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.

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