CIRM CEO Search: The Burden of Being in the Vanguard

The article spoke of the "strange beast," the nexus of forces and an organization like no other. But topic No. 1 was the ongoing search for a new permanent president for the California stem cell agency.

Monya Baker, news editor for Nature Reports Stem Cell, explored the effort in a piece that appeared online.

She began by describing CIRM as a "strange beast" and quoted one observer as likening it to a two-headed monster. Here are some excerpts from Baker's article.

"Many people are watching CIRM, says Mary Woolley, head of Research!America, a health-research advocacy group in Virginia. With other investments in research flat, the institute is 'in a vanguard,', she says. 'It's really important for CIRM to get it right....

"'Failed searches happen all the time,' she says. Without a clear consensus about what they are looking for, she continues, a board could go through a search three or four times, each ending in disappointment."

Baker continued:

"Board member Jeff Sheehy, an AIDS patient advocate, thinks experts with an industry background might be most adept at transforming research into therapies. 'My pill bottles don't say UCSF,' he explains. 'Someone from the foundation world or the business community might be an interesting choice.'"

Baker quoted Hamilton Moses, a biomedical consultant in Virginia who focuses on non-profit governance.

"'CIRM operates at the nexus of the Political (with a capital P), scientific, institutional, and business forces of an aggressive state that views economic development as a priority.' Its organization, he adds, doesn't help. 'Noah's Ark' boards, where each member is appointed to represent a constituency, rarely work.'"

Baker continued:

"'This is mainly a skilled management job, requiring wisdom, scientific expertise, and a good list of known contacts to go to for advice and help, but not necessarily a background in medicine or stem cells,' says Bruce Alberts at the University of California, San Francisco, who served two six-year terms as president of the US National Academy of Sciences. Management jobs require many tasks that scientists find boring, adds (Tom) Cech, (president of the Howard Hughes Medical Institute). Only someone with tremendous skills at working with diverse groups of people could thrive in this job."

She quoted California stem cell chairman Robert Klein as saying that none of the presidential candidates has cited the board's or his own role as an obstacle.

Baker also interviewed interim CIRM President Richard Murphy, who said that CIRM's governance structure is sound.

"...(T)he diversity of the board is an asset, he says; basic scientists who value 'curiosity-driven research' and patient advocates intent on clinical progress have much to teach each other. The trick, he says, is establishing mechanisms so groups work together. '''I bring that experience, an understanding of how the board can interact effectively with the institution.'"

She pointed out that the Salk Institute, which Murphy left in July, had four presidents in four years before he joined the organization in 2000.

Baker's final paragraph:

"But if there is one thing people agree on, it is that CIRM is an organization like no other. 'CIRM represents an experiment,' says Moses. 'It is too soon to know whether it will be successful.'"

$122 Million Disease Team Proposal

Preliminary plans for an innovative research effort that could possibly even involve scientists from outside California will be aired publicly at a meeting next Wednesday of the Grants Working Group of the California stem call agency.

The Disease Team initiative is part of CIRM's strategic plan, which was approved last year. That document said the initiative is designed to organize "the highest quality basic, translational and clinical research with the specific aim of producing a therapy for a particular disease or group of diseases whose research is poised for development of therapies."

The plan said out-of-state activities could be included if funding were available from other sources. The initial grants would total about $100,000 each and go for one-year planning efforts. Later grants would run as high as $20 million over eight years. Total size of the program is estimated at $122 million.

Next week's session in San Francisco is aimed at generating input from members of the Grants group, the public or other interested parties. Planning grants are likely to go out next year.

Free Link to Gottlieb Article

Ken Taymor, executive director of the UC Berkeley Center for Law, Business and the Economy, points us to a non-subscription link to the article referenced in the item below. It can be found here: http://www.aei.org/publications/filter.all,pubID.26718/pub_detail.asp

New Drugs, Old Drugs, Openness and Cost Implications

The efficacy of magic or not-so-magic cures – particularly new ones and their costs -- came under scrutiny in a recent article in the Wall Street Journal called "The War on (Expensive) Drugs."

The opinion piece has relevance to California's grand experiment in scientific research with its promise of finding cures through embryonic stem cells. The expected costs of those cures, funded in part – perhaps a crucial part – by California taxpayers, have already generated concerns that they will not be available to many Californians.

Scott Gottlieb, physician and fellow at the American Enterprise Institute as well as a former senior official at the FDA and Medicare, wrote the WSJ article, which focuses on a Congressional proposal "to spend more than $300 million to establish a new federal 'Center for Comparative Effectiveness' to conduct government-run studies of the economic considerations that go into drug choices."

Gottlieb is critical of the processes involved in what he says are politically popular studies "that pit expensive new medicines against older, cheaper alternatives with the aim of cutting health-care spending."

But he also shines some light on the lack of transparency in science and medicine as well as methodologies that seem to be driven by desires for a certain result.

Gottlieb deals with three well-known studies that have been subject to considerable attention: The $725 million Women's Health Initiative, the $135 million Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (Allhat)and the $40 million Clinical Antipsychotic Trials in Intervention Effectiveness (Catie) trial.

Gottlieb wrote:

"Like the Women's Health Initiative, bottom-line data from Allhat and Catie were subject to parochial secrecy. Catie's complete safety data are only being released this September, almost four years after the study was completed. Moreover, the drugs involved in these studies were for conditions where one expects a great deal of individual variation in how people might respond. The studies didn't take measure of that.

"Now the government is sponsoring a poorly designed trial to test whether Avastin, a drug that is meant for injection into the veins to treat cancer, can also -- when injected directly into the eye -- treat macular degeneration, a leading cause of blindness. Never mind that Avastin's manufacturer, Genentech, developed a completely new drug called Lucentis, which is specifically designed to be injected into the eye and is better adapted to treat blindness.

"Since a single cancer infusion of Avastin contains a large volume of the drug, breaking that same dose down into the small aliquots needed for the eye injections is literally pennies on the dollar, making the government's study of it -- when it was clearly not designed for eye treatments -- a matter of cost containment. Surely if Avastin ends up harming those eyes -- a plausible consequence of this off-label, if not illegally 'compounded' use -- it won't be Uncle Sam on the hook with product liability lawyers, but Genentech.

"Not all government-funded studies have speckled histories. Many uncover significant advances. Problems arise when the government pursues studies to achieve its own economic goals, where political motivations seem to intrude on the design and conduct of the trials and bias not only how results are interpreted, but more especially, how they are reported."

Some readers wrote to the WSJ concerning Gottlieb's piece, including Bryan R. Luce and Dennis A. Revicki, both senior vice presidents at United BioSource in Maryland. They said,

"It seems to us, the solution is clear. Government-funded research and interpretation need to be fully open for critical peer review by independent and stakeholder experts from any sector (including manufacturers) at all stages of the process. Similarly, funded research by private industry would be well advised to follow suit. Then, perhaps, we would have less rancor and better supportable scientific evidence for informing clinical and public policy and the health and well being of the public would be better served."

Gottlieb is dubious of some government-funded studies. Others are equally dubious of business-funded studies that seem to overlook results that are not favorable to introduction of a new product. Meanwhile astronomical prices are charged patients to recoup drug development costs. Increasingly this mulligan stew of medicine and science and business is leaving few satisfied. Even fewer will be satisfied if the $3 billion ($6 billion including interest) investment by California taxpayers results in therapies that are out of the reach of millions who need them.

Stem Cell Media Coverage to Crow About

By many measures, the $20 million gift to UCLA this week brought major media attention to the stem cell research efforts in the Golden State.

The size of the gift by Eli Broad, the presence of Gov. Arnold Schwarzenegger and a set-up story Monday morning in the Los Angeles Times all drove the coverage. But so what? Who cares about PR, right?

But when 55 percent of the public nationally says it has little or no knowledge of stem cell research, the field still needs major help. And Monday's event was a chance to tell a positive tale – one that did not involve warnings of expensive therapies, dubious results or even research fraud.

To give you an idea of the sweep of the attention, a Google Web search on the term "UCLA stem cell million broad" generated 244,000 hits this afternoon. That compared to 487,000 for "CIRM" alone. But the institute has been around for nearly three years, and it is naturally going to generate more response. The number of hits on the UCLA/Broad story is likely to climb in coming weeks as other outlets and Web sites pick it up.

The story ran internationally and on television and radio, which are the prime sources of news for most people. Newspapers and the Internet remain a secondary source.

