Thursday, July 12, 2007

CIRM Directors Still Looking for New President

Directors of the California stem cell agency this morning met again behind closed doors to discuss candidates to head the $3 billion research effort but adjourned without announcing a decision.

The search is now into its seven month. CIRM's first president, Zach Hall, announced his plans to leave early last December. The agency has been without a permanent president since the beginning of May, when Hall departed.

The Oversight Committee could have acted this morning. The matter of presidential compensation and candidates was properly noticed on its agenda. But virtually the entire teleconference meeting, which included a link to one director in Portugal, was in executive session, and no announcements were made during the public segment.

John M. Simpson
, stem cell project director for the Foundation for Taxpayer and Consumer Rights, asked during the public portion whether a new president would be named prior to the directors meeting in August.

Chair Robert Klein replied that artificial timelines could not be imposed and and that the search must focus on finding a president with the right scientific vision for the agency, according to CIRM officials. Previously the Oversight Committee had expected to fill the position in June.

Klein may call another presidential meeting within the next 10 or 15 days.

Stem Cell Snippets: Pachter, Kessler and Google

CIRM General CounselJessica Jones has a brief Q&A on law.com with CIRM's new general counsel, Tamar Pachter. Among other things, Pachter was asked what is like working for a controversial agency. Her reply, "Is there a state agency that isn't controversial (laughs). It really doesn't affect my work all that much."

Egg Concerns
Anna Salleh for ABC Online reports concern in Australia about international trafficking in human eggs for stem cell research. Catherine Waldby of the University of Sydney is quoted as saying there are already problems in eastern Europe. Waldby's research is to be published in the New Genetics and Society Journal.


Kessler and Google Health CommitteeCIRM Oversight Committee member David Kessler has been named to Google's Health Advisory Council. Kessler is also dean of the UC San Francisco medical school. The Google council is aimed at understanding health issues and providing "feedback on product ideas and development." Sergey Brin, co-founder of Google, contributed at least $100,000 to the Prop.71 campaign.

Wednesday, July 11, 2007

Poultry and CIRM's Oversight Committee

The California stem cell agency has two lame ducks on its board and another vacancy that has remained unfilled as the result of gubernatorial inaction since last February.

The vacancy on the Oversight Committee is the seat formerly held by Leon Thal, who died in a plane crash on Feb. 3.

Thal was appointed to the board by Gov. Arnold Schwarzenegger. State law requires him to fill the vacancy within 30 days. We asked the governor's office today when the post would be filled. Sabrina Lockhart, a spokeswoman, replied:

"Gov. Schwarzenegger is proud of California's leadership in stem cell research - which has placed our state on the cutting-edge of this potentially life-saving science. Because stem cell research is such an important priority for the Governor, he will fill the vacancy as soon as he finds an ideal candidate to fill the position."

It is not uncommon for governors to flout deadlines such as the one created by Prop. 71 for filling vacancies.

The lame ducks on the board are David Baltimore, former president of Caltech, and Richard Murphy, who retired earlier this month from his position as head of the Salk Institute.

Both hold their seats on the 29-member Oversight Committee as the result of their former professional positions. Both are expected to continue to serve at least for some time, which appears to be permissible under Prop. 71.

More Fresh Comments

Anonymous weighs in with more on the "cronyism" business related to the "90 Percent" item below. We have posted an answer to the question of why only 27 biographical sketches are found on the CIRM website for the 29-member Oversight Committee.

Fresh Comments

An anonymous comment has been posted on the "90 percent" item below, which raises a question about the significance of the item. We have posted a reply. "Faye" also had a comment about the terms of Oversight Committee members and whether they can be rotated out. We have posted additional information in response to her query. You can find all of this by going to the "90 percent" item and looking at comments at the end of the item.

Tuesday, July 10, 2007

New Lab Proposal Info Now Available

The California stem cell agency this afternoon posted 58 Power Point slides for the meeting of the Facilities Working Group Thursday afternoon. The slides summarize comments made at four earlier hearings, identify some questions that should be answered at this week's session and outline steps to be taken before the proposal is presented to the Oversight Committee Aug. 8 in San Francisco for approval.

While obviously sketchy, they are useful -- in fact mandatory reading -- for anyone interested in the subject of giving away $220 million for construction of new stem cell research labs in California.

Monday, July 09, 2007

Five-hour Research Lab Meeting: A Mockery?

The California stem cell agency Thursday afternoon is going to attempt to set criteria in five hours for handing out $220 million in research lab grants in a process that one watchdog likens to a "public relations sham."

No proposed criteria will be available prior to the public meeting. They may not be available at the beginning of the meeting either. Instead, the only advance, online offerings are likely to be marginally useful, Power Point presentations that will summarize issues and suggestions presented during previous four public sessions of the Facilities Working Group.

John M. Simpson
, stem cell project director for the Foundation of Taxpayer and Consumer Rights, Monday said in an email to California stem cell Chairman Robert Klein,
"This facilities RFA is one of the most important and potentially contentious RFAs that CIRM will issue. It's supposed to be based on the input of four public hearings held around the state.

"The ICOC is to be commended for authorizing those hearings to gather public input about the policies.

"However, not making a draft of the policies to be discussed available with ample time for review by the public so they can make intelligent comments at the meeting makes a mockery of the entire process. It forces one to conclude that there was no real interest in meaningful public input and that your process was nothing more than a public relations sham."
Simpson added that not having the information in advance also makes it difficult for members of the working group to take intelligent action.

The only documents available online until late Monday afternoon were two facilities group transcripts from May 31 and June 4. Transcripts from hearings June 11 and June 19 were not available until Simpson called -- in his email to Klein -- for them to be posted forthwith.

The failure to post important material well in advance harkens back to earlier days of CIRM, when even members of its Oversight Committee complained publicly about not getting background material in advance. Some of that can be chalked up to growing pains.

But problem is obviously continuing. It has been compounded by not allowing enough time at meetings -- called by Klein or other committee chairs -- to cover all the necessary ground. In this case, for example, 11 persons sit on the Facilities Working Group. If each took only 10 minutes asking questions or making comments, that would consume nearly two hours. Then there is a staff presentation, questions and comments from representatives of California universities and institutions as well as from the general public. All with no draft criteria to actually read and study ahead of time.

Encumbering the process of handing out research lab grants fits with what one might call a modified stonewall strategy. CIRM does not have to make grants for lab construction. If it did not, CIRM would would have more money for research, which seems to be a priority of patient advocates on the Oversight Committee. On the other hand, executives from institutions represented on the committee could understandably take a different view although grants for their researchers are certainly important to them.

Whatever the case, the facilities group's hearings on the research lab criteria have been one of CIRM's more heavily attended series of events – mainly by folks from universities and nonprofit institutions.

It is a disservice to them, the public and CIRM itself not to provide a better opportunity for comment as well as thoughtful consideration by the working group.

Conflicts at CIRM: The 90 Percent Test

About ninety percent of the $209 million handed out so far by the California stem cell agency has gone to institutions that have "representatives" on the board that approves the funding.

The grants have gone for training new stem cell scientists, funding research and remodeling laboratories.

The group that approves the money is the 29-member Oversight Committee. Fourteen members of that committee have close links to the institutions that have received about $190 million in grants.

None of this is illegal but it illuminates the nature of the built-in conflicts of interest on the board. Prop. 71 created the situation. Nearly all the institutions in California that could be suitable recipients of stem cell research have some sort of representation on the decision-making board. The measure spelled out, for example, that five executive officers from University of California medical schools have seats on the board. It also stipulated that four executive officers from California research institutions sit on the Oversight Committee. The group would be hard pressed to come up with a long list of other institutions that would make suitable candidates for hefty stem cell funding.

Members of the Oversight Committee are barred from voting on grants to their institutions, and CIRM goes to considerable lengths to make sure that does not happen. However, all members of the committee can vote on the rules and standards for making the grants. And this week, a working group of CIRM is scheduled to devise rules for $220 million in grants for major labs at California institutions. Those standards will help establish, among other things, whether the money will be accessible to smaller institutions and spread geographically around the state or even whether that is a good idea.

