers.
Other issues cited by directors include the integrity of review process, fairness, consistency, shifting appeals procedures, transparency and board discipline on appeals.
James Harrison, outside counsel to the board, said the board's action today includes "eliminating the reference to unpublished data in the discussion of 'material new information," imposing a 3-page limit on other correspondence, explaining that applicants should have seven business days from the time the (grants review group) recommendation is made available to them to file an (extraordinary petition), and posting all of the information regarding these policies in one place on CIRM's website."
For a list of articles and CIRM documents dealing with the appeal process, see here.
Directors of the California stem cell agency today approved about $38 million for research into basic biology, including two appeals by researchers on applications initially rejected by reviewers.
The governing board turned down five appeals in the round, which attracted 357 applications in its "pre-app" process, 64 of which were invited to apply. Reviewers approved 25 applications.
The board also approved another application that was rejected by reviewers based on a recommendation by CIRM President Alan Trounson. It is very unusual for the board to approve rejected applications based on staff recommendations following a review. Trounson described the grant addressed a major bottleneck in stem cell science.
The California stem cell agency is expected to post a press release shortly with the names of all recipients. The agency usually withholds names of applicants until the the board formally acts.
The governing board of the California stem cell agency this morning approved a $6.7 million grant to recruit Dennis Steindler of the University of Florida to the Parkinson's Institute in Sunnyvale, Ca.
The governing board of the California stem cell agency has just concluded a 45 minute executive session on a $6.7 million grant to recruit a Florida scientist to the Parkinson's Institute in Sunnyvale, Ca.
It was the longest executive session ever on a recruitment grant, which are usually approved routinely with little serious discussion.
The CIRM summary of the review on the $6.7 million grant to recruit Florida scientist Dennis Steindler to the Parkinson's Institute in California carried a strong minority report. However, the review itself drew fire this morning from some CIRM board members.
They included patient advocate Jeff Sheehy, co-vice chair of the grant review group, who supported approval of the grant. He noted that the low score reflected two extreme opinions. He said some of the reviewers were doing their research on the Parkinson's Institute on the Internet during the actual review. Sheehy said that was not a "good way" to perform a review and reflected a "major short-coming."
"In summary, this is an application from an established leader in NSC biology to pursue research focused on disease mechanisms in PD. Strengths of the proposal include the quality of the PI, the focus of the project on an interesting hypothesis, and the leadership in basic science that the candidate would bring to the applicant institution. Weaknesses included deficiencies in the research plan, the limited track-record of the PI in PD research and an institutional environment lacking adequate support for basic science investigations."
"During programmatic discussion some GWG (grant review group) members cited a need to broaden stem cell leadership not only at the large universities but also at the smaller institutions as well. They felt that the candidate's recruitment would strengthen the applicant institution and provide leadership and strength in basic research. The need for increased research focused on Parkinson's Disease was also cited by some reviewers. A motion to recommend the application for funding carried with a majority vote. Because more than 35% of GWG members opposed the motion, opponents have exercised their right to have that position reported to the ICOC. The consensus statement from this group is as follows: 'Despite the facts that the applicant has many excellent attributes, that Parkinson's disease is a key area of interest, and that the applicant institution may deserve additional consideration, our opinion is that the application clearly falls short in several critical scientific areas that outweigh the programmatic concerns and do not justify a recommendation for funding. We believe that the people of California depend upon us to make recommendations based on our scientific expertise, for outcomes that are most likely to impact medicine and the health and treatment of their citizens. We believe that their money can be better spent.'"
The board of the California stem cell agency is discussing a proposal to award $6.7 million to recruit a Florida scientist to the Parkinson's Institute in Sunnyvale, Ca.
The scientist is Dennis Steindler of the University of Florida. The recruitment award received a score of 57, although the scores ranged from 30 to 75. Jeff Sheehy, a member of the grant review group and CIRM board member, said the score reflected two extremely divergent positions by two reviewers.
The board has awarded four grants in its recruitment round over the past couple of years, but this is the first extended discussion of an award recommended by reviewers. It is also the first to have a representative of the applicant institution speaking publicly for the grant.
