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.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

(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:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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

"

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

IRVINE, Ca. – The Consumer Watchdog organization says that serious consideration should be given to whether the state should halt borrowing money to finance the $3 billion California stem cell agency.

The statement was prepared for delivery tomorrow here to a blue-ribbon Institute of Medicine panel evaluating the performance of the research effort, which was created by a ballot initiative in 2004. The agency's only real source of cash is bonds issued by the state, which means the agency will cost $6 billion including interest by end of its grant-making life in about 2017.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said that the political and scientific environment has changed substantially since 2004. The Bush Administration had restricted federal funding of hESC research then, causing an uproar in the scientific community. Funding has since been restored.

Simpson said the stem cell measure "made sense" seven years ago. He said the stem cell agency and its governing board "must recognize that the political, scientific and economic environment have dramatically altered since the passage of Proposition 71."

His statement continued,

"It is also appropriate to consider seriously whether issuing all $3 billion in authorized bonds is the correct policy in light of the new environment and economic realties facing the state."

Simpson was invited make his statement to the IOM panel, which is midway through its public process of looking into CIRM's operations. It is doing so at the behest of CIRM, which is paying the prestigious organization $700,000 to perform the work.

Simpson also made a number of recommendations for changes at CIRM, many of which would require a change in state law or passage of another ballot measure. Proposition 71, which created CIRM and altered the state Constitution, requires a super, super-majority vote (70 percent) by the legislature to make changes at CIRM.

The Consumer Watchdog proposals (full text below) include reducing the size of the 29-member board to 15, including public members on the board, reducing the super-majority requirement on board quorums to a majority, eliminating the controversial dual executive arrangement at CIRM, conducting grant reviews in public and publicly disclosing the financial interests of reviewers.Consumer Watchdog Statement to IOM-CIRM Panel April 9, 2012

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

PR Web (press release)

Alltopics.com Offers Newest News Flashes about Biotechnology PR Web (press release) Alltopics.com has created a new section devoted to Biotechnology. The information, news and current articles are instantly available on Alltopics.com. Biotechnology.alltopics.com rates the issues by popularity. All the hot and current news, ... and more »

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By Ben Butkus

Stanford University researchers have published a method for using Fluidigm's digital PCR platform to conduct single-cell, real-time PCR to compare gene expression patterns of single cells.

The protocol is indicative of the increased use of Fluidigm's products for single-cell biology, an application area that the company has been heavily promoting over the past year.

In addition, the method may provide a powerful tool for understanding gene expression and differentiation in induced pluripotent stem cells and human embryonic stem cells for regenerative medicine, the researchers said.

In a paper published last week in Nature Protocols, researchers led by Joseph Wu, associate professor of medicine, cardiology, and radiology at Stanford University School of Medicine, described how they used Fluidigm's BioMark HD platform and Dynamic Array chips to analyze gene expression profiles of single iPSCs or hESCs approximately 11 hours after collection.

The team decided to publish the method after using it to conduct a study published last March in the Journal of Clinical Investigation that demonstrated how single-cell transcriptional profiling revealed heterogeneity in human iPSCs. "A lot of people asked us after that JCI paper how we exactly do this, so we decided to write a detailed protocol," Wu told PCR Insider.

Wu and colleagues began using Fluidigm's platform through the laboratory of fellow Stanford scientist Stephen Quake, a co-founder of the company and a co-author on the recent Nature Protocols paper.

According to Veronica Sanchez-Freire, a postdoc in Wu's lab and also a co-author on the paper, the group needed a tool to compare gene expression between individual cells in single colonies of iPSCs or hESCs with high sensitivity using a limiting amount of sample.

"We were interested in seeing how different gene expression could be in the cell depending on its position in the colony," Sanchez-Freire said. "We are looking at these iPS cells from different cell types and donors, and we always compare them to [human embryonic] stem cells, the gold standard but we also wanted to see how similar they are [to each other]."

Most traditional gene expression studies, using, for example, quantitative real-time PCR, extract RNA from a large population of cells for downstream expression analysis. "And we saw that when you do that, iPS cells and stem cells are very similar," Sanchez-Freire said. "But when you go to the single-cell level, we saw how the iPS cells are more heterogeneous than the ES cells."

