Minnesota Twins may add extra autism section games in 2013

Sunday, July 29, will be Autism Awareness Day at Target Field, with 250 fans watching the series finale against the Indians from a dedicated section in left field. It has been an annual event for the Twins since 2004, but team president Dave St. Peter said it may grow to a handful of games as early as next season.

"As an organization there hasn't been anything decided, but it's definitely a consideration for the future," St. Peter said. "We'll certainly look at the possibility this offseason."

The event is designed to raise awareness of Autism Spectrum Disorders, a set of brain-based disorders that affect a person's behavior, as well as social and communications skills. It also is an opportunity for people with ASD, their families and friends to enjoy a game in a supportive environment.

"Once people realize we have this going on, they're more apt to bring their kids to a game, whereas in the past they may have felt isolated and lonely," said Brad Trahan, executive director for RT Autism Awareness Foundation in Rochester, Minn., which promotes the Twins event each year. "Now we're all together with parents and caregivers."

That social engagement is important for ASD families, who often get out only rarely because of social or economic issues, Trahan said. His foundation, named after his son, Reece, is petitioning Major League Baseball to add an autism awareness weekend to the schedule similar to those dedicated to raising awareness for breast and prostate

The New York Mets announced in June they are thinking of creating a permanent "quiet" autism section. Because many on the autism spectrum can be overwhelmed by even everyday stimuli, the section would drastically lower the volume on the PA announcements, and cut out music and cheerleading. St. Peter said he is familiar with the Mets' plan, and the Twins could do something similar.

"We are able to modify the PA system speakers for certain sections; we can turn them down or off," he said. "It would mainly be the sound piece we focus on. Our challenge is to get out in front of it -- identify the section and the game so that we can deliver on that experience while allowing others to enjoy a typical game-day experience. We've been able to do that with our peanut-free sections. It's on our list of things to consider."

Trahan expects 250 to sit in the autism section on Sunday, 230 of whom got their tickets through the foundation. Tickets were $19, but an anonymous donor bought the last 41 and donated them to ASD families.

Read the rest here:
Minnesota Twins may add extra autism section games in 2013

Lexington psychiatrist writes book on parenting kids with autism

Lexington resident Dr. Blaise Aguirre has seen firsthand the impact an autism spectrum diagnosis can have, not just on the child but on the childs family.

An expert in child, adolescent and adult psychotherapy, Aguirre is the medical director of 3East at McLean Hospital in Belmont and an assistant professor of psychiatry at Harvard University. His recent book, Parenting Your Child with Autism: Practical Solutions, Strategies, and Advice for Helping Your Family, which he co-wrote with M. Anjali Sastry, PhD, serves as a guidebook for parents of children diagnosed with autism spectrum disorder (ASD).

Aguirre spoke with the Lexington Minuteman about his new book and the rise in autism diagnoses in children.

What is your book about?

Many parents learn that their child has autism at a time when life is hectic for even the most typical of families. We asked ourselves the question: How can parents educate themselves about what the diagnosis means, navigate the medical and educational systems, and deal with difficult decisions about what to do and what not to do? How do they come to terms with the implications for their families while advocating for their child? This is the book that answers those questions. It is recognizing the parent as central to the process, that parents can become the experts of their particular situation, and that a parent who can take care of themselves is going to be a more effective parent.

Why did you want to write a book for parents?

Parents of children with autism report high levels of stress, but theres evidence that they rebound in the years that follow an initial diagnosis. Our advice to families acknowledges that the way forward may be difficult and that it can also get better. If our book helps people get there any faster, well have reached our goal.

We want to equip caregivers by giving them the tools to choose the right treatments and educational approaches for their child. We want to draw on science and the study of mindfulness, combining parent-tested tips with systematic approaches to making decisions amid limited information and insufficient resources. This is in contrast to what can at times be a reactive, headline-driven approach to parenting.

