Sunday, October 24, 2010

Coffey Not Committed to Moving to California Despite $4.9 Million Grant from CIRM

Last Thursday directors of the California stem cell agency awarded $4.9 million to an eminent British scientist after being assured by CIRM President Alan Trounson that his relocation to the Golden State was all but a done deal.

The $3 billion agency put out a news release in which CIRM Chairman Robert Klein hailed the move by Peter Coffey to UC Santa Barbara. Klein said,
“Recruiting internationally renowned stem cell experts such as Dr. Coffey builds a critical mass of stem cell leadership in California to drive the creation of innovative therapies for patients suffering from chronic disease or injury.”
The next day, the Financial Times of London quoted Coffey as saying he was not relocating to California. It was the second faux pas in CIRM's new, $44 million research recruitment program and raised questions about whether CIRM officials had a firm grasp on Coffey's status and their role in the touchy negotiations. It also raised questions about whether Coffey and UC Santa Barbara had met the terms of the grant application.

The RFA for the recruitment program makes several references to requirements that a recipient be a full-time employee at a California institution. Here is just one:
"The applicant institution will make adequate commitments to the PI including appointment to a full-time faculty position."
Friday's Financial Times article by Clive Cookson said,
"Although Mr Klein’s statement suggested that Prof. Coffey would be moving his base to California, Prof. Coffey said that impression was misleading. 'I am staying here [in London],' he said, 'though I can foresee more and more pressure from CIRM to up sticks and move there.'

"He said the $4.8m (sic) grant would enable him to set up a second laboratory at UC Santa Barbara, where he is already an adjunct professor, and accelerate his research."
Late Friday, we queried Coffey about the Financial Times story. On Saturday morning, we sent a query to the stem cell agency and UCSB. We told all the parties we would carry their responses verbatim when they were received.

Coffey has not replied. Dennis Clegg, co-director of the Santa Barbara stem cell program, said,
“UCSB is working hard to recruit Dr. Coffey to a full-time position, and CIRM has provided an invaluable tool to help us do that. However, as common sense would dictate, our negotiations are a private matter.”
Don Gibbons, CIRM's chief communications officer, said,
“By definition, these applications come from PIs who are not currently, eligible for CIRM funding. They are intended to be used as a recruitment tool by the CA institution. Once UCSB and Dr. Coffey decide when and how he will come to UCSB, CIRM will issue the award if Dr. Coffey's new position meets the requirements of the RFA. We would be delighted to see Dr. Coffey relocate to California on a full-time basis, but we respect the fact that he and UCSB will have to make that decision.”
At last week's board meeting at UCLA, Klein specifically asked Trounson about the status of Coffey's recruitment before calling for a vote on the grant. Coffey's name, however, was not specifically mentioned in keeping with CIRM's practice of withholding the names of winning applicants until after the board votes. Trounson assured the board that it was virtually certain that the researcher would be joining UCSB. The question of full or part-time work was not mentioned. Trounson said the applicant was “clearly one of the best scientists in the world.”

Last summer, the CIRM board put off action on Coffey grant. The agency said in August,
"The candidate being brought forward wanted more time to notify their current home institution.”
Coffey was quoted last month as deploring cuts in research in the UK. The Financial Times story said that if funding were not increased Coffey said he might have “to make members of his research team redundant and he would then succumb to the “enormous pressure” to move abroad. He said California was “very attractive” to scientists. The newspaper said the efforts by Coffey and other prominent scientists were subsequently successful in maintaining funding.

Last April, the board approved its first recruitment award. It was a $6 million inducement for Rob Wechsler-Reya to move to the Sanford-Burnham Institute in La Jolla from Duke University. He was identified as the recipient in an item on the California Stem Cell Report prior to the expected action by the board. Wechsler-Reya subsequently said he had not made a decision to come to California, which appeared to come as a surprise to CIRM officials. CIRM attempted to set a June 30 deadline for negotiations. Finally, in August, Burnham announced that they had successfully concluded a deal with the Duke researcher to come to California as a fulltime researcher.

In California, the chief institutional beneficiaries of CIRM's $44 million recruitment program are enterprises that are linked to members of the CIRM board of directors. Only academic and nonprofit institutions may apply. A relocation by Coffey to California would be a major international coup for the state and UC Santa Barbara.

Friday, October 22, 2010

Slim Coverage Today of California Stem Cell Agency Awards

The California stem cell agency's latest grants – more than $70 million – drew scant attention in the media this morning.

Most of the coverage was a routine rehash of the CIRM news release. Here are links to the various stories that surfaced today: Keith Darcé of the San Diego Union-Tribune, Ron Leuty of the San Francisco Business Times, Richard Halstead of the Marin Independent Journal, Loralee Stevens of North Bay Business Journal, Pat Brennan of the Orange County Register.

Here are the press releases from recipient institutions that popped up this morning in a search.
University of California, UC Irvine, Cedars-Sinai.

Thursday, October 21, 2010

Stem Cell Agency Approves More than $70 Million Including Signing Bonus for Star at UCSB

LOS ANGELES -- The California stem cell agency today awarded $67 million for translational research and approved one appeal from a scientist whose application was turned down by grant reviewers.

The grants are a “key element of CIRM's pipeline to the clinic,” directors were told. The research is aimed at creating a “development candidate ready for IND-enabling preclinical development” or making progress on a development candidate.