Visit link:
Stanford Group Publishes Fluidigm-Based Method for Gene Expression Profiling of Single Stem Cells

HOUSTON, April 12, 2012 /PRNewswire/ --Bellicum Pharmaceuticals, Inc. announced today the appointment of David M. Spencer, Ph.D. to Chief Scientific Officer. Dr. Spencer, a co-founder of Bellicum, joins the Company from Baylor College of Medicine where he was Vice Chairman of Pathology and Immunology.Dr. Spencer is the co-inventor of chemical induction of dimerization (CID), a technology used to control a wide range of biologic functions in cells, and applied in the Company's two lead product candidates.

(Photo: http://photos.prnewswire.com/prnh/20120412/NY85667 )

"We're pleased to have David join Bellicum and bring with him a singularly unique knowledge of the science behind our products," commented Tom Farrell, CEO of Bellicum Pharmaceuticals. "I look forward to his many contributions as we evaluate two new potentially breakthrough product candidates."

Dr. Spencer received The Michael E. DeBakey, M.D., Excellence in Research Award from Baylor College of Medicine in 2007 for his work developing a novel immune therapy-based approach to treating cancer, which relies on a small-molecule, CID, to improve dendritic cell function. In one iteration, Dr. Spencer's team used CID technology, which he co-invented, to create a much more potent vaccine against poorly immunogenic self-peptides. Dr. Spencer also developed a series of state-of-the-art, non-immunogenic suicide genes for gene therapy, which utilize endogenous caspase family proteases and CID technology. These inducible caspases are likely to become increasingly important as a safety switch for retrovirus-based gene therapy and cellular therapies, in general. This technology is the basis of two Bellicum clinical programs, including CaspaCIDe for the management of graft-versus-host disease (GVHD).

Phase 1 results from an ongoing clinical trial of CaspaCIDe were published in the New England Journal of Medicine in November of last year. The study reported that the "suicide gene" effectively caused the rapid and complete reversal of GVHD in acute leukemia patients who underwent stem cell transplant.

Dr. Spencer earned his Ph.D. from the Massachusetts Institute of Technology and completed his postdoctoral degree at Stanford University.

About Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, Inc. is developing clinical applications of chemical induction of dimerization (CID), a drug-based remote control technology that extends the physician's reach beyond the point at which a treatment has been administered. Bellicum's mission is to leverage this smart technology to bring safe, effective, innovative cell therapies to market for patients with serious and life threatening diseases. The company's DeCIDe vaccines are designed to kill targeted cells by inducing a potent, durable, fully activated antigen-specific T cell immune response. Lead product BPX-101, an autologous DeCIDe vaccine, is in clinical development for patients with metastatic castrate resistant prostate cancer (mCRPC). CaspaCIDe is a cell therapy safety switch, permitting the rapid elimination of cells in the event of toxicity. CaspaCIDe DLI is a donor lymphocyte infusion administered following a hematopoietic stem cell transplant, in which the safety switch may be activated to resolve graft-versus-host disease (GVHD). For more information, visit http://www.bellicum.com

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Bellicum Appoints Baylor College of Medicine's David M. Spencer as Chief Scientific Officer

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC)s Hans S. Keirstead, Ph.D. will speak at todays Global Emerging Leaders Forum in New York City, participating in a panel of the worlds leading innovators, philanthropists, and business thought-leaders who have gathered to discuss global issues. This symposium is the latest in a series of thought leadership and panel discussion appearances by CSC team members in recent months.

The NYC-based Global Emerging Leadership Forum was founded in 2011 to support emerging professionals through the discussion of the top social and economic issues of today, as well as emerging trends of the future. Dr. Keirstead will speak at 1pm in New York Citys Kaufmann Concert Hall, joining a diverse panel of influential and forward-thinking leaders in their respective fields. Attendees will gain valuable insight into the future of global society, global citizenship, corporate responsibility, and the politics of being an emerging global leader.

In February of this year, Dr. Keirstead presented at Singularity Universitys FutureMed event Exploring the Future of Healthcare. He delivered a presentation highlighting the powerful potential uses of stem cells for spinal cord injury and beyond. More recently, California Stem Cells Gabriel Nistor, M.D. participated in an Institute of Medicine (IOM) hosted review of the California Institute of Regenerative Medicine (CIRM)s programs, operations, strategies, and performance.