One observer connected to the event, who must remain nameless, provided a summary of the coverage that said the story was

"...featured Monday and Tuesday by the Associated Press, Los Angeles Daily News, City News Service, KNBC-TV, KCBS-TV, KABC-TV, KCAL 9 News, KTTV-TV, KTLA, Bloomberg News, KPCC 98.3 FM, KNX 1070 AM, KFI 640 AM, Telemundo 54, Univision, Chinese Daily News, Sing Tao Newspaper and LA Channel 18.

"Dr. Owen Witte, director of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, was quoted in English language outlets. Stem cell researcher Luisa Iruela-Arispe, professor and vice-chairman of molecular, cellular and developmental biology, was quoted in Spanish language outlets. Stem cell researchers Yi Sun and Dr. Andy Huang are quoted in Chinese language outlets.

"The AP story also appeared in the International Herald Tribune, Houston Chronicle, San Jose Mercury News, Pravda, Press-Enterprise, Enterprise Record (CA), Contra Costa Times, Monterey County Herald, San Jose Mercury News, San Luis Obispo Tribune and the Daily Breeze.

"The Los Angeles Daily News story also appeared in the San Gabriel Valley Tribune, Whittier Daily, Pasadena Star News, Inland Valley Daily Bulletin, San Bernardino Sun and the Long Beach Press Telegram. The Los Angeles Times today ran a photo of Gov. Arnold Schwarzenegger at UCLA announcing the gift."

One story helped particularly to drive the coverage, a Los Angeles Times article on Monday morning ahead of the actual event(see item below). The piece put the gift in the broader perspective of stem cell research growth in California, declaring that the donation and others recently "position California universities at the forefront of the promising scientific field." That type of buildup helps to focus the attention of harried TV and radio assignment editors and helps to convince them to give a story major play.

The governor's office announced last Friday that a news event would occur involving the gift, but the size was not disclosed until Monday's story in the Times, which appeared to have it exclusively. Crafty media relations people sometimes provide such key information to an influential news outlet such as the Times in advance of an actual event to help drive coverage media. We do not know whether that occurred in this case, but it is probably a good bet.

Adding frosting to this stem cell cake was the use of researchers who could speak in languages other than English, which is important in a diverse state such as California, but very important as well for international coverage.

Photo Information: The photo above was found on a conservative web site, which seemed to be using it in a fashion that would trigger negative reaction from conservatives. The original source of the photo was not given. Left to right, Broad, the governor and Los Angeles Mayor Antonio Villaraigosa.

$20 Million Stem Cell Pay Day for UCLA

UCLA will receive $20 million from philanthropist Eli Broad for embryonic stem cell research, the "latest in a series of large gifts that position California universities at the forefront of the promising scientific field," the Los Angeles Times said today.

The article by Charles Ornstein noted that Broad has already given $25 million to USC. And he wrote,

"California universities have landed large donations to build new labs and begin their research. In May 2006, UC San Francisco received a $16-million donation. Two months later, UC Irvine landed a $10-million gift from Newport Beach fund manager Bill Gross and his wife, Sue. Stanford University has received gifts of $20 million and $33 million for research and construction."

Ornstein quoted Broad as saying,

"California, in my mind, will without a doubt be the leader in North American stem cell research as a result of Proposition 71 and the great research universities we have."

California Gov. Arnold Schwarzenegger will take part in the news conference at 10 a.m. today PDT announcing the gift. The news conference will be webcast live on the governor's website, www.gov.ca.gov.

California Stem Cell Companies Not Too Displeased with CIRM Rules

Sometimes directors of the $3 billion California stem cell agency worry that they are imposing too many restrictions on future grants to the biotech companies that will be the key to turning research into therapies.

Now comes a report that a number of companies "seem willing to do whatever they must to qualify for state grants." They, in fact, are not looking down their noses at the largess to be disbursed from CIRM.

Reporter Terri Somers of the San Diego Union-Tribune reported on the business response that came out of a CIRM informational meeting Friday that was designed to shape state policy on the qualifications and criteria for companies that receive stem cell grants from the state.

She wrote,

"The response yesterday to the institute's questions was a surprise to the institute staff.

"Representatives from the biotechnology industry said they only need to tweak the (intellectual property) policy to make it work for companies.

"For instance, the companies don't want to publicly disclose competitive information, such as what percentage of royalties they receive for licensing out their discoveries or the amount of their product sales.

"Industry representatives said they also are concerned about how the state defines money for research and money for goods and services. Currently, Proposition 71, the voter initiative that created the stem cell institute, requires all the research it funds to be conducted in California. Goods and services bought with state funds do not necessarily have to come from California.

"If clinical trials are defined as a 'research' expense, rather than 'goods and services,' it could be a problem, company executives said.

"For speed, efficacy and even savings, companies often conduct clinical trials worldwide in order to get quick enrollment and a diversity of participants."

The response from the companies seems strikingly different than earlier, more hostile reactions from the California Healthcare Institute, which says it represents the biomedical industry in California. However, the reaction was not too surprising to those who attended the Burrill stem cell meeting in San Francisco last spring. A CHI representative appeared on a panel with several representatives of stem cell companies, who did not echo the lobbying group's more strident position.

Somers appears to be the only reporter who covered the teleconference meeting on Friday.

Stem Cell Snippets: Drooping Support, Farmland, Goldstein's Views and CIRM Scholar

Declining Support for Stem Cell Research –- The Pew Forum for Religion and Public Life has released a public opinion poll that shows weakening support for stem cell research, dropping from 57 percent two years ago to 51 percent in August this year. It also showed that 55 percent of the public had heard little or nothing about stem cell research. The polling question involving support used the phrasing "destroying potential life." The results certainly would have been more negative if the word "potential" had been omitted. "Destroying life" is how many opponents view the issue. The "take-home" point? Support for human embryonic stem cell research is fragile and can easily be undermined by events ranging from a dubious experiment or result or perceived misconduct by those funding stem cell research.

ISSCR and Farmland –- Jesse Reynolds of the Center for Genetics and Society comments critically on the involvement of the International Society for Stem Cell Research in a land development proposal that also proposes the creation of a stem cell research nonprofit. You can read it here.

Stem Cells After Bush -- Lawrence Goldstein, director of stem cell research at the University of California at San Diego, was quoted on CNN Money.com concerning the future of federal funding for stem cell research after Bush. He said. "Personally, I think it's a mistake for the scientific community to assume anything about what the likely policy will be of a government that doesn't yet exist." He also said, "I would not build a business plan based on the assumption there will be federal funding for stem cell research." The article largely covered the perspective from business on stem cell research.

CIRM Scholar – A recent cover story in Nature magazine featured research by a CIRM scholar, Laura Elias at the University of California, San Francisco. She led a neural stem cell study that revealed a mechanism that may play a role in cancer. Elias is a neuroscience graduate student in the lab of senior author Arnold Kriegstein, director of UCSF Institute for Regeneration Medicine.

Fresh Comment

Larry Ebert has published a comment on the item below.

Stem Cell Bonds, Royalties and Campaign Promises

The upcoming sale of California state bonds for its unprecedented stem cell research effort raises anew a $700 million question along with allegations of deceit in the campaign for Prop. 71, the measure that created the Golden State program.

On the surface, the matters involve an arcane financial issue. Can California sell non-taxable bonds to finance the activities of CIRM or must they be taxable. If they are taxable (meaning the dividends are taxable to buyers), the state will have to offer a higher interest rate to purchasers. That, according to one estimate, could mean as much as $700 million in additional costs to the state.

Such additional potential costs did not surface in the 2004 campaign. At the time, interest costs to the state were reported as $3 billion, rather than as much as $3.7 billion. Those amounts would be needed to borrow the $3 billion for the grants for stem cell research.

Nearly a year after Prop. 71 passed, reporter Bernadette Tansey of the San Francisco Chronicle wrote that California stem cell chairman Robert Klein knew before the election that taxable bonds might be needed but did not disclose the matter to the public. Klein was leading the effort on behalf of Prop. 71.

What triggers the use of taxable bonds is CIRM's requirement that royalties be paid to the state if state-funded research generates a significant amount of income.

Tansey reported,

"The potential problems have to do with a complex and unsettled question: how federal tax law will apply to a novel state research venture, supported by tax-exempt bonds, that involves a state split of private profits.

"But IRS rules largely forbid the states to use tax-exempt bonds to benefit specific private enterprises rather than serving a general public good -- and to share revenue from an enterprise to the extent that the state becomes like a business partner."

The issue of taxability was nearly invisible prior to Tansey's article, which subsequently generated allegations of bait-and-switch tactics and statements that Klein had a moral responsibility to be more forthright about the matter.