While some have deplored the conflicts on the board, the situation is not likely to change soon. Prop. 71 can only be modified by another vote of the people or by a super, supermajority vote in the legislature and approval of the governor.

In the absence of a change, the Oversight Committee's structure and actions make it even clearer that CIRM should operate with a maximum of disclosure and openness, something the committee sometimes feels uncomfortable with.

Here are the names of the members of the Oversight Committee with links to institutions that have received grants and the size of the grants. Some members directly represent their institutions, such as the deans. Others, such as Sherry Lansing, have close links to an institution but serve as the result of some other designation. Lansing is a University of California regent, but serves on the board as a patient advocate.

David Baltimore, president emeritus Caltech, $2 million; Robert Birgeneau, chancellor UC Berkeley, $5.5 million; David Brenner, dean UC San Diego medical school, $17.7 million; Susan V. Bryant, dean School of Biological Science UC Irvine, $17.5 million; Michael A. Friedman, president City of Hope, $357,978; Brian E. Henderson, dean USC medical school, $9 million; David A. Kessler, dean UC San Francisco medical school, $30 million; Sherry Lansing, UC regent, 10 UC campuses have received grants; Gerald S. Levey, dean UCLA medical school, $15.8 million; Richard A. Murphy, president Salk Institute, $8.9 million; Philip Pizzo, dean Stanford medical school, $31 million; Claire Pomeroy, dean UC Davis medical school, $11 million; John C. Reed, president Burnham Institute, $17 million, and Oswald Steward, chair of the Reeve, Irvine Research Center, UC Irvine, as noted under Bryant, the campus has received $17. 5 million.

The amounts could be larger, for example, if we included the $8 million in grants to Children's Hospital of Los Angeles, which has close ties with USC. Or the $10 million to the Gladstone Institute, which has ties to UC San Francisco.

Short biographies of members of the Oversight Committee can be found here. More specifics on the size and nature of the grants can be found here(see the list at the end of the press release.

Friday, July 06, 2007

UC Davis Tightens Rules on Industry Influence

Efforts to control the influence of the medical industry in academia received more support recently at the UC Davis medical school, whose dean sits on the Oversight Committee for the $3 billion California stem cell agency.

Reporter Dorsey Griffith of The Sacramento Bee wrote earlier this week:
"UC Davis' ban against drug industry gifts, lunches and samples has expanded to include a prohibition of freebies from any company that markets its wares to the large health system.

"University of California, Davis, officials Monday announced the expanded new policy, which took effect Sunday.

"'There was consensus that we really needed to make sure that all our policies ensure that our behavior is totally transparent and ethical,' said Dr. Claire Pomeroy, vice chancellor and dean of the UC Davis School of Medicine. 'I think it's consistent with our values here of really being focused on the patient.'"
Pomeroy is one of 29 members of the Oversight Committee, which has its own set of issues dealing with conflicts of interests.

Stanford and UCLA, whose medical school deans also sit on the Oversight Committee, have similar rules, along with Kaiser Permanente Northern California, Yale and the University of Pennsylvania.

Thursday, July 05, 2007

Yolo Stem Cell Proposal Attracts More Attention

A "farmland war," "unethical" – two of the descriptions emerging today in a fresh story about the Northern California land development/stem cell research project involving the head of the state's $3 billion stem cell agency.

CIRM
Chair Robert Klein and Angelo Tsakopolous, a Sacramento area land developer, are lobbying for a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million. Earlier this spring, Klein's private lobbying organization received a $125,000 contribution from Tsakopolous' company. Klein would chair the proposed nonprofit.

In a story written by reporter Ralph Brave, the Sacramento News & Review today painted a bucolic picture of the development's location, which is hard on a very busy freeway just west of Sacramento. Brave wrote:
"This acreage has become the latest battleground in the ongoing war over the fate of Yolo County’s distinctive dedication to preserving farmland and open space. Although it’s just commenced, this particular battle’s mix of the area’s most powerful real-estate magnate, the head of the state’s stem-cell oversight committee, the re-evaluation of Yolo County’s General Plan governing development, and next year’s elections promises a prolonged, intense struggle that could determine much about the county’s and the region’s future."
The election issue involves at least the chair of the Yolo supervisors, a locally elected official who is seeking a seat in the California legislature. The dispute was characterized as a "farmland war" in a caption on a photo of a portion of the site.

Brave continued:
"Environmental attorney James Pachl told SN&R that Tsakopoulos’ 'proposal is an attempt to bribe the supervisors by offering to contribute to a fashionable charity in exchange for approval of AKT’s development project(AKT is Tsakopolous' company). Perhaps legal, but too unethical for most public officials to consider. The AKT property is valuable farmland, wildlife habitat and open space that should continue to be farmed.' A supporter of stem-cell research, Pachl expressed concern that 'the proposal will create a local political firestorm that will likely stop the project and damage the credibility of stem-cell researchers.'"
The newspaper also brought into its coverage another CIRM official, Claire Pomeroy, a member of the Oversight Committee and dean of the UC Davis School of Medicine.

Brave wrote that attendees at one dinner promoting the project included two Yolo supervisors, Klein and Pomeroy.

Brave said Pomeroy later told him that "it would not be 'appropriate to involve myself in land-use decisions.'"

Last Saturday, reporter Luke Gianni of the Woodland Daily Democrat quoted Pomeroy as saying,
"The concept of a research center for stem cells is a good one and something I support. A new research park in this region, in addition to the stem cell facilities we're currently building in Sacramento, could help complement the promising work our scientists are now doing in regenerative medicine."
Brave's story contained more details on financing the stem cell research facility, provided by Amy Daly, executive director of the Klein lobbying group, Americans for Stem Cell Therapies and Cures.

"Upon approval for residential and commercial development for some portion of the Tsakopoulos 2,800-acre property, 200 acres would be donated to a new nonprofit called Bridge to Cures. One hundred of those acres would be taken to a bank and used as collateral for a loan to finance the building of the research center and its labs. Part of the profits from the residential and commercial development would go into an endowment, to be used as loans, grants and other financing for biotech companies to advance stem cell and other biomedical discoveries into clinical applications."

Daly said the center's labs would be leased to for-profit companies. Earlier, she told the California Stem Cell Report that Klein would chair Bridge To Cures.

Size of the endowment has ranged from $50 to $400 million, depending on the size of the development that might be approved.

To see all the items on this subject, click on the label "yolo" below.

Tuesday, July 03, 2007

Recent Comments

Yvonne Perry, author of "Right to Recover, Winning the Political and Religious Wars over Stem Cell Research in America," has posted comments on the "Internet radio program" and the "TV coverage" items below.

News Coverage of Monday's WARF Stem Cell Matters

The latest developments in the WARF stem cell patent case received light coverage today among mainstream newspapers.

Stories appeared in three newspapers – the San Diego Union-Tribune, Milwaukee Journal Sentinel and the Wisconsin State Journal.

Coverage was straight forward. Wisconsin State Journal reporter David Walhlberg had this item concerning scientist James Thomson and his stem cell discoveries in 1998.
"...(T)he challengers added a new twist. They said Thomson had 'unique access' to an Israeli scientist who provided him with human embryos and enviable funding from the biotech firm Geron.

"'Had other scientists in the field been given the same access to those limited resources, they, too, would have been able to make the same accomplishment Dr. Thomson did,' the challengers wrote.

"Thomson did not respond to a request for comment Monday. In an e-mail interview last year, he said, "Some very good, simple ideas only seem obvious afterwards.'

"Andy Cohn, WARF spokesman, called the new filing 'a minor step in a long process.'"
Terri Somers of the San Diego Union-Tribune noted this case is a long way from being resolved and could wind up in court following the patent challenge.

No Aussie Location for July 12 Presidential Meeting

The folks down under are not going to have a chance to comment on the selection process for the next president of the $3 billion California stem cell agency.