Sophie Deng, an ophthalmologist at UCLA, was successful in her pitch to reverse a negative decision by reviewers. Following her presentation to the board, CIRM Director Jeff Sheehy, vice chairman of the grants review group, said the $1.5 million grant was a “no brainer.” He said it could lead to FDA approval of a treatment already being used in Europe.

One business, iPierian, Inc., of South San Francisco, was awarded $5.7 million, which will come in the form of a loan, assuming CIRM completes its paper work. James Harrison, outside counsel to the board, said that more documents needed to be processed. Ipierian is heavily backed by venture capitalists who contributed more than $6 million to the ballot initiative campaign that created the Calfiornia stem cell agency. The firm has already received a $1.5 million grant.

Directors put off action on an appeal petition by Leif Havton of UCLA as they were pressed for time at midafternoon. Members of the board needed to catch flights and lost a quorum. The board concurred earlier with reviewers' negative decisions on other two appeals by Frederick Meyers and Kit Lam of UC Davis and WenYong Chen of the City of Hope.

Another application, 1778, related to Parkinson's Disease was sent back to CIRM President Alan Trounson for additional review. The board has funded little research connected to Parkinson's because of the dearth of researchers in that area in California. Director Joan Samuelson, a patient advocate for Parkinson's Disease, pushed for funding of the grant.

Separately, the board awarded a $4.9 million grant to Peter Coffey of the United Kingdom, who was described by Trounson as “clearly one of the best scientists in the world.” The grant is aimed at helping to recruit Coffey to UC Santa Barbara. It was the second recruitment award by CIRM.

Coffey is already collaborating with Dennis Clegg, co-director of the UCSB Center for Stem Cell Biology and Engineering, in connection with another CIRM grant.

Here is a link to the CIRM press release on the awards.

$80 Million to Be Given Way Later Today

LOS ANGELES – The board of the California stem cell agency begins its meeting this morning with consideration of requests for $80 million for translational research high on its agenda, including four appeals by scientists rejected by reviewers.

Also on today's agenda is a proposal for modification of the grant appeal process. It would provide a formal way for the CIRM board to send a grant back for re-examination by reviewers.

The board met Wednesday night mostly in a closed-door session dealing with the evaluation of CIRM President Alan Trounson.

The board briefly discussed projections for spending through the current decade but arrived at no firm conclusions. Director Michael Goldberg, a venture capitalist, said the agency needed to settle on a fixed projection. He said it could be modified but that CIRM should not be caught up in “scenario du jour” plans for strategic spending.

The meeting can be heard on an Internet audiocast and at a teleconference location in Pleasanton. Directions for both can be found on the agenda.
We will have more coverage of the meeting later today.

Wednesday, October 20, 2010

City of Hope Scientist Seeks to Reverse Negative Finding on Grant Application

A fourth researcher is seeking to overturn a negative decision on a grant application that comes before the California stem cell agency later today.

The scientist is WenYong Chen of the City of Hope in Duarte in Southern California. Chen's 4-page petition said the reviewers may not have “fully appreciated” certain points of the proposal.

CIRM directors will take up the applications for $80 million in translational research funding at their meeting this afternoon in Los Angeles. Three researchers have already appealed the negative decisions on their proposals. Summaries of the reviewer comments on all the grants can be found here.

Monday, October 18, 2010

How Fast Should the Stem Cell Agency Spend its Remaining $1.6 Billion?

Directors of the California stem cell agency will give away more than $80 million this week and wrestle with the question of what to do with their remaining $1.6 billion and how fast to spend it.

The $1.6 billion is a new figure for the public. Previously it was assumed the agency had $2 billion left, having committed $1 billion in awards. However, $2 billion figure did not include operational expenses, such as interest, legal costs and $180 million for administration through 2016.

The CIRM board is not likely to make a final decision on its strategic spending plan at the meeting Wednesday and Thursday in Los Angeles and at UCLA. Directors will have more information to work with in December when they consider the report of CIRM's external review panel, which conducted three days of hearings last week. The public was barred from most of those proceedings, and there are few clues concerning the direction of the blue-ribbon panel's recommendations.

Here are links to key documents on CIRM's future spending scenarios: Projected cash flow, memo on cash flow and more projections.

Also before the board are applications for $80 million for early translational research. Three applicants whose proposals were rejected by reviewers have filed petitions seeking to reverse the decisions. They are Sophie Deng of the Jules Stein Eye Institute at UCLA, Leif Havton, also of UCLA and Frederick Meyers and Kit Lam of UC Davis. (You can find their appeals by clicking on their names.)

The appeal process itself, which has troubled the board for several years, may also be modified this week. A proposal that would formalize a process for sending grants back to reviewers for additional examination is on the table. The staff information on the plan said,
“When a material dispute of fact exists and the Board is unable to resolve the issue at the meeting at which the application is considered, the Board may conditionally deny funding for the application, subject to a limited analysis of the factual issue or issues identified by the Board. The option for additional analysis is not a reconsideration of the application as a whole, but is limited to consideration of the issue or issues identified by the Board. This option should be reserved only for those circumstances in which the Board is unable to reach a decision at meeting at which the application is presented because of the factual dispute or question. Programmatic issues, such as whether the agency’s portfolio is well-balanced among diseases, should not be a justification for additional analysis, nor should clear errors in the review of an application that have been identified by staff and presented to the Board during the meeting at which the application is considered.”
Also before the board is CIRM's second recruiting grant to a scientist, as yet unidentified. It would provide $4.9 million to the “mid-career neuroscientist” in addition to incentives provided by the recruiting institution. The reviewer summary said,
“Reviewers characterized the PI’s research vision and plans as truly innovative, novel, ambitious, and important. The research focus on devastating and currently incurable blinding diseases was viewed as highly significant, with a potential to revolutionize the field. Reviewers were confident that the PI’s research would contribute to both the critical basic science and preclinical advances that will underlie novel therapies.”
Other items before the board include a proposal to spend $600,000 to provide seed money for an online, open-access journal for translational stem cell research, and changes in the loan administration policy. Most of the changes appear to be a straight-forward clarification of language that removes questions by business, which is the target of the loan program that was once described as a $500 million effort.