Stu Leavenworth, associate editor of The Sacramento Bee, interviewed Klein following the Chronicle report. Leavenworth wrote,

"The integrity of Prop. 71 is at stake in the royalty(taxable bond) debate. During the campaign, advocates of Prop. 71 mentioned royalties repeatedly, with Klein touting it on the PBS NewsHour with Jim Lehrer. This wasn't by accident. California was in the midst of a budget crisis, so Klein needed to create the impression - no matter how tenuous - that Californians would get some direct return on their investment."

Leavenworth described the conduct during the campaign at best misleading. "At worst, it was a cynical ruse," he wrote.

We queried both CIRM and the office of state Treasurer Bill Lockyer, which issues the bonds, concerning whether future stem cell bonds would be taxable.

Dale Carlson, chief communications officer for CIRM, replied,

"Bonds have never been used before to fund research, and so we want to be certain that the Prop 71 offerings are eligible for tax-exempt status. (See, for example, the transcript of the 11/05 IP task force meeting beginning at page 19 (http://www.cirm.ca.gov/transcripts/pdf/2005/11-22-05.pdf)) The Treasurer's office assumes that they'll qualify, but will be seeking guidance from the IRS to be sure. In the meantime, this first offering will be taxable."

The response from spokesmanTom Dreassler in the treasurer's office was similar:

"We want to complete the initial sale ASAP so we can pay back the bridge financing provided by the state General Fund and private foundations. At this point, however, we do not have an IRS determination that we can sell stem cell bonds as tax-exempt. So, we will issue this initial $250 as taxable. Then we hope to get a formal determination from the IRS that establishes the extent to which we can issue tax-exempt stem cell bonds. Once we get that ruling, we can refinance the $250 million as tax-exempt, thus cutting taxpayers' costs. Our long-term intent is to sell as much as possible of the $3 billion as tax-exempt, consistent with the IRS determination."

CIRM presumably could eliminate the cost of the added interest by withdrawing requirements that royalties be paid. However, that is extremely unlikely. Meanwhile, the IRS opinion could be some time in coming.

You can find all the coverage by the California Stem Cell Report and links to the stories mentioned above, plus much, much more by searching the label "bonds" below.

UCLA to Receive Multimillion Dollar Stem Cell Gift

Don't stand under the stem cell money spigot -- especially with your mouth open. You might drown. First came the news of the pending sale of California stem cell bonds. Now comes the announcement that multimillionaire Eli Broad is going to make a whopping gift to UCLA.

So big that California Gov. Arnold Schwarzenegger is going to preside at the announcement on Monday, which will be televised live at 10 a.m. PDT on the governor's web site. The exact amount is not known, but Broad gave $25 million to UCLA's crosstown rival, USC for stem cell research, but apparently that was not enough to justify a gubernatorial presence. Of course, the governor may have just had a vacant spot in his calendar, and the amount may be less than the $25 million.

Broad also loaned $2 million to the California stem cell agency when it was strapped for funds because of lawsuits.

Broad and his wife, Edythe, were among the 50 most generous philanthropists in the country, according to a Business Week ranking in 2005. They have given close to $2 billion to various charities. Bravo to them. They help set an example that could well be emulated by others.

Whoopee! CIRM To Dive Into The Dough

Those of you of a certain age may remember the Scrooge McDuck comic books of the 1950s. He was the gazallionaire uncle of Donald Duck. The richest duck in the world, old Scrooge was fond of diving into the mounds of loose money in his vault and throwing the stuff into the air.

Come Sept. 27, California stem cell Chairman Robert Klein and company will finally be able to do that -- sort of – after the state sells $250 million in state bonds to finance the grants and operations of the California Institute for Regenerative Medicine.

According to Reuters, State Treasurer Bill Lockyer this week set the date for the sale, nearly three years after voters approved Prop. 71, which created CIRM and authorized $3 billion in bond financing. Lawsuits made the state unable to sell the bonds. After that was cleared up in May, state budget issues delayed them further.

Since 2004, CIRM has made to do with loans from the state and private philanthropists. All of those will have to be repaid, but it is unclear whether the bond money will go to that first or directly to grant recipients.

Interestingly, Reuters said the stem cell bonds will be taxable, which means that they will require a higher interest rate than the non-taxable bonds, costing the state more.

Christmas Coming Early for 25 California Scientists

Fifty-nine "young" California scientists are seeking awards from the California stem cell agency that could run as high as $3 million a year.

CIRM is scheduled to give away $85 million to 25 scientists in December, which should make a fine holiday treat.

Dale Carlson, chief communications officer for CIRM, told the California Stem Cell Report that applications came from researchers at 28 organizations. Eleven University of California and California State University campuses were represented. The California State Univesity system is separate from UC. Four private universities submitted applications. Thirteen non-profit research institutions were included.

The institute refuses to disclose both the names of individual applicants and institutions, even those that are taxpayer-funded enterprises.

The five-year faculty award program is aimed at drawing the best and brightest into stem cell research in California and not just embryonic stem cell research. Arlene Chiu, CIRM's top scientist, 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.”

Director Says CIRM "More Effective" Than Other State Agencies

One of the directors of the California stem cell agency, David Serrano Sewell, has responded to comments critical of the agency in an Internet piece headlined "California's stem-cell management disarray."

Written by David Hamilton, the article said CIRM "is probably one of the most grueling places to work in all of biomedicine." He noted the departure of several top staffers at the agency this year.

Sewell, who is a member of the CIRM Oversight Committee, responded directly with an online comment on Hamilton's Venture Beat piece. Sewell said in part,

"I challenge you to find a state agency that has been more effective. Those grants don’t just happen, it takes hard work and lots of meetings. And, we’ve been transparent throughout the entire process. Thus, the system envisioned by Prop 71 works. I can appreciate that it’s your job to read the tea leaves and make some half baked spin, but you’re just wrong here."

Hamilton responded in part,

"I intended no denigration of the ICOC membership, but it’s a bureaucratic fact that when you have a 26-headed hydra trying to run a public agency, whoever controls the agenda and many if not most staff resources effectively directs the body’s effort — and that’s more or less what (California stem cell chairman) Bob (Klein) does."

You can read the entire exchange, including the original article, here. Scroll down to the bottom to find the comments.

Fresh Bustling in CIRM Presidential Search

The search for a new and permanent chief executive officer to direct the world's largest single source of funding for human embryonic stem cell research is generating a flurry of activity this month.

Robert Klein, chairman of the Oversight Committee for CIRM, scheduled a special teleconference meeting Sept. 14 of the full Oversight Committee at 3 p.m. and a meeting of the presidential search committee at 5 p.m. Another meeting of the search committee is scheduled for Sept. 28. (You can find the agendas and teleconference locations here.)

Topics on the agenda include compensation. Despite a salary range for the position that reaches $412,500 annually, the amount does not appear enough. The cost of housing in the San Francisco area appears to be one of the reasons. Other issues as well seem to be raising difficulties in finding a new president. (Search on the label "presidential search" to see full details.)

Similar rounds of meetings, which are conducted almost entirely behind closed doors, have occurred in the past with no result. The $3 billion agency has been operating on a lame-duck status for nine months since the former president, Zach Hall, announced his plans to retire.

Early in August, the Oversight Committee hired Richard Murphy, former head of the Salk Institute, to serve as interim president for six months.

Fresh Comment

Christine has posted a comment on the "Framing News Coverage" item.

ISSCR Backs Controversial California Effort

The prestigious International Society for Stem Cell Research has stepped into the flap over a land development proposal in Northern California, endorsing the concept of a stem cell research facility linked to the plan.

California stem cell Chairman Robert Klein, who backs the proposal, said in an interview that it was the first time the society has taken such an action. The group represents 2,500 scientists and others in 47 countries.

In a July letter to Yolo County officials, George Daley, president of the ISSCR, said,

"There is a severe shortage of funds for bridging the gap between academic discovery research and industry-sponsored clinical development. This gap of funding is a harsh place where small firms struggling to bring regenerative medicine to patients receive very little support from government and/or private investors. The need for philanthropic support of medical research has never been more urgently needed than today. The substantial gift offered by the Tsakopoulos Family would create a Translational Medicine Development Fund to bridge the gap between basic research and tangible potential therapies and/or cures for seventy or more chronic diseases and injuries within the field of regenerative medicine.

"We also endorse this unique concept because it will bring international institutions together and create a critical mass of scientific research that will allow collaboration and progress in a way that has never been seen before. This exciting proposal would create a world class model for scientific research and collaboration that is the first of its kind.