Australia will be dropped from the list of remote locations for the teleconference meeting of the Oversight Committee on July 12. The site in Australia was listed on the agenda because California stem cell chairman Robert Klein was visiting the country. However, he will return on July 8. We are told that listing the Australian location was an error.

Monday, July 02, 2007

CIRM Takes Another Whack at Hiring President

In another attempt at hiring a new president for the California stem cell agency, directors of the $3 billion effort have scheduled their second unusual teleconference meeting in the last few weeks to consider compensation for the post and candidates for the position.

This one is for July 12. The last such meeting was held on June 26 and ended with no public action. The directors have sealed off any public comment after an embarrassing information leak earlier this year.

In order to act on candidates and compensation, state law requires that advance notice be given. Posting such a notice could just be a hopeful contingency measure in case a deal can be concluded by the meeting date. Nonetheless, a decision must be quite close.

One of the sticking points in the recruitment process has been the $400,000 salary for the position, which apparently has been too low for some. For more details on that see the "ticklish" item posted earlier.

Members of the Oversight Committee are calling in from 14 locations in California, according to the agenda, and one in Australia, where California stem cell Chairman Robert Klein is visiting. Members of the public can listen in at those locations during the public portions of the meeting and speak out as well. The June 26 meeting was almost entirely in executive session.

Twenty-nine persons sit on the Oversight Committee. Presumably more locations will be added as the meeting approaches. Otherwise, there may not be enough members on the teleconference to take legal action.

Melton, Cowan and Trounson Beef Up WARF Challenge

Three prominent stem cell scientists – two from Harvard and one from Australia – have bolstered a challenge to the embryonic stem cell patents held by the Wisconsin Alumni Research Foundation.

They are Douglas Melton and Chad Cowan, both of Harvard, and Alan Trounson of Monash University in Australia. Previously Jeanne Loring of the Burnham Institute had filed statements in support of the challenge to the patents of the discoveries by James Thomson of the University of Wisconsin.

Melton said,
"I very much believe Dr. Thomson deserves the scientific and public recognition he has received. However, he deserves that recognition because he undertook the arduous and timely task of getting fresh and high quality embryos to use as starting material for his work, and sufficient funding for such research, not because he did anything that was inventive... His perseverance and commitment deserve recognition and accolades. But I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious."
Melton's statement was released today by the Foundation for Taxpayer and Consumers Rights and the Public Patent Foundation. They filed the challenge last year in the wake of complaints in the scientific and commercial stem cell community about the restrictions and costs involving the WARF patents. The challenge won favorable preliminary ruling from the federal government, which WARF has responded to.

Carl Gulbrandsen, managing director of WARF, said earlier in a news release that:
"...the patents and publications the (Patent and Trademark Office) relied upon were not relevant to the isolation and proliferation of human embryonic stem cells. Gulbrandsen's comments were echoed by Dr. Colin Stewart, a leading stem cell researcher at the Institute of Medical Biology in Singapore, who submitted a declaration in support of the Thomson patents that emphasized the differences between mouse stem cells, which were prominent in the PTO's rejections, and the human embryonic stem cells that were isolated and characterized by Thomson."
More on the WARF response can be found at this site.

FTCR also has additional material, including the declarations from Trounson, Cowan and Loring, on its site.

The PTO now takes the arguments under submission. It is not expected to render a judgment for many months, perhaps as a long as a year.

Sunday, July 01, 2007

Stem Cell Snippets: Burnham's Reed, Politics, Roth and the Non-meeting Meeting

Burnham Receives $2.5 MillionDonald Bren, an Orange County developer, is giving $2.5 million to the Burnham Institute to support research by its president, John Reed, who sits on the Oversight Committee for the California stem cell agency. On the Burnham board are Bren's wife, Brigitte, and Gayle Wilson, a former member of the Oversight Committee and wife of former Gov. Pete Wilson. Both were added to the Burnham board earlier this month.

Lansing Covering Bets? -- Los Angeles TV station KNBC reported that Sherry Lansing, a CIRM Oversight Committee member, could be covering her presidential bets. The station says she has made the maximum individual contribution -- $2,300 – to both Hillary Clinton and Barack Obama. The station reported that multiple contributions are common among major contributors. Variety also reported she hosted a fundraising dinner at her home for Democratic Sen. James Webb of Virginia.

Penhoet and Bloomberg
CIRM Vice Chairman Ed Penhoet dined with New York Mayor Michael Bloomberg shortly before the mayor renounced his membership in the Grand Old Party. Penhoet was at an affair at the home of technology financier Sandy Robertson, a partner in Francisco Partners, according to Kevin Maney on the Tech Observer blog. Testing the Silicon waters was how Maney described Bloomberg's foray.

Baltimore and Science
David Baltimore, former president of Caltech and a member of the CIRM Oversight Committee, is chairing the search committee to find a new editor for Science magazine to replaced retiring editor Donald Kennedy.

CIRM Director Has New ResponsibilitiesDuane Roth, a member of the CIRM Oversight Committee, has been named interim chairman of CleanTECH, a nonprofit group supporting environmental technology businesses in the San Diego area. Roth is also chief executive officer of Connect, a UC San Diego entrepreneurial program.

Meeting with No Business – The CIRM Standards Group has scheduled a meeting for July 27. Nothing is on the agenda.

Friday, June 29, 2007

Klein Rep Says No Financial Ties in Land-Stem Cell Proposal

California stem cell Chairman Robert Klein, who owns a real estate development firm based in Palo Alto, is not financially involved in a land development proposal in Northern California that promises to create a stem cell research center, according to a Klein representative.

In response to questions from the California Stem Cell Report, Amy Daly, executive director of Americans for Stem Cell Therapies and Cures, Klein's private lobbying group, said:
"Bob Klein's company's is not at all involved in this project other than to allow Bob to donate his time to the endeavor. There is no monetary benefit for Bob in this project. He is not getting paid and there will be no financial (or other) benefit to his company as a result of this project."
She also said that CIRM is not connected with the proposal near Sacramento and is "completely separate." CIRM itself has had no comment on the plan. The agency said it knows nothing about it.

Daly's response came as the Center for Genetics and Society Friday published sharp criticism of the plan on its blog "Biopolitical Times."

Jesse Reynolds, project director on biotechnology accountability, wrote that the proposal raises a question of whether another stem cell research center is justified. He continued:
"The second issue is the egregious nature of Robert Klein's conflicting roles. His lobbying group gets a hefty donation, and his imprimatur hints that the new center would be a likely magnet for public financial support. And who knows if he's got his own finger in the pot, given that his business dealings are obfuscated via dozens of corporations and holding companies.

"Meanwhile, he sits as not only a public servant, but as one with significant influence over how billions of public dollars are spent. Although he's promised not to profit from biotech while he's chair of the state stem cell agency, does he consider an investment in the land development part of this vow? And how would the public ever know?

"Regardless, as we've said before, Klein needs to decide whether he is a lobbyist or a public official. He can't be both."
Daly said that Klein and Sacramento developer Angelo Tsakopolous met only recently. She said that they "have not worked on any project in the past."

She wrote,
"As I understand it, they met in January 2007 when they both were in Washington for inaugural activities. Both are strong supporters of Nancy Pelosi.

"Around that same time, Yolo County had put into their general plan a desire to have an economic development proposal. The Tsakopoulos family owns land there and they were hoping to leave some lasting legacy for the county beyond just immediate economic development.

"Bob and Angelo had dinner here in California upon their return and discussed the possibility of a Regenerative Medicine Institute in Yolo County. Angelo and his children were thrilled to have an opportunity to change the world much in the way we believe Proposition 71 will change it. As I mentioned in my email to you yesterday, we are hoping that this Regenerative Medicine Institute, funded by the soon to be formed non-profit, Bridge to Cures, will bridge the funding gap for translational medicine that currently exists and that CIRM has not yet addressed."
She said opponents are trying to stop the project, which will be discussed by Yolo County supervisors July 17, before it moves beyond the discussion stage.

See below for an information sheet on the Yolo stem cell proposal being circulated on behalf of the effort.