Missing from the proposed changes is one dealing with automatic forgiveness of loans to businesses under specified conditions. It appears to be connected to an application from iPierian, Inc., in the early translational round. However, the changes would apply to all loans to businesses and remove financial ambiguity that could be a stumbling block for some enterprises.

The changes came before the Finance Subcommittee last week, but some board members raised questions about them. Plus the panel did not have a quorum and could not legally act. The Finance Subcommittee has scheduled a meeting for Oct. 26 to consider the proposal again. It would then go to a special teleconference meeting in the board, if necessary.

CIRM has not provided a link to the loan forgiveness changes in the Oct. 26 agenda, but they can be found in a document here.

The public will be able to participate in the CIRM board meeting this week at teleconference locations in Washington, D.C., and Pleasanton in Northern California. The meeting can be heard on the Internet as well, but that audiocast does not permit participation.

Specific locations and instructions for the audiocast can be found on the agenda.

CIRM Poetry Kerfuffle Attracts More Publicity

The flap over the California stem cell agency's poetry contest continues to draw attention with the most recent coming yesterday on the widely read Huffington Post blog.

An item by John Lundberg, who describes himself as a poet, teacher and a former Wallace Stegner Fellow at Stanford, said the use of “language considered sacred by most opponents of stem cell research in order to promote the research is, well, provocative.”

Lundberg's item drew a wide range of comments from readers. One said the $3 billion stem cell agency was “cowardly” for pulling the offending poem and apologizing. Another said,
“Embryonic stem-cell research requires the destruction of a human embryo - a living being that, if not destroyed, becomes a human being. Fact, not opinion.”
Last week, The Associated Press also picked up the story. The news service reaches into news outlets internationally, although it is not clear whether the story was distributed that widely. Accounts of the flap have also appeared elsewhere on the Internet, mainly on sites devoted to opposition to hESC rsearch.

Is this affair a plus or minus for the stem cell agency? The controversy has raised somewhat the visibility of the stem cell agency. However, generally the agency is more inclined to seek favorable mention of its research efforts, which this poem and subsequent publicity do not. The agency's action actually energizes opponents, who see it as a validation of their hostile views of CIRM. If the agency has slipped below the horizon of some opponents, it reminds them they still have a significant foe lurking out there who needs to be dealt with. The pluses, if any, are neglible.

Don Gibbons, chief communications officer for CIRM and one of the judges of the poetry contest, took issue last week with our characterization that the poetry contest was not worth the effort under any circumstances. He pointed to articles on the Los Angeles Times and USA Today Web site that were published prior to the controversy as worthwhile mentions of CIRM. Gibbons faulted us for not mentioning them.

Last week, the public sessions of the external review of CIRM highlighted, however, the need for the agency to focus on its higher priorities. Reviewers said more than once that they were concerned about the “bandwidth” and size of staff at CIRM compared to its ambitious goals.

Our take: Handing out prizes for poetry probably is not one of the essential tasks for CIRM's small staff.

Friday, October 15, 2010

Final Wrap-up for Blue Ribbon Review of California Stem Cell Agency

SAN FRANCISCO – The blue-ribbon panel reviewing the operations of the $3 billion California stem cell agency is wrapping up its on-site sessions today and framing the general outlines of what it wants to say.

The panel conducted a final, one-hour public comment session that attracted only one person – yours truly. The bulk of this week's hearings were conducted behind closed-doors and were orchestrated by CIRM.

I presented a statement which can be found below and answered questions for about 20 minutes.

The panel plans to have a report ready for the December meeting of the CIRM board, where the public will have an opportunity to respond. Hopefully, the stem cell agency will post the report at least two business weeks prior to the board meeting. That will provide ample time for all interested parties to prepare thoughtful comments and plan to attend the meeting, if they so desire.

Here's the statement.

Statement to CIRM External Review Panel Oct. 15, 2010

Thursday, October 14, 2010

Does the Stem Cell Agency Have Enough 'Bandwidth' to Do The Job?

SAN FRANCISCO – A blue-ribbon panel examining California's $3 billion stem cell agency began its second public session this morning with some of its members saying they are impressed by what they have learned so far and with some expressing concern about whether CIRM has enough “bandwidth” to achieve its goals.

Alan Bernstein, chairman of the panel and executive director of the Global HIV Vaccine Enterprise of New York, described the agency as a “very exciting experiment in science,” one that the “world is watching.” Others also said they were impressed by how much CIRM has accomplished during its nearly six-year existence.

