Stem Cell Patent Flap Gains Wide Media Exposure

Three of the top names in California stem cell research – not to mention the world – surfaced during the weekend in a piece in the Los Angeles Times about a matter that is at the heart of the field – money.

Michael Hiltzik, a columnist at California's largest newspaper, brought up the scientists in connection with a patent imbroglio in Orange County that reaches into Stanford, the Salk Institute and Caltech via the researchers, who are Irv Weismann, Fred Gage and David Anderson, respectively of the three institutions.

Generally, such disputes put the general public to sleep. But Hiltzik wrote today,

"...(T)he penetration of private investment concerns into what used to be largely academic pastures threatens to hobble, rather than hasten, the march of science. The harvest may be secrecy, delay and the directing of research only toward developments that promise quick financial returns."

The matter pits researcher Philip Schwartz of the Children's Hospital of Orange County against StemCells, Inc., of Palo Alto, Ca., which was founded by Weissman, Gage and Anderson. Schwartz has spent six years providing academic researchers with neural stem cells cultured by a method he helped to invent at Salk, Hiltzik wrote.

But StemCells Inc. has effectively put a halt to Schwartz' distribution. That occurred after the firm wrote a letter to Children's Hospital warning that Schwartz' efforts infringed on its patents in the neural stem cell field and that it wanted to discuss a licensing arrangement.

This all started two years ago, but nothing has been resolved, although little apparent conflict exists between the “core clienteles” of StemCells Inc. and Children's Hospital. Hiltzik said,

"...(I)n the biotech world, where millions or even billions of dollars in profits beckon to those who can assert ownership of important discoveries, good intentions and purely scientific goals don't matter like they used to. Access by basic researchers to the essential building blocks of biomedical advances has been shrinking for years, thanks to a land rush by entrepreneurs wielding patent portfolios."

Hiltzik reported that the conflict between research and business has gone beyond biotech. He noted that Andy Grove, the fabled former CEO of Intel, this month warned of the evil effects of over zealous protection of IP.

The problem has become more serious, however, in stem cell science, according to Gregory Graff, a patent expert at Colorado State University.

According to Hiltzik,

"Graff says this phenomenon is becoming especially pronounced in stem cell science, which is especially dependent on collaboration but is already being cordoned off by commercial entities claiming property rights to essential research. The best solution, he says, may be for academic institutions -- where 45 percent of all stem cell research is performed -- to create collaborative patent pools so they can more freely disseminate information and technology without giving up all their potentially lucrative patent rights."

The issues raised by the Children's Hospital-StemCells, Inc., flap were first publicly reported April 15 by John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca. We carried a follow-up on April 16, noting that Harvard business professor and biotech industry consultant Gary Pisano warned in 2006 about the harmful impact of the "monetization of IP" on the biotech business. Our item triggered a robust exchange of comments that are attached at the end of the piece.

We asked Weissman, Gage and Anderson for comment a couple of times over the last several weeks. They did not respond to our queries. Nor they did respond to Hiltzik.

Little Hoover Hearing on CIRM on Wednesday

Possible recommendations for changes in the operations of the $3 billion California state stem cell agency will be discussed on Wednesday in Sacramento at a meeting of the CIRM subcommittee of the state's Little Hoover Commission.

The nonpartisan commission is California's longstanding good government and efficiency body and has been examining CIRM since last November, including the agency's accountability and transparency. The Little Hoover report is expected to be out this summer.

The session this Wednesday afternoon will provide a preview of its thinking and allow the public to make comments. To read more about its proceedings, click on the label below that says "hoover."

Consumer Watchdog Seeks Alteration of NIH Plan

Citing the “perverse effect” of proposed NIH stem cell research rules, the Consumer Watchdog group today called for changes in the guidelines along the lines recommended by the California stem cell agency and the Interstate Alliance on Stem Cell Research.

John M. Simpson, stem cell project director of the Santa Monica, Ca., group, said that the NIH plan would bar funding of research that had received financial support from the Bush Administration.

In a press release from his organization, Simpson said,

"Most of us were heartened when President Obama lifted Bush Administration restrictions on funding stem cell research, but the perverse effect of these proposed NIH rules is that the limited research scientists were able to conduct under Bush will now be ineligible for federal funding,

"Certainly this is not what President Obama intended and the regulations must be modified."

Simpson also noted that comments can be sent to the NIH online at the following Web site: http://nihoerextra.nih.gov/stem_cells/add.htm

Oceanside Firm Disappointed by NIH hESC Proposal

A California stem cell company has filed a strong critique of the NIH's proposed rules for human embryonic stem cell research.

International Stem Cell Corp. of Oceanside Tuesday said it was “surprised and disappointed” by the draft guidelines.

The company said the government is proposing to fund research that involves the destruction of human embryos while barring funding for research that uses cells from unfertilized eggs (parthenogenetic stem cells). International Stem Cell uses unfertilized eggs.

The firm said in a news release that use of such cells has been approved by CIRM and three independent embryonic stem cell research oversight committees in the United States.

International Stem Cell also said the proposed NIH rules will limit opportunities for U.S. researchers, potentially lead to lost jobs and researcher flight to other countries and create a de-facto monopoly for two organizations that control most of the patents for current embryonic stem cells.

Latest CIRM Comments on NIH hESC Rules

Here is a link to the most recent version of CIRM's comments on the proposed NIH rules on human embryonic stem cell research. Comments to the NIH must be filed by May 26.

CIRM Seeks Changes in NIH hESC Plans

The CIRM board of directors today approved recommendations for changes in proposed NIH rules for research involving human embryonic stem cells.

The action came on a 20-0 vote in a session during which directors were told that 7,000 responses to the rules had been received by the NIH. CIRM Chairman Robert Klein said the responses were running 7 to 1 against.

CIRM supports the NIH plans with some changes. The opposition appears to oppose them outright for religious reasons.

Board members were encouraged to individually call on their constituencies to file comments on behalf of hESC research with the NIH. Philip Pizzo, dean of the Stanford School of Medicine, said he had already done so in his weekly newsletter and emailed a copy of his comments to board staff for wider distribution.

Klein said the agency could not legally ask all its grant recipients in a “mass mailing” to support hESC research, but he said individual board members were free to do whatever they wished.

Geoff Lomax, senior officer for the CIRM Standards Working Group, developed the recommendations following a public hearing and contacts with researchers. He said the suggestions were aimed at avoiding the loss of material that is needed scientifically and already in use.

The document presented to the board will be refined by attorneys and staff before it is sent to the NIH by May 26.

CIRM Backs Biotech Industry Legislation, Aiming for Greater Federal Influence

The California stem cell agency today performed something of a semi-reversal and endorsed industry-supported federal legislation that would set rules for creation of generic biotech drugs.

CIRM’s board of directors last month supported a move to develop a statement of principles on the legislation, declining to ratify a recommendation by its Legislative Subcommittee that it support the industry bill.

However, this morning the board decided to back the industry measure rather than acting on the statement of principles developed by its staff over the last two weeks. The vote was 16-2 with two abstentions.

The consensus was that the industry needed to be encouraged financially to develop therapies, generally following the arguments made at the board meeting April 28-29.

Board member Joan Samuelson of Healdsburg, Ca., a patient advocate representative on the board, today said,

“The overriding concern is getting therapies to patients.”

Board member Oswald Steward, chair and director, Reeve, Irvine Research Center, University of California, Irvine, said, however, the board “should not act like a political action committee.” He said it “should be respected as much as the National Academy of Sciences.”