"We strongly encourage you to study this concept as a part of a general plan to bring economic development to your county."

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 head the research center.

Yolo County's elected supervisors shelved the plan at least temporarily in July.

Daley serves as an ad hoc membe of the California stem cell agency's grants review group and served on the advisory panel for its strategic plan. In June Klein was named to the ISSCR's advisory group.

The text of the ISSCR letter, which was provided to the California Stem Cell Report by Klein, follows in the item below.

Text of ISSCR Letter

Here is the text of the letter from the ISSCR concerning the Northern California county land development/research center proposal.

July 11, 2007

The Honorable Supervisor Mariko Yamada, Chair
Yolo County Board of Supervisors
625 Court Street, Room 204
Woodland, CA 95695

Dear Supervisor Yamada,

The International Society for Stem Cell Research (ISSCR), which represents over 2500 scientists, ethicists, and clinical researchers in the field of stem cell biology from 47 countries, heartily endorses the concept of an International Center for Regenerative Medicine at the Davis Ranch site, dedicated to the translational development of new therapies.

There is a severe shortage of funds for bridging the gap between academic discovery research and industry-sponsored clinical development. This gap of funding is a harsh place where small firms struggling to bring regenerative medicine to patients receive very little support from government and/or private investors. The need for philanthropic support of medical research has never been more urgently needed than today. The substantial gift offered by the Tsakopoulos Family would create a Translational Medicine Development Fund to bridge the gap between basic research and tangible potential therapies and/or cures for seventy or more chronic diseases and
injuries within the field of regenerative medicine.

We also endorse this unique concept because it will bring international institutions together and create a critical mass of scientific research that will allow collaboration and progress in a way that has never been seen before. This exciting proposal would create a world class model for scientific research and collaboration that is the first of its kind.

We strongly encourage you to study this concept as a part of a general plan to bring economic development to your county. We believe that stem cell research will inevitably spawn commercial interest and change the lives of your residents and millions of Americans who live with intense suffering and face premature death. We urge you to carefully consider this unique and innovative proposal to find therapies and/or cures to treat devastating illnesses and injuries.

Respectfully,
George Q. Daley, MD, PhD
President, ISSCR

New CIRM Director, Salk, UC San Diego, Coziness and Much More

The Salk Institute for Biological Studies seems to be doing well in connection with the $3 billion stem cell agency. So is the University of California campus in San Diego.

At least so it appears from the latest appointment to the 29-member Oversight Committee that serves as the board of directors for CIRM. On Friday (Aug. 31), Democratic Lt. Gov. John Garamendi announced that he had named Marsha Chandler to the committee as one of four executive officers from a California research organization who sit on the panel.

Chandler is executive vice president and chief operating officer of the Salk Institute in La Jolla, Ca., a job she has held since July 1. That was the date when Richard Murphy retired both as president of Salk, which is a $100 million-a-year enterprise, and from the CIRM Oversight Committee. Early in August, Murphy was hired for six months by the Oversight Committee to serve as the interim president of CIRM. Murphy has said he will not participate in any matters affecting Salk. Chandler was appointed to fill the vacancy left by Murphy's departure from the Oversight Committee.

Prior to joining Salk, Chandler was the No. 2 executive at the UC San Diego campus. The dean of the medical school there, David Brenner, also serves on the Oversight Committee.

The Oversight Committee awards research and lab construction grants to academic institutions such as the University of California and non-profit institutions such as Salk. The committee also sets the rules and standards for awarding the grants. Oversight Committee members are barred by law, however, from voting directly on grants to institutions in which they have economic ties.

So far UC San Diego has received $14.8 million in CIRM grants. Salk has received $6.6 million.

Similar relationships exist involving CIRM and other UC campuses, other universities and other nonprofits, and it all appears suspiciously cozy to many outsiders. But there is no evidence of any wrongdoing. Nonetheless, the links between the persons who control the $3 billion in taxpayer funds and the beneficiaries of that largess virtually demand that the Oversight Committee and CIRM operate with more openness and transparency than most other state agencies or the NIH. Those entities are subject to executive and legislative controls from which CIRM is constitutionally exempt. The stem cell institute, however, has been reluctant at times to make its operations totally transparent. For example, it refuses to disclose the names of public or private universities or research organizations that seek grants until after the grants are approved, which makes it impossible for the public or other interested parties to comment.

Chandler's academic background is in political science, but she has been a university administrator for nearly 20 years. At Salk she fills a newly created position, one aimed at giving Salk's yet-to-be-named, new president more time for scientific work. Ironically, CIRM cannot easily make similar executive management changes because its executive structure is locked in state law that, for all practical purposes, is impossible to change. Chalk that up to the drafters of Prop. 71, the ballot initiative that created CIRM. For readers not familiar with California law, an initiative is drafted by private individuals, usually in secret and outside of the legislative process. We have never seen a list of all the persons involved in drafting the language of Prop. 71, but California stem cell Chairman Robert Klein takes credit for writing most of it.

A check of news sources shows that Chandler has not made headlines in San Diego, although her name surfaced along with many others in stories about the UC executive pay flap and a piece in the San Diego Union-Tribune about the UC housing assistance program. Ironically, CIRM is barred by law from offering such housing assistance in its search for a new, permanent president.

Two vacancies still exist on the Oversight Committee, and it is not known when they will be filled.

(An appeal to readers: If you know of the names of individuals who participated in writing Prop. 71, please send their names along to the California Stem Cell Report – djensen@californiastemcellreport.com. Or you can just post them anonymously, if necessary, by clicking on the word "comments" below.)

Klein Speaks Out on Presidential Search

California stem cell chairman Robert Klein today defended the conduct of the search for a permanent president of his agency, declaring that there is "great interest" in the opportunity to head the $3 billion enterprise.

In an op-ed piece in The Sacramento Bee, Klein responded to a Bee editorial Aug. 12 that summarized issues complicating CIRM's presidential search, which we have written about on this blog and for Wired.com. The institute has operated in a lame-duck management status since early last December. Some CIRM Oversight Committee members worried as early as last January about the negative impact of a lengthy search.

Klein wrote:

"The CIRM governing board is committed to recruiting a new president who can provide the global strategic leadership this position requires. Academic searches for comparable positions traditionally take 12 to 18 months. Our recruitment effort has a more aggressive schedule; but as I stated in an interview with The Scientist, recruiting a great scientist with a proven record in directing and managing major ongoing research involves finding medical scientists who can take over existing grants, assume the responsibility of mentoring graduate students and post-doctorate students in the labs, and assume the institutional management responsibilities for leading the stem cell efforts of a major university or research facility."

That statement seems to indicate that the board is currently committed to finding an active scientist with a major research portfolio that he or she would have to give up to become president of CIRM. It also seems to mean that the board is not actively pursuing candidates who would be top notch administrators but have a lesser scientific pedigree.

Fresh Comments

Comments have been posted on the Burger King item below from David Hamilton and David Jensen.

Chris Scott: Rocky Road Ahead for CIRM

A onetime candidate for the presidency of the California stem cell agency today outlined his views of the challenges facing the agency in the next 12 months or so. They include the "K-factor," the politics of the CIRM Oversight Committee and micromanagement.

Christopher Scott, head of the Stem Cells in Society Program at Stanford, said, among other things, in an op-ed piece in The Sacramento Bee:

"The institute must quickly find a replacement for (its No. 1 scientist, Arlene) Chiu and double its staff; put in place efficient mechanisms for research and ethical oversight; generate new rounds of proposals, renewals and reviews."

The Bee noted that Scott had been a candidate earlier for the permanent presidency of the institute but said he is not a candidate currently.

Scott wrote that Richard Murphy, the new interim presidency of CIRM "should demand more control over the institute's budget line items and governance decisions while listening to the strong personalities on the citizens committee and in Sacramento."

Scott said:

"The Red Cross collapsed under the weight of its hydra-headed board; the difficult issues centered on control and the dysfunction of consensus management. CIRM faces some of the same problems. Paying attention to the needs of the major players and being flexible to alternate views will help him balance control."

Scott continued, hitting various topics:

"The K-Factor. Robert Klein(chairman of the Oversight Committee) is a blue-chip entrepreneur, passionate advocate and hero to many. His forceful personality and charisma made the institute what it is, but these qualities may not be suited for efficiently executing its mission. Though Klein has said he will step down in 2008, some founding entrepreneurs mistime their exit. Murphy will have to deftly manage Klein's freewheeling ways, leveraging his strengths while covering his weaknesses. Checking the ego at the door will help."

