Texas board approves controversial stem-cell therapy Houston Chronicle Copyright 2012 Houston Chronicle. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. Updated 11:05 p.m., Friday, April 13, 2012 The Texas Medical Board approved rules regulating adult stem cell therapy Friday, concerned that the proliferation of the experimental treatment Gov …Source:
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GULF SHORES, Ala., April 3, 2012 /PRNewswire/ – When standout University of Alabama wide receiver and return specialist Marquis Maze partially tore his hamstring in the final game of the Bowl Championship …Source:
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A Bellevue doctor is one of only two researchers in the country testing stem cells as an anti-aging treatment.Source:
http://news.search.yahoo.com/news/rss?p=Stem+Cell+therapy&ei=UTF-8

WESTON, Fla. — Stemlogix, a regenerative medicine company offering premier in-clinic stem cell therapy solutions to veterinarians, announced today that it has selected Butler Schein Animal Health(TM) …Source:
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The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.

The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort’s existence.  CIRM‘s dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.

The proposed changes will be considered next Thursday by the CIRM directors’ Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.

Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only “if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine.” CIRM offered no explanation of what it means by “of the type to receive” funds from the agency.

The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM’s changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.

The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that “all” investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative’s intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.

The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.

While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point

Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM’s new senior director of public communications and patient advocate outreach, replied that the changes were “proposed” by the state Fair Political Practices Commission, which oversees state disclosure laws.

He said the FPPC says agencies “should tailor their disclosure categories to type of work performed by the agency.”

McCormack cited as examples the State Board of Education and the state retirement system.

As for the specific changes in CIRM’s code, McCormack said,

“Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate.”

McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)

The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM’s new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.

Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with
more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.

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Medical board approves controversial adult stem-cell rules Houston Chronicle Copyright 2012 Houston Chronicle. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. Updated 10:16 p.m., Friday, April 13, 2012 AUSTIN – The Texas Medical Board approved rules regulating adult stem cell therapy Friday, concerned that the proliferation of the experimental …Source:
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The Texas Medical Board on Friday approved new rules on experimental stem cell therapies such as the one Gov. Rick Perry underwent during back surgery last year, despite objections they don't do enough to protect patients and could led to an explosion of doctors promoting unproven, expensive treatments.Source:
http://news.search.yahoo.com/news/rss?p=Stem+Cell+therapy&ei=UTF-8

“In answer to your question, we
are proposing changes to the Conflict of Interest Code based upon
recommendations from the California Fair Political Practices
Commission (FPPC). The Political Reform Act requires state
agencies like CIRM to review their Conflict of Interest Codes every
two years.  The FPPC, which is charged with enforcing the
Political Reform Act, is responsible for reviewing and approving
CIRM’s Conflict of Interest Code.  In preparation for this
review, CIRM’s counsel met with the FPPC staff who suggested the
proposed amendments which are the subject of the upcoming Governance
Subcommittee meeting.  The proposed amendments to CIRM’s
Conflict of Interest Code are consistent with the FPPC’s position
that agencies should tailor their disclosure categories to type of
work performed by the agency.  For example, CalPERS’s
conflict of interest code requires CalPERS officials to disclose
investments in, and income from, entities that are of the type with
which CalPERS contracts and entities in which funds administered by
CalPERS could be invested.  Likewise, the State Board of
Education requires its members to disclose investments, business
positions, and income from a publisher, manufacturer, or vendor of
instructional materials, or services offered to educational
institutions in the State of California and investments, positions of
management and income from any private school in the State of
California.  Similar to these codes, the FPPC proposed that
CIRM’s Code be tailored to the nature of CIRM’s work.  Thus,
the FPPC proposed that CIRM require its board members and high-level
employees to disclose investments in, and income from, entities that
are of the type with which CIRM would contract or from which CIRM
could procure goods or services as well as investments in, and income
from, biotech and pharmaceutical companies.  Because these
are the types of entities that are likely to create potential
conflicts of interest, we believe the disclosure categories are
appropriate.  It is important to remember, however, that
this is a preliminary proposal.  CIRM will seek input from
the Governance Subcommittee, the Board, and members of the public
before seeking approval of the amendments.”

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Just one week after the $3 billion California stem cell agency was sharply criticized for its failure to adequately support biotech firms, the agency formally kicked off a $30 million effort to engage industry more closely.

The initiative, in the works since the middle of last year, was heralded as the beginning of a “new era” for CIRM, which is moving to transform into cures the stem cell research it has funded over the last seven years. The agency has scheduled a webinar for April 25 for prospective applicants.

CIRM’s press release, crafted by the agency’s new PR/communications director, Kevin McCormack, yesterday quoted CIRM President Alan Trounson as saying,

“This initiative is a major new development in the progress towards providing new medical treatments for patients by engaging the most effective global industry partners.”