But panelists also said it could be difficult for the agency to do all that it is proposing. Richard Klausner, managing partner of The Column Group, a San Francisco venture capital firm, and Igor Gonda, CEO of Aradigm of Hayward, Ca., were among those concerned about CIRM's “bandwidth” problems. Klausner said he was “completely amazed” at what CIRM is trying to accomplish. But both expressed concern about whether CIRM had the necessary “resources” to do all that it proposes

Their comments apparently referred to the size of CIRM's staff, which was limited by Prop. 71 to 50 persons in addition to a 6 percent cap on its administrative budget. The agency has never had 50 employees although CIRM President Alan Trounson earlier this year warned that the quality of work was in danger because of the limit. Since then, the legislature has removed the cap in a new law that will take effect Jan. 1. However, according to CIRM officials, the size of the CIRM staff is not likely to exceed about 54 persons any time soon.

Although recruiting and hiring usually takes months, CIRM also does not seem to be making a running start on its opportunity to hire more staff. The agency has not yet posted significant numbers of new openings on its Web site. One key position, the new vice president for research and development, has been vacant for about 14 months. The post was supposed to represent a major effort to engage industry, which has been less than happy about its meager share of CIRM grants, about 4.5 percent.

The limit on CIRM staff has forced it to rely heavily on outside contractors, whose expenses are the second largest component in its operational budget. This year contractors are expected to cost $2.8 million, up 21 percent from last year.

This morning, the external review panel conducted a three-hour public session and then moved into a closed-door meeting. Today's meeting was consumed by presentations from CIRM Chairman Robert Klein and others. Public comment was called for with about 15 minutes left in the session. No members of the public offered comments, and only perhaps one or two were in attendance. Another one-hour public comment session is scheduled for tomorrow morning at 8:30 a.m.

Klein and others offered an overview of the agency, its history and underlying philosophy. He noted that the use of bond financing (money borrowed by the state) was aimed at assuring long-term financial stability for scientific research. He also said the debt, which will extend over 42 years, will be paid by the beneficiaries of the results of the research. At one point, he noted that borrowing the $3 billion will cost another $3 billion or so in interest.

Scientist George Daley of Harvard, another of member of the external review panel, raised a question about whether efforts such as CIRM are a threat to the “paradigm” of federal funding of research through the NIH.

CIRM Vice Chairman Art Torres said that the results of CIRM research will benefit the entire nation. Klein said the California effort will put pressure on Congress to develop more stable ways of financing scientific research.

Wednesday, October 13, 2010

Blue-Ribbon Panel Hears Recommendations for More Openness at California Stem Cell Agency

SAN FRANCISCO – Only four members of the public attended the first day of a blue-ribbon review of the operations of the $3 billion California stem cell agency during the brief period permitted for public comment.

The panel shut down its public session after about one hour and moved from the Marriott Hotel in San Francisco to CIRM headquarters to continue the meetings behind closed doors.

The small number of persons at the public comment session was to be expected. The agency made a late decision to permit public comment and then two days ago changed the location. Moreover, even CIRM board meetings rarely attract more than a handful of people. But again, CIRM makes little attempt to actively publicize directors' meetings.

Public comment sessions are also scheduled for tomorrow and Friday morning. The specifics and location can be found here. 

Three of the persons appearing this morning before the panel had type one diabetes and praised the agency for its search for therapies. One, Jessica Ching, is involved in the medical device and marketing field. She urged the panels to ensure that financing and development of commercial products are the primary goals of CIRM's efforts.

The fourth member of the public was yours truly. I read a statement to the panel urging more openness and transparency on the part of the agency and recommended several specific changes. In response, several members of the panel commented about the importance of openness in generating public trust. One later noted that scientists sometimes have difficulty understanding the need for transparency.

Here is the statement.
Statement by California Stem Cell Report to CIRM External Review Panel

Public Still Barred from Sweeping CIRM Review

The California stem cell agency confirmed this morning that the public remains barred from the key sessions of this week's sweeping review of the operations of the $3 billion public enterprise.

In response to a query, Don Gibbons, chief communications officer for CIRM, said,
“The public is only invited to the sessions that are marked as public.”
We raised the question because CIRM removed information this week from its Web site that explicitly said the public was banned. Also removed was information about the location, time and subjects of the closed-door proceedings. The  new announcement, posted just two days ago, additionally said that more time was being allotted for public comment.

The external review of CIRM,  the most comprehensive ever, begins this morning at San Francisco's Marriott Hotel.

We will be providing coverage today of the proceedings that we have access to.

Tuesday, October 12, 2010

More Time for Public Comment at CIRM Review But Doors Still Closed Otherwise to Public

Making a last minute change, the California stem cell agency has decided to allow more time for public comment during the sweeping review this week of its operations, but still will apparently bar the public from hearing testimony by witnesses.

The first public comment session will come tomorrow morning at 8 a.m. Other public comment sessions will be on Thursday and Friday mornings.

In the announcement posted just yesterday on the CIRM Web site, the agency also changed the location of the public comment sessions from CIRM headquarters to the Marriott Hotel in San Francisco.

The new information on the CIRM Web site removed an earlier agenda that said that the public would be barred from the panel's other sessions. However, this afternoon when we encountered Don Gibbons, CIRM's chief communications officer, at CIRM headquarters, he did not mention any change in policy. But that encounter was before we saw CIRM's new announcement, and we are querying Gibbons again concerning the likelihood of a change.

Also posted on Monday was a 29-page report (dated Oct. 8) by CIRM Chairman Robert Klein that will be presented to the blue-ribbon panel that is conducting the most comprehensive review ever of the $3 billion agency.

Our view on these last minute changes? The notice comes too late for all nearly all interested parties to find the time and make the effort necessary to prepare thoughtful comments. Plus the public still is apparently banned from hearing information that will be critical in determing the future direction of an agency that is spending $6 billion (including interest) of taxpayer funds.