Scott wrote,

"Secession. Any executive who has worked in a startup knows six months will pass in an instant. A permanent president must be found, one who can handle the political challenges while tending to the small stuff, the decidedly unsexy but essential routine of ramping up and running a large research granting agency."

He concluded:

"CIRM's second phase is more important than the first. California voters put their money on the line for a vision of science and medicine. Now comes the hard part. The institute must execute the plan, bringing new knowledge, discoveries and therapies to California."

Grueling Work, CIRM and Burger King

Is the $3 billion California stem cell agency a Rube Goldberg-like contraption deliberately designed to function on a shoestring?

Reporter David Hamilton of Venture Beat says yes. Hamilton, who once covered biotech for the Wall Street Journal, today wrote about the state of the CIRM in the wake of the departure of its No. 1 scientist.

“…(I)t seems safe to say that the stem-cell agency is probably one of the most grueling places to work in all of biomedicine. Structually, CIRM is a Rube Goldberg-inspired contraption in which a panel of 26 appointed academic luminaries, business types and patient advocates oversees a professional staff of no more than 50. The powerful oversight committee chairman, Robert Klein II, essentially runs the show, which undoubtedly complicates the job of finding a prominent biologist — not usually the shyest and most self-effacing people around — willing to give up their laboratory in order to butt heads with Klein over the institute’s management and direction.

“What’s more, CIRM itself was deliberately designed to function on a shoestring. That hard cap of 50 staffers was initially intended to reassure California voters that the agency wouldn’t waste taxpayer money on a hiring binge, and in that sense, it’s clearly worked. On the other hand, add the fact that the agency hasn’t even come close to filling all 50 positions to the string of departures, and it begins to look a lot like the institute is paying the price by burning through its human resources at an accelerated rate.”

We should add that as of a couple a weeks ago, CIRM had 26 employees, perhaps the equivalent of the staff needed for a 24-hour Burger King. CIRM´s board of directors numbers 29.

CIRM Challenges Report on Chiu

The California stem cell agency has responded to our item on Monday dealing with the implications of the departure of its No. 1 scientist, Arlene Chiu. Dale Carlson, chief communications officer for the institute, cited the following sentence from the post:

"While it would be incorrect to say that all CIRM staff departures this
year are related to the presidential situation..."

Carlson then said,

"In fact, it wouldn't be correct to say that ANY of the staff departures were related to the presidential situation, nor to each other. Each of these folks left or is leaving for individual reasons. The timing is coincidental and nothing more should be read into them.

"Contrary to Mr. Simpson's speculation, Dr. Chiu's desire to return to Southern California and pursue other interests is exactly as stated. She would not be staying longer if the presidential vacancy did not exist."

Stem Cell Snippets: McGee, Lansing, Prinz

Pricing Stem Cell Cures – The California stem cell agency is still wrestling with anticipated prices of stem cell therapies. Not directly, mind you. It comes under the topic of intellectual property. Glenn McGee, director of the Alden March Bioethics Institute, wrote recently about a drug pricing issue that could resonate in the future – if not currently -- with CIRM. The issue involves Merck and its cervical cancer drug, Gardasil, which he said is priced out of the reach of millions of women. McGee cited a report that Merck has spent $48 million in the last 10 years on lobbying. He wrote:

"If the company can afford to spend huge amounts convincing legislators the vaccine is something every woman deserves, it can afford to take its own advice, and reduce the price."

Variations of McGee's argument are certain to surface in the future involving stem cell cures. Plus they will be freighted with heated rhetoric about how those cures owe their very existence to funds provided by California taxpayers. Something for the good burghers on CIRM Oversight Committee to consider.

Another Presidential Search – Sherry Lansing, a member of the Oversight Committee for the California stem cell agency, has added more to her plate. She will serve as vice chair of the search committee to find a new president for the University of California. As a CIRM director, she is already involved in the search for a new president for CIRM in addition to her other many philanthropic activities. Incidentally, the current UC president earns $405,000 annually, which is apparently not enough to attract a CIRM president. However, the UC position has other benefits, but may or may not involve less aggravation than the CIRM post.

Prisons vs. Stem Cell Research -- California attorney Kristie Prinz wants to know. Writing on her California Biotech Law Blog, she raises a fundamental question about the $3 billion California stem cell agency,

"One cannot help but wonder if the money couldn't have been better spent elsewhere, even if you are a supporter of the biotech industry and of the concept of the research generally. Our schools, health care, keeping drugs off the street, illegal immigration, crime, overcrowded prisons, and terrorism are just some of the many issues facing this state that could have also been better funded with the same money. Did we as taxpayers make a good decision when we voted to use the funds instead on stem cell research? It's a thought-provoking question that all Californians should consider."

More Analysis on the Chiu Resignation

The following came in today from Christopher Thomas Scott, head of the Stem Cells in Society Program at Stanford, concerning the departure of Arlene Chiu(see item below). He makes the very good point that, compared to the NIH, CIRM is working with quite lean staff resources.

Here are Scott's comments:

"The other shoe dropped at CIRM. Arlene Chiu, the top executive responsible for the nuts and bolts of the organization, resigned. Her manifold responsibilities included the tough work of writing and disseminating the agency's request for proposals, scheduling and running a time consuming and complicated scientific review process, overseeing the awards, managing staff, and most recently, filling a leadership vacuum left by the departure of former president Zach Hall. For those of us familiar with the research grants business, we know Dr. Chiu as a tireless and enthusiastic science professional, and understood how she kept CIRM on its feet. She did much of this working with less staff than stipulated by the operating budget. Even at full strength, the numbers of professionals in her group would be far fewer than a comparable agency of the NIH, where she and Hall had made their professional careers. There, the institutes have the benefit of massive federal support. Here, Hall and Chiu, along with a skeleton crew, had to manage the launch of an organization while fighting lawsuits, scrabbling for money, and dancing through political hoops. While the reasons for Dr. Chiu's departure are known only to her, its likely she's tired of the long hours, the pressures of running a research enterprise on thin margins and the purgatory caused by an unsuccessful presidential search.

"Interim president Richard Murphy, on the state rolls for only 180 days, has a doubly difficult task in front of him. He must find a replacement for his top scientist and one for himself. And, the award money must reach the California labs, which have begun to ramp up the experiments that will bring new knowledge and hopefully, new therapies to Californians. Any executive who has been in a start up knows that six months will pass in an instant. More importantly, it is just as hard, perhaps harder, to execute a vision as ambitious as this than to have it in the first place."

Lab Grant RFA Now Available

The California stem cell agency has posted the request for applications for $227 million in lab construction grants, the largest round in its history. Letters of intent are required by Sept. 26. The news release can be found here. The RFA can be found here.

CIRM Loses its No. 1 Scientist

The top scientist at the California stem cell agency, Arlene Chiu, will soon depart in a move that reinforces the importance of maintaining the organization's stability and finding a new, permanent president.

CIRM has been in a lame-duck mode since last December when former President Zach Hall announced that he planned to leave. John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said Chiu's resignation "underscores the importance" of finding a permanent president.

Simpson said the failure to have a new, permanent CEO in place represents "a substantial failure of leadership first and foremost on the part of board Chairman Bob Klein and to a lesser extent on the part of all board members."

Earlier this month, the CIRM Oversight Committee installed Richard Murphy, former president of the Salk Institute, as interim president for at least six months as it continues to seek a permanent replacement for Hall.

CIRM is still a young organization (less than three years old) with a small staff (26 persons)that has seen other significant departures relatively recently. They include Kirk Kleinschmidt, director of legislative relations; Mary Maxon, the lead staff person on intellectural property, Scott Tocher, associate general counsel; and scientific officer Ruth Globus. While it would be incorrect to say that all CIRM staff departures this year are related to the presidential situation, voids in permanent leadership create uncertainties and instability. Departures for unrelated reasons can take on a life of their own, triggering others to consider making job changes. Couple that with the regularly long hours that CIRM staffers put in, and you have the potential for more losses.

In several ways, the press release on Chiu's departure acknowledged those concerns. Indeed, the headline on the release did not even say she was resigning. Carefully crafted to stress continuity and stability, it noted that she will continue through the end of October on a fulltime basis and after that as a consultant on some of CIRM's important efforts. Chiu as well issued a statement emphasizing the progress at CIRM and the credentials of interim President Murphy.

On a personal note, Chiu is one of the first persons that we met at CIRM. Her diligence, integrity and dedication have always impressed us. And as one of the earliest regular staff members, she set a tone and example that was important in establishing a healthy organizational culture at the new enterprise.

