CIRM Sponsoring Online Session with FDA on Thursday
By Dr. Matthew Watson
One of the lesser known activities of
the California stem cell agency is webinars that put researchers
together with the folks who make the federal decisions about whether
stem cell research will be turned into therapies.
parties to get on board.
Cynthia Schaffer, CIRM's contract administrator and compliance officer
had this to say today about the webinars.
“The FDA very graciously donates
their time to speak on these webinars because they too have pledged
to maintain an active dialogue with the industry and provide
education on their regulatory expectations for product development in
the regenerative medicine field. CIRM science officer Kevin
Whittlesey recently
wrote a paper with Celia Witten of the FDA about the role of the
FDA in reaching out to regenerative medicine community, including
webinars such as these.
“In that paper they point out that
the communication goes both ways:
“'Appropriate regulation requires a
strong understanding of the latest scientific developments to meet
current and future regulatory needs and challenges.'
“So the FDA benefits by learning from
the other speakers in the webinar – what is the current state of
the technology, what are investigator’s current thoughts on best
practices and the latest research findings, etc. They also learn what
the industry is facing by listening to the questions asked and the
discussion of the challenges during the Q&A sessions. A group of
FDA employees attend each of these CIRM sponsored webinars, and the
wide variety of other workshops and meetings that CIRM hosts
throughout the year.”
(Editor's note: An earlier version of this item incorrectly identified Cynthia Schaffer as Cynthia Adams.)
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September 30th, 2012
$1.5 Billion in Stem Cell Awards Goes to Directors’ Institutions
By Dr. Matthew Watson
The Sacramento Bee today published an article that reported that $1.5 billion, more than 90 percent of the amount dispensed by the California stem cell agency, has gone to institutions linked to past and present directors of the agency.
The piece was carried on the front page of the newspaper's Sunday Forum section and was written by David Jensen, publisher-editor of the California Stem Cell Report.
The text of the Forum article is below. The Bee also carried a chart listing the top 10 recipient institution. The full text of the comments from Alan Trounson, president of the California stem cell agency, and two other persons quoted in the article can be found here.
Stem cell cash mostly aids directors' interests
Special to The Bee
By David Jensen
With its latest round of awards earlier this month, California's stem cell agency has now handed out $1.5 billion to enterprises linked to its directors.
The University of California, Davis, has received $128 million. Claire Pomeroy, chief executive officer of UC Davis Health System, is another one of the 29 board members. In all, 27 institutions with past or present representatives on the agency board have received funding.
None of this is illegal. And none of it is likely to change. The situation was created by Proposition 71, the 2004 ballot measure that established the state's $3 billion stem cell agency, formally known as the California Institute for Regenerative Medicine, or CIRM. The initiative was crafted so that virtually all of the institutions that stood to benefit from the state's largesse had seats at the table where the money is handed out.
The built-in conflicts of interest at CIRM have perturbed some experts in California government, but concerns have also reached into the scientific community. The prestigious journal Nature, in 2008, editorialized against what it called cronyism at CIRM. It said the agency "must fight the tendency of the academic institutions on the board to hoard dollars."
Some California scientists, wary of offending those who control the lifeblood of their research, privately grumble about an "old boys network."
Joe Mathews, co-author of "California Crackup," a study of major issues in state government, said last week: "California ballot initiatives are a terrible way to make public policy. And they are even worse as a method for making scientific policy."
The stem cell agency has a different view. Alan Trounson, president of the San Francisco-based enterprise, said: "There is no evidence that any of CIRM's funding decisions have been driven by conflicts of interest. Indeed, CIRM rigorously enforces its conflict of interest rules at each stage of the funding process to ensure that all decisions are made on the merits of the proposal for funding and not as a result of any conflicts of interest."
Mathews, California editor of Zocalo Public Square, and others point to the creation of the California stem cell agency as an example of abuse of the initiative process by special interests. The 10,000 words in Proposition 71 were written in private by Bay Area real estate investment banker Robert Klein and a handful of associates, who quietly determined the composition of the board. Klein later served six years as the first chairman of the stem cell agency, leaving in June 2011.
Klein later argued publicly that placing medical school deans and university and research institution executives on the board provided the expertise needed to make the decisions about how to spend the research money. However, the makeup of the board also served to win the support of institutions that envisioned the prospect of fresh cash – in this case money that the state borrows via bonds.
Mathews described the state's initiative process this way: "Essentially, to win the support of various groups whose money and backing is important to passage of a bond, a sponsor of an initiative bond will set up rules and include money specifically intended for each group. This is a form of pay-to-play. Agree to back the initiative, and you're in."
Bob Stern, who co-wrote the California Political Reform Act, said, "It would have been better had institutions receiving grants not to have had their representatives on the board awarding grants."
Trounson said the board follows "best practices" when it comes to grants and legal conflicts of interest. The agency has worked out an unusual procedure to prevent its directors from violating conflict of interest laws as they vote on applications that seek as much as $20 million each. Before each public session, agency attorneys determine which board members cannot vote on a proposal because of legal conflicts of interest. Applications to be approved are considered as a group. Each board member then votes on the entire group by saying, "Yes, on all those except with which I have a conflict."
No final tally is announced. The public can ferret out the overall vote a month or two later in the minutes of the meeting on the CIRM website (http://www.cirm.ca.gov). But the minutes do not list individual votes or conflicts of interest.
Domination of the board by academics and nonprofit institutions has led to bitter complaints from business. Less than 7 percent of all awards have gone to for-profit enterprises. Currently, however, the agency is embracing industry more warmly in an effort to commercialize stem cell research, which raises another set of coziness problems. They surfaced in July and again this month.
Klein, who led the stem cell ballot campaign before becoming chairman of the agency, appeared before his old board to lobby on behalf of a $20 million request from StemCells Inc. of Newark. The California firm was founded by the eminent Stanford stem cell scientist Irv Weissman. He sits on StemCells Inc.'s board, and he and his wife hold 273,821 shares of stock in the firm. Weissman was also an important backer of Proposition 71, working the "billionaire circuit" and raising more than $1 million for the campaign, according to an article in San Francisco magazine.
CIRM's reviewers had rejected StemCells Inc.'s application. After Klein made his pitch in July, the board sent the application back for re-review, an unusual procedure.
When the application returned to the board early this month, reviewers again rejected it. Klein again importuned his former colleagues, and – following a closed door session – the board approved the award, 7-5.
Eleven members were disqualified from voting because of legal conflicts of interest. It was the first time in the board's eight-year history that it approved an application twice rejected by reviewers.
Mathews said no likelihood exists of changing the board structure at CIRM. He said it is "baked in" by Proposition 71. That's because Klein and company wrote into the initiative a requirement for a super, super-majority vote – 70 percent – of each house of the Legislature to make any modifications.
Another initiative could be mounted, but that possibility is also exceedingly remote.
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September 30th, 2012
Text of Comments on Awards to Stem Cell Directors’ Institutions
By Dr. Matthew Watson
Here is the full text of comments made
by the California stem cell agency, Joe Mathews, co-author of
“California Crack-Up” and Bob Stern, former president of the
Center for Governmental Studies and co-author of the California
Political Reform Act, in connection with the Sept. 23, 2012, article
in The Sacramento Bee headlined “Stem Cell Cash Mostly Aids Directors' Interests.” The comments were abbreviated for
publication in The Bee because of newspaper space constraints.
CIRM:
“To make sure we do the best job of
managing taxpayer's money it's natural that we turn to people who
know most about stem cells and stem cell research. In fact, as the
state's own Little Hoover Commission reported in its analysis of
CIRM: “The fact that CIRM funding has gone largely to prestigious
California universities and research institutes is hardly surprising
and should be expected, given the goals of Proposition 71 and the
considerable expertise resident in these research centers.” But in
recruiting the best minds, we also adopt best practices to ensure
that there is no conflict of interest. Every board member has to
recuse themselves from voting on, or even being part of a discussion
on anything to do with their own institution, or to an institution or
company that they have any connections to. All this is done in
meetings that are open to the public. CIRM’s conflict of interest
rules have been subject to multiple reviews – by the Bureau of
State Audits, the Little Hoover Commission and the Controller – and
there is no evidence that any of CIRM’s funding decisions have been
driven by conflicts of interest. Indeed, CIRM rigorously enforces its
conflict of interest rules at each stage of the funding process to
ensure that all decisions are made on the merits of the proposal for
funding and not as a result of any conflicts of interest.
“In addition all funding applications
are reviewed by an independent panel of scientists on our Grants
Working Groups, all of whom are out-of-state and meet strict conflict
of interest requirements, and it is their recommendations that help
guide the ICOC (CIRM governing board) on what to fund.”
“California ballot initiatives are a
terrible way to make public policy. And they are even worse as a
method for making scientific policy.
“It's not merely that
this initiative was drafted in such a way as to benefit the
enterprises of its directors. It's that, under this initiative's own
provisions and the California constitution, it's so hard to change
Proposition 71 and fix what ails CIRM. Effectively, these provisions are
baked in, and nothing short of another vote of people can really make
the change. (Yes, there are provisions, as you know, that permit the
legislature by super-majority to do things, but supermajorities are
effectively out of reach in California).
“Sadly, initiatives
like Proposition 71 are not uncommon. Many measures are drafted to benefit
the people who would support the measure, or oversee the program
established. This has been very common with bonds. Essentially, to
win the support of various groups whose money and backing is
important to passage of a bond, a sponsor of an initiative bond will
set up rules and include money specifically intended for each group.
This is a form of pay-to-play. Agree to back the initiative and
you're in. And it happens because there's no rule against it and
because passing initiatives in California require difficult,
expensive campaigns.
“And this sort of thing will continue
to happen. There is no serious push to do anything about this.
Indeed, good government groups and reformers in California have
opposed changes to the initiative process -- because they want to use
the process for their own schemes.”
“It would have been better had
institutions receiving grants not to have had their representatives
on the board awarding grants. On the other hand, we want to have the
most knowledgeable people on the board overseeing this very important
program. The question: Were these people the only qualified ones to
sit on the board?”
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September 30th, 2012
Safety in handling LMOs to feature in deliberations – The Hindu
By Dr. Matthew Watson
 The Hindu | Safety in handling LMOs to feature in deliberations The Hindu Come Monday, over 2,000 delegates from more than 150 countries will converge in Hyderabad to discuss about ensuring safe transfer, handling and use of Living Modified Organisms (LMOs) resulting from the modern biotechnology. The LMOs are broadly ... Hyderabad to host bio-diversity conference from MondayDeccan Herald Convention on Biological Diversity meeting from tomorrowHindu Business Line AP to host UN biodiversity meet from Oct 1Firstpost |
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September 30th, 2012
Neuralstem Approved To Commence Ischemic Stroke Trial In China
By Dr. Matthew Watson
ROCKVILLE, Md., Sept. 27, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced it has been approved to commence a clinical trial to treat motor deficits due to ischemic stroke with its spinal cord stem cells (NSI-566) at BaYi Brain Hospital, in Beijing, China, through its subsidiary, Neuralstem China (Suzhou Neuralstem Biopharmaceutical Company, Ltd.). The trial approval includes a combined phase I/II design and will test direct injections into the brain of NSI-566, the same cell product tested by Neuralstem in a recently-completed Phase IALS trial in the United States. The trial is expected to begin early next year. Ischemic strokes, the most common type of stroke, occur as a result of an obstruction within a blood vessel supplying blood to the brain. Post-stroke motor deficits include paralysis in arms and legs and can be permanent.
(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )
"China is rapidly moving to become a prominent player in the field of stem cell transplantation and regenerative medicine," said Karl Johe PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "We are honored and excited to begin this process at BaYi Brain Hospital in Beijing, China. BaYi is one of the premier neurological hospitals in China, and we can assure all of our stake holders that the quality of the medical care and treatment our patients receive, as well as the entire protocol, will be the equal of any trial we do anywhere in the world, including our FDA-approved trial in the U.S."
"BaYi prides itself on its world class research capabilities," said Professor Xu RuXiang, President of the BaYi Hospital and principal investigator of the trial. "Chronic motor disorder from stroke is a serious public health issue for China, where we, as a population, now suffer over 2 million ischemic strokes per year.We are ready to be the world's first site for Neuralstem's cell therapy stroke trial and excited about its potential."
About the Trial
The trial is designed to enroll up to 118 patients who have suffered an ischemic stroke with chronic residual motor disorder with Neuralstem's NSI-566 cell line, 4-24 months post-stroke. The stem cell treatment involves a one-time treatment of intracerebral injections of Neuralstem's neural stem cells into the stroke area using well-accepted stereotactic injection procedures. The trial will be conducted in 2 parts. The first part of the study, Phase I, will be open-label and enroll up to 18 patients who will be assigned to 3 cohorts. Each of these will receive ascending doses of NSI-566 to define the maximal safe dose. The maximal safe dose defined in the first phase will be used to evaluate efficacy in the second part of the study, a Phase II/Proof-of-Concept study. This Phase will be a multi-site, randomized, controlled, single-blind study and enroll up to 100 randomized subjects. 50% of the subjects will receive a one-time treatment with the cells and physical therapy and the other 50% will receive only the physical therapy with no surgery. Outcome measures during the follow-up period in Phase II will be conducted in single-blinded manner. The combined study, including patient monitoring and data collection, is expected to take approximately two years.
About Neuralstem China
Founded in 2010, Neuralstem China (Suzhou Sun-Now Biopharmaceutical Co. Ltd. is a wholly-owned subsidiary of Neuralstem, Inc., headquartered in Suzhou, roughly one hundred miles west of Shanghai. Neuralstem China has constructed a clinical-grade manufacturing facility), and holds the license required by the Chinese government for conducting business in China. Neuralstem's mission in China is to bring its world-leading neural stem cell technology to China to address the unmet medical needs of tens of millions of patients suffering from diseases of, and injuries to, the central nervous system (CNS).
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September 28th, 2012
Making it easier to make stem cells
By Dr. Matthew Watson
Public release date: 25-Sep-2012 [ | E-mail | Share ]
Contact: Heather Buschman hbuschman@sanfordburnham.org 858-795-5343 Sanford-Burnham Medical Research Institute
LA JOLLA, Calif., September 25, 2012 The process researchers use to generate induced pluripotent stem cells (iPSCs)a special type of stem cell that can be made in the lab from any type of adult cellis time consuming and inefficient. To speed things up, researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham) turned to kinase inhibitors. These chemical compounds block the activity of kinases, enzymes responsible for many aspects of cellular communication, survival, and growth. As they outline in a paper published September 25 in Nature Communications, the team found several kinase inhibitors that, when added to starter cells, help generate many more iPSCs than the standard method. This new capability will likely speed up research in many fields, better enabling scientists around the world to study human disease and develop new treatments.
"Generating iPSCs depends on the regulation of communication networks within cells," explained Tariq Rana, Ph.D., program director in Sanford-Burnham's Sanford Children's Health Research Center and senior author of the study. "So, when you start manipulating which genes are turned on or off in cells to create pluripotent stem cells, you are probably activating a large number of kinases. Since many of these active kinases are likely inhibiting the conversion to iPSCs, it made sense to us that adding inhibitors might lower the barrier."
According to Tony Hunter, Ph.D., professor in the Molecular and Cell Biology Laboratory at the Salk Institute for Biological Studies and director of the Salk Institute Cancer Center, "The identification of small molecules that improve the efficiency of generating iPSCs is an important step forward in being able to use these cells therapeutically. Tariq Rana's exciting new work has uncovered a class of protein kinase inhibitors that override the normal barriers to efficient iPSC formation, and these inhibitors should prove useful in generating iPSCs from new sources for experimental and ultimately therapeutic purposes." Hunter, a kinase expert, was not involved in this study.
The promise of iPSCs
At the moment, the only treatment option available to many heart failure patients is a heart transplant. Looking for a better alternative, many researchers are coaxing stem cells into new heart muscle. In Alzheimer's disease, researchers are also interested in stem cells, using them to reproduce a person's own malfunctioning brain cells in a dish, where they can be used to test therapeutic drugs. But where do these stem cells come from? Since the advent of iPSC technology, the answer in many cases is the lab. Like their embryonic cousins, iPSCs can be used to generate just about any cell typeheart, brain, or muscle, to name a fewthat can be used to test new therapies or potentially to replace diseased or damaged tissue.
It sounds simple enough: you start with any type of differentiated cell, such as skin cells, add four molecules that reprogram the cells' genomes, and then try to catch those that successfully revert to unspecialized iPSCs. But the process takes a long time and isn't very efficientyou can start with thousands of skin cells and end up with just a few iPSCs.
Inhibiting kinases to make more iPSCs
Zhonghan Li, a graduate student in Rana's laboratory, took on the task of finding kinase inhibitors that might speed up the iPSC-generating process. Scientists in the Conrad Prebys Center for Chemical Genomics, Sanford-Burnham's drug discovery facility, provided Li with a collection of more than 240 chemical compounds that inhibit kinases. Li painstakingly added them one-by-one to his cells and waited to see what happened. Several kinase inhibitors produced many more iPSCs than the untreated cellsin some cases too many iPSCs for the tiny dish housing them. The most potent inhibitors targeted three kinases in particular: AurkA, P38, and IP3K.
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Flanders Institute for Biotechnology exceptionally sceptical about the … – Phys.Org
By Dr. Matthew Watson
 PublicServiceEurope.com | Flanders Institute for Biotechnology exceptionally sceptical about the ... Phys.Org The VIB scientists had serious reservations about the Séralini publication, which appeared today in the journal Food and Chemical Toxicology. The conclusions drawn by Séralini could not be derived from the publication. The data will have to be ... Controversy rages over Monsanto/GM cancer studyThe Grocer France and European Commission Order Review of Controversial GM Study in ...Science Now VIB exceptionally sceptical about the Séralini researchScience Codex |
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September 23rd, 2012
Alabama’s HudsonAlpha Institute for Biotechnology in global look into the … – al.com (blog)
By Dr. Matthew Watson
al.com (blog) | Alabama's HudsonAlpha Institute for Biotechnology in global look into the ... al.com (blog) Dr. Rick Myers, president and director at HudsonAlpha, talks about the research project is called ENCODE during a press conference at Hudson Alpha Institute for Biotechnology Sept., 2012 in Huntsville, Ala. HudsonAlpha was one of the lead research ... |
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September 23rd, 2012
Jeffrey M. Friedman awarded 11th IPSEN Endocrine Regulation Prize – The Rockefeller University Newswire
By Dr. Matthew Watson
 The Rockefeller University Newswire | Jeffrey M. Friedman awarded 11th IPSEN Endocrine Regulation Prize The Rockefeller University Newswire The Fondation IPSEN has awarded its 11th Endocrine Regulation Prize to Jeffrey M. Friedman, the Marilyn M. Simpson Professor and head of the Laboratory of Molecular Genetics, for his discovery of the hormone leptin and its role in regulating body weight. |
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September 23rd, 2012
Reproducing Research Results: Removing a Scientific Roadblock
By Dr. Matthew Watson
The California stem cell agency faces
no easy task in trying to translate basic research findings into
something that can be used to treat patients and be sold commercially.
long after the basic research is done and which involve more ordinary
therapeutic treatments than stem cells, fail at an astonishing rate.
Only one out of five that enter the clinical trial gauntlet
successfully finish the second stage, according to industry data
cited last spring by Pat Olson, executive director of scientific activities at the stem cell agency. And
then come even more challenges.
research there is the “problem of irreproducible results,” in the
words of writer Monya Baker of the journal Nature. Baker last month reported on
moves by a firm called Science Exchange in Palo Alto, Ca., to
do something to ease the problem and speed up preclinical research.
The effort is called the Reproducibility Initiative and also involves
PLOS and figshare, an open science Internet project.
 |
| Elizabeth Iorns Science Exchange Photo |
Iorns, a scientist and co-founder of the firm. She wrote about test-tube-to-clinic translation issues in a recent article in New
Scientist that was headlined, “Is medical science built on shaky
foundations?”
“One goal of scientific publication
is to share results in enough detail to allow other research teams to
reproduce them and build on them. However, many recent reports have
raised the alarm that a shocking amount of the published literature
in fields ranging from cancer biology to psychology is not
reproducible.”
reported that Bayer cannot “replicate about two-thirds of published
studies identifying possible drug targets” and that Amgen failed at
even a higher rate. It could not “replicate 47 of 53 highly
promising results they examined.”
this week asked Iorns for her thoughts on the implications for the
California stem cell agency, whose motto is "Turning stem cells into cures." Here is the full text of her response.
“First, I think it is important to
accept that there is a crisis affecting preclinical research. Recent
studies estimate that 70% of preclinical research cannot be
reproduced. This is the research that should form the foundation upon
which new discoveries can be made to enhance health, lengthen life,
and reduce the burdens of illness and disability. The
irreproducibility of preclinical research is a significant impediment
to the achievement of these goals. To solve this problem requires
immediate and concrete action. It is not enough to make
recommendations and issue guidelines to researchers. Funders must act
to ensure they fund researchers to produce high quality reproducible
research. One such way to do so, is to reward, or require,
independent validation of results. The reproducibility initiative
provides a mechanism for independent validation, allowing the
identification of high quality reproducible research. It is vital
that funders act now to address this problem, to prevent the wasted
time and money that is currently spent funding non-reproducible
research and to prevent the erosion of public trust and support for
research.”
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September 23rd, 2012
Prop. 37: Another example of the perils of the initiative process – Los Angeles Times
By Dr. Matthew Watson
 Los Angeles Times | Prop. 37: Another example of the perils of the initiative process Los Angeles Times Genetic engineering, or genetic modification, which involves manipulating DNA or transferring it from one species to another, is increasingly common in agriculture and food processing, and wouldn't be banned or even regulated by the measure. Genetic ... Barnridge: Prop. 37 promises a big food fightDaily Democrat Food Fight: New ads about Proposition 37, the labeling effort for GMOs89.3 KPCC (blog) Students show support for Proposition 37Lariat Saddleback College EI Tecolote -Forbes -New York Times (blog) all 45 news articles » |
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September 16th, 2012
Move Over Genetic-Engineering; Biomimicry Seems The Better Bet For Solving … – Forbes
By Dr. Matthew Watson
Forbes | Move Over Genetic-Engineering; Biomimicry Seems The Better Bet For Solving ... Forbes Move Over Genetic-Engineering; Biomimicry Seems The Better Bet For Solving Global Hunger. 0 comments, 0 called-out. + Comment now. + Comment now. Biomimicry is maybe the best idea you haven't heard too much about. The term, for those unfamiliar, ... |
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September 16th, 2012
Biotechnology Stock in Focus; Neuralstem Inc. (CUR) – SmallCap Network
By Dr. Matthew Watson
 Daily Mail | Biotechnology Stock in Focus; Neuralstem Inc. (CUR) SmallCap Network Shares of Neuralstem Inc. (AMEX: CUR) surged in trading on Thursday after the biotechnology company announced that its neural stem cells were part of a study published online in a leading scientific journal CELL. In the study, called Long Distance ... Neuralstem Gains on Stem Cell Therapy for Paralyzed RatsBusinessweek |
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September 16th, 2012
Biotechnology Park to boost economy – King – Times of Swaziland
By Dr. Matthew Watson
Times of Swaziland | Biotechnology Park to boost economy - King Times of Swaziland He called upon every Swazi citizen to impart knowledge, skills and expertise to fulfil government's endeavour of attaining First World status through the construction of the much anticipated Science and Biotechnology Park, among other priorities. The ... |
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September 16th, 2012
Angel Biotechnology expects to complete Materia Medica jv by end of 2012 – Proactive Investors UK
By Dr. Matthew Watson
Proactive Investors UK | Angel Biotechnology expects to complete Materia Medica jv by end of 2012 Proactive Investors UK Biopharmaceutical contract manufacturer Angel Biotechnology (LON:ABH) expects its joint venture with Russian firm Materia Medica to be completed before the end of the year. The firm is still dealing with the details of the agreement, it said in a wide ... |
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September 16th, 2012
Two lessons I learned this week.
By Dr. Matthew Watson
I always read WIRED magazine. Aside from GEN it's the only magazine I read. Just reading something outside of cell therapy or biotech often infuses me with an idea that otherwise would have never occurred to me like the need for a cell therapy X Prize or cellular aggregates as microcarriers or tissue-engineered memory and processing devices or even just the conviction to better represent cell therapy to the broader world out there of scientists, engineers, journalists, policy-makers, or perhaps people with too much money looking to be inspired and wanting to make a difference.
Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs
By Dr. Matthew Watson
Looking for a good job at an
enterprise that is on the cutting edge of biotechnology?
billion California stem cell agency, headquartered in San Francisco.
Some of them could pay more than $200,000 a year.
aligned with the agency's fresh focus on commercializing stem cell
research and driving therapies into the clinic. Scientists and
lawyers are being recruited along with a business development
officer. For some of the positions, travel is required.
described as a senior development officer. The job posting calls for
“expertise in product development for stem cell therapies.” The
person would “directly interact with investigators on CIRM’s
clinically applicable research programs to help provide product
development guidance from preclinical, manufacturing, and first in
human to early phase clinical regulatory perspectives.” An M.D. or
Ph.D. degree in a biomedical science is required. Pay tops out at
$232,891. This person would report to Ellen Feigal, senior vice
president for research and development.
agency's portfolio aimed at commercialization of stem cell research,
specifically “focused on IND enabling and clinical development
projects.” This also requires an M.D. or Ph.D. and substantial professional experience in development of biomedical research and
products. Pay also could run as high $232.891 annually.
business development officer. That person would help generate
“outside investment in stem cell research in California for both
CIRM-funded and not currently CIRM-funded programs by
biopharmaceutical strategic partners; equity investors (venture
capital and others); and disease foundations.” The salary range
hits $216,270 annually. It wouldn't be surprising if the person in
this job also became involved in developing a funding mechanism for
CIRM after it runs out of state cash in 2017 or so.
general counsel and vice president, business development.
director of alliance management. The job deals with the agency's
extensive collaborative funding partnerships, many of which are
abroad. CIRM wants somebody with a law degree, experience in
intellectual property and business law along with strong negotiating
skills. The pay range for the post tops out at $232,891 annually. This position reports to CIRM President
Alan Trounson.
general counsel, two science officers and office manager.
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September 16th, 2012
StemCells, Inc., Discloses How it Will Generate $40 Million in Matching Funds
By Dr. Matthew Watson
StemCells, Inc., said yesterday that it
will come up with the $40 million needed to match loans from the California
stem cell agency through “existing infrastructure and overhead”
and will not be issuing stocks or warrants to the agency.
McGlynn, CEO of the publicly traded firm, discussed the $40 million in loans awarded by agency this summer, including $20 million last
week. The stem cell agency's governing board, after it emerged from
an executive session on the matter, last Wednesday night adopted a
motion requiring the company to demonstrate that it has the matching
funds.
concerns were expressed during the executive session that the agency
“would account for such a large part of the assets of the company.”
At his suggestion, the board approved the loan on the condition that
“it show it has access” to the $20 million in matching funds that
company offered during the application process. StemCells, Inc., also
offered a $20 million match on another loan approved in July by CIRM.
StemCells, Inc., which is based in Newark, Ca., show that it had
assets of $17 million as of June 30 and liabilities of $11.6 million.
The company reported net income for the second quarter of $833,522
compared to a loss of $4 million for the same period a year ago.
said,
“We have incurred significant
operating losses since inception. We expect to incur additional
operating losses over the foreseeable future. We have very limited
liquidity and capital resources and must obtain significant
additional capital and other resources in order to provide funding
for our product development efforts....”
said the California stem cell agency had “doubled down” on
StemCells, Inc., in approving the two loans. He said the company is
not concerned about meeting the matching requirements. McGlynn said,
 |
| Martin McGlynn StemCells, Inc., Photo |
“To be clear, we do not interpret the
diligence requirement as an obligation to raise a specific amount of
money in a particular period of time, and we wish to correct the
misstatements made by some uninformed third parties that the ICOC is
requiring us to raise $20 million in matching funds. In
point of fact, we expect that a substantial amount of our
contribution towards these projects will come from existing
infrastructure and overhead, salaries for our existing personnel, and
other contributions in kind. Furthermore, we will soon be
reviewing the budgets for both projects in detail with CIRM
staff. Because each disease team budget was prepared on a
stand-alone basis, we expect to see significant economies and
efficiencies now that the company has in fact been awarded funding
for both.”
"Under this particular CIRM
program (RFA 10-05), funding for companies will be in the form of
unsecured, non-recourse, interest-bearing, term loans, which will be
forgivable in the event the funded research fails to result in a
commercialized product. On the other hand, should the product be
successfully commercialized, CIRM would earn milestone payments
depending on how successful the product becomes. Because CIRM
shares the downside risk, and could participate handsomely on the
upside, the structure makes the loan about as close to 'equity' as one could, without having to dilute existing shareholders in order
to gain access to significant amounts of capital. The company
will not issue stock, warrants or other equity to CIRM in connection
with these awards.
"Of course, we realize that CIRM
prefers that applicants from industry provide evidence of their
ability to secure whatever additional funds may be needed to complete
any CIRM-funded project, in this case the filing of an IND for each
indication. This is stated in the text of RFA 10-05 itself and
was repeated in various comments by CIRM staff during the application
process. When making the second award on September 5, the
ICOC naturally recognized the sizeable commitment it was making
to StemCells, so it instructed CIRM staff to satisfy themselves
of the company's ability to access the capital needed to fund the
project, namely the Alzheimer's program through to the filing of the
IND.”
another $10 million from CIRM could come in the form of a grant
instead of a loan. He said,
"Finally, I can confirm that in
June of this year the Company applied for up to $10
million under CIRM's Strategic Partnership I program
(RFA 12-05). Unlike the disease team awards under RFA
10-05, if companies are approved for funding under RFA 12-05, they
may elect to take such funding in the form of a grant, not a
loan. Our application under RFA 12-05 is for a controlled Phase
II clinical trial of HuCNS-SC cells in Pelizaeus-Merzbacher disease
(PMD), a rare myelination disorder. StemCells completed a Phase
I study in PMD in February 2012 and in April announced that
all of the patients from that study showed evidence of cell-derived
myelination and three of the four patients in the study showed
measurable gains in motor and/or cognitive function.”
$1.85 at the time of this writing. Last week, it rose to $2.43.
During the last 12 months, its high was $2.67 and its low was 59
cents.
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September 16th, 2012
California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards
By Dr. Matthew Watson
During the last few months, the $3 billion California stem cell
agency, which is approaching its eight-year anniversary, has chalked up a
number of important firsts.
September meetings of its 29-member governing board and were related to strenuous efforts by researchers to win approval of awards of up to
$20 million each. Several firsts involved the agency's former
chairman, Robert Klein, who could be considered the father of the
state's stem cell research effort.
Report's list of firsts at the California Institute of Regenerative
Medicine (as CIRM, the stem cell agency, is formally known) for the
summer of 2012.
company – in this case, StemCells, Inc. , of Newark, Ca. –
received two awards in the same round.
been awarded as much as $40 million. Again, StemCells, Inc.
behalf of a particular grant application. That occurred in both July
and September with one of StemCells, Inc.'s application.
has approved an application that has been rejected twice by
reviewers, again the StemCells, Inc., proposal backed by Klein.
received such a large outpouring of appeals by rejected applicants.
has received such lengthy presentations of emotional appeals by
patient advocates on behalf of rejected applicants.
grant round has been extended over three months(see here and here). The disease team
round began in July. Action will not be completed until the end of
October.
governing board has sent so many applications back for re-review –
five, six if the one to be acted on in October is included.
board has ordered a full-blown review of its grant appeal process
with an eye to making making major changes in it.
firsts racked up by CIRM. One is the high stakes involved in the
disease team round that began in July and the low number approved by reviewers – six compared to the 12 approved by the board, as of
today, out of 21 applications. Another reason involves the
increasing understanding on the part of many scientists that they can
appeal directly to the board when reviewers reject their
applications. However, it is also clear that not all applicants
grasp the full range of appeal possibilities. A third reason involves
the agency's muddled appeal process, which has been a problem for
years. And a fourth reason involves the board's push to drive research into
the clinic and commercialization, which applicants are quickly
learning how to exploit.
own firsts to this list. They can do so – even, anonymously – by
clicking on the word “comments” at the end of this item.
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September 16th, 2012
UC San Diego Researchers Use Stem Cells To Restore Mobility
By Dr. Matthew Watson
SAN DIEGO UC San Diego researchers have used early stage stem cells to restore movement in rats that had suffered severe spinal cord injuries. Researchers say the stem cells in essence rewired the spinal cord.
Previous studies showed stem cells implanted at the site of a spinal cord injury didn't survive for long.
In this study, researchers embedded the stem cells in a gel. That allowed the cells to stick to and completely fill the injury site. Scientists also added a cocktail of growth factors.
UC San Diego's Mark Tuszynski, the study's principal investigator, said the technique generated an enormous amount of new neurons.
"That amount of growth, and the ability of this to improve function after the most severe spinal cord injury, moves this into the realm of potential human translation," Tuszynski explained.
Tuzynski said after the therapy, rats were able to move their hind legs again, but not at full strength.
Paul Lu, assistant research scientist at UC San Diego's Center for Neural Repair, contributed to the study.
Their research is published in the journal Cell.
Originally posted here:
UC San Diego Researchers Use Stem Cells To Restore Mobility
Spinal Cord Stem Cells
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September 14th, 2012