We first wrote about the external review on Sept. 23. At that time, CIRM had not notified the public that the external review would occur nor had it solicited publicly any comments from interested parties, although the review had been planned for many months. Nor was any provision being made for public testimony at the review. CIRM has changed its position somewhat, but the public is still barred from what essentially is its own business.

Monday, October 11, 2010

Stem Cell Agency Apologizes for Its Choice of Poetry

The California stem cell agency stepped into a bit of an unnecessary mess last week that, of all things, involved poetry.

Perhaps it was a sign from above that government agencies should not try to commit literature, if you could call it that.

The case in point was a poem that won a prize from CIRM as part of its “stem cell awareness day,” a drum-beating effort to build support for human embryonic stem cell research. Winners of CIRM's poetry contest were announced last Wednesday in a widely distributed news release that was also posted on the CIRM Web site.

However, not only did the contest draw exceedingly few entries (only 18), the poem by one of the two winners was offensive to some who take their religion quite seriously. That in connection with research that already has more than its share of controversy.

In an item headlined “How to Offend 101,” one critic, J. Wesley Smith, wrote,
“One of the two top winners wrote a poem using the words of Jesus at the Last Supper to apply to embryonic stem cell research....

“Was it an intentional slam on Christians, many of which oppose ESCR, which the CIRM realized in retrospect would blow up in their faces?  Or did they think the poem, by using the words of Jesus at the Last Supper, would somehow appeal to Christians?  Or did they just think it was clever?   Whatever it was the judges were thinking–they weren’t thinking.”
Smith also used words like “hubris,” “arrogance” and “clueless.”

By Friday, CIRM had excised from its Web site the poem in question, which you can find at the end of this item. And the agency published an apology on its Web site that said,
“CIRM recently announced two winners of the second annual poetry contest, one of which contained some religious language that is identical to liturgical language used in the context of Christian and Catholic sacraments. The language introduces a religious element that we now realize was offensive to some people.

“We are deeply sorry for any offense caused by the poem. Neither the author nor CIRM intended for the language to insult or offend any religious group.

“When CIRM recognized that the language was of concern we removed all four poems from the CIRM web site and from the Stem Cell Awareness Day web site.”
CIRM's statement carried no comment from the three judges of the contest: Don Gibbons, CIRM's chief of communications, who said in the poetry press release that he studied poetry and creative writing at Indiana University; Margaret Hermes, also an Indiana alum and a “practicing poet and teacher,” and Don Reed of Fremont, Ca., a patient advocate.

The issue here is not the poem itself, which would have attracted little attention in a literary venue. But it was not published and touted privately. It was ballyhooed by a $3 billion California state agency, which has responsibilities to all of California – not just the scientific community.

CIRM had little to gain from running a poetry competition. Even under the best of circumstances, it would not generate sufficient PR payback to justify the time and expense involved, which was not much. And the prize for winners was equally neglible – “a framed stem cell image of their choice from CIRM’s Flickr web site.” Here is the poem from Tyson Anderson, a U.S. Army linguist from Tampa Fla.

Stem C.

This is my body
which is given for you.
But I am not great.
I have neither wealth,
nor fame, nor grace.
I cannot comfort with words,
nor inspire to march.
I am small and simple,
so leave me this.
Let me heal you.
This is my body
which is given for you.
Take this
in remembrance of me.

Friday, October 08, 2010

Parsing Statistics vs. the Reality of Biotech Concerns About CIRM

The California stem cell agency is missing the essential point of complaints from the biotech industry concerning CIRM's record on funding commercial research.

In its response to the biotech concerns, CIRM parsed statistics compiled by BayBio, the biotech industry group in Northern California, but ignored the reason for the private dinner meeting in August between top executives of the $3 billion agency and the area's stem cell firms.

Industry is less than happy with the California Institute of Regenerative Medicine. BayBio and the Orrick law firm did not bring together all those CEOs in August to pat CIRM on the back.

The industry concerns are not new. They have been around for several years. They have been acknowledged more than once by CIRM directors, some of whom have spoken pointedly about the need to funnel more cash to stem cell businesses. It is not just a matter of spreading money around equally. It is a matter of actually creating usable medical products, something that Stanford, the University of California and nonprofits are not going to do.

Director Jeff Sheehy, a patient advocate member of the CIRM board who works at UC San Francisco, said at the August CIRM board meeting,
“From the minute I've been on this agency I've heard...(at)all the industry meetings -- I've heard (that) we've got products waiting for money.”
According to the transcript of the meeting, CIRM Chairman Robert Klein, a real estate investment banker, acknowledged that CIRM does not have a “big supply” of grant reviewers with industry expenence – one of the problems cited by BayBio for the lack of grants to business. Finding them is “difficult,” Klein said.

Director Philip Pizzo, dean of the Stanford School of Medicine, additionally raised a question about CIRM's outreach to business.
“If industry has got things in the pipeline...are there ways that we could seed this to happen in more novel manners?

“Have we had, for example, as part of our strategic planning effort, an off-the-record kind of think tank between industry leaders, academic, venture capitalists in the same room at the same time, not separate -- would you buy into this ...approach -- but really coming together and say if we could create the world differently, how might we think about novel ways of approaching these kinds of both research and translation efforts?”
The question went unanswered at the board meeting. The strategic plan, however, comes up next week at CIRM headquarters in San Francisco when a blue-ribbon panel of external reviewers will conduct a closed-door examination of CIRM and its performance. The meeting's agenda, however, does not mention the stem cell industry's concerns.