Jeff Sheehy, another board member and director for communications, UCSF AIDS Research Institute, supported Steward’s position, declaring he had “a lot of problems supporting a particular bill.” He said it would take the board “fairly deeply into the legislative process.”

Several board members, including Chairman Robert Klein, argued that CIRM could not become a player on the legislation without taking a specific stand. A statement of principles was meaningless at this point, they said.

The bill backed by CIRM is HR 1548 by Rep. Anna Eshoo, D-Palo Alto, which is favored by the Biotechnology Industry Organization. The board took no position on a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles, which BIO opposes. The Generic Pharmaceutical Association opposes the Eshoo bill.

Some board members were concerned about irritating Waxman, including Gerald Levey, dean of the UCLA School of Medicine. He said he did not “want to see CIRM caught in a political battle because we have enough of those.”

CIRM Vice Chairman Art Torres, a former state legislator who worked with Waxman, indicated that relations with Waxman would not be a problem as long the board did not directly oppose the Waxman bill.

Torres also indicated that the competing proposals may be wrapped into President Obama’s health initiative, which Waxman would carry.

A subtext of today’s session concerned the extent of CIRM’s role as a lobbyist at the federal level. The statement of principles on the legislation made a strong case for federal activities by CIRM as did Klein. CIRM recently hired a powerful Washington lobbyist, the Podesta Group, on a $240,000, 10-month contract, but the board has never had a full-blown discussion about how far it wants to go in lobbying at the federal level. The state of California has its own lobbyist, who works out of the governor’s office, but few, if any, state agencies engage in major federal lobbying efforts.

To be a significant player on the federal scene requires a hefty effort. Spending on lobbyists (nearly 11,000 in all) totaled $3.3 billion last year, and that figure does not reflect all expenditures made in attempts to influence federal legislation and regulations.

We invite comment on this subject or others. You can comment by clicking on the word "comment" below. Anonymous comments are permitted.

More Info on CIRM Board Webcast

You will need the following conference ID number to log into the Internet audiocast for this morning's meeting of the board of the California stem cell agency: 100945.
The url is http://65.197.1.15/att/confcast

CIRM Debate on Federal Issues Available at Many Locations Throughout California

Federal biotech legislation and proposed NIH rules on hESC research are the topics early Tuesday morning at a meeting of the board of the California stem cell agency that will be accessible at teleconference locations throughout California and on the Internet.

Interactivity will not be available for the Internet audiocast, but will be possible at multiple locations, including San Francisco (4), Los Angeles(2), Sacramento, La Jolla(3), Pleasanton, Berkeley, Elk Grove, Healdsburg, Hillsborouugh, Irvine(2), Stanford and Beverly Hills. Specific addresses where the public can attend can be found on the agenda.

CIRM said that the meeting can be heard on the Internet by using this URL:
http://65.197.1.15/att/confcast

No background material has been posted yet for the meeting, but you can read more about the issues here.

Podesta, CIRM and the Biotech Industry

The federal lobbyist for the California stem cell agency is doing quite well financially so far this year, but the CIRM account represents only a tiny fraction of its business.

During the first quarter of this year, the Podesta Group raked in $5.2 million, up 50 percent from a year ago, according to a story by Kevin Bogardus of The Hill Web site. The Washington, D.C., lobbyist won a $240,000, 10-month contract from CIRM earlier this year. In addition to California's publicly funded stem cell research effort, Podesta counts some major players in the pharmaceutical industry among its clients.

Federal lobbying is a big business. Total spending in 2008 hit $3.27 billion (yes, Billion) in 2008, up from $2.84 billion the previous year, according to Opensecrets.org. But the number of federal lobbyists is down to 10,785 from 15,287 last year.

Podesta accounted for only $16 million of the 2008 total. Most of its clients paid the firm less than $500,000 last year. They include Amgen, $240,000; Amylin, $180,00; Cubist Pharamceuticals, $150,000; Millenium Pharmaceuticals, $200,000; Novartis, $210,00; Reed Elsevier, $690,000; Roche, $240,000; Sereno, $350,000; Sunshine in Government Initiative, $200,000, and the University of Texas Anderson Medical Center, $300,000.

One of the issues currently being lobbied hard in Washington involves the financial future of the biotech industry. Competing legislation is before Congress that would set the rules for creation of generic biotech drugs -- biosimiliars.

It is also an issue on which CIRM is scheduled to take a position on May 12, although the CIRM board has backed away from a stand on specific bills.

J.K. Wall of the Indianapolis Business Journal on March 23 wrote about the lobbying efforts of Eli Lilly on biosimiliars.

Wall wrote:

"Indeed, generic biotech drugs represent a big threat to the large pharmaceutical companies, which increasingly have turned to biotech drugs for growth as their most successful chemical-pill-form medicines cruise toward the end of their patent lives."

Wall continued,

"Trouble is, biotech has become a synonym for exorbitant. For example, Herceptin, a biotech breast cancer treatment introduced 11 years ago by Genentech Inc, costs $40,000 for one year of treatment.

"'Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines,' said Kathleen Jaeger, CEO of the Generic Pharmaceutical Association, in a statement. 'Timely access to affordable biogenerics will save lives and save consumers and state and federal governments billions of dollars.'"

At its board meeting last month, some CIRM directors exhibited considerable discomfort at entering the fray with specific endorsements of competing legislation. Some questioned not only the appropriateness of CIRM taking a position, but whether it could have any significant impact on the legislative process. Mission creep was one complaint.

But the need to "protect" the biotech industry carried the day, and CIRM is scheduled to approve a statement of principles on generic biotech drugs on May 12.

No doubt exists that this is an important issue, affecting the industry and the development of drugs that could potentially ease much misery and suffering.

But one wonders whether California voters, in approving Prop. 71, envisioned hundreds of thousands of taxpayer dollars being spent for lobbying on behalf of any industry.

One also wonders about CIRM's relationship with Podesta and its array of drug industry clients. Which is the dog and which is the tail? Do CIRM's interests become subsumed in the pharmaceutical mix? And how can California taxpayers know for sure? Perhaps they can ask one of Podesta's other clients: The Sunshine in Government Initiative.

CIRM Takes on Federal Chores

The California stem cell agency will be dealing with federal stem cell and biotech matters over the next couple of weeks, including the proposed NIH rules on hESC research.

The agency has created a task force that will meet publicly this Thursday to hear comments on the rules. The panel is preparing a report that will be submitted to the full CIRM board on May 12 with the intent of getting the comments to the NIH later this month.

You can find CIRM's preliminary work on the subject here and our report here. Comments for CIRM can also be submitted via email at info@cirm.ca.gov.

Also on tap for the May 12 board meeting is consideration of a statement of principles dealing with federal legislation on production of biosimiliars, which would be copies of biotech drugs following expiration of their patents.

Teleconference locations are available for the May 12 meeting in San Francisco, Los Angeles(2), Sacramento, La Jolla(2), Pleasanton, Berkeley, Elk Grove, Healdsburg, and Irvine(2). Specific addresses can be found on the agenda.

Five teleconference locations exist for Thursday's meeting: San Francisco Elk Grove, Los Angeles, Healdsburg and Duarte. You find the addresses on the agenda.

