FTCR on Trounson: 'Highest Regard'

The Foundation for Taxpayer and Consumers Right is a longtime observer of and participant in California stem cell issues. John M. Simpson is the organizations's stem cell project director. We asked him today for his reaction to the appointment of Alan Trounson as the new president of CIRM. Here is Simpson's statement verbatim.

Alan Trounson is one of the scientists we sought to support our challenge of the the human embryonic stem cell patents held by WARF. He in fact filed a statement to the PTO on our behalf. He agrees with our view that the work done by Jamie Thomson was important and laudable, but not patentable because it was "obvious" to those in the field based on prior research.

Trounson is a stem cell scientist with a worldwide reputation for excellence. I hold him in the highest regard.

He has experience in both basic research and translational research -- moving discoveries in the lab to actual cures.

Trounson has expressed his willingness to turn away from his laboratory and take the helm at CIRM fulltime. He also will divest himself of any investments in stem cell companies. Both steps are necessary.

I believe Trounson can make a major contribution to CIRM, California and stem cell research in general as president, so long as he never forgets his responsibility and accountability as a public official to the citizens of California. If needed, FTCR will remind him of those duties.

Trounson Resume and Management Experience

The resume of Alan Trounson, the new president of the $3 billion California stem cell agency, is 70 pages long and you can find it here. Here is a document from CIRM on his management experience.

Dr. Alan Trounson Management Experience
1990-Present
I. Director, Monash Immunology and Stem Cell Laboratories (2004- Present)

• Developed this lab and continues to direct it

• Deputy Director Richard Boyd

• 120 people

• 50 PhD students

• 30 PIs/Senior PIs

• Administrative staff

• Research Support staff

• Finance staff

• Facilities staff

II. Founder, Australian Stem Cell Centre (2003)

• Chief Executive Officer, 2003

• Executive Vice-Chairman, 2003-2006

• Secured funding from Australian Government to found

III. Monash Institute of Reproduction and Development

• Director, 2002-2003

• Assistant Director, 1990-2002

• 250+ people

• Now named Monash Institute of Medical Research (MIMR

Trounson's Business Activities

Alan Trounson, just named as president of the California stem cell, agency, has said he will divest any interests he has in stem cell companies. Here is a list of companies that Trounson founded. The list was provided by CIRM.

Abstracts of Companies Founded by Alan Trounson
1. Infertility Medical Centre/ Monash IVF Pty Ltd (http://www.monashivf.com )

- Established 1978 as a company providing services to infertile couples. In 1982 the original company was absorbed by Monash University as 51% ownership, with the majority other ownership by private gynaecologists who manage the patient treatments. The primary activity is now to service patients requiring IVF and related therapies and diagnosis of inheritable genetic diseases using preimplantation genetic diagnosis. Largest provider in Australia – New Zealand. Clinics in Victoria and Queensland. Presently in sale mode for $100mill+

2. Sydney IVF Pty Ltd (http://www.sydneyivf.com )

- Founded by Trounson and Dr R Jansen in 1986 for provision of infertility services in Sydney. Sydney IVF has international clinical and business relationships in infertility services and stem cell provider activities (eg. GMP embryonic stem cells to ESI Pte Ltd., Huntington’s Disease embryonic stem cell lines to US distributor)

3. Intergramed America Inc (http://www.intergramed.com )

- The company was founded by Robert Moses (foundation CEO), Vicki Baldwin, David Beams and Trounson in 1984 as IVF Australia Inc/ then IVF America Inc, initiating new IVF clinical services and for provision of services in women's health care and physician practice. The management company focuses on infertility and assisted reproductive technology. Raised $20mill as public float on NYSE. Present market cap ~ $80mill. Services provided to clinics nationally across the US and is one of the largest providers in the US.

4. Embryonic Stem Cells International (ESI) Pte (http://www.escellinternational.com )

- Founded by Trounson and Drs Pera, Reubinoff, Bongso in 2000 to support our research in embryonic stem cells (ESCs). Commercial rights and IP to the initial 6 ESC lines developed by the founders were transferred to ESI. These ESCs are part of the “NIH recognised” cell lines and were the subject of the change in ESC support by NIH when Trounson and colleagues applied for NIH funding under President Clinton’s administration. The initial investment was obtained equally from Business Angels associates from the Melbourne community and the Economic Development Board of Singapore. The company was registered in Singapore. Carl Strachan (Melbourne) chaired the Board and the foundation CEO was Robert Klupacs (previously Commercial Manager of Institute Reproduction and Development under Trounson’s directorship}. The company provided the initial financial support for


Trounson and Pera at Monash, Reubinoff at Hadassa Medical Center, Jerusalem and Bongso at National University of Singapore. The company focused their commercial interests under Alan Coleman (CEO) for ESCs and diabetes (funding Drs Elefanty and Stanley in Trounson’s Centre) and ESCs and cardiac therapy (funding Dr Christine Mummery, Utrecht, Holland).
Trounson and his wife exited all shareholdings in ESI Pte in 2002 to avoid conflict of interest of management with the award of the National Stem Cell Center.