The governing board of the California stem cell agency last night rejected appeals by two applicants -- OncoMed Pharmaceuticals of Redwood City and Albert Wong of Stanford -- in the $200 million disease team round.
Both petitions generated little discussion. You can find more on their petitions here and here.
The audiocast for the meeting this morning of the governing board of the California stem cell agency is now up. Be sure to use the correct code to sign in(there are two different ones). This writer did not and initially received yesterday's audiocast.
StemCells, Inc., was quick this morning with a press release about winning a $20 million award last night from the California stem cell agency.
The publicly traded, Newark, Ca., firm also pointed out that the CIRM board in July awarded another $20 million to the business.
"CIRM's approval of two awards to StemCells illustrates the tremendous promise of our neural stem cell technology and the high degree of confidence in the world class team of scientists and clinicians who will be working to translate this technology into potential treatments and cures for these devastating diseases."
"With the recent spate of late-stage clinical failures in Alzheimer's disease, it is clear that the field could benefit from alternative approaches to lessen the huge burden on families, caregivers and our healthcare system.
"Our recently reported preclinical data, which showed that our neural stem cells restored memory and enhanced synaptic function in two animal models relevant to Alzheimer's disease, shows our approach has promise. We greatly appreciate the support from CIRM, which should help us accelerate our efforts to test our HuCNS-SC cells in Alzheimer's disease."
The news release did not note that the board has required that the firm must show proof that it has access to $20 million in matching funds prior to receiving cash from the agency on the Alzheimer's grant. The California Stem Cell Report is asking CIRM whether that requirement extends to the earlier grant as well.
At the time of this writing, the firm's stock was trading at $2.20 up seven cents. Its 52 week high is $2.67 and its 52 week low is 59 cents.
Approval came on a 7-5 vote with the condition that the company demonstrate it has access to $20 million in matching funds prior to funding. It is the second $20 million award that the company has received in the disease team round, which now totals $214 million. Another disease team application has been tabled and will not be considered until October.
The current CIRM chairman, J.T. Thomas, a Los Angeles bond financier, asked for the financial proof because he said some concerns were expressed during an executive session that CIRM would now "account for such a large part of the assets of the company." Martin McGlynn, CEO of StemCells, Inc., also told the board that the company might have to drop its Alzheimer's research if it did not receive the CIRM award.
The StemCells, Inc., application was rejected twice by reviewers. The original rejection came before the July meeting at which Klein first appeared (see here and here). The proposal was then sent back for re-review, during which it was rejected again.
However, the 29-member board narrowly approved the application following discussion tonight and following its rejection of another Alzheimer's research proposal from USC. Both applicants produced a number of witnesses, including patients, on behalf of their appeals.
A footnote: The CIRM staff said that as a result of two StemCells application, a proposal is being prepared to limit applications to one per entity in later rounds.
The governing board of the California stem cell agency is meeting in executive session to consider proprietary information on an appeal by StemCells, Inc., following a second public pitch by the agency's former chairman, Robert Klein, on behalf of the financially strapped business.
Martin McGlynn, CEO of the publicly traded firm, indicated to the board that it may have to drop its Alzheimer's research program if it does not receive the $20 million from CIRM.
Directors of the California stem cell agency this evening rejected an application for a $20 million research grant to a team at the University of the Southern California.
The team, led by Roberta Diaz Brinton, filed an appeal last month in the $200 million disease team round, which first came up for consideration in July. CIRM staff pointed out that normally such appeals are considered at the time the round is first considered by the board.
Brinton and other investigators spoke to the board along with several patient advocates.
Directors of the California stem cell agency today approved a $6 million research grant for Stanley F. Nelson and M. Carrie Miceli of UCLA, who appealed a negative decision by grant reviewers on its earlier $20 million request.
Following a re-review of the proposal, a special CIRM panel recommended the lower amount and conversion of the proposal to an early translational grant instead of a disease team. The UCLA team will be asked to send a revised proposal to CIRM prior to funding.
Nelson told the board that he was "okay" with the revision and said his team would be back later for more funding for a larger project.
Directors of the California stem cell agency this evening approved a $17.3 million grant to Henry Klassen of UC Irvine following a re-review of the application in the agency's disease team round. The action came with no debate.