Advisory

The California Stem Cell Report will be publishing intermittently over the next couple of weeks. We are back from Mexico for a visit to the Old Country (California) for visits with family and friends, who sometimes get in the way of daily publication of items on stem cell matters. And, no, we did not bring swine flu back with us from Mexico although a herd of wild swine chased us down the street as we ran to catch our plane out of Mazatlan.

Skimpy Coverage of CIRM Board Meeting

News coverage of the meeting of the board of the California stem cell agency was quite light today, focusing entirely on the approval of $68 million in grants.

Here are links to the stories and the few news releases put out by recipients. More publicity handouts are likely to surface over the next few days.

News

Terri Somers, San Diego Union Tribune

San Francisco Business Times

News releases

BioTime

Stanford

UC Irvine

CIRM Approves $68 Million in Grants; Wrestles with Executive Evaluation

LOS ANGELES -- The California stem cell agency today approved $68 million in grants for early translational research and left open the possibility that more might be awarded in June.

CIRM said in a news release,

"The 15 early translational grants approved by the board will go to 13 not-for-profit and two for-profit organizations. These grants are intended to either lead to a drug candidate for an unmet medical need or address a bottleneck in the development of new therapies."

CIRM President Alan Trounson was quoted as saying,

“With these early translational grants CIRM has taken the first step in funding translational research that will be critical for the development of future therapies.”

CIRM has talked about the importance of making grants to business. In this round, Novocell of San Diego, received $5.4 million and BioTime of Alameda, Ca., received $4.7 million. You can see a complete list of the approved applicants here.

Twelve additional grants had been recommended for funding by reviewers – if funds were available. But the board decided to put off a decision on those until June in hopes that CIRM will have an improved financial situation.

The board took no action on four letters from applicants seeking to reverse negative decisions by reviewers, but it rejected all applications ranked in the bottom tier. You can find the text of the petitions via the meeting agenda.

The board additionally approved $200,000 to co-sponsor the annual convention of the International Society for Stem Cell Research in San Francisco during the summer of 2010. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., supported the move although he was critical when the subject was first broached last December with a $400,000 price tag. Simpson praised as thorough the CIRM staff justification for the expenditure.

In other business, CIRM directors approved an evaluation process for the CIRM chair, vice chairs and president – the first such in the four-year history of the organization. The plan stirred debate concerning the composition and chairmanship of a new Evaluation Subcommittee of directors.

Some directors objected to permitting the Evaluation Subcommittee, which includes three of the four persons to be evaluated, decide who chairs the panel. Board member Jeff Sheehy, director for communications at the AIDS Research Institute at UC San Francisco, moved to designate the chair and vice chair of the Governance Subcommittee to fill the same positions on the Evaluation Subcommittee. Sherry Lansing, a UC regent and former movie studio CEO, and Claire Pomeroy, dean of the UC Davis School of Medicine, are chair and vice chair of the governance panel. They were key to working out the evaluation process.

Sheehy said it was not appropriate for the people being evaluated to have a voice in picking the chair of the Evaluation Subcommittee.

Klein, who will sit on the Evaluation Subcommittee, opposed Sheehy's motion although he indicated he was willing to permit the full board to select the heads of the evaluation panel. Sheehy's motion failed on a vote of 5-15 with four self-recusals and two abstentions.

Directors Robert Azziz, chairman of the department of obstetrics and gynecology at Cedars of Sinai in Los Angeles, and Carmen Puliafito, dean of the USC School of Medicine, expressed concern about the composition of the committee. Azziz said he wanted to avoid the perception of a conflict of interest. Puliafito said that the membership could give the appearance of "self-dealing."

The process was finally approved on an 18-5 vote with one self-recusal and two abstentions.

The board will make a decision on the chairs at a later date.

Here is the structure of the subcommittee as presented during today's board meeting. It will include:

• The chair and vice chairs of the Governance(Sherry Lansing), Finance (Michael Goldberg) and Legislative(CIRM Chairman Robert Klein) directors subcommittees.
• The chairs of the IP Task Force(Ed Penhoet) and the Biotech Loan Task Force (Duane Roth, who is also vice chair of the CIRM board of directors).
• The vice chairs or acting vice chair or co-chair where applicable of the Grants(Joan Samuelson or Sheehy), Standards (Lansing), Facilities (David Serrano Sewell) working groups.
• Two members appointed by the board but not yet named.
• The chair (Klein) and vice chairs (Roth and Art Torres)of the board except when they are the subject of an evaluation.

CIRM Debates Federal Legislation; $60 Million Grant Approvals Scheduled for Today

LOS ANGELES -- The board of the California stem cell agency last night backed away from endorsing industry-supported federal legislation dealing with biosimiliars, which would be copies of original biotechnological drugs following expiration of patent protection.

The board did not go along with its Legislative Subcommittee recommendation to support HR 1548 by Rep. Anna Eshoo, D-Palo Alto, which is favored by the Biotechnology Industry Organization. The subcommittee took no position on a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles, which BIO opposes.

Instead of endorsing the Eshoo measure, the board voted to seek development of a statement of principles that it would like to see in any such legislation. That statement could come up before the full board during a telephonic meeting May 12.

Robert Price, who sits on the board as an alternate for UC Berkeley Chancellor Robert Birgeneau, questioned the value of CIRM taking any position at all on the legislation.

Price, who is associate vice chancellor for research at UC Berkeley, asked,

"Do we really matter that much? I think we don't. Let's not engage in hubris here."

A number of other members of the board spoke both on behalf of the legislation and the need to protect businesses that put up the cash to develop new drugs.

Board member Ed Penhoet, former president of Chiron and a member of the National Academcy Sciences Board on Science, Technoloogy and Economic Policy, said the two pieces of legislation deal with the balance between the cost of therapies and the cost of innovation. He said it was "the most important issue in health care today."

Board member Sherry Lansing, the former head of a Hollywood film studio and a University of California regent, said,

"There will be no drugs unless we protect the people who take the risk."

As for the argument over high costs denying access to drugs, CIRM Vice Chairman Art Torres, former chairman of the California state Democratic Party, said,

"You can't have accessibility unless you have something to access."

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., characterized the push for CIRM to become a player in Congress as a "little bit of mission creep."

In other business, CIRM communications chief Don Gibbons previewed the agency's new website, which he said should be up in a few days. He said it was designed to offer more information that will be better organized and accessible.

CIRM officials also officially confirmed for board members the news on the California Stem Cell Report that the agency's financial woes are over for some time. The agency will receive $505 million from the recent state bond sale. However, cash will get tight again by the end of 2010 unless CIRM raises more funds through the sale of state bonds.

In light of the good financial news, the board indicated that it wanted to reconsider its one-year delay in a training grant program. That topic is expected to come up in June. Additionally put off was an update on CIRM grantee progress report monitoring. Earlier a CIRM official had said said grants would be pulled because of a lack of progress, but he did not say when that would be announced.

Also on the board agenda last night were applications for $60 million in grants, including four petitions to overturn negative recommendations from reviewers. However, that was put off until this morning along with a request for $200,000 to co-sponsor the annual convention of the International Society for Stem Cell Research.

Another item scheduled to be acted on today is the performance evaluation process for the Chairman Robert Klein, President Alan Trounson and Vice Chairs Torres and Duane Roth. It is the first time the CIRM board has officially promulgated publicly an evaluation procedure for the positions. But until recently the chair and vice chairs did not receive compensation. Roth has declined a salary, but Torres is receiving one.