Industry executives have been reluctant to go public with their issues, understandably wary of offending a financially powerful organization. Privately, they are more frank. We have heard bitterness and frustration from a number of them.

The industry found an unusual ally, at least on this issue, in Consumer Watchdog's John M. Simpson, who worked closely with some firms during CIRM hearings on its IP policy. He came up with a constructive proposal in June to deal with business issues that was brushed off by Klein.

But, as on any matter, there is not complete unanimity within the industry about CIRM. Funded firms are not likely to complain much.

CIRM has an additional $5 billion reason to move concretely to deal with biotech's concerns. Klein is touting for the ballot a CIRM bond measure of that magnitude, possibly in two years. The electoral campaign that created CIRM six years ago cost $30 million. Another ballot measure will run upwards of that amount, which means raising buckets of cash. And the only likely major donors will come from the biotech industry and its investors.

(A footnote: CIRM disputes statistics produced by BayBio on the percentage of awards given to business. We suspect the industry's figures were based on earlier grant numbers published by CIRM. The agency's totals change each time it approves another grant round every month or so. The presumably old percentages probably indicate that BayBio has been stewing over this issue for quite some time. BayBio has also filed a comment on an earlier item on this subject. Its carefully worded remarks said the August meeting created “a renewed sense of collaboration and areas to address.” BayBio did not speak to CIRM's criticism of its statistics.)

Thursday, October 07, 2010

Stem Cell Agency Says It Is "Not Biased Against Industry"

The California stem cell agency responded today to an item reporting dissatisfaction on the part of the biotech industry concerning its meager share of the $1 billion that CIRM has awarded so far.

Don Gibbons, chief communications officer for the agency, filed his remarks earlier today as a comment on the second piece we wrote on the subject. (Here is a link to the first.) Because of the important nature of the controversy, we are reprinting his statement verbatim below to give it greater visibility. We are sure it is not the last to be heard on the subject from either the agency or industry.

Here is what Gibbons wrote as a comment on the item on the California Stem Cell Report.
“Your post distorts the facts. The document you quote from BayBio is not a 'report' it was a letter written to highlight issues and get the group’s membership excited about attending the session. It was not intended to be a document of record regarding the organization’s stance on CIRM.

“You did not check the facts in the letter. You could quickly tally the for-profit grants on our web site and see that the $45 million awarded to industry is 4.5 percent of the amount awarded not the 3 percent cited. But you know that even this number is not a good comparative number. Anyone who follows CIRM knows we are working from a 'pipeline' strategy moving from basic research and infrastructure to clinical application. Industry was not, and should not have been, eligible for the early rounds of grants. I do not believe the taxpayers wanted us building facilities for for-profit entities. Also companies would not have been appropriate recipients for our training grants. So, if you look at only research dollars, the pie shrinks to $628 million and industry’s share is 7 percent.

“However, that is still not an appropriate number to use. The first two research awards, the SEED and Comprehensive grants, were called the Jumpstart program designed to get this new field launched. They were issued before we had an intellectual property (IP) policy in place and therefore could not be offered to industry. (And don’t suggest we should have had an IP policy in place by then given the vast number of new systems the agency was developing simultaneously.) If you subtract those dollars the pie shrinks to $511 million and industry’s share rises to almost 9 percent.

“Given our pipeline strategy and our stated intent to start out more focused on basic science and move into the translational and clinical arenas when the science matured, this is a respectable percentage. As you well know we have a $50 million Targeted Clinical Development Request For Applications active now and that could double industry’s share in one grant round.

“If you look at the industry partnerships our academic grantees have formed, the dollar amount committed to industry is already probably double actual grant total. While only one disease team Principal Investigator was from industry, a second team had a co-PI from industry and another eight have major contracted relationships with industry.

“CIRM’s management team is certainly not biased against industry. Seven of 12 science officers came to us from industry, and there is frequent discussion in the office about ways to bring industry more firmly on board with our mission and to clear misconceptions on our policy.  This is the reason we developed a webinar on grant writing that is now on our website

“Also, a little fact checking would have revealed that the number of industry reviewers on our grants working group was wrong in the BayBio letter. Thirteen members are currently employed by industry and another 13 have strong ties to industry as former industry employees or having been involved in founding a company. So, that is 26 out of 136 reviewers, not the six suggested.

“Your posting did not represent the over all tone of the BayBio meeting. It was generally a very constructive session. One executive present noted that when our regulations were explained, his company was comfortable enough to apply.

“Distortions relying heavily on a single disgruntled source do not do a service for the stem cell field or help the reputation of the blogosphere.”

Full BayBio Report on Lack of CIRM Grants to Business

The California Stem Cell Report has offered the state's stem cell agency and its directors an opportunity to respond at length in connection with the biotech industry's concerns about the paucity of awards to business.

BayBio, which represents the industry in Northern California, documented the complaints in a six-page paper in August, just two months after CIRM Chairman Robert Klein dismissed a call by a non-industry source for action on the matter. The entire BayBio document can be found here. It was used to prepare industry executives for a closed-door meeting with Klein and other CIRM officials in August.

We have emailed directors and CIRM, asking them if they would like to respond. We promised that any comments would be carried verbatim, which is almost never done in the mainstream media.