Text on Development Plan Involving Klein

Here is the verbatim text of information supplied on behalf of a Northern California land development/stem cell research proposal involving California stem cell Chairman Robert Klein. It was supplied by the Sacramento political consulting and PR firm of Townsend Raimundo Besler & Usher.


Innovation Corridor

California and the nation face a serious shortage of comprehensive sites devoted to cutting-edge biomedical research, life science incubators and allied private enterprise support for university-related research and therapy development. A group of researchers, civic leaders and private entrepreneurs are working on a plan to provide the physical and economic infrastructure to support an international research center for regenerative medicine and biotechnology on Interstate 80 between Mace Boulevard and E. Chiles Road interchanges.

Life and Health Sciences – Leading California Into the Future

California is the world leader in life and health sciences and technological research. Biotechnology was born in California and today is one of the state's most important economic engines. A quarter of a million Californians work for more than 2,700 companies, making biotech a larger employer than the computer, aerospace, telecommunications or motion picture industries.

Demand for Research and Development Centers is Growing


Advanced R & D in the biosciences will be the most significant contributor to the well-being of Americans and to the nation's economic well-being for decades. That promise can only be realized, however, if researchers, civic leaders, universities, government officials and private entrepreneurs work together to overcome serious financial barriers and a shortage of sites where new therapies can be discovered.

Californians recently voted to make $3 billion available for stem-cell research but only $300 million for construction of sophisticated facilities to carry out that research. A leading California life sciences consortium recently found that high costs and a scarcity of approved R & D sites is a growing problem. It urged leaders "…to cooperate to identify areas where facilities (e.g., bio-research parks) can be located, to secure those areas, to provide incentives for development and for companies to locate there, and, most importantly, to maintain a level of ongoing support to keep these areas vital."

Innovation Campuses can Provide Infrastructure to Sustain R&D

Operational mixed-discipline research centers, life science incubators and therapy development centers cannot support themselves. Many potential tenants are start-up companies or non-profits. Most require venture capital, government subsidies, non-profit foundation grants and other support to provide working capital needed to carry a new medical therapy from validated discovery to clinical trial.

Regional Leaders Working with Yolo County to Identify Potential Innovation Corridor


The Yolo County Board of Supervisors has identified the Interstate 80 corridor between East Chiles Road and Mace Boulevard as a planning study area for a university-related research and development corridor. Regional leaders are working with the county to explore a practical plan to support the county's goal of a local environmentally sensitive, university-related R&D site.

Innovation Place Foundation to Provide the Incubator


Governed by a panel of leading local and international researchers, entrepreneurs and university representatives, an Innovation Place Foundation would develop a not-for-profit regenerative medicine and biomedical research incubator; support allied research in clean energy, agriculture and environmental sciences; and administer a for-profit mixed-discipline research park.

The foundation would operate with more than $200 million to provide working capital for research and therapy development advancing validated discoveries to clinical trials. Financial support would come from a share of the proceeds of ancillary and adjacent commercial and residential development that would follow SACOG Blueprint guidelines, provide a jobs-housing balance and protect agriculture and open space in step with Yolo County's heritage.

CIRM Faculty Awards Deadline in August

The big day – at least a day some scientists will not want to miss -- for the handsome faculty awards from the California stem cell agency is Aug. 9.

That is when the letters of intent are due from applicants for the $85 million program, which will provide salary and research support for up to five years for 25 California stem cell scientists. Arlene Chiu, CIRM’s interim chief scientific officer, said,

"These grants are designed to encourage newly independent investigators to pursue bold and innovative studies across the full range of stem cell types – human and animal, embryonic and adult. We will consider providing successful applicants salary and research funding for up to five years, ensuring that they have stable, secure financial support as they begin their independent scientific careers."

The awards are scheduled to be approved in December with cash actually coming next spring.

CIRM's press release can be found here. The RFA here. And an earlier item on the program here.

Thursday, June 28, 2007

Klein and His Role on Proposed Stem Cell Research Center

The Northern California land deal/stem cell research center involving California stem cell chairman Robert Klein calls for him to head a new nonprofit group that would be endowed by the family of developer Angelo Tsakopolous.

In response to a query from the California Stem Cell Report, Amy Daly, executive director of Klein's lobbying group, Americans for Stem Cell Therapies and Cures, said,
"As you may be aware, there is a gap in funding in the life of therapy development where many good ideas for therapies and cures die for lack of funding. It is this funding gap that we hope to address with this project. California Institute for Regenerative Medicine has focused (and we believe will continue to focus) much of ithat come from early research and safely see them to the point in time where they are picked up by biotech and VCs (venture capitalists).

"We hope to inspire international collaboration by having board members from world-class institutions from around the world. These institutions, as well as UC Davis and other California institutions, will also have the opportunity to have satellite lab space near the incubator space that we are building for the therapy development."
She continued:
"This project will create a non-profit to bridge that funding gap and we believe it will be called Bridge to Cures. The family donating the land and endowment funds, the Tsakopoulos family, have asked Bob to chair the board of Bridge to Cures. The structure of the board will be similar to the Independent Citizens Oversight Committee with the addition of Angelo and Kyriakos Tsakopoulos and Eleni Tsakopoulos-Kounalakis. We expect that the board will choose to have working groups make recommendations to them similar to the working groups of California Institute for Regenerative Medicine. We hope to inspire international collaboration by having board members from world-class institutions from around the world. These institutions, as well as UC Davis and other California institutions, will also have the opportunity to have satellite lab space near the incubator space that we are building for the therapy development."
Daly's full statement is below.

Amy Daly Statement on Bridge to Cures

We queried Amy Daly, executive director of the Americans for Stem Cell Therapies and Cures, concerning the proposal for a land development project and stem cell research center near Sacramento. Here is her response verbatim.

Bob and Angelo had been spending time talking about this project to fund therapy development around the same time that Americans for Stem Cell Therapies & Cures was holding a fundraising dinner at the home of Robin and Marsha Williams to retire the outstanding campaign debt. The suggested donation for a couple to attend this dinner was $125,000. Angelo is very supportive of stem cell research (as you can see by his incredible generosity with this project) and so he and his wife attended this dinner.

As far as the project referred to in the Sacramento Bee today, there are
many details that were discussed but not included in the article.

"No one tried to strangle Herceptin, but it came near to starving in the
cradle."

As you may be aware, there is a gap in funding in the life of therapy
development where many good ideas for therapies and cures die for lack of
funding. It is this funding gap that we hope to address with this project.
California Institute for Regenerative Medicine has focused (and we believe
will continue to focus) much of its funding to fill the funding gap in early
research. We hope to take the ideas that come from early research and safely
see them to the point in time where they are picked up by biotech and VCs.
An example of this funding gap is found in the history of the development of
Herceptin, as noted here:
http://www.nytimes.com/books/98/09/20/reviews/980920.20henigt.html?_r=1&oref
=slogin.

Without philanthropic financial support for Herceptin during that funding
gap, it would not have been developed to the point where Genentech picked it
up. It is now the number one choice for the treatment of certain types of
breast cancer and saves countless lives.

This project will create a non-profit to bridge that funding gap and we
believe it will be called Bridge to Cures. The family donating the land and
endowment funds, the Tsakopoulos family, have asked Bob to chair the board
of Bridge to Cures. The structure of the board will be similar to the
Independent Citizens Oversight Committee with the addition of Angelo and
Kyriakos Tsakopoulos and Eleni Tsakopoulos-Kounalakis. We expect that the
board will choose to have working groups make recommendations to them
similar to the working groups of California Institute for Regenerative
Medicine. We hope to inspire international collaboration by having board
members from world-class institutions from around the world. These
institutions, as well as UC Davis and other California institutions, will
also have the opportunity to have satellite lab space near the incubator
space that we are building for the therapy development.

This is an incredible opportunity to help further stem cell research and
mitigate human suffering and I am proud that our non-profit has chosen to
support this effort.

Klein Involved in Major Land Deal-Stem Cell Research Center Proposal

California stem cell chairman Robert Klein and a prominent Sacramento area land developer are involved in a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million.