Continued here:
Lexington psychiatrist writes book on parenting kids with autism

Utah autism solution continues to frustrate parents

(Scott Sommerdorf | The Salt Lake Tribune) Six-year-old Logan Hilton, who is autistic, plays on his parents' bed while watching a kid's video, Friday July 27, 2012. Logan's mother, Michelle Hilton, qualifies for a new pilot program to treat Logan. The problem is she needs to contribute $6,000 to fully benefit.

Health Families must pay $6,000 per year toward treatment.

The adorable little boy wearing the backpack is 6 years old, but Logan Hilton cant hold a conversation and doesnt understand how to make friends.

A website designed to raise $12,000 for two years of Applied Behavior Analysis autism treatment for him explains that without help, "Logan would require constant costly care for the rest of his life."

Utahs two-year autism treatment pilot, which launched this year, is intended to help kids like Logan. His mom works for the Department of Corrections, and as the child of a public employee, he can now receive up to $30,000 worth of behavioral treatment each year.

The problem is that families covered by the Public Employees Health Program still need to contribute $6,000 annually to take advantage of the maximum state benefit.

"Im grateful for it, but at the same time its not enough," said his mom, Michelle Hilton. "They havent made it affordable enough."

The Eagle Mountain mom believes more families would have participated if the requirements paying 20 percent of the cost, and open only to children from age 2 to 6 had been more flexible.

Only 25 children are signed up for the 50 autism pilot slots in the PEHP portion.

"I think because of that age limit we dont capture all of the autistic kids in our population," said Toan Lam, the PEHP medical director.

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Utah autism solution continues to frustrate parents

CIRM awards $151 million in stem cell grants to 8 projects statewide

American Cancer Society/Getty Images

File photo: Close up of cancer cells in the cervix. CIRM awarded UCLA $20 million for the university's study on the reprogramming of cancer cells.

This week, Californias public stem-cell agency awarded more than $150 million to advance research into eight diseases now under study by researchers at several California universities, one L.A. hospital and a biotech company.

The University of California Davis received the largest share of stem cell research grants from the California Institute of Regenerative Medicine.

The voter-approved agency, also known as CIRM, awarded nearly $50 million to three UC Davis research teams studying treatments for the bone disease osteoperosis, for the genetic brain disorder known as Huntingtons Disease and for Critical Limb Ischemia, a painful condition caused by severe blockage of arteries.

CIRM gave $20 million to a UCLA study on the reprogramming of cancer cells. And the agency awarded UC-Irvine and the biotech firm, StemCells, Inc. of Newark, California $20 million for their joint study into treatments for cervical spinal injuries.

Cedar Sinai Medical Center also made the list with an $18 million grant to speed their research into possible treatments for Lou Gehrigs disease, a neuromuscular condition that leads to paralysis and death.

And Stanford University won two awards of $20 million each to study cardiovascular disease at metastatic melanoma.

See the original post here:
CIRM awards $151 million in stem cell grants to 8 projects statewide

Papers on Pharmaceutical Innovation and Longevity Gains

Earlier this year, I noted a paper by Frank Lichtenberg that correlates life expectancy with the pace of introduction of new drugs - both of which are metrics that can be measured fairly well, and are fairly well recorded over the past few decades. So we see the expected result: one fairly general measure of the pace of progress in medicine is linked to longevity, most likely indicating that more rapid development of new medicine leads to longer lives, even when that medical progress is largely old-style drug discovery and commercial development. Here, I'll point out a few other papers along the same lines by the same author, one recent and the others from past years:

Pharmaceutical Innovation and Longevity Growth in 30 Developing and High-income Countries, 2000-2009

We examine the impact of pharmaceutical innovation, as measured by the vintage of prescription drugs used, on longevity, using longitudinal, country-level data on 30 developing and high-income countries during the period 2000-2009. We control for fixed country and year effects, real per capita income, the unemployment rate, mean years of schooling, the urbanization rate, real per capita health expenditure (public and private), the DPT immunization rate, HIV prevalence and tuberculosis incidence.