Details of California Stem Cell pubic speaking appearances are at: http://californiastemcell.com/press_cal

More information about the Global Emerging Leadership Forum: http://www.emergingleadersnyc.com/

More information about FutureMed: http://futuremed2020.com/

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company with proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is currently focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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California Stem Cell Chairman Hans Keirstead Speaks at Prominent Global Emerging Leadership Forum

AUSTIN - The Texas Medical Board Friday approved rules regulating adult stem cell therapy, concerned that the proliferation of the experimental treatment constitutes "an emergency state."

Despite opposition from some board members concerned that its action could wind up putting more patients in danger of harm from the unproven, unlicensed therapy, the board approved a policy that allows doctors to use it as long as they get the patient's consent and the approval of a review board that evaluates clinical research for safety. The therapy has been in the news since Gov. Rick Perry received it for an ailing back last year.

"We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection," said Dr. Irwin Zeitler, the board president. "The wheels of the federal government move so slowly - we're not willing to wait to protect our patients."

The board, which voted 10-4 to approve the regulations, promised it would work to improve them, pledging to bring revisions to its June meeting. No date has been set for when the policy approved Friday will take effect, but it will be at least 30 days, board staff said.

The policy, thought to be the first of its kind, has drawn criticism nationally and internationally for appearing to circumvent the Food and Drug Administration and for making the therapy commercially available before it has been proven safe and effective. The treatment is not approved by the FDA and patients typically must pay tens of thousands of dollars for it.

Adult stem cells, which multiply to replenish dying cells, have long been used to treat leukemia and other cancers, but in the last decade they have shown promise for tissue repair in many other diseases. Less versatile than embryonic stem cells, they are championed by many as a more ethical alternative because no embryo is destroyed.

But they are mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

The therapy gained national attention after it was revealed Perry received it last summer. Houston surgeon Stanley Jones injected the governor during his July 1 back surgery and intravenously in follow-up appointments.

todd.ackerman@chron.com

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Medical board approves controversial adult stem-cell rules

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A little more than three years ago a medical team from Berlin published the results of a unique experiment that astonished HIV researchers. The German group had taken bone marrow--the source of the body’s immune cells--from an anonymous donor whose genetic inheritance made him or her naturally resistant to HIV. Then the researchers transplanted the cells into a man with leukemia who had been HIV-positive for more than 10 years. Although treatment of the patient’s leukemia was the rationale for the bone marrow transplant therapy, the group also hoped that the transplant would provide enough HIV-resistant cells to control the man’s infection. The therapy exceeded the team’s expectations. Instead of just decreasing the amount of HIV in the patient’s blood, the transplant wiped out all detectable traces of the virus from his body, including in multiple tissues where it could have lain dormant. The German researchers were so surprised by the spectacularly positive results that they waited nearly two years before publishing their data.

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Antidepressants restore well-being to many people, but sometimes at the cost of such side effects as weight gain or loss of interest in sex. And these side effects can be just part of the frustration. As Robin Marantz Henig wrote in " Lifting the Black Cloud ," in the March issue of Scientific American , the drugs that have long dominated the market--the selective serotonin reuptake inhibitors (SSRIs) and the serotonin and norepinephrine reuptake inhibitors (SNRIs)--"do not help everyone and eventually fail in more than a third of users. A pill that seems to be working today might well stop helping tomorrow. And the drugs can take several weeks to start having a marked effect." Equally disturbing, some major pharmaceutical houses, such as GlaxoSmithKline , are pulling back from developing psychiatric medicines.

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A young woman who calls herself blue­berryoctopus had been taking anti­depressants for three years, mostly for anxiety and panic attacks, when she recounted her struggles with them on the Web site Experience Project. She said she had spent a year on Paxil, one of the popular SSRIs (selective serotonin reuptake inhibitors), but finally stopped because it destroyed her sex drive. She switched to Xanax, an ­antianxiety drug , which brought back her libido but at the cost of renewed symptoms. Then Paxil again, then Lexapro (another SSRI), then Pristiq, a member of a related class of antidepressants, the SNRIs (serotonin and norepinephrine reuptake inhibitors). At the time of the post, she was on yet another SSRI, Zoloft, plus Wellbutrin (a cousin of SNRIs that affects the activity of dopamine as well as norepinephrine), which was intended to counteract the sexual side effects of Zoloft. “I don’t notice much of a difference with the Wellbutrin, but I’m on the lowest dose now,” she wrote. “I’m going back to my psychiatrist next week, so maybe he’ll up it. Who knows.”