This morning's meeting can be heard via the Internet. Details for the Web access are here. Teleconference locations for listening and participating are available in Sacramento, Pleasanton and at Stanford. Specific addresses can be found here.

Controller Calls for Online Posting of Financial Holdings of CIRM Officials

California's top fiscal officer wants to see posted on the Internet the statements of economic interests and travel and other expense forms of the top officials of the state's $3 billion stem cell agency.

Controller John Chiang, who chairs the committee that oversees CIRM's financial practices, will soon call a meeting of the panel to discuss how to implement the postings.

Chiang's plan would cover the 29-member CIRM board of directors, its executive staff and the members of the financial practices panel, which is officially called the Citizens Financial Accountability and Oversight Committee (CFAOC).

Chiang's move follows the lead of Gov. Arnold Schwarzenegger, who posts his top staff's economic interest statements and expenses on the Web. On April 2, we wrote about governor's postings and recommended the practice as something to be emulated by CIRM.

Internet publication of CIRM's information came up April 14 at a meeting of the CFAOC. Ruth Holton-Hodson, deputy controller for health and consumer policy, was filling for Chiang, who was ill.

According to the transcript, she said,

"The public is naturally very concerned about transparency, especially in these times when it comes to spending public dollars and potential conflicts of interest that might arise."

She noted that Chiang will be offering online the financial information for himself and his staff.

Posting the information serves the public well. But it is also healthy for CIRM, an agency that is riddled with built-in conflicts of interest, perhaps more so than any other state department.

The CIRM board of directors is dominated by folks from the institutions that have been the chief beneficiaries of CIRM´s largess. As of last October, 18 institutions with representatives on the board (past and present) had received $552 million in CIRM grants. More has been awarded since then. This week the CIRM board is expected to approve an additional $60 million in grants, most of which is likely to go to institutions connected to board members. Board members cannot vote on grants to their institutions, but the entire board sets the rules under which the grants are made and establishes the priorities for spending the billions of dollars.

Hallye Jordan, spokeswoman for Chiang, said a date has not yet been set for the meeting of the CFAOC to discuss implementing postings by CIRM. The subject will be the only item on the agenda.

Public CIRM Hearing Next Week on NIH hESC Rules

If you are interested in the proposed NIH regulations for hESC research and California's reaction to them, put a May 7 meeting of the California stem cell agency on your calendar.

Not long after the CIRM directors Legislative Subcommittee Monday approved creation of a task force on the subject, a meeting with teleconference locations in San Francisco, Elk Grove, Los Angeles, Healdsburg and Duarte was scheduled for next week. Specific addresses can be found on the agenda.

Comments on the proposed rules must be submitted by May 24 to the NIH. You can read more on what CIRM has done so far here, but keep in mind that this is very much a work in progress.

California's Stem Cell Education Bill Comes Before CIRM and Senate on Wednesday

The board of directors of the California stem cell agency on Wednesday will discuss newly strengthened legislation to push stem cell research training and education into California public schools.

The bill, SB 471 by Sen. Gloria Romero, D-East Los Angeles, and Senate President Pro Tem Darrell Steinberg, D-Sacramento, will now require state schools to establish and promote as a state priority a stem cell and biotech education program. Previously the legislation said such an effort "should" occur.

The bill is now dubbed the "California Stem Cell and Biotechnology Education and Workforce Development Act of 2009." It is supported by the BIOCOM industry group and opposed by the California Catholic Conference. CIRM has not yet officially taken a position on the measure, but has been working with the measure's authors.

The measure was added Monday afternoon to the board's agenda for its meeting that begins today in Los Angeles. Remote, interactive teleconference locations for the meeting are available in Sacramento, Pleasanton and at Stanford. Specific sites can be found on the board's agenda.

The bill is now before the Senate Education Committee, where it is certain to be approved on Wednesday. The legislation is likely to move easily through the Senate because the top Senate leader, Steinberg, is one of the authors.

Here is a link to the legislative staff analysis of the measure.

Public Can Participate in CIRM Board Meetings at Stanford, Sacramento and Pleasanton

For those of you unable to be personally present at the Tuesday and Wednesday meetings of the board of the $3 billion California stem cell agency, you can hear and participate in the proceedings from remote locations in Sacramento, Pleasanton and at Stanford.

The specific locations can be found on the agenda for the meetings. The remote access is being provided for the convenience of board members whose schedules make it difficult for them to attend the meetings in Los Angeles.

The practice began a few months ago to help avoid the problem of mustering the super-quorum needed for the CIRM board to officially do its business.

Also available is an Internet audiocast of the proceedings – one-way only. No participation is permitted via the audiocast. You can find details of how to gain access to the audiocast here.

For your planning purposes, the Tuesday session usually is devoted mainly to grant reviews, although Chairman Robert Klein is likely to discuss CIRM finances. Other business may come up as well.

CIRM's Initial Assessment on NIH hESC Rules; Task Force to Develop More Analysis

A key group of directors of the California stem cell agency this morning moved to create a task force to study and comment on the proposed NIH rules for human embryonic stem cell research.

The Legislative Subcommittee of the CIRM board of directors voted 7-0 to proceed with the work on the NIH rules, which have drawn fire from scientists in California. The action now goes to the full board for expected approval at its meeting Tuesday and Wednesday in Los Angeles.

CIRM plans to consult with institutions, scientists, the public and others in developing an analysis and recommendations on the NIH rules by May 24. Meetings of the task force are expected to be conducted in public. The CIRM board will hold a telephonic, public meeting on the final CIRM document, according to CIRM Chairman Robert Klein.

CIRM will also work with the Interstate Alliance on Stem Cell Research in developing its proposal. The alliance previously scheduled a May 5 meeting in Washington, D.C., which could provide a venue for exploration of the issues, said Geoff Lomax, senior officer for medical and ethical standards.

Following the 7:30 a.m. meeting today, CIRM posted background material and other information on the issues on its website. They include a comparison between the NIH guidelines and CIRM regulations and an intial assessment of the impact of the NIH proposal.

Among other things, CIRM's first-cut at the rules said,

"Our conclusion from this preliminary analysis is that the consent protocol for some lines does not include all items identified by NIH in its eligibility criteria, suggesting some scientifically significant lines may not qualify. All lines evaluated were derived from balstocysts created for reproductive purposes but no longer required for family planning."

"The draft policy sets ' high bar' for consent and disclosure. There are concerns that established cell lines may not meet the proposed standard. Substantial foundational research has been performed utilizing established lines. NIH should consider a 'grandfathering' clause or other mechanism that enables continued use of established lines. NIH should give consideration to whether a particular line was derived in accordance with consensus guidelines or the legal requirements at the time of consent or derivation."

"Further, experience suggests there may be uncertainty to whether specific cell lines conform to every requirement of the draft guidelines. This uncertainty may result in qualifying lines not being utilized. There was broad consensus that a registry of compliant lines would be the most efficient method for identifying lines and ensuring promising research materials are not unnecessarily disqualified."

"For grantee institutions the promulgation of NIH guidelines raises question related to the implementation of grants where a mix of funding is involved. For example, one institution identified the case where research involves a comparative analysis of multiple hESC lines. It is conceivable that such a study could involve lines not recognized or approved by every funding source. Harmonization of rules, to the extent allowed by law, would be desirable from this grantees perspective."

CIRM said,

"As the largest funder of human embryonic stem cell research in the world, CIRM has an interest in ensuring that the NIH rules are consistent with CIRM’s medical and ethical standards, which were modeled upon guidelines adopted by the National Academies of Science, and with the best interests of science and patients."