She was recruited by Hall, who issued the following statement, which is not currently available on the CIRM Web site:

"Persuading Dr. Arlene Chiu to come to CIRM from NIH was one of the most important accomplishments of my presidency. As the senior CIRM scientist during its first three years - a time of constrained resources, Arlene recruited, mentored and led the scientific team responsible for awarding the first $200 M in grants for stem cell research in California - a remarkable legacy. She has a deep understanding of stem cell research, expert knowledge of grants administration, and extraordinary personal qualities of integrity, grace and a passion for the mission of CIRM. Arlene has left her mark on the DNA of CIRM. She will be hard to replace."

Murphy and Klein also issued statements which can be found in the CIRM press release. Chiu's statement can also be found in the press release.

Here is the complete statement from Simpson:

"Dr. Chiu is one of the all-too-often unsung heroes of CIRM, regularly going beyond the call of duty to ensure scientific excellence in the agency's efforts. She has built an excellent scientific staff that should be able to carry on in her absence.

"We agreed to disagree on some things, like the amount of transparency and openness that belongs in the peer review process; but I have tremendous respect for her and her contributions.

"I believe Dr. Chiu's departure underscores the importance of the oversight committee performing its single most important task: hiring a president and chief executive.

"Had the committee done so in a timely way, I believe Dr. Chiu would still be at CIRM. Given the situation, the selection of Richard Murphy as interim president is a necessary stopgap to hold the agency together.

"But the failure to hire a permanent president, given Zach Hall's announcement of his plans last December, is a substantial failure of leadership first and foremost on the part of board Chairman Bob Klein and too a lesser extent on the part of all board members."

News coverage of Chiu's resignation was light. Here are links to the stories we saw: Jim Downing of The Sacramento Bee, Kristen Philipkoski, Wired.com, Sacramento Business Journal (the same story appeared in other Business Journals), and the Associated Press.

Back in Mexico

For those of you unfamiliar with all the details of this blog, we produce it primarily from west coast of Mexico where we live on a sailboat. We have returned once again to Mexico after a stay in the Old Country minding grandchildren and providing low-skill labor for our children. But never fear. The items will continue to be posted on a reasonably regular basis. Later today, we will have an item on the departure of Arlene Chiu, the top scientist at the California stem cell agency.

Cash is Coming: Time for Stem Cell Firms To Show Up

Attention California stem cell firms: If you are looking for millions in grants from the state's stem cell agency and if you want to have an impact on how the money is given out, mark Sept. 7 on your calendar.

On that date, the California Institute for Regenerative Medicine has scheduled an "interested parties" meeting with teleconference locations in San Diego and San Francisco.

Here are some of the topics to be discussed.

"What unique situations might arise in for-profit organizations as opposed to academic or non-profit settings that would impact a current or previously-funded CIRM project (e.g., partnering, bankruptcy)? How should these changes be effectively managed?

"Given that the CIRM will require annual financial and programmatic reports, as well as reports of licensing activities, patent applications, and commercialization activities, what information can reasonably be provided to the CIRM by grantees or their successors? How can the CIRM best monitor the performance and commercial development activities of grantees and licensees of CIRM-funded patented inventions?

"In the context of the CIRM’s preference for California suppliers of goods and services, what proposals or concerns should be considered by the CIRM in managing potential pass-through costs to non-Californian entities?

"Given that there are various methods of accounting for grant-related activities in for-profit organizations, how well do the Proposition 71 definitions of 'direct research funding costs' and 'indirect costs' reflect these activities?"

A couple of things can said about the Sept. 7 session. One is that the CIRM staff has done a fine job of posting a public notice of this session well in advance. That allows time for interested parties to prepare and to come to the table with well-thought-out suggestions. We might add that it is also useful if recommendations are written, which provides more nuanced information that can be easily referred to later. Oral presentations are necessarily shorter and transitory.

The other comment that can be made is that California's biotech community sometimes seems as if it doesn't know that regulations and grant procedures are being established that could have a major impact on their enterprises within the next year or so. While it is difficult to quantify, business turnout at some CIRM sessions seems limited to a handful of firms. CIRM has $3 billion to hand out. If biotech firms want a healthy chunk of that on good terms, now is the time to make their case. Otherwise, they can continue to wrestle with the usual financial alligators. And, as they know, that can be an unpleasant and fruitless experience.

Fresh Comment

An anonymous comment has been posted on the Kessler item Aug. 10 concerning his professional aspirations.

Comments can be left on any item by clicking on the word "comments" below the item or they can be sent directly to me at djensen@californiastemcellreport.com.

Wisconsin and California: Dueling Views on Stem Cell IP

Cyberspace is sizzling between California and Wisconsin in a stem cell contrempts involving Tom Still, president of the Wisconsin Technology Council, and John M. Simpson, the stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca.

Well, sizzling might be a little strong. But these two former newspaper editors are whacking each other around a bit.

It all started Aug. 11 with an opinion piece that Simpson wrote for the web site of the Wisconsin Technology Network.

In it, he argued that a basic question is being left not entirely answered as states step up to the stem cell funding plate. He wrote:

"Who should control, profit, and otherwise benefit from discoveries made in state-funded laboratories across Wisconsin? How you settle such matters are known as intellectual property policy, and like most states, Wisconsin apparently doesn't have a coherent, across-the-board policy."

On Aug. 20, Still responded, also on the Wisconsin Technlogy Network:

"Not only does Simpson think the historic Bayh-Dole Act has been a colossal waste of time and money, even though many experts believe it unchained the innovative potential of the nation's research universities, but he doesn't understand the basics about 'technology transfer' on those same campuses."

Simpson responded in a comment filed Tuesday below Still's column:

"I never said the Bayh-Dole Act 'has been a colossal waste of time and money.' I said that it was 'flawed.' That means it has problems that need fixing. I also would assert that it ought not serve as the model for state funding programs without appropriate modification."

Simpson's final paragraph in his response to Still:

"Again, I do appreciate your thoughtful and carefully reasoned analysis of my first column. I'd ask you to ponder what I've just suggested and look forward to your comments."

CSUS Responds on $31 Million Training Plan

Susan Baxter, executive director of the California State University Program for Education and Research in Biotechnology, sent the following comment on our item Aug. 13 on the $31 million training proposal her system presented to the Oversight Committee of the California stem cell agency.

You wrote, “One could wonder why this proposal was not presented to the staff earlier.”

The CCC/CSU partnership presented its proposal to CIRM staff in August of 2006. Since then, conversations between CIRM staff and CSU and CCC faculty have taken place. Many of the concepts and ideas presented in the proposal were considered during the scientific strategic planning process at CIRM. The CIRM Scientific Strategic Plan, approved by the ICOC in December 2006, includes a five year goal to “increase the workforce of stem cell researchers in California” and calls for CIRM to increase the number of scientists (basic, translational and clinical), as well as trained technical staff. CIRM will also strive to increase the diversity of the workforce at all levels. The CSU/CCC proposal clearly connects to the CIRM Scientific Strategic Plan and conversations about the proposal with CIRM staff are continuing.

Second, you wrote, “The proposal keyed off the widespread belief that biotech firms in California have difficulty finding skilled workers.”

To clarify, we recognize that life science graduates are not often exposed to medical product development. Typically, a life science student’s first exposure to real-world research is in academic laboratory coursework or in faculty research laboratories. In contrast, the life sciences industry works within a highly regulated environment in order to develop safe, effective human therapies. Increased exposure and understanding of this business environment will better prepare California’s students for careers in the life science industry, including the emerging stem cell industry sector which faces unique challenges as it develops clinical best practices for new cell-based product testing, formulation, and delivery. Also, exposing life sciences students to issues and challenges around clinical research and product development may encourage more interest in this aspect of therapeutic, device and diagnostic development. Not only does the field need physicians interested in clinical research, but also project managers, statisticians, engineers, computer scientists, preclinical researchers and regulatory experts able to work in interdisciplinary teams. The CSU/CCC is uniquely positioned to deliver this high-level workforce to assist in ground-breaking research efforts and bring them to commercialization.
 

Leveraging the Media, Money and Change

One could call it the rhetoric of money and momentum. "Bidding wars," "stealing" and "fierce" competition. It's all are part of the coverage of California stem cell issues that is emerging in the wake of the announcement that a noted Japanese researcher is opening a lab in San Francisco.

Dale Carlson, chief communications officer at the California stem cell agency, fed the generally positive stories with the separate release of a list of nearly 50 other researchers who have moved to California since the passage of Prop. 71. The list turned an already meaty scientific story into an even meatier one – a trend with national and global implications.