5. Maccine Pte (http://www.maccine.com)
Maccine was founded by Trounson in 2002 with Australian investors to provide primate discovery support services to Pharmaceutical and Biotechnology companies worldwide. The initial facilities were based at the Primate Research Center in Bogor, Indonesia and was moved to Bin Tan Island under Singapore lease to develop a new state of the art primate center to service Singapore and world commercial interests. The Singapore Development Corporation now has the majority ownership and the Australian parent company (Trounson – Chairman of Board) is being dissolved. The business involves the development of primate efficacy models in various therapeutic areas (e.g. cognition, diabetes, cardiovascular, pain, oncology); pharmacokinetic screening and ranking; and early toxicokinetic evaluation of candidate drugs for use in human medicine.

6. CopyRat/InjenKO Pty Ltd.
CopyRat is a spinout company from Monash University founded by Trounson in 2001 that was developing novel gene-targeting and stem cell technology in the rat in order to supply Knockout animals as models for human diseases.
IngenKO was a subsidiary of CopyRat Pty Ltd, a company formed in 2002 by Drs Hertzog and Trounson that aimed to become a world leading supplier of mouse and rat models of human disease to the biomedical industry. The investment was limited to $4mill by local Melbourne investors and despite limited cash flow from providing mouse Knockout and Knock in services to non-profit organizations and biotech companies, Monash University decided to close the merged company in 2005 because of the limited capital available.

7. National (Australian) Stem Cell Center (http:// www.nscc.edu.au/ascc)
- Trounson (with help of David de Kretser, Monash University, now Governor of Victoria), Dianna DeVore (US patent attorney), Bob Moses (biotechnology business leader) and colleagues won the national competitive grant for the first Australian Biotechnology Centre of Excellence, the National Stem Cell Center (now the Australian Stem Cell Centre - ASCC) in 2002. Funding was from the Australian Government to the tune of ~A$110 million over 10 years supplemented by other Federal and State funds, and provided support for a national endeavour for building strong platforms in adult and embryonic stem
cell research. The key scientists at the onset included Paul Simmons (adult mesenchymal stem cells), Peter Rathjen (mouse embryonic and neural stem cells), Martin Pera (human ES cells), Bernie Tuch (clinical diabetes research), Harvey (adult cardiac stem cells and heart repair), Mal Horne (neural stem cells and Neuro degeneration), Andrew Elefanty and Ed Stanley (embryonic stem cells differentiation into blood and pancreatic lineages), Richard Boyd (thymic immunology and stem cells) and Trounson (embryonic and adult stem cells and respiratory repair). A Board of Governors drawn from business, law, academia, ethics and politics heads the ASCC. A Stakeholders Committee represents the Research and Academic Institutions involved and reports to the Australian Government through a Deed of Agreement. The founding Chairman of the Board was R. Moses, CEO was Trounson, and COO was DeVore. Trounson stepped down to head a new research institute at Monash 2004 (Monash Immunology and Stem cell laboratories) and was made Deputy Chairman of the Board and Global International Strategic Advisor. These positions were concluded in 2006 and 2007, respectively.

Trounson Statement

The California stem cell agency released the following statement from its new permanent President, Alan Trounson.

Vision Statement for Relationship Between CIRM President and the Governing Board (ICOC)

Alan Trounson

The art of delivery of new developments in science and medicine, in my experience, has been dependent on creating partnerships with others with expertise in a different discipline. A shared vision then provides for a working relationship where the partners invest their expertise in achieving the potential outcome.

Historical Partnerships in Delivery of New Developments

There are many historical examples of productive partnerships, and in my case the key models include:

1.In vitro fertilization and associated technologies Trounson (scientist) and Dr. Carl Wood (clinician). Wood was a man of extraordinary vision and lateral thinking who provided the clinical platform for the embryology developed in basic research by Trounson and colleagues. There are now >4 million IVF children in the world as a consequence of this partnership and others.

2. The Institute of Reproduction and Development (IRD) Trounson (female reproduction and development – Deputy Director) and Dr. David de Kretser (male infertility expert – Director) came together as a partnership to develop a new Institute of Reproduction and Development at Monash University by fusing their research groups – Centre for Early Human Development (Trounson) and Andrology research group (de Kretser) in 1990. The IRD was the first research only institute at Monash University and rose quickly to international prominence as the world leading research institute in human reproduction, with more than 350 scientists by 2001. de Kretser was appointed Governor of Victoria in 2006 and Trounson left to establish the National (Australian) Stem Cell Centre in 2002.

3.The Australian Stem Cell Centre (ASCC) Trounson (scientist), Robert Moses (biotechnology business) and Dianna DeVore (patent attorney and molecular geneticist) joined in a partnership to win the Australian Biotechnology Centre of Excellence from all other disciplines in biotechnology. The ASCC was initiated with a grant of A$54 million for 3 years, followed by another tranche of A$54 million to carry through to 2011. Moses was made foundation Chairman of the Board, Trounson CEO and DeVore COO.

4. Embryonic Stem Cells Trounson (embryologist) and Martin Pera (embryonal carcinoma specialist from Oxford) joined together in a partnership at the IRD to develop human embryonic stem cells. They were successful, producing these cells in the late 1990s and led the new science of directing differentiation of these extremely interesting cells into the neuronal and other lineages.