Directors of the California stem cell agency this evening approved an award of up to $20 million to Capricor, Inc., of Los Angeles, rejecting a negative decision on the application by agency reviewers.
Approval of the application came after a re-review triggered by Capricor's appeal in July. The governing board also declined to impose a staff-recommended condition dealing with the patient cohort.
The California Stem Cell Report will bring you gavel-to-gavel coverage this afternoon and evening of the meeting of the governing board of the $3 billion California stem cell agency. A spokesman says the primary order of business tonight will be finishing action on appeals in the $243 million disease team round and approval of changes in the grants administration policy. The meeting begins at 4 p.m. PDT. It resumes tomorrow at 9 a.m. PDT and is scheduled to go all day.
The session is being audiocast on the Internet. It is also accessible via an 800 number. Interested parties can participate from teleconference locations in La Jolla, Los Angeles and Pleasanton. Details are on the agenda.
A Stanford researcher is seeking to overturn reviewer rejection of his application for $20 million in the California stem cell agency's largest ever research round and bringing to a record 11 the number of appeals in the round.
The previous record number of appeals in a round was nine in 2010. In the current $243 million disease team round, 11 of 15 applicants rejected by reviewers filed appeals, nine in July and two since then, including the Stanford researcher. Two of the appeals were successful in July. And it appears that three more appeals will be approved, albeit with conditions, later today.
He said that his team can "refute nearly every negative comment made either through referencing available scientific information or our application." Additionally he indicated that his team did not fully understand the opportunities for appeals during the application review process.
Wong and CIRM did not disclose the score on the application (5373), but it was listed next to last on the CIRM list of reviewer summaries. Generally, those summaries are listed in order of their scientific score ranking.
Wong's appeal is on the agenda for today's meeting of the CIRM governing board, which is expected to act tonight on all the appeals filed in the $243 million disease team round. The $35 million basic biology round is expected to be acted on tomorrow.
A Los Angeles biotech firm, Capricor, Inc., and a UC Irvine researcher, Henry Klassen, appear to be assured tonight of winning their appeals for nearly $20 million each from the California stem cell agency.
A research team at UCLA – Stanley F. Nelson and M. Carrie Miceli – also apparently won its appeal on its application but only on a substantially revised basis, according to a CIRM document. The agency indicated it would fund the grant but at reduced scope and cost – $6 million instead of $20 million.
A fifth applicant who appealed, Tim Hoey of OncoMed Pharmaceutical of Redwod City, Ca., was also rejected during the re-review process on a $20 million application.
The CIRM governing board, in July, sent all five applications back for reconsideration as a result of appeals of negative decisions by reviewers. The move followed a record-breaking level of appeals by researchers during an emotional meeting filled with testimony from patient advocates. The appeals came in a round that was budgeted originally for $243 million and that represents one of the agency's key efforts to commercialize stem cell research.
It was also the first time the agency's governing board has engaged in such an extensive re-review process on applications.
The revised recommendations for funding are scheduled to be acted on tonight at a meeting of the CIRM board in Burlingame, Ca. The panel has almost never rejected positive decisions by its review group and is likely to accept the latest recommendations. The board is deeply concerned about maintaining the integrity of the review process and not rejecting reviewer decisions without ample consideration.
"In consultation with the Chair of the ICOC and CIRM scientific staff, the President and the Co-Vice Chair determined that the additional analysis should be conducted by the Review Chair of the GWG(grant review group), another scientific member of the review panel, and a patient advocate member of the GWG. The additional scientist reviewer was selected based on the expertise necessary to assess the new information. Each of the 3 individuals (chair, scientist, and patient advocate) voted on whether the information changed the funding recommendation by the GWG. A new score was not assigned."
Feigal's report does not identify the applicants by name – only by application number. Here is the number and name for those who do not want to wade through the CIRM web site to determine who is who: 5735 Capricor, 5739 Klassen, 5426 UCLA, 5352 Oncomed, 5416 StemCells, Inc.
The California Stem Cell Report will provide gavel-to-gavel coverage of tonight's and tomorrow's meeting of the CIRM board. The session will be audiocast live on the Internet. Interested parties can participate in the meeting at teleconference locations in Pleasanton, Los Angeles and La Jolla. The agency has added another way of listening to the proceedings -- a dial-in method using an 800 number. Details are on the agenda.