Reporter Mary Lynne Vellinga broke the news in The Sacramento Bee this morning. The developer is Angelo Tsakopolous, who has been active in Democratic fundraising and a major Sacramento developer for decades.

Tsakopolous' company, AKT Development, also contributed $125,000 on April 17 to Klein's private stem cell lobbying group, Americans for Stem Cell Therapies and Cures, which grew out of the Prop. 71 campaign committee. The contribution was not reported in The Bee story.

The Bee story "raises serious and troubling questions, some of which originate from Bob Klein's dual role as chairman of the ICOC and a stem cell political advocacy," said John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights. He told the California Stem Cell Report:
"I've said repeatedly that the dual role is inappropriate and word of this deal and the suggestion that Klein is involved in it while taking contributions is even more troubling."
Klein's activities with the lobbying group have stirred other concerns in the past about conflicts in the case of a man to heads a state agency giving away $3 billion in public funds. (See below for links to previous items on this subject.) Klein still presides over his own development firm, which is based in Palo Alto at the same address as the lobbying group.

The stem cell agency said it had no comment on the development proposal. "We don't know anything about this," said Dale Carlson, chief communications officer for CIRM.

Vellinga wrote that the proposal appears to be in the concept stage, but Tsakopolous and his supporters have hired a well-known political consulting and PR firm, Townsend Raimundo Besler & Usher, and promoted the plan with Yolo County officials.

Vellinga reported:
"The plan is similar in approach to efforts Tsakopoulos has made in Sacramento and Placer counties, where he offered to fund an NBA arena and a university, respectively, with the proceeds from new development on agricultural land that is now off limits to building.

"As outlined Wednesday by Tsakopoulos' spokesman, Jeff Raimundo, the Yolo proposal is short on specifics, such as how much housing, office or retail space he would seek permission to build on about 2,800 acres of land he controls between the city of Davis and the Vic Fazio Yolo Wildlife Area.

"In meetings with Yolo officials, including a dinner held at the Sutter Club in downtown Sacramento, Tsakopoulos and his supporters have stressed the benefits of the stem cell facility but have offered little detail about what it would take to finance it."
Vellinga continued:
"'Bob and Angelo thought this up,' Amy Daly, executive director of the Alliance for Stem Cell Research, said of the new idea for a research center. 'My understanding is that Angelo is looking for a legacy he can leave. He wants to do something big. And Bob lives, eats and breathes stem cell research.'

"Daly, who worked with Klein on the stem cell initiative, also is helping promote the Tsakopoulos plan. She said there is a significant funding gap for research that's beyond the basic stage but not ready to hit the market. The new center could fill that gap, she said."
Daly also worked for the California stem cell agency as director of patient and medical organization relations from Jan. 14, 2005, to Nov. 25, 2005.

Raimundo told the California Stem Cell Report that Yolo County supervisors "first started the dialogue about a biomedical research corridor." Raimundo said the project had a goal of generating a $200 million endowment for the center, although there were no details how the funds would be raised. He said any development would likely include residential and commercial building.

He told CSCR:
"This is a real convergence of a county that wants to boost its economic development and is willing to look at biomedical research complexes along I-80, a biotech community looking for research incubators in a comprehensive university-oriented R&D complex with allied ventures, and a willing and enthusiastic landowner.

"No specific plan has been created yet, but what ultimately is built here will be determined by the county as part of their general plan update."
Simpson, of FTCR, said,
"I'm extremely doubtful of a commercial real estate project that tries to ride on the coattails of 'stem cell research.'

"Many questions need to be answered about this deal by both Angelo Tsakopoulos and Bob Klein.

"A good start for Klein would be to decide if he wants to be chairman of the ICOC or of his political advocacy group. He should not serve as both."
Here are links to some previous items on Americans for Stem Cell Therapies and Cures. "Ongoing Threat," "Background Statement," "Two Hats" and "Unseemly Position."

(Personal disclosure from the California Stem Cell Report: Raimundo is a friend and former colleague at The Bee. Vellinga is also a former colleague. I have met Tsakopolous on several occasions and have directed news coverage of some of his enterprises. I have exchanged email with Markos Kounalakis, Tsakopolous' son-in-law and president of the Washington Monthly, and once submitted an article to that magazine that I ultimately withdrew from consideration because of the length of the editing process.)

Wednesday, June 27, 2007

Kuehl on CIRM Bill: Breathing Room, Yes -- Abandonment, No

In what may be the only mainstream media story on the subject today, the San Jose Mercury News quoted a powerful state legislator as saying she is not giving up on her legislation to guarantee the state a better return on its $3 billion stem cell research investment.

Reporter Steve Johnson quoted Sen. Sheila Kuehl, D-Santa Monica, chair of the Health Committee, as saying,
"I'm not abandoning the issue in any way."
Johnson wrote:
"Delaying the measure until the institute completes its (intellectual property) policy 'would remove one more thing they could say in opposition to my bill,' she said."
Johnson also quoted Dale Carlson, chief communications officer for CIRM, as saying the agency appreciates "being able to finish their policy without having to worry about legislators passing a competing one."
"We begged and pleaded for time to complete our regulatory process and it appears that's what they're giving us."
For more on SB771, see the items below.

Tuesday, June 26, 2007

CIRM Legislation: A Political Muscle Story or Casualty of a Full Plate or Both?

The legislative effort to step into the affairs of the California stem cell agency attracted virtually no public notice during its short life this year.

Only a handful of stories – or less – recognized the existence of SB771 (see item below).

But John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, has been active in the area involving the legislation and is a regular presence at CIRM meetings. He was acutely aware of the measure.

Today he issued a news release that said the legislature "missed an opportunity to ensure affordable access to any stem cell discoveries financed by California taxpayers."

Simpson continued:
"Sadly, both the proposed bill and regulations being developed by the stem cell institute fail to protect consumers from the possibility of unreasonable pricing of discoveries resulting from research they paid for. The bill was really about political muscle and how much influence the legislature should have over the stem cell institute, not the people's interests."
Another analysis could also note that the bill's author, Sen. Sheila Kuehl, has a very full legislative plate and that winning passage of the measure would be akin to winning the California lottery. In a word, remote.

Whatever the case, Simpson's statement and the shelving of the legislation are likely to attract little – or less – attention in the media.

CIRM Legislation Finished for 2007

Legislation to ensure a fair return to the state on its $6 billion stem cell research investment and to provide affordable access to any resultant therapies has been shelved for at least the remainder of the year.

A spokesman for Sen. Sheila Kuehl, D-Santa Monica, lead author on SB771, said the measure was put off to allow the stem cell agency to finish its regulations for intellectual property, the vehicle for determining how to split up potential largess from stem call products.

The spokesman, Peter Hansel, said that if the regulations "come up short," the authors of the bill intend to push it in 2008. Sen. George Runner of Antelope Valley, one of the legislature's Republican leaders, is also an author of the bill.

Hansel said,
"In the near term, the bill is going to be used to used for another unrelated purpose, but the authors intend to amend its provisions into another Senate bill in the Assembly once we identify a vehicle that is not moving. This should be viewed as a temporary move and not as any diminishment of the authors' underlying commitment to the issue."
The bill was opposed by CIRM and the California biotech industry. It easily passed the Senate. But to become law it needs a super, supermajority vote (70 percent) as well in the Assembly and the signature of the governor, who is a strong supporter of CIRM.

No Action Today on New CIRM President

Directors of the California stem cell agency met Tuesday in executive session to discuss candidates to fill the vacant post of president of the $3 billion enterprise, but came to no public decision.

Dale Carlson, chief communications officer for CIRM, said the special, teleconference meeting of the Oversight Committee adjourned without acting on a public agenda item calling for consideration of presidential compensation and candidates.

At this point, one can only speculate on why those matters were placed on the public agenda if no action was planned. One explanation is that hopes existed that a deal with an applicant could be concluded in time for the meeting, but for some reason an agreement could not be reached. State law does not permit the Oversight Committee to act on matters without adequate public notice.

Former president Zach Hall announced last December that he would leave the agency this month. In April, he said he was leaving earlier following a contentious meeting of the CIRM Facilities group.

The first presidential search was prolonged as well, missing the Oversight Committee's self-imposed deadline in 2005 by three months.

Monday, June 25, 2007

Presidential Search Committee Anticipates No Public Action Tonight

The presidential search subcommittee of the California stem cell agency has begun its meeting but is not expected to announce any action tonight.

Dale Carlson, chief communications officer for CIRM, said the group convened its teleconference meeting and promptly went into executive session to consider presidential selection issues. He said the group was not scheduled to make an announcement this evening.

The full Oversight Committee meets tomorrow morning at 7 a.m. to consider presidential salaries and candidates.

Coming Up

The presidential search subcommittee of the California stem cell agency meets at 5 p.m. California time today (midnight Greenwich Mean Time 6/26) with an unusual international teleconference meeting of the full Oversight Committee scheduled for 7 a.m. California time (2 p.m. Greenwich) tomorrow.

Presidential compensation and candidates are on the agenda for the Oversight meeting. But first they will pass through the subcommittee.

We expect to bring you coverage of any action by the subcommittee tonight, which will be largely behind closed doors, if anything is announced. The meeting is estimated to run for perhaps two hours.

Internet Radio Program: Stem Cells After Bush

The award-winning California public radio program, Forum with Michael Krasny, Tuesday morning will explore stem cell issues in the wake of the presidential veto.

The KQED program will begin at 9 a.m. Pacific Daylight Time and can be heard live on the Internet as well as downloaded after the broadcast. You can find directions on how to tune in on your computer at this location.

Scheduled to appear are bioethicist and law professor Alta Charo, Christopher Scott, executive director of the Stem Cells in Society Program at Stanford, and Dale Carlson, chief communications officer for the California stem cell agency, as well as yours truly, David Jensen, the publisher of this web site..

Listeners can call in with their questions on a toll-free number, 866-733-6786. Comments can be sent in to forum@kqed.org

CIRM Plan: $85 Million Split Among 25 Stem Cell Researchers

Polish up your resumes, folks. The California stem cell institute is preparing to give away $3 million a year or so to 25 promising, "young" researchers and physician-scientists. The money could be awarded as early as next winter.

The concept for the five-year program was approved by CIRM's Oversight Committee earlier this month. It is aimed at drawing the best and brightest into stem cell research in California -- and not just embryonic stem cell research.

The $85 million proposal encountered virtually no opposition at the Oversight Committee meeting. However, it did shed some light on issues related to have and have-not institutions, quality of grant recipients and spreading the CIRM wealth geographically around the state.

Arlene Chiu, interim chief scientific officer for CIRM, presented the concept to the ICOC. She told the board:
"Independent scientists at this early stage in their careers are very vulnerable...because they face a number of challenges: Tight federal funding pressures to get data and results out quickly, to publish papers, and demonstrate productivity and the potential of their work. They also must get grants to support their fledgling labs. And last, and certainly not least, physician-scientists often have to have clinical service as well. Faced with these challenges, plus the restrictions and uncertainties imposed by the presidential policy on human embryonic stem cells, it's not surprising that many new faculty are discouraged, feel discouraged from rushing into this new field."
Under the plan, the awards would go to persons who hold fulltime, faculty-level positions at academic or non-profit institutions in California and who are "young," meaning in the early stages of their careers. Academic institutions with a medical school could submit four applications in support of new Ph.D.'s and two new physician-scientist faculty members. Institutions without a medical school would be limited to two applications. The grants would go for research, salaries and possibly educational loans. They are akin to Pioneer grants awarded by the National Institutes of Health.

Chiu said the cap on the applications from each institution was needed to keep the total number from become unmanageable given the problems of processing them with CIRM's small staff. Ed Penhoet, vice chairman of the ICOC, said the total could hit 600 or 700 without a cap. He said he was more concerned about the load on grant reviewers, who come from out-of-state.

Philip Pizzo
, dean of the the School of Medicine at Stanford, and others advocated no institutional cap on applications. Pizzo said,
"This is a very big award that you're putting forth, that it's best to have the very most outstanding individuals."
Later he said,
"I'll say this carefully, and I hope no one will be offended. I think we must have a very high standard. The tendency that we've had recently is we're trying to spread things around, and I think it's good. We should do that, but we should have a high bar on these grants and not simply come in and say,well, we need to have many more of them to sort of prime the seat. I think that would be going in the wrong direction."
David Baltimore, former president of Caltech and a Nobel Laureate, replied,
"There are only 25 grants. If four of those grants were given to one institution, that would be probably scandalous. For six grants to be given to one institution would certainly be scandalous when it's such a limited resource for the state."
Also speaking for limits on each institution were Oversight Committee Chair Robert Klein, Claire Pomeroy, dean of the School of Medicine at UC Davis, and patient advocates Jeff Sheehy and Sherry Lansing, a former Hollywood film executive. .

At one point, Oswald Steward, chair and director of the Reeve, Irvine Research Center at UC Irvine, supported Pizzo as did Duane Roth, chairman and CEO of Alliance Pharmaceutical Corp., who said he favored stringent criteria for the awards.

The discussion of the faculty award program reflected some of the questions recently rippling through CIRM. Do the big, well-established programs continue to receive generous grants? How much should go to institutions without the reputations and facilities that UC San Francisco and Stanford have? Should the location of institutions be a consideration? Does spreading the money around mean that unworthy science is being funded? Does it dilute funding for what is very expensive research, a question raised by Penhoet, who said,
"I just wanted to caution against trying to cut the budgets and spread it around over more people. This is a disease most prevalent at the National Science Foundation. You end up with lots of people with not enough money to do anything important. So I think we're better off to choose the very best people and fund them well rather than try to spread the money further. This research is expensive. Salaries are high, all of these things. It takes a lot of money to do modern cell biology and microbiology."
The questions of sharing the wealth have surfaced particularly during recent sessions of the Facilities group, which is developing criteria for a $200 million research lab construction program. The issues are likely to surface anew on July 12 when that group actually writes the specifics.

As for the faculty awards, Chiu will bring back more specifics to the ICOC in August. Review of applications, which she estimates could come from as many as 35 institutions, is tentatively scheduled for this fall. Approval of grants could come during the holiday season. Consider them a Christmas bonus.

A Retrospective on CIRM: The View from Wyoming

The former president of the California stem cell agency – Zach Hall -- reflects on his two years in the job, CIRM's accomplishments and the challenges facing in the $3 billion program in a piece in the San Diego Union-Tribune.

Reporter Terri Somers wrote the Sunday story on the eve of this evening's and tomorrow's meetings dealing with the appointment of a new president. Hall had planned to leave the agency this month, but accelerated his departure following an acrimonious session of CIRM's Facilities group.

Hall was circumspect on some topics, including the longstanding structural problems at CIRM with its dual executive arrangement that is locked into state law by Prop. 71.

Nonetheless, Somers' story offered some insights. She wrote that the president has no clear voice in grant funding. Hall noted that the CIRM president has no seat on CIRM's controlling body, the Oversight Committee, as contrasted to the NIH. Hall said:
"Proposition 71 poses an administrative challenge in that it gives significant leadership responsibility to both the chairman and president. In a small organization, which at the time I was president it was, two strong leaders often posed a challenge. Both of us had (previously) been in leadership positions and had strong views about how things should be done.

"This sometimes led to conflict. In the end, results can best be judged by the record of accomplishment of the institute."
Hall on relations with Oversight Committee members:
"'In retrospect, I think I could have probably worked harder to improve my relations with some of the board members. I think it wasn't clear to me as early as it might have been how important that was,' Hall said. 'I mostly confined my interactions to official occasions, and I think it would have helped if I did some things to meet with people individually.'"
Somers continued:
"There are a number of internal problems at CIRM that need to be worked out, he said.

For example, there needs to be a unified vision among the groups represented on the board and the staff, he said.