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Via Scoop.it – inPharmatics

 Quintiles and the American Diabetes Association announced a strategic agreement in which Quintiles’ Digital Patient Unit will provide the Association’s millions of website users access to Quintiles’ medication monitoring service.

The Association’s constituents who opt in for the service will receive free safety checks of their medications to identify potential interactions and other risk factors, which are already provided to the 2.5 million registered users of Quintiles’ http://www.MediGuard.org. Registrants will also be eligible to participate in select direct-to-patient programs to benefit their medical conditions and advance global diabetes patient care.

The Association’s constituents may opt in to this service from the Association’s website http://www.Diabetes.org

Via http://www.quintiles.com

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A blue-ribbon Institute of Medicine panel is broadening its reach in its examination of the performance of the $3 billion California stem cell agency.

The group will hold a one-day public hearing next Tuesday at UC Irvine that will include independent perspectives along with comments from biotech firms, some of which have been unhappy with the paucity of CIRM funding for industry. The IOM has additionally expanded its efforts to generate responses to its questionnaires to include rejected applicants and the general public.

The hearing is the last public session scheduled in California and will be audiocast on the Internet. The IOM's fourth and final public session is scheduled for some time later this year with release of the full report in November. The stem cell agency is paying the IOM $700,000 to conduct the study. The public sessions so far have been taken up with testimony from recipients of CIRM largesse or from employees or directors of the agency.

The list of independent witnesses next week includes Stuart Drown, executive director of the state's good government agency, the Little Hoover Commission, which conducted a lengthy study of the stem cell agency. Also on tap are others including:

• Ruth Holton-Hodson, California deputy state controller, and who deals with CIRM issues for the state controller, who chairs the only state body officially charged with overseeing the agency.
• Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Berkeley, an organization that has been critical of CIRM
• David Jensen, publisher of the California Stem Cell Report, which has posted more than 3,000 items on the agency since 2004 in addition to a number of freelance articles. 

The IOM has widened its efforts to secure comments from persons who cannot appear at its hearings. At the IOM's request, CIRM sent emails about the questionnaires to the 4,039 persons who have asked the agency to be notified about its RFAs. Recipients were asked by CIRM to complete the IOM surveys.

The online forms are due by April 23. Here are links in the various categories:  general public, CIRM investigators,CIRM industry partners, leadership from CIRM-funded institutions, technology transfer professionals,CIRM's international collaborators, members of the Independent Citizens' Oversight Committee (the CIRM governing board), and investigators not funded by CIRM.

The IOM said access to the Internet audiocast of the meeting can be gained on April 10 through this web page.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Chuck Winner is a name that doesn't surface often in connection with California's $3 billion stem cell research effort.

Chuck Winner (left) at USC in 2006 USC Photo

In fact, he rarely appears in the news. Winner's name, however, did surface yesterday when Gov. Jerry Brown appointed him to the state's horse racing board. Most of the stories about the appointment were in horse racing publications. But none, including The Sacramento Bee's, mentioned the Prop. 71 campaign managed by his firm, Winner & Mandabach Campaigns of Santa Monica, Ca.

Nonetheless, he and his firm were the key to winning approval of the 2004 ballot measure that created the California Institute of Regenerative Medicine, an enterprise that is unprecedented in state or national history.

The firm's $35 million campaign for Prop. 71 attracted 59 percent of the vote. That same year, the firm also successfully managed four other ballot measures in the Golden State. Its lifetime average is remarkable. The firm's web site says it has won 90 percent of the 150 ballot measure campaigns it has run throughout the country.

Winner-Mandabach has this to say about how it pulled off the Prop. 71 campaign:

"Surveys (in 2003-04) showed that most voters supported the basic concept of expanding stem cell research. However, because of the state’s serious budget and debt problems, it was also clear that passing such a huge bond measure for any purpose would be a major challenge.

"The campaign overseen by Winner & Mandabach to overcome those odds involved a year-long coalition building effort that ultimately recruited over 40 Nobel Prize winning scientists and more than 100 patient groups, disease foundations and business groups – the largest, most diverse coalition of its kind ever formed to support a state ballot measure. The supporting groups helped mount an intense grassroots outreach and activation effort to their members, who numbered in the millions."