The NIH announced its proposed new rules only 10 days ago. CIRM completed its preliminary analysis last Friday. However, the actually posting of documents relies on a state department that does not work during the weekend.

The Legislative Subcommittee also voted to support 6-0 with one abstention (Jeff Sheehy) a federal bill dealing with biosimiliars, which are copies of the original biotechnological drugs following the expiration of patent protection.

The panel backed HR 1548, by Rep. Anna Eshoo, D-Palo Alto, which is also supported by the Biotechnology Industry Organization. The industry group opposes a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles. The subcommittee did not take a position on Waxman's bill.

CIRM Panel to Debate NIH Rules This Morning

The San Francisco Chronicle this morning carried a stout defense of the NIH's proposed rules for human embryonic stem cell research just hours before the California stem cell agency is scheduled to debate the proposal.

The proposed regulations, opposed by some scientists in California, were endorsed Jesse Reynolds of the Center for Genetics and Society of Oakland, Ca., in an op-ed piece in the Chronicle.

Reynolds said the proposals were thoughtful and the "right thing to do."

He said that that barring federal funds for cloning-based stem cell research would help to prevent creation of a technical foundation for reproductive cloning, which "continues to tempt rogue scientists."

The CIRM directors Legislative Subcommittee is scheduled to take up the NIH proposal at 7:30 a.m. PDT today. The agency has only posted a cryptic agenda item on the subject and has not offered to the public any analysis of the regulations or a rationale for why CIRM should take a position on the federal plan.

We will have coverage of the meeting later today.

CIRM Reassures Grantees on Their Cash

Late Friday, the California stem cell agency sent the following email to CIRM grantees:

"We at CIRM headquarters want to send you some reassuring news regarding CIRM’s finances and our plans to continue a full and robust research portfolio. This week the California State Treasurer successfully sold $6.85 billion in bonds, more than twice the amount originally sought by the treasurer. This vote of confidence by the investor community is good news for CIRM, our grantees and all the patients in California and elsewhere we seek to serve.

"Robert Klein, chair of the CIRM governing board, thanked the State Department of Finance and the State Treasurer’s Office for their tremendous efforts. He indicated that the estimated $275 million in additional funds expected for the agency raises the funds available for grants and facilities to some $400 million and this will cover all commitments, existing and expected, for the next 18 months."

More on the $505 Million for CIRM

The San Francisco Weekly, which produced a thorough overview of CIRM earlier this month, today picked up our report on the $505 million cash infusion that is expected to bail out the California stem cell agency.

Peter Jamison wrote,

"CIRM spokesman Don Gibbons said he could not confirm (David) Jensen's figures, because the agency has received nothing in writing from the state treasurer. However, Gibbons said CIRM 'has indications' that the report is accurate and hopes to make a definitive announcement at a board meeting next week in Los Angeles. Jensen quoted Robert Feyer, bond counsel to the treasurer's office, as confirming that $505 million was set aside for CIRM and would be available next Tuesday."

CIRM: Some Scientists' Grants to be Pulled

Some researchers who have been funded by California's $3 billion stem cell agency are going to lose their grants because of a lack of progress, according to a top CIRM official.

John Robson, CIRM vice president for operations, made the statement April 14 at a meeting of the Citizens Financial Accountability Oversight Committee, a five-member panel chaired by state Controller John Chiang, California's top fiscal officer. The committee is is charged with assessing CIRM's financial practices.

Robson's remarks came as part of a general response to questions about risk assessments by CIRM.

According to the transcript, he said,

"....(W)e get annual reviews, progress reports and our science officers go through those. And it's not a perfunctory exercise. They go through these things quite carefully. If there's things they don't understand or if it doesn't look (like) there's been much progress, they call up the PI (principal investigator) and they say, 'What's going on? You know, we've seen these experiments being done. What's your progress?' And then we work from there.

"If it turns out that there's no progress, we can cut the grant. I suspect that's going to happen. Some people are going to lose some grants."

Ruth Holton-Hodson, deputy controller for health and consumer policy, raised the questions about risk. She chaired the meeting in the absence of Chiang, who had suffered a foot injury, and said she brought up the matter on his behalf.

The Citizens Financial Accountability Oversight Committee is not to be confused with CIRM's Independent Citizens Oversight Committee, which is the 29-member CIRM board of directors. Chiang, a Democrat, is a statewide elected official. He was given the role of chairman of the financial accountability committee by Prop. 71, the ballot measure that created CIRM.

The CIRM board of directors meets next Tuesday and Wednesday in Los Angeles. Item No. 8 on the agenda is an "update on CIRM grantee progress report monitoring." No further details were provided on the agenda on that item.

State Bond Sale Provides $505 Million for CIRM

The California stem cell agency, once on its way to running out of money by next fall, is now slated to receive $505 million as the result of the sale this week of $6.86 billion in state bonds.

Robert Feyer of Orrick, Herrington & Sutcliffe, bond counsel to the state treasurer, told the California Stem Cell Report,

"I can confirm for your readers that the large state bond issue which was priced today (total of $6.855 billion) includes $505 million for the stem cell program. This money will be available next Tuesday, when the transaction closes."

CIRM Chairman Robert Klein is likely to discuss the impact of the funding at next week's board of directors meeting in Los Angeles. Feyer said that a "good portion" of the bond cash is expected to go for facilities grants. It is not clear whether CIRM will give up its plan to market state bonds privately.

CIRM relies almost totally on state bond funding. The measure that created the agency, Prop. 71, specified the nature of the funding so that CIRM did not have to ask the legislature and the governor for cash. Because of its budget crisis, California, until recently, had not sold any bonds since last June.

Translational Grant Reviews Now Available From CIRM

The California stem cell agency has posted the reviews of grant applications for $60 million for early translational research that will be awarded at next week's meeting of CIRM's board of directors in Los Angeles.

Ten grants are scheduled to be approved by directors. However, grant reviewers have given the okay to 15 totaling about $68 million. If the directors want to stay within their original budget, they will have to take the rare step of rejecting a positive decision on grants by reviewers.

The grants that have won reviewer approval include proposals dealing with cartilage regeneration and osteoarthritis, Alzheimer's, Parkinson's and macular degeneration. You can find the reviews here along with their scores.

The names of the applicants have been withheld by CIRM, but the identities of some may be discerned from the reviews by persons familiar with stem cell research.

Also now available on the directors' agenda is a side-by-side comparison of two federal bills dealing with biosimiliars, which are copies of the original biotechnological drugs following the expiration of patent protection. Directors are expected to be asked to take a position on the measures, but they will first be discussed Monday morning by the Legislative Subcommittee.

One of the bills, HR 1548, by Rep. Anna Eshoo, D-Palo Alto, is supported by the Biotechnology Industry Organization, which opposes a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles. It would be interesting to know whether CIRM's $240,000, federal lobbyist, the Podesta Group, is lobbying for or against either one of the bills.

With three business days remaining before the directors meeting, CIRM has not posted any background material on its possible position on the proposed NIH rules on hESC research and several other items. They include the monitoring of CIRM grantees, the agency's statewide education program and evaluation procedures for the chair, vice chair and president.

CIRM Board Meeting Will be Available on the Internet

Next week's meeting of the board of directors of the California stem cell agency can be heard on the Web via an audiocast, but it will not be available through a dial-in connection.

The Tuesday session begins at 4:30 p.m.and can be at this url: http://65.197.1.15/att/confcast

CIRM said interested parties should enter conference ID# 997897 then click go.

For the Wednesday session, use the same procedure beginning at 8:30 a.m.

The general procedure at CIRM board meetings is go over the grants on Tuesday, but other business is often taken up. CIRM Chairman Robert Klein is likely to open with a statement. CIRM President Alan Trounson could also make his report, including his take on the latest stem cell research in the news.

No audiocast via a dial-in connection will be available next week because of logistical issues, CIRM said.

CIRM Provides Justification for $200,000 for ISSCR Meeting

Much to its credit, the California stem cell agency Tuesday posted a dandy backgrounder on its recommendation that CIRM directors next week approve $200,000 to assist the International Society for Stem Cell Research with its convention in San Francisco in 2010.

The document is a far cry from the original request in December that sought $400,000 but did not provide any justification or explanation. This week's document is a good example of the type of information that CIRM can provide that assists in meaningful public participation in the agency's activities.

While one may or may not agree with the recommendation to co-sponsor the convention, CIRM does a fine job in pointing out the benefits to the agency, the state and science in general. The document lists eight benefits from the contribution, including no-cost attendance by CIRM staff and interaction of CIRM grantees and trainees with the world's top stem cell scientists. CIRM said,

"All of these benefits will be continuous reminders to the attendees, including the leading stem cell scientists in the world, that California drives the field and is an attractive, vibrant location for academic researchers and biotech companies. As new funding opportunities become available for stem cell research elsewhere, California cannot rest on its laurels, if it is to attract and retain the best scientists and companies. We think that conference co-sponsorship is a valuable means to enhance those efforts."

CIRM said that about 500 California scientists are expected to attend the 2010 meeting. (About 2,800 persons attended the ISSCR convention in 2008.)

CIRM said,

"If the meeting were to be held outside California, the increased travel costs alone for 500 attendees could easily exceed $250,000, much of which would have to be paid with CIRM grant funds."

We wonder about that assertion, largely because we were not aware that CIRM grants provided for travel and participation in the annual conventions of the ISSCR. This year's meeting is in Barcelona. One would think that financing international jaunts is not necessarily an appropriate use of taxpayer funds unless it can be very explicitly tied to the purpose of the grant.

Total cost of the San Francisco meeting is an estimated $1.5 million. CIRM is also helping out in arranging for the no-cost use of Moscone Center for the meeting and the rotunda at city hall for a reception. The value of those contributions by the City of San Francisco is placed at $125,000.

CIRM's proposed $200,000 contribution would go for travel expenses for organizers and speakers ($50,000) and conference services, publicity and publications ($150,000).

CIRM said the $200,000 should be taken from privately donated funds, which now total $3.4 million. That would be a good PR move, helping to ease any criticism of the expenditures. Nonetheless, the money is still public money. It became that when it was donated.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., publicly criticized the earlier CIRM moves to assist with the meeting. We have not heard from him yet on the latest proposal.

CIRM staff provided the breakdown and detailed justification for its recommendation as the result of requests by CIRM directors in December.

The recommendation for funding is expected to be voted on at next Tuesday's and Wednesday's meeting of the board of directors in Los Angeles.

CIRM to Hand Out $60 Million Next Week in Move Towards the Clinic

Directors of the California's financially troubled stem cell agency are likely to receive a bit of good news one week from today as they meet in Los Angeles to give away $60 million for projects to push stem cells into the clinic.

CIRM has been suffering from a cash crunch, but today the state of California is going to market with as much as $4 billion in taxable bonds. CIRM is on tap to receive a good chunk of that, probably enough to keep it from running out of funds by this fall.

The bond sale is not mentioned in the formal agenda, but Chairman Bob Klein will certainly discuss it along with his plan to sell state bonds privately on behalf of the $3 billion enterprise.

The directors are also scheduled to approve 10 grants totaling $60 million for early translational research. CIRM says the awards

"...are designed to move promising basic research in stem cell science toward the clinic. These awards will support two categories of projects including research that: 1) results in a development candidate that meets an unmet medical need; or 2) addresses a significant bottleneck in the translation of stem cell biology that hinders advancement of effective, novel cell therapies to the clinic."

The topic of the awards could trigger general discussion of the direction of CIRM and its strategic plan, although the plan is not on the agenda. CIRM President Alan Trounson may bring it up during his report to the board.

CIRM's direction recently came under review in a piece in the San Francisco Weekly that was headlined "Stem-cell stalemate: The push for cures may produce only disappointment - or worse."

Also on tap is the proposed co-sponsorship of the 2010 San Francisco convention of the International Society for Stem Cell Research. The latest price tag for that is $250,000, down from $400,000. CIRM has said it will help the group raise $150,000, a move that drew some fire from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca.

Also on tap are evaluation procedures for CIRM's chair, vice chair and president along with consideration of two pieces of federal legislation and the proposed NIH rules for human embryonic stem cell research (see "CIRM and the NIH").

As usual, CIRM has not provided any links or background information on all these issues on the agenda on its web site. That means that the public is hard pressed to determine the significance of the cryptic listings of matters to come before directors of the world's largest source of funding for human embryonic stem cell research. Without some frame of reference, interested parties – be they business, academic or otherwise – find it difficult to determine whether their enterprises are being affected.

Although Klein has repeatedly pledged to adhere to the highest standards of openness, CIRM's chronic failure to post background material in a timely fashion demonstrates the bankruptcy of that pledge.

We are asking CIRM whether there are issues or other problems that we do not understand concerning the failure to post background material.

CIRM and the NIH: A Stand on the Proposed hESC Rules?

Directors of the California stem cell agency next week will take up the proposed NIH regulations for human embryonic stem cell research that have triggered dismay among some scientists in the state and elsewhere.

The topic is on the agenda of the CIRM directors' Legislative Subcommittee meeting one week from today and then it comes before the full board the following day or two at its Los Angeles meeting.

In the eyes of some influential scientists, the proposed regulations are too restrictive. Irv Weissman of Stanford promptly criticized them last Friday as just substituting one ideology for another. Susan Fisher, co-director of stem cell research at UC San Francisco, also was not pleased. She told Lisa Krieger of the San Jose Mercury News,

"This mostly moves the line in the sand from 2001 to 2009."

Fisher said,

"We still desperately need CIRM and private funding,"

On the East Coast, reporter Ceci Connolly of the Washington Post wrote,

"'I am really, really startled,' said Susan L. Solomon, chief executive of the private New York Stem Cell Foundation. 'This seems to be a political calculus when what we want in this country is a scientific research calculus.'"

Generally, however, the proposed NIH rules received mild or better praise in most of the stories that we have seen. Jesse Reynolds of the Center for Genetics and Society in Oakland, Ca., wrote on his organization's blog, Biopolitical Times, that the NIH "got it right."

He said the regulations are "consistent with his (Obama's) campaign promises, consistent with public opinion, and draw lines in a way that will allow promising research to go forward while preventing potential abuses."

It was clear, however, that the NIH rules are very much a product that was based on a reading of public opinion about stem cell science, a fact that was mentioned in several stories.

Reporter Gardiner Harris of the New York Times also noted a bit of presidential political history, writing,

"During the campaign last year, Mr. Obama said he supported 'therapeutic cloning of stem cells,' a policy his administration rejected Friday. A White House spokesman, Reid Cherlin, said the president 'directed N.I.H. to formulate the best method for moving forward with stem cell research, both ethically and scientifically,' in an independent process."

CIRM's decision to place the regulations before its directors raises some interesting questions.
What does CIRM have to gain by entering this particular fray? Failure to oppose them will alienate some influential researchers and perhaps their parent institutions.

Supporting the rules could be regarded as institutionally self-serving and as an attempt to justify the continued existence of CIRM, whose origins were based on former President Bush's restrictive policies. Some of have argued that CIRM is now irrelevant, given Obama's moves and the changing nature of stem cell science. However, it is hard to see how $3 billion in research funding could be considered irrelevant by anyone. The NIH is certainly not going to fund all the fondest desires of even those who qualify under its proposed rules.

Also on next week's CIRM agendas are other federal matters that could place CIRM in the middle of a pharmaceutical war. Up for consideration by CIRM directors are two Congressional bills involving biosimiliars – HR 1427 by Rep. Henry Waxman, D-Los Angeles, and HR 1548 by Rep. Anna Eshoo, D-Palo Alto.

The Biotechnology Industry Organization does not care for Waxman's bill, declaring that it "would jeopardize patient safety and undermine future medical breakthroughs," according to Patricia Van Arnum of Pharmatech.com. Waxman, of course, thinks differently.

He said his bill would "allow the Food and Drug Administration to approve affordable copies of biotech drugs." He said,

"Biotech drugs, while often life-saving, are the fastest growing and most expensive components of the nation’s prescription drug bill."

BIO favors Eshoo's bill, according to Van Arnum, declaring that it balances "the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs."

The Legislative Subcommittee meeting will have teleconference access available 7:30 a.m. next Monday at seven locations: two in San Francisco and others in Portola Valley, Menlo Park, Elk Grove, Healdsburg and La Jolla. You can listen in and participate from those locations. If you are unable to attend, you may submit a statement by sending it to info@cirm.ca.gov.

The full board meeting does not have interactive teleconference access, but it may be available via the Internet and a phone line audiocast.

We invite comment on this item and CIRM's role in NIH affairs. You can submit comments by clicking on the word "comments" below. Anonymous comments are permitted.

Torres, Palin and Stem Cell Research

It was the first known public comment by a member of the board of directors of the California stem cell agency on onetime vice presidential nominee Sarah Palin.

The remarks came Friday from Art Torres, recently elected co- vice chairman of the CIRM board,

The occasion was a tour of stem cell lab facilities at UC San Francisco and the Gladstone Institute involving House Speaker Nancy Pelosi, according to an account by reporter Carla Marinucci in the San Francisco Chronicle.

Pelosi was asked about comments by Palin, attacking President Obama for his support for hESC research. Pelosi stoutly defended the research, declaring, "We need science, science, science, science, science."

Torres said that Palin's comments were "very disappointing...because it's such a blatant campaign move."

Marinucci wrote,

"He said she was 'playing to the crowd' for a 2012 run, but hasn't offered any alternatives to the major advances that might be made in biomedical research."

Readers left 124 comments on the Chronicle piece, but not one mentioned Torres' comments, as far as we can tell. However, one commentator said that Pelosi said science only four times – not five.

Stanford's Weissman Flays Proposed NIH hESC Regs

The NIH's proposed hESC regulations were hardly off the presses today before they came under fire from an eminent stem cell researcher for flying in the face of President Obama's March proclamation on stem cell research.

Irv Weissman(pictured), director of stem cell research at Stanford, took on the NIH in a news release from the Stanfod School of Medicine.

Weissman said,

"Instead of facts, the NIH placed its own version of ethics in place of the president’s clear proclamation. As head of the National Academy of Sciences' panel that unanimously endorsed research using SCNT, and as a drafter of the guidelines for the International Society for Stem Cell Research, I know that this suggested ban on federal funding of SCNT-derived human embryonic stem cell lines is against our policies and against President Obama’s March 9 comments. The NIH has not served its president well."

The news release continued,

"'I am happy that these are draft guidelines,” said Weissman, who noted that the NIH did not solicit input from either the National Academy of Sciences or the International Society for Stem Cell Research during the consensus process. 'I’d like to remind the NIH of the principles enunciated by the president on March 9. Research in this area is moving very fast, and it’s not possible to say whether advances will come from work on adult-derived iPS cells or from embryonic stem cells created by nuclear transfer. Policy needs to be developed as the field develops, rather than precluding something based on ideology.'"

Across San Francisco Bay in Oakland, the Center for Genetics and Society praised the regulations,

Its news release said,

"Cloning-based stem cell research lays the technical foundation for human reproductive cloning - which the U.S., unlike dozens of other countries, has not yet prohibited - and requires enormous numbers of human eggs, whose extraction poses health risks to women. Despite years of work, no researcher has created a clonal human embryo viable enough to yield stem cells," said Jesse Reynolds, policy analyst at the Center. "In contrast, alternative methods of cellular reprogramming have largely achieved the goals of cloning-based work. The NIH was wise in leaving such risky work outside the domain of federal funding."

The group did not address CIRM's position on the proposed rules, but it has been an advocate of strong national standards.

CIRM Able to Fund Research Excluded by Proposed NIH Regulations

The California stem cell agency today said that the proposed NIH regulations for human embryonic stem cell research are "largely consistent" with the state regulations, although CIRM will be able to fund projects that would be barred from federal funds.

The agency issued a news release on the matter this afternoon. It said,

"The conditions required by the NIH are largely consistent with requirements CIRM has developed for derivation performed by our grantees, according to Geoff Lomax, senior officer for medical and ethical standards. 'For our grantees working with lines derived under CIRM standards, these regulations open the door to broader sources of funding, expanding important research in California,' Lomax said.

"Lomax said that under both sets of guidelines, researchers hoping to use a particular stem cell line must prove that the couple who donated the embryo knew that they would not personally benefit from the work, that they would not benefit from possible commercial applications of the cells, and that they could not place restrictions on the type of research performed with the cell line, among other conditions. He added that CIRM may need to make a minor revision to its regulations requiring that couples be specifically informed of all options for disposing of their excess embryos before donating to research.

"Lomax added that there are important avenues of research funded by CIRM that are prohibited under the draft regulations. These include the creation of new stem cell lines, and any work with lines created through nuclear transfer (sometimes called therapeutic cloning) or parthenogenesis, in which the egg is stimulated to begin division without fertilization.

"'CIRM remains a critical source of funding in California for work that is not eligible for funding by the NIH but that has important scientific value,' Lomax said. For example, embryonic stem cell lines created through parthenogenesis are genetically identical to the donor and could be an important source of stem cells for therapies."

UC Sounds Cautionary Note on Stem Cell Therapy Amid 'Guarded Optimism'

Rays of economic hope were scattered through two stem cell/biotech conferences this week in the San Francisco Bay Area – one focusing on industry and one more oriented towards academe.

The BayBio industry group sponsored one meeting in South San Francisco that attracted 700 participants, according to David Morill's account on InsideBayArea.com, a Web site for six daily newspapers in that area.

While acknowledging the difficult economic times, Morrill quoted Matt Gardner, president of BayBio, as saying,

"We've had a couple of companies shut down, but overall there is definitely a guarded optimism here. There is a lot of focus this year on partnering and venture marketing."

No one from the mainstream media wrote about the other affair so the University of California presented its version online in an article by an unnamed author.

UC reported that 320 researchers, biotech execs and money folks attended the April 15 meeting hosted by the UC Office of Technology Transfer and the British and Canadian consulates. One speaker, Gregory Bonfiglio of Proteus Venture Partners, said the commercial market in regenerative medicine will grow to $118 billion next year compared to $3.6 billion last year.

UC took pride in pointing out that it has snagged $420 million out of the $694 million that CIRM has handed out in research and construction grants. The university did not mention that 11 of the 29 members of the CIRM board of directors, which sets both the rules for grants and awards them, have links to the University of California.

UC also fired a shot in the debate about CIRM's push into clinical trials vs. basic research. And given that the article came from the Office of the President, it carries some considerable weight. Here is what it said,

"The biggest contribution UC is making to this new stem cell economy is in advancing basic research and training, said Steven Beckwith, vice president of research and graduate studies in the UC office of the President, who delivered one of the keynote speeches at the forum.

"'There are now avenues where stem cells can be used for therapeutic remedies, but they're limited,' Beckwith said. The real potential won't be realized until we understand the fundamental mechanisms behind these cells. That's the strength of university research.'"

San Diego's Stem Cell Consortium Still Hunting For Cash

San Diego's Sanford stem cell consortium is buoyed by the latest assurances that it will receive $43 million from CIRM to assist with its new research lab, but it still needs to borrow as much as $65 million more, the San Diego Union-Tribune reported today.

Reporter Terri Somers wrote:

"For months, the state could not sell bonds to support voter-approved projects such as the stem cell institute because it did not have an approved budget. And some lenders questioned whether the fiscally challenged state could make good on its promise to provide the consortium's funding. The escrow account should address those fears, said Louis Coffman, the consortium's vice president.

"UCSD Chancellor Marye Anne Fox also welcomed the news.

“We are happy to learn that we are now one step closer to building an important new stem cell research facility for the Sanford Consortium for Regenerative Medicine, which will enable researchers from the University of California San Diego, the Salk Institute, the Burnham Institute and The Scripps Research Institute to more effectively collaborate to find cures for some of the world's most devastating diseases,' Fox said."

Somers also wrote,

"'Now we can go to the market and say there is no risk associated with the California money,' Coffman said.

"To raise the rest of its financing, the consortium has selected Barclay's Capital as its investment banker to underwrite a bond offering, Coffman said.

"The underwriter typically agrees to buy a certain amount of bonds, and then sell them to investors on behalf of the consortium.

"The consortium has also applied for funding from the federal stimulus package, which would be administered through a grant from the National Institutes of Health, Coffman said. Any stimulus money received would reduce the amount of funding the consortium would have to raise through the bond financing, he said."

Somers reported that ground has not been broken on the project, which raises questions about whether the consortium can meet the CIRM completion deadline. The labs were to have been finished within two years, according to a CIRM news release May 7, 2008.

Stem Cells and Cyberspace Info

Jim Till, a member of the board of the Cancer Stem Cell Consortium in Canada, runs a blog called the Cancer Stem Cell News.

Most of it appears oriented towards nitty-gritty research, but occasionally he picks up other types of information. Today he linked to the San Francisco Weekly piece on CIRM with an acknowledgement that he found it via the California Stem Cell Report.

Till carried a paragraph from the Weekly's story but otherwise offered no comment.

Till's blog is a good example of how news and information originally targeted for a geographically small audience can rocket around the world, courtesy of the Internet. With the waning power of the print media and its TV and radio cousins, the Web is increasingly likely to be a key information source on relatively specialized topics such as stem cell research – more so than general news.

The conduct of stem cell research would not have been high profile news even during the golden days of newspapers. Less so now and in the years to come.

New Stem Cell Patent Ruckus in California

The delicate interface between science and business has come a cropper again.

The latest set-to involves the National Human Neural Stem Cell Resource of Children's Hospital of Orange County Research Institute and Stem Cells Inc. of Palo Alto, Ca.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., Wednesday provided a summary of the dispute. He reported that Philip Schwartz, head of the Resource, said his organization's efforts to promote research with human neural stem cells has been effectively blocked by patents held by Stem Cells Inc.

The entire story can be read on Simpson's organization's blog along with a response from Stem Cells, which said it did not control actions by the Resource.

The situation reminds us of a book, "Science Business," by Harvard business professor Gary Pisano, published a couple of years ago. He has studied and consulted with the biotech industry for decades and has written about its consistent lack of profits. He suggests that part of the problem lies in the "monetization of IP" and inappropriate application of high tech industry IP principles in the biotech industry.

In 2006, he said in an interview on the Harvard Business School web site:

"Science and business work differently. They have different cultures, values, and norms. For instance, science holds methods sacred; business cherishes results. Science should be about openness; business is about secrecy. Science demands validity; business requires utility. So, the tensions are deep.

"What has happened is that we have tried to mash these two worlds together in biotech and may not be doing either very well. Science could be suffering and business certainly is suffering. If you try to take something that is science, and then jam it into normal business institutions, it just doesn't work that well for either science or business."

Stem Cells Inc. was founded by scientists Irv Weissman of Stanford, Fred Gage of the Salk Institute and David Anderson of Caltech.

Simpson wrote,

"You would have thought that with academic heavyweights like these involved with the company it would have been a no-brainer to figure out a way for Schwartz to distribute cells he has derived from CHOC patients to qualified researchers.

"The root of the problem is the Bayh-Dole act governing federally funded research. It has turned our universities into commercial entities where scientists rush to patent their discoveries rather than rush to publish and explain them."

We are querying Weissman, Gage and Anderson about their thoughts on the general issues raised by Schwartz along with the specifics.

Simpson's piece was the result of a notice by Schwartz to about 2,700 persons, mostly academics, about the patent issue. Simpson sent out a note to about 75 journalists nationwide about his item.

Stem Cells and Three California Movers and Shakers

The Capitol Weekly newspaper in Sacramento today identified three men with close ties to California stem cell issues as among the top 50 political players in the state.

The list included Eli Broad, Richard Blum and the man behind CIRM's Sacramento lobbying firm. The rankings did not include elected officials, such as the governor, who is a good friend of the California stem cell agency.

Ranked No. 5 was Broad, the Los Angeles billionaire businessman who has funded stem cell research at UCLA, USC and UC San Francisco with tens of millions of dollars. In the 2007-08 election cycle, he spent nearly $1 million on political efforts. "If money talks, then everybody listens to Eli...," the newspaper reported.

Ranked No. 6 was Steve Merksamer of the firm of Nielsen, Merksamer, Parrinello, Mueller & Naylor, which is the Sacramento lobbyist for CIRM. Merksamer was one of its founding partners. The firm has been on retainer with CIRM since the agency's earliest days and currently has a $49,200-a-year contract with the agency for its services, which CIRM coyly describes as "public education." Capitol Weekly said Merksamer is "is one of the state’s most influential political-legal players. His 16-lawyer firm is involved in a myriad of political issues and dispenses legal advice and political strategy to a national and international big-business clientele."

Ranked No. 14 was Blum, chairman and president, Blum Capital, a major equity investment management firm. Blum is a University of California regent as is Sherry Lansing, a member of the board of directors of CIRM. Blum is also the husband of Democratic U.S. Sen. Dianne Feinstein. Blum Capital Partners purchased $1 million in bond anticipation notes to help fund CIRM in 2006.

The list of 50 is the first installment in a Top 100 count, with more "influence peddlers, power brokers and political players" to come next week.