"'I hope that out of that process would come a strong sense of mutual trust, which I think was one of the issues at the facilities working group meeting.'"
Hall on relations between CIRM staff and the 29-member Oversight Committee, which sometimes engages in micromanagement (our word, not Hall's):
"The institute has a tremendously talented staff and I think it is important the board trust the staff to do its work, and work in the direction that is congenial with where the board wants to go. There needs to be a sense that the board doesn't need to participate in every decision, or be involved in all details of the administration."
Hall on the private sector and the future:
"The institute's next president, he said, could really make an impact by developing a strategy for working with private industry. So far, the institute has developed plans only for dealing with nonprofit research institutions and universities. Ultimately, the institute wants to partner with companies by helping with clinical trials and getting therapies to patients.

"'This is a whole new territory, and we don't have good models,' Hall said.

"'Because of the way the field has developed, a lot of important discoveries have been made on the private side, and we don't always know what they are. We need to know who it's worth putting money into, while not violating their need for confidentiality, which will be a challenge.'"
Hall's plans? Enjoy the summer at his place in Wyoming and serve on the scientific advisory board of the New York Stem Cell Institute.

Coming Up

Later today, we will have a look at CIRM's plans to establish an $85 million program to fund as many as 25 California physician-scientists with as much as $400,000 a year.

Friday, June 22, 2007

NAS Letter Arrives

We have received word from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, that he has now received (on June 21) a response from the National Academy of Sciences regarding his letter of protest about his ouster from a stem cell meeting in May. The NAS letter to him was dated June 13 and postmarked June 15. Copies of it were also sent to some other parties, one of whom received it as early as June 14. We carried an item on the NAS response last week based on the copy of the letter.

If It Can't Stand the Light of Day...

Attention Scientists! Want to keep the gravy train moving and the research grants flowing? Want to see more shiny new labs with the latest in sparkling equipment?

Build public confidence. Open the doors and explain the mystery. Don't shut out the people. Don't feed the anti-science Luddites.

Much has been written about distrust of scientists and their arcane ways. Most people are more concerned about the pedestrian issues of daily life than the esoteric issues that researchers probe. The public turns its attention to scientific matters in times of major achievement but also in times of scandal and suspicion. And when little is known about a subject, bad information can easily carry the day in the court of public opinion.

Which brings us to the National Academy of Sciences and its closed door sessions on the seemingly innocuous subject of interstate cooperation on embryonic stem cell research. We have written a few times about how the academy ousted a member of the public from its meeting on the matter last month in California. The academy apparently plans to continue this dubious policy.

Today the question is: Why should you care? The answer: If you favor good science, well-funded by government, you have something at stake.

Can scientists be trusted with public money? Are they open to public concerns? High-handed tactics, closed door meetings and secret agendas generate negative responses to those questions and play into the hands of those who fear science and seek to bring it to heel. No good reason exists for barring the public from the meetings on interstate cooperation. The meetings are attended by public officials discussing public policy about billions of dollars in public money.

The NAS itself owes its existence to an act of Congress. Many of its proceedings are already public, including such sessions as one dealing with adverse biological and health effects of cell phones and another dealing with "The 1,000-ship Navy -- A Distributed and Global Maritime Network." Is interstate cooperation on stem research more "sensitive" than those issues? We think not.

In many cases, the NAS has the legal right to close its doors. But the various state stem cell officials should not be party to such proceedings concerning interstate cooperation. We have queried a number of participants in May's closed door meeting to see if they planned to continue to attend meetings that bar the public. None has responded although we promised to carry their comments verbatim. Several possible reasons exist for the non-response. The officials may feel that this flap -- a relatively minor matter in many ways at this point -- will go away. They may feel uncomfortable as public officials in stating that they approve of closed door meetings. And they may be unwilling to publicly offend the National Academy of Sciences.

The NAS itself has not responded to our repeated queries. It also has not responded even to questions about the date for the next interstate meeting. And its written response to the man ousted from the May meeting was delivered to him one week after it went to agencies that were copied in on the letter.

When we worked in the California governor's office years ago, we were sometimes asked by top appointees about public meetings. Our response was, "If it can't stand the light of day, don't do it." That is good advice also for the National Academy of Sciences and its meetings on stem cell cooperation.

(Editor's note: An earlier version of this contained slightly different information re the NAS response to the ousted man. This item has been updated to reflect the latest information.)

Thursday, June 21, 2007

TV Coverage on California Stem Cell Research

California's $3 billion stem cell research program received favorable mention in some television news coverage of the president's stem cell veto.

We mentioned the ABC News blog item earlier. The same reporter, Ned Potter, who wrote the blog also prepared a piece for the network's national news program, which carried on camera commentary from Arnold Kriegstein of UC San Francisco and Dale Carlson, chief communications officer for CIRM.

In Sacramento, Channel 10 carried a piece by Marcey Brightwell that discussed California's program with a special focus on UC Davis and researcher Jan Nolta.

As we have mentioned earlier, TV news coverage is important because more people get their news that way than by reading the newspaper. TV news coverage of the California stem cell agency is also rare.

You can see the actual video of the stories by clicking on here for Channel 10 and here for ABC.

A Dissection: CIRM's Presidential Meeting Next Week

A couple of alert readers have raised questions concerning next Tuesday's special meeting of the Oversight Committee of the $3 billion California stem cell agency, which is scheduled to consider presidential candidates and a new salary for the position.

The teleconference meeting will be conducted from sites that span the length of California, reaching even into Australia. They offer an unusual opportunity for the public to take part in discussions of the agency.

Veterans of California state public meetings have some idea how this might work. Others are not entirely clear and wonder whether it really meets the requirements of state open meeting laws.

One stem cell observer, who asked for anonymity, wrote in an email:
"I have this image of a large crowd being ushered in and immediately being ushered out, waiting 90 minutes and then being ushered in and then out again."
That observer is not far off. However, it is unlikely that a large crowd will be on the scene at any of the locations. Most Oversight Committee meetings draw only about 10 or so members of the public, and that is when the meeting is only in one location.

We could be wrong, but this is likely how the session on Tuesday morning will go.

The committee will convene in public. It will then go into executive session to consider personnel matters – the hiring of a new president. Such sessions are permitted by state law. The public will have to wait outside the meeting room while this goes on. Then the meeting will go public. At that point, the committee has the ability to vote on the salary for a presidential candidate in public session and a new president because the matters have been properly noticed as required by state law. The committee does not have to vote on those matters. They could be delayed to another time. But once the committee is back in public session, members of the public can address the presidential topics or any other topic they choose. However, by state law the committee cannot act on matters that have not been announced in advance.

That means that a person could show up at one of these locations, sit around for about 90 minutes or so and not hear any significant discussions of CIRM matters. Unless you are interested in saying something to the directors of the $3 billion research effort, it may not be worth your time to attend the meeting. Or you may want to test public access -- required by law -- to site locations around the state for the teleconference meeting.

Will the new president be announced or voted on at Tuesday's meeting? Probably, but again we could be wrong. There is only one reason to put consideration of presidential candidates on the agenda, and that is to vote on them. One possible scenario is that the candidate is all but in the bag, with only ratification of a new salary or compensation package needed to clinch the deal. Another scenario could be that California stem cell Chairman Robert Klein put consideration of presidential candidates on the agenda just in case the deal would come to fruition in time for the 7 a.m. meeting next Tuesday. But given the unusual nature of the session, that may be unlikely.

Finally, if the Oversight Committee does fail to make a decision on Tuesday, it could mean that some sort of snag has once again hit the presidential selection process.

Stem Cell Research State by State

Stateline.org today carried a detailed overview of embryonic stem cell research efforts state by state, including the case of a woman who unsuccessfully tried to donate a leftover embryo from her IVF treatment in Michigan.

She was told she had to go to another state because Michigan law bans research on human embryos.

Writer Christine Vestal put together the piece, which goes into some detail on each state with links to the agencies that do the work.

Here is an excerpt:
"Seven states — California, Connecticut, Illinois, Maryland, New Jersey, New York and Wisconsin — are providing seed money for the fledgling science, and Massachusetts Gov. Deval Patrick (D) in May called on lawmakers in his state to follow suit.