Three more researchers are attempting to overturn rejection of their applications for millions from the $3 billion California stem cell agency, including one who reported detecting an "evil" stem cell earlier this year.
They are competing in the $35 million basic biology grant round to be acted on tomorrow and Thursday by the governing board of the agency. They join four other scientists who are also asking the board to overturn reviewer rejection of their applications.
The latest three appellants are Song Li of UC Berkeley, who is seeking $1.3 million: Yanhong Shi of the City of Hope, who is asking for $1.4 million, and Wange Lu of USC, who is seeking $1.3 million..
Of the total of seven researchers appealing decisions, five received higher scientific scores on their applications than the lowest approved by reviewers.
Of the latest three appellants, Shi received a scientific score of 70, ranking above three grants approved by reviewers. Li's application received a scientific score of 67, ranking above two grants approved by reviewers. Li received international attention last June with published research that identified an "evil" stem cell involving heart disease. CIRM did not release a score for Lu's application but its review summary was listed below that of the lowest scoring application that was approved.
The seven appeals follow a record outpouring in July. During this week's week meeting, the CIRM governing board is expected to move to curb researcher appeals. More are likely be heard in the future as the reviewers diverge from scientific scores as they make their decisions.
David Serrano Sewell has confirmed that he has resigned as a director of the $3 billion California stem cell agency.
In an email to the California Stem Cell Report, he said he is "excited and honored about the new assignment" on the California state board that regulates physicians. Gov. Jerry Brown appointed Sewell, who is a deputy city attorney for the city of San Francisco, to the board last week.
The chairs are shifting a tad on the governing board of the $3 billion California stem cell agency as a French immigrant is added, a Latino leaves and a veteran patient advocate is reappointed.
Coming on board for next week's meeting is Anne-Marie Duliege, chief medical officer of Affymax Inc., of Palo Alto, a publicly traded biopharmaceutical company that deals with kidney disease. Leaving is David Serrano Sewell, who has been named to the state Medical Board by Gov. Jerry Brown. Reappointed is Jeff Sheehy, an HIV/AIDs patient advocate who may be the most public face of patient advocates on the stem cell agency.
In May, Duliege made a presentation to the Bioscience Forum in South San Francisco called "Beating the Odds," a discussion of Affymax's first commercial product. According to information posted by the group, Duliege led the way by shepherding it through a 10-month gauntlet at the FDA.
Duliege has been with Affymax since 2007. Her prior positions included time at Chiron and Genentech. She is a practicing physician, working part-time, and received her medical degree from Paris Medical School.
Affymax has had a previous tie to the stem cell agency. Ted Love, one of the initial members of the CIRM board, also sits on the Affymax board of directors. Indeed, Duliege fills the seat vacated by Love when he resigned from the CIRM board. The position must be filled by an officer of a California life science company.
Serrano Sewell, who has also served on the CIRM board since its inception, is apparently resigning to accept an appointment to the board that regulates California physicians. Apparently – because the stem cell agency has not confirmed that he is leaving, although this morning it placed a resolution honoring him on the agenda for next week's meeting. That almost invariably means a board member is departing.
Serrano Sewell, an attorney for the city of San Francisco, was one of 10 patient advocate members on the 29-member board. Sewell was apppointed by the California lieutenant governor. His seat will remain vacant until the current lieutenant governor, Gavin Newsom, makes an appointment, who must also be a patient advocate.
Sheehy was reappointed recently by state Senate President Pro Tem Darrell Steinberg. Sheehy is a communications manager at UC San Francisco and a nationally known HIV/AIDS advocate. He is co-chairman of CIRM's Science Subcommittee and vice chairman of the grants review group. Sheehy leads the discussion of grant applications when they come before the full board in public session.
With the latest shuffling, the board has essentially lost its only African-American member – Ted Love. Eugene Washington, dean of the UCLA medical school, is a member of the board but never attends the meetings. Instead he sends a surrogate. Serrano Sewell's departure brings the number of Hispanics to three, co-vice chairman Art Torres, Francisco Prieto and Marcy Feit. No Asians sit on the board.