5. Monash Immunology and Stem Cell Laboratories Trounson (stem cell biologist - Director) and Richard Boyd (thymic immunologist – Deputy Director) joined together to form a new research centre at Monash University – Monash Immunology and Stem Cell Laboratories. The two disciplines of stem cells and immunology created a unique focus for the delivery of stem cell technologies. Regulating the immune system is critical for delivery of allogenic cell therapies, and embryonic stem cells are being developed to reprogram tolerance and autoimmunity for transplantation and regenerative medicine.

Prospective Partnership Between Governing Board (ICOC) and the President of the CIRM

Partnership with the ICOC offers a unique mechanism for integrating key stakeholders from academic research, industry and advocacy in the discovery and development processes as we move toward therapies. The initiative (Prop 71) creates a participatory partnership between the leadership of the President of the CIRM and the governing board; the board represents a high-value spectrum of knowledge in medical research, patient advocacy and biotech experience that the President can draw upon in advancing the mission.

Klein, the visionary financier and designer of innovative systems, Chair of the governing board, and Trounson will form a partnership to deliver the incredible opportunity of cell therapies for regenerative medicine. Together they have the financial, political and scientific capacity to take the well prepared CIRM strategy to the desired outcomes in the clinic efficiently and effectively. The partnership provides the further opportunity to engage nationally and internationally with other leading groups in stem cell science to avoid duplication of effort and to hasten clinical applications.

Alan Trounson Named President of CIRM

California's $3 billion stem cell institute has found a new president, eminent Australian scientist Alan Trounson who is giving up his research to immigrate to California and oversee the world's largest single source of funding for embryonic stem cell research.

Reporter Sabin Russell of the San Francisco Chronicle quoted George Daley, president of the International Society for Stem Cell Research, as saying,

"It's a surprise move to have someone of his prominence in this role. This is a recognition of the incredible impact the California initiative has had. He's voting with his feet."

California stem cell chairman Robert Klein, who headed the presidential search, was obviously pleased by the move. He cited Trounson's "global vision."

The California Institute for Regenerative Medicine had been operating on lame duck status since last December, when former President Zach Hall announced he was going to retire. Early in August, the CIRM Oversight Committee named Richard Murphy, former president of the Salk Institute, as interim president.

Media reports indicated that Trounson hoped to begin work in San Francisco by the end of the year, but has not worked out all the visa requirements. Trounson will be paid either $490,000 or $475,000 annually depending on whether the state picks up his moving expenses. The salary is a substantial increase over the previous cap of $412,500 on the president's salary. Trounson is also giving up any investments in stem cell companies. Mary Engel of the Los Angeles Times said he will be able to work part-time on a pro-rated salary for up to six months as he closes his laboratory.

Reporter Terri Somers of the San Diego Union-Tribune wrote that the appointment is "viewed as a coup for California's ground-breaking institute because of his research resume, his entrepreneurial and management abilities and his experience navigating Australia's rocky political climate on human embryonic stem cell research."

Somers continued:

"'I have great respect for Alan as a scientific colleague and a deeply ethical and moral individual who will provide great leadership to the CIRM in coming years,' said Larry Goldstein, an embryonic stem cell researcher at the University of California San Diego who has collaborated with Trounson."

The Los Angeles Times' Engel quoted John Simpson of the Foundation for Taxpayer and Consumers Right as saying, "This is an excellent move. I am wonderfully impressed and completely surprised."

Somers also reported:

"As well as founding the Australian Stem Cell Centre at Monash University in 2003, Trounson has founded or co-founded eight companies. Among those companies is globally recognized Embryonic Stem Cells International in Singapore.
"Started in 2000 with angel investor money and investment from Singapore's research-loving government, Embryonic Stem Cells International holds the commercial rights and intellectual property to the initial six embryonic stem cell lines developed by the founders, who include Ariff Bongso, a Singapore IVF specialist considered to be a pioneer in deriving stem cells from human embryos."

Trounson told the Sydney Morning Herald:

"It's obviously a tremendous personal opportunity and honour, but it is also a sign of the high regard in which Australian research organisations and scientists are held internationally in stem cell research.

"This is a research field in which our achievements are world class - I see myself as an ambassador for all Australian medical researchers."

Trounson surfaced in American media earlier this year in support of challenges to stem cell patents held by the Wisconsin Alumni Research Organization.

The Los Angeles Times also reported:

"Trounson's career has not been free of controversy. He was criticized in 2002 after showing Australian legislators -- who were voting to legalize embryonic stem cell research -- a video of a rat that he said had been cured of paralysis using embryonic stem cells. It turned out that the rat had been given slightly older cells called foetal germ cells.

"Trounson said Friday that he had apologized to the parliament and learned "a very valuable lesson about ensuring precision in what you say to people."

Here are links to stories on the Trounson appointment. CIRM has not yet posted a news release. San Diego Union-Tribune, Los Angeles Times, San Francisco Chronicle, San Jose Mercury News , The Sydney Morning Telegraph, The Associated Press, Cellnews.

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.