Winner-Mandabach continued,

"The TV advertising developed by the firm featured award-winning scientists, patients and their families, and highly-respected patient advocates like Michael J. Fox and the late Christopher Reeve. The ads focused on the potential for cures that could save millions of lives. Details of the initiative and economic issues were addressed through in-depth mail pieces and earned media efforts that included the release of an economic study showing that stem cell cures would help reduce the state’s skyrocketing health care costs. Prior to the implementation of the paid media campaign in late-September, polling showed Proposition 71 below the 50% threshold. But after an intense 6-week advertising, earned media and grassroots campaign, Prop. 71 steadily gained support, even in the face of final attacks by conservative groups and activists like Mel Gibson, and attacks from the left by some anti-biotech groups. Because of its precedent-setting nature, the Prop. 71 campaign became the most watched ballot measure campaign in the nation and generated worldwide press attention. On election day, it was approved overwhelmingly by a vote of 59% to 41%."

The key to success on any ballot measure is a firm like Winner-Mandabach, although high profile individuals – in the case of Prop. 71, Robert Klein, who became the first chairman of the stem cell agency – are often given complete credit. Top notch campaign firms have a keen understanding of voters, appropriate political timing and effective PR and TV advertising campaigns. Without Winner-Mandabach – or a firm with the same skillset – the California stem cell agency would not exist.

Chuck Winner, however, does not have an uncritical view of the ballot initiative process, which has resulted in much expensive mischief in California. He told a USC audience in 2006,

"It’s abused time and again. My opinion is that when you circumvent the legislative process or representative democracy to solve a problem, you can take it to an extreme and that extreme becomes, in some ways, worse than the problem you were trying to solve in the first place. Single-issue up or down initiative votes are very often not the best way to govern."

As for the horse racing business, Winner, a Beverly Hills resident, has been involved in horse racing since 1986. His partner, Paul Mandabach, is also involved in the sport of kings. Their firm has not disclosed their record at the track.

(Click here to see two powerful ads developed for the 2004 campaign, including the famous Christopher Reeve spot.)

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

SAN FRANCISCO – A proposed $17.9 million operational budget for the California stem cell agency has cleared a key hurdle despite objections concerning the addition of another attorney to its $2.4 million annual legal effort.

The spending plan was approved yesterday by the CIRM directors' Finance Subcommittee on an 8-0 vote. The proposal is 7.2 percent higher than spending for the current fiscal year, which ends in June. The agency by law operates with a stringent budget cap of 6 percent of its bond funding.

Most of the budget goes for salaries at the agency, which has slightly more than 50 employees. The agency spends $8.4 million annually administering its 400-plus grants and developing new grant programs.

The proposal to add another lawyer to its staff drew fire from CIRM Co-vice chairman Art Torres. He asked why the agency wanted to spend more money for "a lawyer we don't need."

CIRM President Alan Trounson and CIRM General Counsel Elona Baum defended the plan, saying another lawyer was needed to deal with intellectual property and research commercialization issues. They said that grantee institutions and businesses are not dealing with the legal ramifications in a satisfactory manner.

Trounson said the agency would be "at risk" if it did not have control of the legal issues.

Torres brought up a memo on the subject, which he said did not justify the addition of a lawyer. Other directors said they had not seen the memo and asked for copies. The California Stem Cell Report has also asked for a copy.

Michael Goldberg, a venture capitalist and chair of the Finance Subcommittee, asked CIRM staff and a handful of directors to resolve the matter between now and the end of May, when the budget is expected to be approved by the full board.

Currently CIRM has five attorneys on staff, not including directors who are lawyers. The budget for the internal legal operation is $1.3 million annually. The rest of the $2.4 million goes for contracted services, including the firm of Remcho, Johansen & Purcell of San Leandro, Ca., a highly regarded political and governmentally oriented law firm that is budgeted for as much as $650,000 for the coming year, down from $695,000 this year. Another attorney is also on contract for $250,000, down from $325,000 this year.

CIRM budget documents projected savings in $190,000 in legal costs from the current year that could be used to help hire another attorney. The total legal costs for next year are budgeted at $2.44 million, compared to $2.39 million for the current year.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss