Category Archives: Stem Cell Therapy

Scientist Stuart Orkin of Harvard, who headed the grant review group of the California stem cell agency for three years, today was named as a member of the blue-ribbon Institute of Medicine panel conducting an examination of the perfomance of the $3 billion enterprise.

Orkin left the grant review group in November of 2008. The IOM posted information about Orkin today but did not mention his earlier connection to CIRM. The grant review group makes the de facto decisions on grants by the stem cell agency.

During Orkin's tenure, the agency began to come under fire from businesses for what they said were deficiencies in the grant review process.

Orkin replaces David Scadden, also of Harvard, who  resigned from the IOM-CIRM panel in December month because of his ties to Fate Therapeutics of San Diego, which lists him as a scientific founder.

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The Institute of Medicine opens its inquiry in San Francisco next week into the performance of the $3 billion California stem cell agency with testimony from representatives of enterprises that have received $418 million from the agency. No independent witnesses are scheduled to appear.

The IOM is being paid $700,000 by the stem cell agency to conduct the study, which was authorized by the CIRM board in 2010, with the hope that the findings would bolster voter support for another multibillion dollar bond measure for the agency.

So far the IOM-CIRM panel has held one day of public hearings in Washington, D.C., only involving CIRM representatives. Next week's session will be one of two days of public hearings in California before the inquiry is concluded. Another one-day public session is scheduled for Washington. So far the IOM-CIRM panel has not publicly heard any independent analysis of CIRM operations.

Earlier this week, the California Stem Cell Report asked Harold Shapiro, chairman of the IOM-CIRM panel, whether the IOM actually expected to receive forthright assessments of CIRM from individuals linked to institutions that have received hundreds of millions of dollars from the agency.

Shapiro did not reply but referred the inquiry to a public relations person at the IOM, Christine Stencel. She said that next week's meeting is one of "several means" by which the panel will gather information. She pointed to a short note on the IOM website linking to survey forms for others who may be interested in communicating with the panel.

Eleven witnessesses are scheduled for next Tuesday's meeting. Five are CIRM employees or members of the CIRM governing board. The remaining six come from institutions that have received $418 million from CIRM: Stanford ($193 million), UC San Francisco ($115 million), UC Davis($62 million) and UC Berkeley ($48 million). Five of the witnesses have received grants directly from CIRM: Alice Tarantal of UC Davis($5 million), Howard Chang of Stanford ($3.2 million), Irina Conboy of UC Berkeley ($2.2 million), Helen Blau of Stanford ($1.4 million) and John Murnane of UC San Francisco ($1 million).

We asked Shapiro how the witnesses for next week were selected. Stencel replied,

"The list of presenters and topics you see on the agenda reflect information and insights that the committee considered useful at this point in its work."

We asked,

"Why weren't representatives from other well-informed California organizations invited, such as the Little Hoover Commission, which performed a lengthy study of CIRM, and the Center for Genetics and Society, which has followed CIRM since 2004.?  Are there any plans to seek them out for public comment?"

The IOM did not respond directly but made the general statement about using "several means" to gather information.

We also asked,

"Why is 50 percent of (next week's) meeting being held behind closed doors? Who is expected to testify? What will be the nature of the business to be discussed? CIRM is a public enterprise, engaged in spending $6 billion (including interest) of taxpayer funds. It would seem that almost nothing that it does should be  barred from public scrutiny."

Stencel replied,

"The closed portion of the meeting will be devoted to internal committee discussions; there will be no presentations. This is per the National Academies study process."

(The National Academies are the parent organization of the IOM.)

Two members and the study director of the IOM-CIRM panel also made an unannounced trip to California last year, visiting Stanford and UC San Francisco in addition to CIRM offices. The IOM did not respond directly to questions from the California Stem Cell Report about whether the trip was at the invitation of CIRM and whether the traveling members met with any representatives of institutions or groups that have not received CIRM funds. Stencel said the trip was undertaken to gain a "better understanding" of the task before the panel.

The text of the questions asked by the California Stem Cell Report and the IOM response can be found here.

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Here is the text of the questions posed this week by the California Stem Cell Report to the Institute of Medicine concerning its performance assessment of the $3 billion California stem cell agency and the IOM hearing Jan. 24 in San Francisco.

Also included is the text of the responses from the IOM, which is being paid $700,000 by the agency to conduct the study. The initial question was addressed to Harold Shapiro, chairman of the IOM-CIRM panel. Christine Stencel, senior media relations officer for the IOM, replied. The second question was addressed directly to Stencel.

Here are the questions sent Jan. 16 to Shapiro.

"Dr. Shapiro --

"I am working on an  article dealing with the upcoming meeting of the CIRM IOM panel Jan. 24. It will discuss the topics to be discussed and the witnesses. I would like your comments particularly in regard to the selection of the witnesses.

"Other than CIRM-connected individuals and media representatives(based on the agenda as of Jan. 16), they come from institutions that have received $356 million from the stem cell agency. Several of them have personally received grants. (UC Davis representatives were later added to the agenda, boosting the figure from $356 million to $418 million.)

"My questions:
"How were these witnesses selected? Does the IOM actually expect to receive forthright assessments of CIRM from individuals that have received hundreds of millions of dollars from the agency?

"Why weren't representatives from other well-informed California organizations invited, such as the Little Hoover Commission, which performed a lengthy study of CIRM, and the Center for Genetics and Society, which has followed CIRM since 2004.?  Are there any plans to seek them out for public comment?

"Why is 50 percent of the meeting being held behind closed doors? Who is expected to testify? What will be the nature of the business to be discussed? CIRM is a public enterprise, engaged in spending $6 billion (including interest) of taxpayer funds. It would seem that almost nothing that it does should be  barred from public scrutiny.

"Finally, who is Larry Fisher? He is listed on the IOM agenda as having a connection with the Los Angeles Times. However, an employee of the Times tells me that Fisher is not listed in any of the directories that he has access to.

"Dr. Shapiro, I will carry any comments that you make verbatim on the California Stem Cell Report. If you would like to add more than responses to the questions, I would welcome your thoughts."

Here is the response Jan. 17 from Stencel.

"Dr. Shapiro forwarded your query to the IOM for response. Our offices were closed yesterday for the MLK holiday, so we are catching up on all the correspondence we’ve received. The upcoming meeting is one of several means by which the committee will gather information and perspectives to inform its deliberations. The list of presenters and topics you see on the agenda reflect information and insights that the committee considered useful at this point in its work. This meeting is not the sole means by which committee members will gather information. For example, you will note that there are links to surveys posted on the project page (http://www.iom.edu/Activities/Research/CIRMReview.aspx) on the IOM website that request information from a variety of sources. The committee has also requested specific data from CIRM; a list of what was requested is in the Public Access File for this study, which is accessible via the Public Access Records Office. In addition, the committee expects to hold another information gathering meeting in California later this year.

"To your query about the extent to which the meeting is open, the committee is holding a day-long open meeting to gather information on Jan. 24. The closed portion of the meeting will be devoted to internal committee discussions; there will be no presentations. This is per the National Academies study process. Please see Stage 3 in the explanation of the National Academies study process on this webpage: http://www.nationalacademies.org/studyprocess/index.html. 

"To your question about Mr. Fisher, due to an oversight in drafting the agenda, he is misidentified as being affiliated with the LA Times. As the agenda you last saw indicated, he was an invited speaker, but since he has not responded, he will not be speaking at the meeting and is being removed from the agenda.

"Thank you for your ongoing interest in this IOM review."

Here are the California Stem Cell Report questions Jan. 17 to Stencel:

"I understand that some members of the CIRM - IOM panel made a publicly unannounced trip to California to visit some recipient institutions. What was the purpose of the trip? Who went? How long did it last? What institutions were visited? Who put together the agenda for the visit? Was it at the invitation of CIRM and facilitated by CIRM? Did the traveling members of the panel meet with any representatives of institutions or groups that have not received CIRM funds? Please feel free to add any other thoughts on this subject if you wish. Thank you."

Here is Stencel's response:

"Harold Shapiro and Terry Magnuson, who had been asked to serve as chair and vice chair of the committee, visited CIRM and two universities conducting stem cell research in September 2011 before the full committee was assembled.  Drs. Shapiro and Magnuson wanted to visit CIRM to gain a better understanding of the task that their committee, when formed, would be undertaking given the many questions being posed (per Statement of Task) and the limited timeframe to complete the review. They also met with leaders of Stanford and the University of California, San Francisco and toured laboratories on the two campuses to get a better feel for the type of stem cell research supported by CIRM. IOM study director Adrienne Stith Butler accompanied them."

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Directors of the California stem cell agency today rejected a $6.3 million grant to recruit an unidentified researcher to the Buck Institute after some of CIRM's grant reviewers raised questions about his/her research, achievements and experience.

The CIRM governing board voted 3-16 with two abstentions on the grant, which scored 76 out of 100 during a closed-door session of reviewers earlier this month. Directors were told that the grants review group voted 11-6 to approve the application.

The CIRM board almost never rejects a recommendation from grant reviewers.

During the board's discussions, several directors raised questions about whether CIRM would be paying -- with the grant -- for research that did not fit within its objectives. Others said the intent of the agency's recruitment grant program was to attract the best scientists to California.

The research proposal was the subject of an unusual, dissenting minority report by reviewers. The CIRM staff-prepared review summary said,

"A motion to recommend the application for funding carried with a majority vote. Because the motion was opposed by more than 35% of members, opponents have exercised their right to have that position reported to the ICOC(the CIRM governing board). The GWG(grant review group) members raised three main opposing points. First, some GWG members were not convinced that the research program proposed by the candidate, despite its scientific merits in a simple model organism (the fruitfly Drosophila), would be translated effectively to mammalian models and human studies. Thus, they questioned whether the work would have significant impact on CIRM's mission of advancing stem cell research toward therapies. Second, some GWG members felt that the candidate's research vision did not extend far beyond significant discoveries to which the candidate has already contributed, and was, therefore, solid and safe but not venturesome or compelling. Third, although the candidate is clearly a rising star, some GWG members were concerned that the candidate's achievements and experience were not yet sufficiently mature for the leadership position expected under this award."

However, the review summary also said,

"The goal of the proposed research is to expand the study of molecular pathways mediating stem cell aging and to extend these investigations into mammalian cells....The proposed studies will investigate the regulation of stem cell activity and aging in response to nutritional conditions and environmental stress. These efforts could yield new insights into a range of chronic diseases and lead to therapeutic approaches to maintain or restore adult stem cell function in humans. "

"The candidate’s emerging leadership and recognition by the field has been reflected in numerous invitations to speak at major meetings and to contribute reviews and commentaries to leading journals. The PI (applicant) was lauded in outstanding letters from leaders in the field of stem cell aging research. They described the candidate as a highly energetic, innovative, and focused scientist who is recognized internationally as a critical thought leader making fundamental contributions to the understanding of aging mechanisms."

Normally the names of institutions connected to grant applications are not disclosed prior to board approval. However, the name of the Buck Institute was mentioned during the discussion about the application. Votes by the grants review group are also not normally disclosed during board discussions.

The award would have been the fourth in CIRM's $44 million programt to help recruit stem cell researchers to California.

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The California stem cell agency plans to spend $40 million to create two stem cell genomic research centers, including possibly one at a for-profit research enterprise.

The proposal was approved today by CIRM directors on a vote by show of hands.

CIRM said the objective of the effort is "to transformatively advance the stem cell field." The grant program was touted by CIRM President Alan Trounson as a way for California to gain a "firm and lasting grip" on global stem cell leadership.

Writing in the January issue of Nature Biotechnology, Trounson and CIRM scientists Natalie DeWitt and Michael Yaffe said an "urgent need" exists "to ramp up efforts to establish stem cells as a leading model system for understanding human biology and disease states and ultimately to accelerate progress toward clinical translation."

They continued,

"For California to take a firm and lasting grip on leadership in stem-cell research—and, as stated in Proposition 71,'advance the biotech industry in California to world leadership as an economic engine for California’s future'— its scientists must have access to these technologies and moreover create a coordinated international enterprise to maximize the reach and impact of stem cell genomics. Genomics is creating a sea change in biomedical research and medicine, and accordingly, the California Institute for Regenerative Medicine (CIRM; San Francisco) can create a process through which stem-cell research can participate and even provide leadership in a new era of medicine."

The stem cell agency staff proposal to directors said,

"Genomics technologies and the data sets they yield are fast becoming the currency of biology and medicine. The cost of genome sequencing is dropping exponentially, a trend that will soon make genome-scale characterization a practical tool for fundamental studies of stem cell biology and for advancing therapeutic applications. Meanwhile, cell therapeutics are advancing toward clinical trials, and hES and hiPS cells have become the gold standard for studying human cell biology, tissue and organ development and repair, and disease. Combining genomic technologies with stem cell research will accelerate fundamental understanding of human biology, disease mechanisms, tissue engineering and cell therapies...."

Awards for the centers of up to $20 million each are scheduled to be awarded next winter.

Here is a link to the CIRM press release on the proposal.

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Geron has two interested potential buyers for its human embryonic stem cell business, the president of the California stem cell agency said today.

Alan Trounson told CIRM directors that at one point four parties had expressed interest  but two have backed out. He did not disclose the names of any of the parties.

Last fall, Geron announced it was giving up its hESC work because of financial concerns about what once was the first clinical trial of a human embryonic stem therapy. Last summer CIRM loaned Geron $25 million for the trial, which has been repaid with interest.  Following Geron's announcement, Trounson said he was working to help find a buyer for Geron's hESC business.

However, today he said he was "suddenly distanced" from the process a few days ago. CIRM director Sherry Lansing, who once headed a Hollywood film studio, asked Trounson whether there was anything that directors could do to help find a buyer for Geron's hESC business. She asked about the amount of money needed by Geron and whether patient advocates could help generate other momentum.

Trounson suggested that the discussion should  be continued privately. He did say that CIRM has prepared a document that outlines what would  be necessary for the agency to resume funding of the hESC trial.

Trounson told directors that Geron's departure from hESC research has had "a very strong negative influence internationally."

Geron, which is based in Menlo Park in California, said last week it has hired Stifel Nicolaus & Co. to help sell the hESC business. . 

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The California stem cell agency is slated to secure additional bond funding this spring when the financially troubled Golden State initiates a new round of borrowing.

CIRM Chairman Jonathan Thomas told directors today that the $3 billion agency will be involved  in the upcoming round. He did not specify the amount that CIRM would receive or the timing of the bond issue.

The agency's only significant funding comes from state bonds, whose funds flow directly to CIRM. The governor and legislature cannot touch the CIRM funds under the terms of the ballot measure that created the research effort in 2004.

Last year at this time, the state suspended bond sales. At the time, CIRM had sufficient funds to meet its commitments until about June of this year. Late last year, Thomas worked out a temporary funding arrangement with the governor's financial aides to cover any possible shortfall.

Thomas made the announcement at the beginning of today's CIRM board meeting in San Diego.

Currently CIRM President Alan Trounson is reviewing new stem cell research that has been published recently.

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The $3 billion California stem cell agency, which is expected to run out of cash in five years, is backing away from an attempt to win voter approval of another multibillion dollar bond measure to finance its research efforts.

The agency disclosed its new position in a document posted in connection with the meeting tomorrow of its governing board in San Diego. CIRM said,

"Although additional funding could be a possibility in the future, it would be premature even to consider another bond measure at this time. Instead, CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work."

The statement is a sharp departure from previous discussion of mounting a ballot campaign for a $4 billion to $5 billion bond measure on behalf of CIRM.

The only significant source of cash for the agency currently is the $3 billion in bonds approved by voters in 2004. Nearly half of that is committed. The latest financial report from CIRM shows its funding of research peaking in 2017-18.

During the last year or so, former CIRM Chairman Robert Klein has repeatedly discussed another bond measure and has even more recently expressed his desire to raise funds for a new electoral campaign. Klein resigned from his post last June. The CIRM board elected Jonathan Thomas, a Los Angeles bond financier, to replace Klein, who was the agency's first chairman and who led the 2004 ballot campaign.

In 2010, the CIRM board approved spending $700,000 for an Institute of Medicine study of CIRM with the expectation that its findings would enhance the likelihood of approval of more bond funding.

The IOM study is currently underway. The blue-ribbon panel is scheduled to hold a two-day public meeting in San Francisco Jan. 24-25 as part of its assessment of CIRM performance.

CIRM largely functions below the news media's radar, but talk of a new pitch for money has triggered negative commentary. Last month, the San Jose Mercury News said in an editorial that the agency should close its doors when its cash runs out because another bond measure would siphon off much-needed money for education and other critical services already "starved" by state budget cuts.

Backing away from another bond measure could benefit CIRM by helping to remove the likelihood that its actions will be judged in the context of an electoral campaign. But the action also raises the possibility that some of CIRM's best employees may leave for better prospects given that they may not have much of a future at an agency that would appear to be going out of business – at least at its current robust level.

The CIRM document dealing with the bond measure is dubbed a "transition plan" and is required by state law.

Instead of seeking to borrow more billions, the document said,

"CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work. Through its funding of state of the art research facilities, collaborative funding agreements, and industry engagement, CIRM has already made progress in creating this platform."

The document also raised the possibility of creation of a nonprofit organization to carry on CIRM's stem cell research, a proposal that has floated quietly for some years. Such an effort could involve raising funds from the biotech industry, which CIRM is currently trying to engage in a more friendly way.

At the top of CIRM's list of transition plan activities is creation -- both nationally and internationally -- of "Alpha Stem Cell Clinics" for delivery of therapies to patients. The clinics also would foster clinical trials and evaluate cell therapies. Additionally included are efforts to drive "follow-on funding" for CIRM projects and strengthened efforts to support industry.

Directors could alter the CIRM transition plan at their meeting tomorrow. But it was placed on the agenda by Chairman Thomas and is unlikely to see major revisions.

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