Elona Baum, the agency’s s general counsel and vice president of business development, said the program “represents a new era for CIRM.”

Under the RFA, the agency will award up to $10 million each for three grants or loans. The program, however, is not limited to businesses. Non-profits may apply as well. Representatives from industry have complained about a strong tilt on the part of CIRM towards academic and non-profit research enterprises. The CIRM board is dominated by representatives from those two sectors.

The program grew out of recommendations in November 2010 from an “external review” panel put together by CIRM that said the agency needed to do better with business. The refrain was heard again directly from stem cell firms at last week’s hearing by the Institute of Medicine on the stem cell agency’s performance. According to CIRM’s figures, businesses have received $54 million in grants and loans since 2005, the first year the CIRM board approved grants, out of a total of $1.3 billion.

Only one news outlet has written a story so far about the posting of the RFA and the press release, as far as can be determined.

Ron Leuty of the San Francisco Business Times said,

“The most likely candidates to attract industry funding would be CIRM’s ‘disease team’ grant winners, who face a deadline of 2014 to bring a project to the point of first-in-human clinical trials. CIRM has weighed options for pushing those projects — there are 13 of them now — deeper into the FDA approval process.”

CIRM said in the RFA material,

“The intent of the initiative is to create incentives and processes that will: (i) enhance the likelihood that CIRM funded projects will obtain funding for Phase III clinical trials (e.g. follow-on financing), (ii) provide a source of co-funding in the earlier stages of clinical development, and (iii) enable CIRM funded projects to access expertise within pharmaceutical and large biotechnology partners in the areas of discovery, preclinical, regulatory, clinical trial design and manufacturing process development.

“This initiative requires applicants to show evidence of either having the financial capacity to move the project through development or of being able to attract the capital to do so. This may be evidenced by, for example, (i) significant investment by venture capital firms, large biotechnology or pharmaceutical companies and/or disease foundations; or (ii) a licensing and development agreement with a large biotechnology or pharmaceutical company or a commitment to enter into such an agreement executed prior to the disbursement of CIRM funding.

“The objective of the first call under this initiative, the Strategic Partnership I Awards, is to achieve, in 4 years or less, the completion of a clinical trial under an Investigational New Drug (IND) application filed with the Food and Drug Administration (FDA).”

CIRM has scheduled a webinar on the RFA for prospective applicants for next Wednesday, April 25. It is asking for registration and questions in advance.



(Editor’s note: An earlier version of this article did not contain the sentence about businesses receiving $54 million out of $1.3 billion awarded by CIRM.)

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Cells on the move reach forward with lamellipodia and filopodia, cytoplasmic sheets and rods supported by branched networks or tight bundles of actin filaments. (2012-04-09)Source:
http://www.brightsurf.com/rss.news.xml?search=Stem_Cells

What happens to a stem cell at the molecular level that causes it to become one type of cell rather than another? At what point is it committed to that cell fate, and how does it become committed? (2012-04-13)Source:
http://www.brightsurf.com/rss.news.xml?search=Stem_Cells

Michael West, CEO of Biotime, Inc.of Alameda, Ca., has published the text of his prepared remarks to the Institute of Medicine panel examining the performance of the $3 billion California stem cell agency.

Here is one excerpt from the statement by West, who was also CEO at Advanced Cell Technology and founded Geron.

“To put it simply, stem cell research by itself will not lead to cures. Research and DEVELOPMENT leads to cures. In my opinion, if CIRM fails to deliver on its goal to deliver cures, it will not be a result of internal governance issues. Instead, it will be a result of inefficient capital allocation. A graphic way of visualizing my point is to say that CIRM has historically funded primarily research, and little product development, i.e. large “R” little “d”. Approximately 5% of CIRM’s expenditures have been allocated to biotechnology and health science entities whose expertise is product development, and 95% has been allocated to nonprofit institutions in the state for basic research. Human therapeutic product development in the United States requires a very intense and expensive process for approval that is primarily focused on development side of the equation. In this respect, therapeutic approvals differ significantly from the discovery and development of silicon-based technologies that have been so successfully commercialized in California.”

Here is a link to the full text of what West posted on the Biotime web site.

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A venture capitalist who said earlier this week that the California stem cell agency rejected 15 grant applications from Advanced Cell Technology this afternoon retracted the statement, which he said was incorrect.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, said in an email,

“Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the principal investigator was substantially below 15.”

Bonfiglio made the assertion Tuesday at a meeting of the Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency, which has been criticized for its lack of funding of biotech firms.