Life expectancy at all ages and survival rates above age 25 increased faster in countries with larger increases in drug vintage. The increase in drug vintage was the only variable that was significantly related to all of these measures of longevity growth. ... Pharmaceutical innovation is estimated to have accounted for almost three-fourths of the 1.74-year increase in life expectancy at birth in the 30 countries in our sample between 2000 and 2009, and for about one third of the 9.1-year difference in life expectancy at birth in 2009 between the top 5 countries (ranked by drug vintage in 2009) and the bottom 5 countries (ranked by the same criterion).

What to take away from this: even under the outright terrible systems of regulation that presently exist in most countries with advanced medical research communities, regulation that greatly slows progress and increases costs, the great utility of biotech research and development still filters through to this degree. Imagine how much better off we'd all be if there were no massive government agencies devoted to slowing down and blocking progress in medicine!

The older papers provide some more numbers to further flesh out the picture sketched by Lichtenberg and his colleagues. Medical progress is good - we should have more of it:

Pharmaceutical innovation and the longevity of Australians: a first look (2008)

We examine the impact of pharmaceutical innovation on the longevity of Australians during the period 1995-2003. Due to the government's Pharmaceutical Benefits Scheme, Australia has much better data on drug utilization than most other countries. We find that mean age at death increased more for diseases with larger increases in mean drug vintage. The estimates indicate that increasing the mean vintage of drugs by 5 years would increase mean age at death by almost 11 months. The estimates also indicate that using newer drugs reduced the number of years of potential life lost before the ages of 65 and 70 (but not before age 75). During the period 1995-2003, mean age at death increased by about 2.0 years, from 74.4 to 76.4. The estimates imply that, in the absence of any increase in drug vintage, mean age at death would have increased by only 0.7 years. The increase in drug vintage accounts for about 65% of the total increase in mean age at death.

Pharmaceutical Innovation, Mortality Reduction, and Economic Growth (1998)

We perform an econometric investigation of the contribution of pharmaceutical innovation to mortality reduction and growth in lifetime per capita income. In both of the periods studied (1970-80 and 1980-91), there is a highly significant positive relationship across diseases between the increase in mean age at death (which is closely related to life expectancy) and rates of introduction of new, priority (as defined by the FDA) drugs. The estimates imply that in the absence of pharmaceutical innovation, there would have been no increase and perhaps even a small decrease in mean age at death, and that new drugs have increased life expectancy, and lifetime income, by about 0.75-1.0% per annum.

The connection between wealth and longevity is strong. For a deeper historical perspective, you might look back at these posts:

Source:
http://www.longevitymeme.org/newsletter/latest_rss_feed.cfm

A Single-Issue Political Party for Longevity Science

In a number of countries one plausible path to advocacy for a cause is the establishment of a single issue political party - see, for example, the original Green Party or Pirate Party as successful examples of the type in Europe. The Russian longevity science community is beginning to take this approach: "On July 19, we made the first step towards the creation of the Longevity Party. The initiative group of 10 people gathered together in Moscow to establish the first political party aimed at extending human lifespan using technological advances. ... Among these 10 people were Mikhail Batin, Alexey Turchin, Leonid Kaganov and Elena Milova. This is the very first step in the long and hard process of legally registering a political party. I believe this is one of the most important things that happened in the past few years in fighting aging. Nowhere in the world ever before have people expressed their desire to live longer in the form of a political movement. ... The main goal of the Longevity Party is to increase human lifespan so that people could live for as long as they would like to and remain young and healthy. We would like to achieve this goal by promoting scientific research and technological advances in regenerative medicine, genetics of aging and longevity, neuroscience, computer modeling of biological processes and other areas of life extension. ... The next big thing we need to do is to finalize the Program of the Party. Then we have to have at least 2 people in 42 regions of Russia as representatives of the Party and have the founding meeting after which the Party can be registered and eventually appear in the voting ballots. Our goal is to influence the authorities to support life extension technologies and increase funding for research aimed at improving people's health and extending longevity."

Link: http://ieet.org/index.php/IEET/more/konovalenko201207261

Source:
http://www.longevitymeme.org/newsletter/latest_rss_feed.cfm

FDA Reaches to Regulate (i.e. Block) Simple Stem Cell Therapies

The FDA seems to be succeeding in the courts with regard to shutting down the few groups in the US trying to offer first generation stem cell therapies, and placing a heavy burden of regulation upon them. This most likely means that for another decade or so the only realistic way to access most of the present variety of stem cell therapies will continue to be medical tourism: "It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than 'minimal manipulation', the FDA maintains that the therapy becomes a 'drug', which must be specifically approved for use. It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx. ... Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials. ... Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling. Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. 'This is really round one. Our position remains that a patient's cells are not drugs.'"

Link: http://www.newscientist.com/blogs/shortsharpscience/2012/07/ruling-frees-fda-to-crack-down.html

Source:
http://www.longevitymeme.org/newsletter/latest_rss_feed.cfm

A Review of Skeletal Muscle Mitochondria in Aging

An open access paper: "Aging is characterized by a progressive loss of muscle mass and muscle strength. Declines in skeletal muscle mitochondria are thought to play a primary role in this process. Mitochondria are the major producers of reactive oxygen species, which damage DNA, proteins, and lipids if not rapidly quenched. Animal and human studies typically show that skeletal muscle mitochondria are altered with aging, including increased mutations in mitochondrial DNA, decreased activity of some mitochondrial enzymes, altered respiration with reduced maximal capacity at least in sedentary individuals, and reduced total mitochondrial content with increased morphological changes. However, there has been much controversy over measurements of mitochondrial energy production, which may largely be explained by differences in approach and by whether physical activity is controlled for. These changes may in turn alter mitochondrial dynamics, such as fusion and fission rates, and mitochondrially induced apoptosis, which may also lead to net muscle fiber loss and age-related sarcopenia. Fortunately, strategies such as exercise and caloric restriction that reduce oxidative damage also improve mitochondrial function. While these strategies may not completely prevent the primary effects of aging, they may help to attenuate the rate of decline."

Link: http://dx.doi.org/10.1155/2012/194821

Source:
http://www.longevitymeme.org/newsletter/latest_rss_feed.cfm

FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012)

As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....

--Lee

Source:
http://feeds.feedburner.com/CellTherapyBlog

News Coverage of CIRM Awards: Substantial but Not Extensive


The California stem cell agency today
enjoyed substantial, if sparse, news coverage of the

$151 million in research funding
approved by its board yesterday.
Both the San Francisco Chronicle and
The Sacramento Bee carried solid stories on the grant awards. In the
case of the Chronicle, the story included compelling photos of
patients who spoke during emotional, tear-filled presentations.
The stories represent a modest change
from the past, when media outlets all but ignored the agency's
awards.
The Bee's Richard Chang wrote,

“For Melissa Biliardi of Santa
Maria,
 the (CIRM board) vote symbolizes hope. Her son, James
Birdsall
, 32, was diagnosed four years ago with Huntington's disease.
The degenerative brain disorder could prove fatal over the next 10 to
15 years. There is currently no cure or treatment, but with the
grant, UC Davis researchers hope to deliver an effective therapy in
four years.
"'This is the most hope we've ever
had for a cure or treatment,' Biliardi said.”

The Chronicle's Erin Allday wrote,

“California's stem cell funding
agency on Thursday approved nearly $100 million in grants for
research into heart disease, cancer and spinal cord injuries, and to
the cheers of dozens of patients and their supporters, it also
awarded money to rare but devastating diseases with no cure.”

The articles demonstrated the
effectiveness of patients and patient advocates in telling the CIRM
story. Reporters are always looking for a warm human dimension –
especially to enhance a dry, bare-bones science and government story.
Responding to a question from the
California Stem Cell Report, Kevin McCormack, spokesman for CIRM,
also mentioned radio news coverage in the San Francisco Bay Area. He
said the awards were covered in “two different stories on KCBS-AM
radio, one that ran several times yesterday and another that ran
several times today. KGO-AM radio also ran a story several tim, and,
of course, the best of all, today's KQED-FM Forum.”
The KQED show, which was also carried
nationally on Sirius radio, consisted of an hour-long look at CIRM,
with some calls from listeners. Guests on the show were CIRM
President, Alan Trounson, UC Davis stem cell researcher Jan Nolta and
yours truly, David Jensen.
Other stories appeared in the SanFrancisco Business Times and Genetic Engineering News. The Bee's
story appeared in the Modesto Bee as well.

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

Two More Disease Team Applications Sent Back for More Review


Directors of the California stem cell agency today referred two additional research applications for $37 million in disease team funding back to reviewers for further consideration.

Both were the subjects of appeals by researchers whose proposals were rejected by grant reviewers.

One was from Timothy Hoey of OncoMed Pharmaceuticals in Redwood City, who sought $20 million.  The other was from Henry Klassen of UC Irvine, who sought $17 million. (See here and here for their appeals.)

The  board began the day by directing staff to come back to the board in early September. But with the large number of grants to be reassessed, it was acknowledged some might not be acted on until the board's meeting in late October.

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

Disease Team Round Hits $151 Million with Final Action


Directors of the California stem cell
agency approved an 
additional
$20 million disease team grant
 today before adjourning their
meeting. The grant brought the disease team round to a total of $151 million.

The award went to Judith  Shizuru 
of Stanford. Scientist Irv Weissman and Robert
Klein
, former chairman of the stem cell agency, both spoke on behalf
of her
appeal of a negative decision
 by grant reviewers. 
At the suggestion of the current board
chairman, J.T. Thomas, the board placed conditions on the grant
would stipulate Stanford pick up certain unknown, additional costs if
necessary. 
Here is a link to the CIRM press release on today's action.

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

Stem Cell Directors Approve $151 Million to Commercialize Stem Cell Research


Directors of the California stem cell
agency today approved $151 million in research awards aimed at
commercializing stem cell research and pushing therapies into
clinical treatment.



Patients and researchers cheered when the action was announced. 


The awards of up to $20 million each
were ratified by CIRM's governing board, which added two to the
six applications approved by reviewers. The 
original
six
 totalled $113 million. Directors budgeted $243 million
for today's round.



Five of the applications involving
appeals were sent back by the board for more review.
(See 
here, here and here.)
They will be considered again in early September or October.

The awards are the
second largest research round
 in CIRM's history,
surpassed only by an another, earlier $211 million “disease team”
round. The latest effort is aimed at bringing
proposed clinical trials to the FDA for approval or possibly starting
trials within four years.
 That deadline coincides roughly
with the date when CIRM is scheduled to run out of cash unless new
funding sources are developed.
CIRM is currently exploring seeking
private financing. It could also ask voters to approve another state
bond issue. (Bonds currently provide the only real source of cash for
CIRM.)  In either case, the agency needs strong, positive
results from its grantees to support a bid for continued funding.
Today's action came after nine out of
the 15  applicants who were rejected by reviewers appealed the
 negative decisions. Two of the appeals were successful at today's meeting. It is a
good bet that at least some of those referred for more review
will be ratified by the board in September. 
The appeals were based on a variety of
issues, ranging from technical science questions to inconsistencies
in CIRM's research approaches and mistakes by reviewers.
The outpouring
of appeals
 was the largest in CIRM history in terms of the
percentage of applicants seeking to overturn reviewer decisions.
The round also marked
another first
 in terms of the total initially approved by
reviewers. On occasion in the past, reviewers have not approved
enough awards to consume all the funds budgeted by the CIRM board.
But never before has the amount fallen so far short.
Most of the awards went to enterprises
connected to persons on 29-member CIRM governing board, continuing a
trend that has existed throughout CIRM's history. Board members with
conflicts, however, are not allowed to vote or participate in the
The full list of the winners and the
CIRM press release can be found here.

(Editor's note: This item was updated from an earlier version and the figures increased as the CIRM board added another grant and took additional action.)

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

Harvard's McMahon on His Way to USC


Andy McMahon
Harvard photo

The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.

The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.

McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”

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

Harvard’s McMahon on His Way to USC


Andy McMahon
Harvard photo

The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.

The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.

McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”

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

$18 Million Cedars Sinai ALS Proposal Headed for Approval


The California stem cell agency today
cleared the way for approval of
an $18 million grant to develop a new
cell-based therapy for treatment of ALS.

