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.

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