Here is more of what Bonfiglio had to say in his email this afternoon,

“Unfortunately, your California Stem Cell Report posting on April 11 contains some inaccurate information, for which I appear to have been the source.  As you will recall, I stated during the IOM Panel that Advanced Cell Technology had submitted multiple applications for funding from CIRM, but had been unsuccessful in obtaining any funding from CIRM.  I also stated that ACT had been involved in “15 grant applications” to CIRM.   You highlighted that number in your April 11 California Stem Cell Report posting.   Unfortunately, that number is not accurate.  Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the Principal Investigator was substantially below 15.   The number I quoted in the IOM Meeting on April 10 included applications in which ACT had some involvement, but was not the lead principal Investigator.  ACT has filed several applications for CIRM funding as the lead PI, but the number of CIRM applications in which ACT was the lead PI was far below 15.   Moreover, some of ACT’s direct applications for CIRM funding were withdrawn by ACT, rather than denied by CIRM.

“I would request that you correct this inaccuracy regarding ACT’s applications for CIRM funding as soon as possible.  I’m sure you will agree that the regenerative medicine community, and the general public, have a real and significant interest in obtaining accurate information about developments at CIRM, and that the publication of inaccurate information is a tremendous disservice to all involved.  More importantly, ACT is a publicly traded company and the publication of inaccurate information regarding ACT, its technologies, or its funding could have adverse consequences for the company.   Furthermore, as an active participant in the regenerative medicine community who has spent his professional career developing a reputation for honesty, accuracy, and integrity I am very concerned that I might be the source of inaccurate information regarding developments within the field of regenerative medicine.  For these reasons, I would ask that you retract the statement in your April 11 Blog posting that ACT was ‘rejected 15 times for funding’ by CIRM, and that you refrain from making any other statements to that effect.

“I appreciate your cooperation in this regard, and I would request that you move quickly to correct the inaccuracy in your April 11 Blog posting.   As I am sure you are aware, information in blog postings is sometimes picked up by more traditional media, and I would not want any republication of this inaccurate information regarding ACT’s grant applications to CIRM.”

At the time Bonfiglio made his comments concerning ACT, top officials of the stem cell agency were in the room, but did not make any statement concerning his assertion. On the morning of April 11 prior to publication of the item, the California Stem Cell Report asked ACT for comment .

No response has been received from ACT about the figure. CIRM also has not commented since the item appeared.

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IRVINE, Ca. – The $3 billion California stem cell agency was praised this week for making progress in accountability and transparency during the last year.

The comments came from a representative of California state Controlller John Chiang, the state’s top fiscal officer and who also chairs the only state entity specifically charged with financial oversight of the stem cell agency and its board.

Ruth Holton-Hodson, deputy state controller, told the blue-ribbon Institute of Medicine panel examining the performance of the stem cell agency that the controller’s office “would like to acknowledge the progress the new leadership has made in the last year towards making CIRM a far more transparent and accountable agency than it has been in the past.”

CIRM has a new chairman, J.T. Thomas, a Los Angeles financier, who has been in place since the beginning of last July. He succeeded Bob Klein, who was the initial agency chairman and who took office in 2004.

In her testimony at the IOM hearing here on Tuesday, Holton-Hodson discussed previous problems that CIRM had with the transparency of its budget. She said,

“We are very pleased that CIRM’s new leadership recognized this as a problem and quickly adopted a much more transparent budget format which is broken down by function. To make CIRM’s expenditures as transparent as possible, we have also recommended that they post the annual budget on the website. Again, we’re pleased to say that the new leadership has agreed to do this.”

She also said,

“At our most recent meeting (of the Citizens Financial Accountability and Oversight Committee), we also recommended that CIRM post all of its private donations and they have agreed to do this.”

Holton-Hodson criticized the dual executive arrangement at CIRM that is written into law by Proposition 71. She said,

“It is difficult to uphold the appearance of accountability and objectivity when the board chair has direct line authority over some CIRM staff positions. In essence under the current model, the chair is responsible for evaluating and approving some of the work of the chair.

“While this issue is still outstanding, it is important to acknowledge that the current leadership has made significant progress in more clearly delineating the responsibilities of the chair and the president.”

Here is the full text of Holton-Hodson’s remarks.Statement from California state controller’s office to IOM-CIRM panel April 10, 2012

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IRVINE, Ca. – The Center for Genetics and Society today said it would “wrong” to ask the people of California for more money to continue financing stem cell research at state expense.

Marcy Darnovsky, associate executive director of the Berkeley, Ca., non-profit group, addressed a blue-ribbon Institute of Medicine panel evaluating the performance of the $3 billion California stem cell agency, which is financed by money borrowed by the state. The agency is expected to run out of cash in about five years.

Darnovsky said,

“In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding ‘would be premature at this time,’ but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important.”

Representatives of the stem cell agency were present at today’s hearing on the UC Irvine campus, but did not speak publicly at today’s session. CIRM officials, however, have testified before the panel on two other days of public hearings. The agency is paying the IOM $700,000 to conduct the study. Its results and recommendations are expected to be published in November.

Darnovsky and others testifying at the morning session were critical of the agency’s lack of accountability, built-in conflicts of interest and immunity from normal government oversight (see here and here).

Darnovsky said, “

The requirement for 70% super-majorities (to change the law regarding CIRM) means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

“Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues.”

Here is the full text of Darnovsky’s comments.
Center for Genetics and Society statement to IOM-CIRM panel, April 10 2012

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(Editor’s note: The assertion in this item that 15 applications by ACT were rejected by the California stem cell agency is incorrect, according to the venture capitalist who made the statement. He retracted it on the afternoon of April 12. His explanation can be found here. )


IRVINE, Ca. –The only firm in the nation conducting an ongoing hESC clinical trial has been rejected 15 times for funding by California’s $3 billion stem cell agency.

The figure was reported yesterday at a hearing by the blue-ribbon Institute of Medicine panel looking into the performance of the stem cell agency, which has been sharply criticized in recent years for its paucity of industry funding.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, a stem cell venture capital firm in Portola Valley, Ca., disclosed the grant attempts by Advanced Cell Technology, whose nominal headquarters are in Santa Monica, Ca. Bonfiglio indicated that it was a high profile example of how CIRM is not taking the necessary steps to fulfill its goal of developing therapies that actually reach the clinic.

He noted that ACT received national attention in January when it posted favorable findings for its clinical trial at UCLA dealing with blindness but that the firm was still unable to win a CIRM grant over the last several years.

ACT had moved much of its operations to California in the wake of passage of Proposition 71, the measure that created the state’s stem cell research effort in 2004. It has since re-centered its operations in Massachusetts.

The California Stem Cell Report has queried ACT on its grant efforts and will carry its response verbatim when it is received.

Another firm, which cannot be identified, said privately yesterday that it was rejected 14 times.

According to our calculations based on figures this morning on the CIRM web site, businesses have received only $54.3 million in grants and loans during the last seven years, 4 percent of the $1.3 billion awarded. However, the CIRM list slightly understates the industry total. At least two other firms are sharing in two $20 million grants involving academic institutions, but are not noted on the list.

Yesterday’s IOM meeting was the second and final California public session for the CIRM inquiry. Most of the day was occupied by a variety of critiques of the organization. The panel has already heard extensively from the agency itself and beneficiaries of its grants. The IOM report is expected in November.

Harold Shapiro, chairman of the panel and former president of Princeton University, described yesterday afternoon’s panel involving stem cell business executives as “one of the more interesting” of the day.

One of the speakers was Michael West, CEO of Biotime in Alameda, which has received $4.7 million from CIRM. West, the founder of Geron, was also head of ACT when it moved it to California. He said CIRM had several “blind spots,” including misconceptions about how products are made. For example, West said, CIRM’s performance indicates that it does not fully understand that development leads directly to cures — not research.

West said that if the high tech industry had to rely on CIRM-type funding years ago, laptops and iPads would still be in the lab instead of the marketplace.

The business industry representatives said that creation of CIRM has been beneficial for stem cell  research, but cited a number of deficiencies in connection with industry applications.

In some ways, their comments echoed past remarks by several CIRM board members, who have expressed concern about the lack of funding for industry, as well as those of the agency’s own external review panel. One issue raised by those CIRM directors has been the lack of grant reviewers with product development and industry expertise.

At yesterday’s hearing, Gabriel Nistor, vice president of research and development at California Stem Cell in Irvine, said, it is “exceedingly rare to find academics (grant reviewers) that understand the complexities” involving industry. Nistor said his firm has applied for a “few” CIRM grants. None have been awarded.

Also speaking was Allan Robins, CEO of Viacyte in San Diego, who said his firm has done well with CIRM funding. It has received $26.2 million, nearly all of it in the form of a loan. But he said companies develop products – not academia.

Source:
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IRVINE, Ca.– California’s unprecedented stem cell research effort faces a tight timetable for making major progress in fulfilling promises to voters seven years ago, complicated by potential conflicts of interest, a blue-ribbon panel was told this morning.

David Jensen, editor of the California Stem Cell Report, made the comments to the Institute of Medicine panel looking into the performance of the $3 billion California Institute of Regenerative Medicine.

The panel’s inquiry comes as the agency is re-evaluating its strategies as it faces loss of funding in about 2017.

Here is the full text of Jensen’s statement.
Statement to IOM-CIRM Panel by California Stem Cell Report April 9, 2012

“

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