Reporter Daniel Levine of the Journal of Life Sciences produced a good example. His Aug. 20 piece was headlined "Money Changes Everything." He wrote that the move by Shinya Yamanaka caps a trend that has "changed the landscape for stem cell research by drawing top scientists to the Golden State."

Levine also queried Stanford, UCLA and UC San Francisco to flesh out the scientific migration and recruitment story.

We are likely to see at least a few more stories along this line as the news filters out from scientific and regional publications.

In another story on the Yamanaka move, reporter Ron Leuty of the San Francisco Business Times said that Yamanaka expects to be reprogramming human cells to create embryonic stem cells in the "next year or two."

Leuty also reported that the scientist is expected eventually to move his entire lab operation to the Gladstone Institutes. Yamanaka has a 20 person lab at Kyoto University. The Gladstone operation is expected to have four to six persons shortly.

Leuty said the "first fellow" in Yamanaka's California operation is funded by a grant from the California stem cell agency.

More Adding Up on Private Funding for Stem Cell Research

Attorney Ken Taymor. executive director of the Berkeley Center for Law, Business and the Economy at UC Berkeley, sends the following re our earlier item about state and private funding for stem cell research.

Thanks for bringing James Fossett's excellent report to our attention. A very, very quick search online raises questions about the accuracy of the calculation of private support for stem cell research in California (really a nit, but worth clarifying; I don't think it goes to the heart of his insights). At least three other major gifts have been reported in the press - excerpted below with URLs. In addition, as the report does note, the Show Me state is showing the Stowers the door, so while the money is coming from Missouri, it appears that it will be spent everywhere but Missouri. The news reports on donations in California of which I am aware are as follows:

"Sound pioneer Ray Dolby and his wife gave $16 million to the University of California, San Francisco to start a stem cell center that will perform research without federal funds."

http://sfgate.com/cgi-bin/article.cgi?f=/n/a/2006/05/10/financial/f224444D16.DTL

"USC announced it has received $25 million from the Broad Foundation to create the Broad Institute for Integrative Biology and Stem Cell Research at the Keck School of Medicine of USC."

http://www.usc.edu/uscnews/stories/12093.html

"Without seeing a dime of this [Prop 71] money, numerous California universities and research institutes already have committed to expanding their stem cell research programs, often with help from private donors. They are doing it with the help of philanthropists, who have given more than $250 million to California universities and research programs since 2005, Klein said. Those donations include a $20 million gift to the Stanford University Medical School from the New York-based Virginia and D.K. Ludwig Fund. The money from the fund, which is known for its support of cancer research, allows the school to establish a stem cell research center."

http://www.signonsandiego.com/news/business/biotech/20061219-9999-lz1n19stem.html

NAS Opens Session of Public Officials on Stem Cell Cooperation

Following a flap over closed door meetings, the National Academy of Sciences is opening to the public the next meeting of its group looking at interstate cooperation on stem cell research.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said the next session will be held in Boston in October. He attributed the information to Warren Wollschlager of the Connecticut Department of Health, who will chair the session.

Simpson was thrown out of a California meeting of the group earlier this year by an official from the National Academy of Sciences, who said the session was private. The group consisted mainly of public officials who are associated with state programs funding stem cell research with public funds.

Simpson said in a news release:

"I’m glad to see the change of heart. Too often the scientific establishment has displayed a paternalistic 'trust-us-we-know-best' attitude that in fact undercuts public support for science. Scientists need to engage and educate, otherwise we end up with the know-nothing attitude too often exemplified by the current administration."

Our view: The academy is moving in the right direction. This is public business and should be conducted openly. Anything less only feeds the anti-science forces. Closed door meetings and secrecy breed suspicion.

For earlier stories on this subject, click below on the label "interstate cooperation."

Gaining Brains in California

Thomson, now Yamanaka, plus nearly 50 more. So goes the count of a stem cell scientists dipping their toes – if not their entire corpus – into the California stem cell pool.

A few days ago, Shinya Yamanaka of Kyoto University said he was opening a lab at the Gladstone Intitutes in San Francisco. Yamanaka excited the stem cell world recently with his work in reprogramming adult stem cells to return an embryonic state. Earlier this year, UC Santa Barbara said Jamie Thomson of the University of Wisconsin was establishing a lab at the seaside campus.

Dale Carlson, chief communications officer for the California stem cell agency, said the state is a becoming a mecca for stem cell researchers. He produced a list (see item below) of nearly 50 who have come to California since Prop. 71 created CIRM and funded it with $3 billion in state bonds.

The headline on the story by Mary Anne Ostrom in the San Jose Mercury News read, "Japanese scientist's move reflects state's rising clout." David Hamilton's piece on Venture Beat described Yamanaka's move as "certainly a coup," likening it to a "brain gain." But he also said Yamanaka will be spending only a week a month in San Francisco for the next year or two. Rob Waters of Bloomberg quoted CIRM interim chief scientific director Arlene Chiu as saying it was a "great coup" for Gladstone and California. Steven Edwards of Wired.com called Yamanaka "one of the hottest prizes in stem cell reasearch."

Here is a link to the Gladstone press release. See the item below regarding moves by other scientists to California.

Names of Stem Cell Researchers Moving to California Since Prop. 71

Here is the list of stem cell scientists who have come to California since January 2005 following the passage of Prop. 71. The list was prepared by the state's stem cell agency. Scientists that it is currently funding have figures next to their names.

Migration of Stem Cell Researchers to California
(Since January 2005)

Established stem cell investigators who moved to California:

Martin Pera, Ph.D., from Monash University (Australia) to USC

Michael Clarke, M.D., from the University of Michigan to Stanford

Stephan Heller, Ph.D., from Harvard to Stanford $2,469,373

Peter Donovan, Ph.D., from Johns Hopkins to UC Irvine $2,509,438

Jan Aileen Nolta, Ph.D., from Washington University to UC Davis

Gerhard Bauer, M.D., from Washington University to UC Davis

David Rowitch, M.D., from Harvard to UCSF

Benoit Bruneau, Ph.D., from the Hospital for Sick Children in Toronto to a joint appointment at the Gladstone Institutes and UCSF

Michael Kahn, Ph.D., from University of Washington to USC;

M. Ian Phillips, Ph.D., from University of South Florida to USC

Deepak Srivastava, M.D. from University of Texas to the Gladstone Institutes and UCSF
$3,164,000

Markus Muschen, M.D., Ph.D., from Heinrich-Heine-Universitat Dusseldorf to Childrens Hospital Los Angeles and USC

Ronald Li, Ph.D., from Johns Hopkins to UC Davis

Paul Knoepfler, Ph.D., from Fred Hutchinson Cancer Research Center to UC Davis


Young investigators who trained in top labs and moved to California:

Noburo Sato, Ph.D. from lab of Brivanlou at Rockefeller to UC, Riverside

Qi-Long Ying, Ph.D. from lab of Austin Smith, Institute for Stem Cell Research at University of Edinburgh to USC

Kara McCloskey, Ph.D. from Nerem's lab at Georgia Tech to UC Merced

Xianmin Zeng, Ph.D. from Rao's lab at NIH to Buck; Institute $4,140,162

Kathrin Plath, Ph.D., from Jaenisch's lab at MIT to UCLA

Robert Blelloch, M.D., Ph.D., from Jaenisch's lab at MIT to UCSF $631,831

Holger Willenbring, M.D., from Grompe's lab in Oregon to UCSF $342,962

Tiziano Barberi joined City of Hope from Lorenz Studer's lab at Sloan

April Pyle was recruited to UCLA from the Donovan lab at Johns Hopkins

Gage Crump, Ph.D., from Kimmel’s lab at University of Oregon to USC

Tod Kippin, Ph.D., from Van Der Kooy’s lab at University of Toronto to UC Santa Barbara

Leslie Lock, Ph.D., from the Donovan lab at Johns Hopkins to UC Irvine

Gautam Dravid, Ph.D., from Johns Hopkins to Childrens Hospital Los Angeles

Dennis Evseenko, M.D., Ph.D., from New Zealand to Childrens Hospital Los Angeles

Andrew Cuddihy, Ph.D., from Canada to Childrens Hospital Los Angeles

Hanna Mikkola, M.D., Ph.D., from Harvard to UCLA $577,037

William Lowry, Ph.D., from Rockefeller University to UCLA $571,575

Bennett Novitch, Ph.D., from University of Michigan to UCLA

Ping Zhou, Ph.D., from Nolta lab at Washington University to UC Davis

Suzanne Pontow, Ph.D., from Nolta lab at Washington University to UC Davis

Camie Chan, Ph.D., from Johns Hopkins to UC Davis

Wenbin Deng, Ph.D., from Harvard/Children's Hospital Boston to UC Davis

Chong-Xian-Pan, Ph.D., from the University of Indiana to UC Davis

James Byrne, Ph.D., from Oregon Health Sciences University to Stanford



Established stem cell scientists with part-time appointments in California:

James Thomson, Ph.D. – UC Santa Barbara (University of Wisconsin)

Shinya Yamanaka, M.D., Ph.D. – Gladstone Institutes and UCSF (Kyoto University)

Nissim Benvenisty, M.D. – Cedars-Sinai (Hebrew University)

Michal Schwartz, Ph.D. – Cedars-Sinai (Weizmann Institute of Science)

Dan Gazit, Ph.D., D.M.D. – Cedars-Sinai (Hebrew University)

Clive Svendsen, Ph.D. – Stanford (University of Wisconsin)


Private Sector:

Mahendra Rao, M.D., Ph.D., from NIH to Invitrogen and UC Irvine

Advanced Cell Technologies (Michael West, Ph.D.) has expanded with a new facility in Alameda

Stem Cell Sciences (Peter Mountford, President and CEO) is expanding into California from the UK

Melissa Carpenter, Ph.D., from Canada to CyThera, Inc. in San Diego


Transfers within California:

Emmanuelle Passegue, Ph.D., from Stanford to UCSF

Wange Lu, Ph.D., from Caltech to USC

Renee Reijo Pera, Ph.D., from UCSF to Stanford $2,469,104

David Telander, M.D., from Jules Stein Eye Institute/UCLA to UC Davis

Amander Clark, Ph.D., from UCSF to UCLA

08/15/07

The "Show-Me" State and $985 Million in Stem Cell Funding

Jim Fossett of the Rockefeller Institute has pulled together a reasonably complete account of private donor support for stem cell research in the United States – something in the neighborhood of more than $1.7 billion.

Interestingly California is rather low on the list with a piddling $100 million. Missouri is No. 1 with $985 million from the Stowers.

The rundown is part of a policy brief called "Federalism by Necessity," which describes state and private efforts at human embryonic stem cell research. It supports Fossett's belief and mine that we are not likely to see an upsurge in federal stem cell spending after the next presidential election.

Giving Bush The Treatment

Stanford's Chris Scott looks at how George Bush might encounter stem cell therapy some years down the road in a case involving the famed "Jenna" line of stem cells. You can read it here on Scott's blog, The Stem Cell Blog.

Bee Editorializes on CIRM Presidential Search

The Sacramento Bee editorialized this morning on the search for a permanent president of the California stem cell agency, wondering whether obstacles exist that make recruitment difficult.

The editorial pointed out problems with compensation. It noted the structural issues in the management structure along with the role of California stem cell Chairman Robert Klein. And it said interim president Richard Murphy has taken steps to ease concerns about possible conflicts of interest. The final paragraph of the editorial also said:

"In fact, it's quite possible that Murphy could help the institute fashion a management structure in line with that of other prestigious research institutions. Earlier this year, Murphy described the institute's executive structure as a 'dog's breakfast' -- in other words, 'a mess.' For six months, he'll be boss of the kitchen. Bon appetit."

CSUS' $31 Million Training Proposal Faces More Scrutiny

A "breathtaking," $31 million proposal to train 4,000 young persons in biotech skills has been sent off for more critical examination by two directors of the California stem cell agency.

Last week six representatives of the California State University and College system presented the five-year plan to CIRM's directors, who both praised and criticized it. One, Janet Wright, called it "breathtaking" and "visionary."

The proposal represents a joint effort by the 114 community colleges in California and the 23-campus state university and college system (which does not include the University of California).

The proposal keyed off the widespread belief that biotech firms in California have difficulty finding skilled workers. Such expressions by industry groups often can be translated to: "We cannot find enough workers at the wages we are willing to pay."

John Reed, head of the Burnham Institute and a member of the CIRM Oversight Committee, questioned whether CIRM is the best source for funding the training program. He noted that Prop. 71 was aimed at providing funding for research that is not available from the federal government. He said there is no prohibition against any agency providing biotech training. Reed asked for specific statistics on the need in California as opposed national statistics provided by CSUS. (Reporter Terri Somers of the San Diego Union-Tribune had more from Reed on his views.)

Ed Penhoet, vice chairman of CIRM, also expressed an interest in more information. He wanted to know how successful are CSUS' existing training programs.

Other questions could be asked as well. If there is a great need for training and if biotech is as important to the California economy as argued by CSUS, one could wonder why the system is not already doing the training on its own. It would seem to be a basic part of the system's mission. One could ask whether alternative approaches to the training exist – something less costly than $31 million. However, the figure translates to $7,500 a student, which might be a bargain.

One could wonder why this proposal was not presented to the staff earlier and vetted for answers to just such questions, including Reed's and Penhoet's, prior to coming to the board. The CIRM board is constantly pressed for time for matters that only it can decide, such as the rules for the $227 million lab program, which came up later in the day of the presentation. By mid-afternoon, Oversight Committee members were disappearing to catch planes and to take care of their other many responsibilities. A written, staff analysis of the plan would have already developed answers to questions posed by Oversight Committee members and saved valuable time.

CSUS promised to address all the concerns in writing before the October meeting of the Oversight Committee, when committee members David Serrano Sewell and Marcy Feit are scheduled to report back on the proposal. Hopefully, they will ask the staff to weigh in as well.

FTCR: Secrecy Supports Anti-Science Crowd

Does openness on research grant reviews mean bad science? Does cloaking the identities of massive public institutions serve a public purpose?

Earlier today we asked John M. Simpson , longtime CIRM watcher for the Foundation for Taxpayer and Consumers Rights, for his thoughts on the secrecy policies at CIRM(see item below). Here is what he had to say.

"CIRM's penchant for secrecy makes no sense. People who want public money should have to explain how they will use it in public.

"This is not complex. Other states, like Connecticut, have figured out how to do it.

"The argument is that scientists won't apply for grants out of fear that their applications might be rejected. Frankly, all the scientists I know have thicker skins than that. Their egos aren't fragile. In fact a number of junior scientists have said they'd like to see some sun shine into the secrecy-shrouded peer review process.

"But let's set the the question of the individuals' identity aside for a moment. There is absolutely no ground for a refusal to identify the institutions which have applications under consideration.

"The only thing I can figure is that the current scientific culture is elitist and subscribes to the view that the public can't be trusted to make good judgments. Ironically, in the end that's an approach which leads to the know-nothing, anti-science attitude of the current federal administration.

"I want to support science and scientists, but when you insist upon retreating behind closed doors you do not make it easy for me or for yourselves. Engage the public; explain what you do and why. Do it in public. You'll be surprised and pleased at the support you get."

CIRM Says No to Public Access on Faculty Grants

The California stem cell agency today refused to disclose the names of the institutions whose faculty members are seeking $85 million in public funds.

Dale Carlson, chief communications officer for CIRM, said that the institutions' names would not be disclosed until after the grants are awarded in December. He said the justification for the secrecy was the same as for the secrecy on applications for previous research grants.

Basically CIRM wants to ensure candor in the evaluation of individual research proposals and avoid embarrassing them or damaging their reputations. But CIRM did not make it clear how institutions such as UCLA or Stanford could be embarrassed or harmed by the disclosure that they nominated scientists for the prestigious awards or how the evaluation process could be damaged by such identification.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said that not only should the institutions be named but that the individual scientists also should be publicly identified.

In some ways, CIRM is more open than other more cloistered institutions, such as the NIH, we are told. But in other ways, it remains tightly under wraps.

Comparisons are difficult to make with other government agencies or universities. CIRM, although it is a state agency and operates with state funds, is not subject to the normal gubernatorial or legislative oversight. Operational minutia concerning the agency is codified in state law and cannot be changed without another vote of the people or a super, super-majority vote in the legislature. Such independence does not exist at the University of California or the NIH.

At the same time, the board is rife with conflicts – all entirely legal because they were approved by voters in Prop. 71, which created the agency. Fifteen members of its board of directors, for example, have ties to institutions that could stand to benefit by tens of millions dollars in its latest $227 million lab grant program.

What that means is that CIRM should be more, rather than less open in order to maintain public confidence in its worthy endeavors.

Not Upcoming

Our report on the $31 million CSUS training proposal to the California stem cell agency has been delayed until this weekend.