We have also sent links to the items to the blue-ribbon panel of reviewers who will be conducting a sweeping review of CIRM next week. However, the public and industry have been barred from attending the closed-door sessions, with the exception of one-hour to make comments or ask questions. The public and industry will not be permitted to hear testimony from CIRM staff or other witnesses.

CIRM Directors to Consider $600,000 Online Journal Plan

Coming up in only three business days is a meeting of the Finance Subcommittee of the California stem cell agency, which is expected to act on a $600,000 proposal to create an online scientific journal and alter CIRM's fledgling loan program for biotech businesses.

No specifics are available, however, from CIRM's Web site, which makes it difficult for interested parties to comment thoughtfully. In fact, the agency's de facto policy of regularly withholding until the last minute details on proposals coming before its directors discourages the public from commenting.

Also on tap is “consideration” of projected cash flows for the agency in connection with its strategic plan, which is scheduled for a sweeping, two-day, closed-door review next week. It is unclear why the cash flow matter is coming before the directors' Finance Subcommittee since it would not appear to require action. It may be a discussion proposal to set the stage for creating a policy for future expenditures – such as spending the agency's cash more rapidly -- sooner rather than later.

Regarding the loan policy, the agenda for the Finance meeting said only that the program, which originally was touted as a $500 million effort, would be amended. No other clue was offered concerning the changes. CIRM has made only one, $20 million loan in the program.

The journal proposal is part of the CIRM budget that was approved last June. At the time, CIRM President Alan Trounson told directors,
“What we would like to do is create an interest in one of the journals to bring out a translational journal which was focused on stem cell translation and for them to do all of the independent editing and all the reviewing and so forth.”
He said it was needed to provide a forum for discussion of regulatory issues and publication of research with negative results. He said that currently “translational papers” are scattered and hard to find.

We later asked for more details from CIRM. Don Gibbons, CIRM's chief communications officers, sent along a draft of an RFP. The proposed RFP dates back to July 26 and may well change. But it says that raising unique translational issues to a higher priority in journals would accelerate the entire field.

The draft RFP called for a three-year subsidy of the online, open access publication and required a business plan that would demonstrate self-sustainibility at the end of that period.

During next Tuesday's meeting, the public can participate at teleconference locations in San Francisco, San Diego, Stanford, Irvine and La Jolla. Specific addresses can be found on the meeting agenda.

Wednesday, October 06, 2010

The Biotech Industry and the California Stem Cell Agency: An Unhappy Relationship

Late last June, the chairman of the California stem cell agency, Robert Klein, dismissed concerns that biotech firms are not getting a fair shake at the agency's $3 billion in research awards. That's not what he has heard, he told CIRM directors. In fact, Klein said, he had just received an award from a national industry group.

Two months later, leaders of the Northern California biotech industry sat down with Klein at private dinner at a tony San Francisco peninsula restaurant and told him that he was simply wrong.

They showed him the numbers. In the five years that CIRM has been operational, businesses have received only 3 percent of the more than $1 billion awarded so far. If CIRM really wants to produce therapies that can be used, Klein was told, it can only do so by helping to finance enterprises that actually create medical products.

One executive in attendance at the Aug. 25 dinner at the Marche restaurant in Menlo Park had harsh words for the agency. He later told the California Stem Cell Report that CIRM is “completely misaligned and mismanaged.” He said the agency is dominated by the academics on its board, whose institutions have received nearly all of the funding. The executive said the academic institutions are not going to deliver on CIRM's mission of “turning stem cells into cures.”

However, June's message of concern came from an unlikely, non-industry source. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., called for a major effort by CIRM to deal with the matter. The issues he addressed have been simmering for some time, largely in private because of CIRM's enormous funding clout. No one wants to be on the agency's bad side.

In a statement to CIRM directors, Simpson said,
“When Consumer Watchdog began its stem cell project almost five years ago, I naïvely expressed concerns that the program would be hijacked by the biotech industry. That has -- at least so far -- not happened; rather, it has been dominated by academic research institutions, whose representatives hold the largest number of seats on the board.”
He recommended that CIRM take a number of steps, including a public task force, to remedy the situation.

According to the meeting transcript, Klein replied in part,
“I don't think the biotech industry at large has feelings that are reflected in that statement. As some of you may know, I received a reward from biointernational conference (BIO) this year, their humanitarian award.”
The August meeting, however, that Klein attended included top executives from Geron, iPierian, Vistagen, StemCells, Inc., Cellerant and others. “All the major players,” we were told. The dinner was organized with the support of BayBio, the biotech industry organization in Northern California, and the Orrick law firm of San Francisco, which serves as bond counsel to the state of Californa. From CIRM came – in addition to Klein – Director Ted Love and Patricia Olson, the agency's executive director of scientific activities . Missing was CIRM President Alan Trounson. No reason was given for his absence.

A BayBio briefing paper for the meeting, said,
“CIRM has a perception of not being friendly to industry. Private companies with strong track records of receiving NIH funding are frequently unsuccessful in getting grant funding from CIRM. Conversely, in comparison to CIRM for-profit companies have sporadic success rate at best with CIRM grants. CIRM’s contention on this is that the non-profit applicants that are received they tend to come from well-established and research –intensive institutions, as opposed to the less known and established for-profit companies.”
The paper said,
“CIRM’s current grant review policies and practices do not track with the stated goals of RFAs and favor funding academic applications thus reducing funding opportunities for industry and discouraging future company participation.”
CIRM's leadership, including Klein, also came under criticism for a lack of understanding about what is needed bring a stem cell therapy to the clinic. “Everybody is enamored of Klein,” said the source at the meeting. The deans on the board have no knowledge of product development, he continued.

CIRM directors are not unaware of business concerns, but the situation has remained nearly unchanged over the years. Only on rare occasions has a biotech executive publicly voiced concern. One of the issues that has been raised involves the lack of grant reviewers with business backgrounds, a situation that has existed since CIRM's inception. Directors have discussed the need for improvement. Some  have said there is tilt towards basic science among reviewers that manifests itself in a lack of interest in the relatively more pedestrian research needed to produce a product.

The BayBio paper said,
“Currently there are no scientific experts from industry on the grants review group and only six (out of 89) are alternates.”
The briefing paper made three recommendations:
“BayBio and industry need clarification on CIRM IP and public access requirements to increase private sector comfort with CIRM programs and encourage more companies to participate in the program.
“Changes are needed to the grants application and approval process to increase the success rate of companies applying for CIRM funding.
“There needs to be more transparency all around with respect to the process and final decision making.”
The CIRM officials took notes on the August discussion and said they would get back to the participants.

Next week, the stem cell agency will hold a two-day, closed-door review – with the exception of one hour -- of its strategic plan. The “external review” is the most comprehensive examination ever of CIRM's direction. However, the fair treatment of business grant applications is not one of the specific subjects listed on the agenda for the blue-ribbon, international panel.

California Stem Cell Report Honored as One of The Best Stem Cell Blogs

The California Stem Cell Report has been named one of the top 13 stem cell blogs internationally by, a physician-directed Web site aimed at helping physicians and patients obtain reliable information.

Webicina prepared the list because of the plethora of misleading and inaccurate information on the Web. In addition to this blog, the list of best blogs included the Cancer Stem Cell News, authored by Jim Till from the Cancer Stem Cell Consortium in Canada, CellNEWS, authored by Lars Carlsson, a Swedish researcher, and Stem Cell Awareness of the Stem Cell Cell Awareness Association.

Webicina is directed by Dr. Bertalan Mesko from Hungary, who is also responsible for the ScienceRoll blog, which he reports has had more than 1.6 million views. Mesko has also been quoted by Nature, the New York Times and the British Medical Journal, among others, concerning the impact of the Web on science and medicine.

Tuesday, October 05, 2010

Candidates Sought for Board of California Stem Cell Agency

Want to join a small brigade of public servants working on the cutting edge of science and public policy? Looking to take part in giving away $2 billion? Here's your chance.

California's top fiscal officer, Controller John Chiang, is seeking nominations for five openings on the 29-member board of directors for the $3 billion California stem cell, which has already awarded $1 billion to a total of more than 300 recipients.

You can nominate yourself or others. But there are some legal requirements. For example, nominees for chairman of the CIRM board should have “a demonstrated history in successful stem cell research advocacy” and “experience with state and federal legislative processes that must include some experience with medical legislative approvals or standards and/or funding.”

In addition to nominating candidates for chairman and vice chairman of CIRM, Chiang is looking for candidates for three other slots on the board. The positions, which have six-year terms, also have special requirements. One, for example, must come from a California life science business. Prop. 71 did not provide for a general representative from the public.

Chiang's Web site also said,
“The controller has been a leader in promoting public and private sector board diversity and is interested in finding qualified nominees and appointments who reflect the diversity of California.”
The jobs are important, require a fair amount of work and do not pay well, except for the chairman and vice chairman positions, which also involve a great deal more work than regular board positions. The chairman and vice chairman positions carry salaries. The others do not, only a modest per diem.

Other statewide officials, including the governor, lieutenant governor and state treasurer, make nominations for positions on the CIRM board. So interested parties have more than one shot. However, none of the other officials has posted a public appeal on their Web sites. We are sure, however, they are open to suggestions from the public.

The deadline for submitting nominations to Chiang is Oct. 15. Successful applicants could begin work in December.

Monday, October 04, 2010

Public and Scientists Left in Lurch on Proposals Affecting $2 Billion in Taxpayer Funds

A key panel of directors of the California stem cell agency met late last month to consider changes in its grant procedures that will affect hundreds if not thousands of scientists in California to the tune of $2 billion.

The Science Subcommittee discussed the proposals at a session on Sept. 29. However, the public and the affected parties had little clue in advance about the specifics of what was to be considered.

The agency withheld the details of the proposals until a mere two days before the meeting, effectively preventing the public from making any thoughtful comment, even if they knew the documents had been posted on the CIRM Web site. CIRM does not make an effort through its Web site to let the public know when important information has been added to meeting agendas. Its general practice is to wait until a day or two before a meeting to post any significant information concerning matters to be considered by its directors.

The proposals before the subcommittee or variations may come up again at another meeting of the panel or possibly the CIRM board of directors.

Here are links to the documents that were posted no earlier than Sept. 27 and Sept. 28. They deal with appeals processes on grant applications, scoring of grants and a triage process on grant proposals prior to their formal legal review.
"Extraordinary Petition Process Option A / Posting Applications"

"Extraordinary Petition Process Option B / Additional Analysis"

"Extraordinary Petition Process Option C / Limited Investigation"

"Discussion of proposal for programmatic scoring of grant applications by Patient Advocate members of Grants Working Group for inclusion in discussions and decisions regarding applications."

 "Discussion of Pre-Application Process, including but not limited to the process generally and scientific feedback to applicants who are not successful in the process."

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