"Six other states — Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota — ban the research. Three states — Iowa, Massachusetts and Missouri — have affirmed its legality but do not offer funding.

"In Florida and Texas, lawmakers are deadlocked on the issue. Most states have steered clear of it altogether."

Wednesday, June 20, 2007

The Bush Veto: 'Strong Words From the Government of California'

California today received prominent mention on an ABC News blog by science correspondent Ned Potter concerning the presidential veto.

Here are some excerpts:
"Surprisingly strong words from the government of California, which, for lack of federal funding, is the largest backer of research on embryonic stem cells.
Potter continued:
"Dale Carlson of the California Institute for Regenerative Medicine, which handles the $3 billion California has pledged for research over ten years: "California has 25 percent of the biomedical research capability in this country. We need the other 75 percent fully engaged and pursuing these therapies.

"If therapies are going to be discovered we need labs all over the country working on this project. So we’re going to have to wait for a new president and hopefully a new policy to really achieve the potential."
Potter also said Arnold Kriegstein of UC San Francisco expressed "polite frustration" with Bush's position that research can be done without embryonic stem cells. Potter quoted Kriegstein as saying,
"There's been a great deal of discussion about alternative sources for embryonic stem cells, for example using amniotic fluid or umbilical blood and so forth. But the truth is none of these alternatives really have the potential embryonic stem cells do to create cells of different types--heart cells, muscle cells, nerve cells and so forth."

Klein on Bush

President Bush's predictable veto of the federal stem cell bill generated the following response from Robert Klein, chairman of the California Institute for Regenerative Medicine:
"The President has again dashed the hopes of millions of Americans suffering from chronic diseases and conditions, despite the overwhelming support for stem cell research in this country. If we're going to realize the potential of stem cells to treat Alzheimer's, Parkinson's, diabetes, multiple sclerosis, cancer, and 70 other debilitating conditions, we need scientists in every state carrying on this research. California cannot reach the potential of this medical research alone.

"It is a tragedy for patient families throughout this country that this critical new frontier of medical research has been so severely handicapped by the President’s personal religious positions. The Congressional leadership clearly understands the historic potential of stem cell research to reduce human suffering. The Congressional leadership should be commended for serving as the champion of stem cell research in this historic opportunity to impact the devastating medical impact of these terrible, chronic diseases and injuries on America’s children and families."

Down Under With The Niche and Robert Klein

California stem cell Chairman Robert Klein hobnobbed this week with scientists from around the world in Cairns, Australia, at the convention of the International Society of Stem Cell Research.

"The Niche," the new stem cell blog of Nature magazine, reported on some of Klein's doings at the conference, saying that Klein is joining the advisory board for the society. Monya Baker reported that Harvard scientist and incoming president of the society George Daley says Klein is supposed to help ISSCR "figure out what its mission should be."

She said that Daley also wants a "very philanthropically involved" board so the group does not always have to be raising funds.

Baker continued:
"I’m waiting to talk to Klein right now, sitting on the edge of a platform as the crew dismantles a stage in wet Cairns, Australia. He’s talking to three intent people, one a lady in a wheelchair. I’m catching words like 'motivating people' and 'networking' Behind him, a serious-looking woman is taking copious notes. I wish my hand moved that fast. She’s the one who led Klein away when I tried to talk to him."
The headline on Baker's item described Klein as the "Prop. 71 instigator."

San Diego Stem Cell Consortium Unveils Ambitious Plans

Representatives from the high-powered San Diego stem cell consortium laid out their vision Tuesday for a 135,000-square-foot facility to house scientists, engineers, ethicists and to serve as a home for programs for both junior research scientists and senior scholars.

Reporter Terri Somers of the San Diego Union-Tribune reported on the presentation, which was made to the California stem cell institute. It held a hearing in San Diego as part of its effort to devise procedures for giving away $220 million to build embryonic stem cell labs in California.

The consortium consists of the Salk, Burnham and Scripps institutes as well as the University of California at San Diego. Tuesday's hearing was the first time members of consortium had appeared in public together, Somers reported.

She wrote that at least one group favored the consortium's effort:
"'I don't know why the consortium emerged or how they did it, but the fact that it has is one of the key developments that Proposition 71 (the stem cell initiative) envisioned,' said John (M.) Simpson of the Foundation for Taxpayer and Consumer Rights.

"Proposals for such collaboration should be given extra weight in the grant application process, Simpson said."
Not everyone is enamored of the effort. Somers did not report any negative comments on the CIRM or consortium plans, which were probably not made at the session. But one reader of the newspaper's Web site, identified only as "ghoward79" filed this online comment on Somers' story:
"If it has such promise then private investors would be all over it. Think about the investment returns! Either way companies promoting this are making money off it and they want someone else to pay the price."
Tuesday's hearing was the last before a July 12 session of the CIRM Facilities Group to actually come up with the specifics of the lab grant procedures, which would then go to the Oversight Committee for approval.

Earlier sessions of the group were well attended, drawing more attendees than the meetings of the Oversight Committee. Transcripts from the sessions are available online. Institutions planning to seek grants or other interested parties would be well advised to read the transcripts. Additional comments can also be sent to CIRM staff, which is mulling over the proceedings in preparation for July's hearing. Waiting until the day of the hearing is a good way to be overlooked.

Tuesday, June 19, 2007

Time Ripe for CIRM Webcasting

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, made the following observations via email on the meetings of the Oversight Committee of the California stem cell agency.
"Given problems with quorums I have no problem with telephonic meetings SO LONG AS THE PUBLIC HAS GENUINE ACCESS.(Simpson's capitalization)

"Also think regular meetings should be broadcast on the Internet."
Some time ago we asked CIRM about Webcasting Oversight and other committee meetings. Expense was the reason given for not carrying the sessions on the Internet. CIRM Oversight meetings (currently about six a year) currently run about $20,000 a pop. If one or two could be eliminated each year and replaced with an online session, perhaps the money could be found. An online session capability would also help with meetings of the working groups, where many folks have to travel from out of state.

On the other hand, providing online meeting capability on a free basis would be an excellent opportunity for a high tech firm, such as Cisco or Citrix, which has a substantial California operation, to show its interest in supporting a worthwhile scientific and medical endeavor. It might also simply be good marketing and give a firm an entry point in a sector that is scattered around the globe.

Reaching Down Under: A Chance to Weigh In on California Stem Cell Matters

It is not often that the folks in Australia have a chance to sit in on the deliberations of the elite group that operates the largest single source of funding in the world for embryonic stem cell research.

But next Tuesday all of you folks down under will have a chance, particularly if you are already in the Melbourne area, which, unfortunately, is quite distant from the big stem cell conference this week in Cairns. Likewise, Californians throughout the state will have a rare chance to easily be part of the discussions of the Oversight Committee of the California Institute for Regenerative Medicine.

The occasion is an unusual teleconference session of the 29-member Oversight Committee to consider candidates to take over as president of the $3 billion research program as well as their compensation.

The conference call arrangement was set up because it is physically difficult to bring together all 29 directors of the institute.

Three sites are available in San Francisco and two in Los Angeles, not including one at UCLA and one in Pasadena . Locations are also available in Sacramento, Chico, La Jolla, Newport Beach, Carlsbad, Stanford, UC Berkeley, Mill Valley and Healdsburg. The specific addresses can be found on the meeting's agenda.

A couple of tips: Some of the addresses do not include room numbers, such as the one for the Westin Hotel in Melbourne. That is apparently where Robert Klein, chair of the agency, is staying. Query CIRM in advance at info@cirm.ca.gov if you have questions about the specific locations. Also show up well in advance in case some officious type is inclined to delay your entrance. By law, these are public meetings. If you are hampered or barred from entry, please send me a note at djensen@californiastemcellreport.com.

The meeting promises to be short, perhaps 90 minutes, and only has the presidential matter on the agenda. If you like, you can also sit in on the presidential search subcommittee meeting the previous evening at many of the same locations.

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