The agency's governing board moved the
application into a category that is expected to approved later today.
The action came on an appeal by
researcher Clive Svendsen of Cedars Sinai. Also supporting the
application were a number of persons with ALS.

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

StemCells, Inc., and Capricor Stave Off Rejection from Stem Cell Agency


Two California stem cell firms today
won a reprieve from rejection in their bids for $40 million in
funding from the California stem cell agency.

They are StemCells, Inc., of Newark
and Capricor, Inc. of Beverly Hills. StemCells was founded by
Stanford researcher Irv Weissman. Capricor was formed to
commercialize research at Cedars of Sinai that had been previously
financed in part by the state's $3 billion enterprise. Frank
Litvack
, who unsuccessfully vied for the chairmanship of the stem
cell agency in June 2011, is the recently appointed executive
chairman of Capricor.
The CIRM board sent the firms' bids back for more scientific review based on
their appeals of reviewers' negative decisions as well as testimony
at the board meeting today. The board will take up the applications, which seek $20 million each, again in early September.

Robert Klein, who was the first
chairman of the stem cell agency, appeared before his old board as a
member of the public on behalf of the StemCells appeal. He said new
evidence will be published soon in a scientific journal that supports
the StemCells approach. Klein also said that he was personally
involved in three CIRM grant reviews in which scientists affirmed the
company's approach. (Here are links to the appeal and to grant reviewer comments.)
The other application also involved new
information. Litvack, former CEO of Conor Medsystem, told the board
the firm has made considerable progress since CIRM's closed-door
review of applications last April, both in terms of management and
science. The firm's appeal said Litvack's appointment is part of the
management improvements at the firm.
Sherry Lansing, a member of the CIRM
board and former CEO of a Hollywood film studio, enthusiastically
recalled a presentation last year before the board about the results
of the initial research. She the firm has solved the problems cited by reviewers. She said,

“We have a fiduciary responsibility
to select the best science.”

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

Stem Cell Directors Order More Consideration on $20 Million UCLA Research Application


Directors of the California stem cell
agency today deferred action on a $20 million proposal that was
rejected by its grant reviewers and sent it back for more consideration. 

The move involved an application by
Stanley Nelson and M. Carrie Miceli of UCLA dealing with Duchenne
muscular dystrophy. They are parents of a child with the affliction,
which is usually fatal by age 25. The CIRM review summary said it is
“a devastating and incurable muscle-wasting disease caused by
genetic mutations in the gene that codes for dystrophin, a protein
that plays a key role in muscle cell health.”
Nelson had filed an appeal seeking to
overturn reviewers' action. Five  mothers and two fathers with
children suffering from the disease made emotional appeals to
CIRM directors on behalf of the application. Following their presentation, Art
Torres
, co vice chairman of the CIRM board, responded equally
emotionally that the board is dedicated to finding therapies for such
afflictions as Duchenne muscular dystrophy
The board approved more review for the
application after it was disclosed that a company issued a press
release two days ago that showed that  a drug involved in the
proposal was more effective than reviewers believed. Philip Pizzo, a
member of the board and dean of the Stanford medical school,
expressed caution about the press release, given its timing and
source. His comments came prior to the appearance of the parents.
The application is scheduled to be
brought back to the full board in September for further action.

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

Rejected Grants May Be Sent Back for More Review


California stem cell agency chairman J.T. Thomas has raised the possibility of sending some of the disease team applications back for additional review if the board feels that is necessary to consider new information and resolve scientific disputes. 

Thomas discussed such a move at the beginning of the discussion of the $243 million disease team round. Nine out of 15 rejected applicants have appealed to the full board.  Some have presented new information. Others have disputed the scientific work of reviewers. 
The board used such a referral process for one application in the past. That grant was ultimately approved.

Source:
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Short-term Borrowing to Continue to Provide California Stem Cell Cash


The California stem cell agency will continue to be funded with short-term borrowing -- commercial paper -- provided through the state treasurer's office, J.T. Thomas, chairman of the agency's governing board, said today. 

Until late last year, the $3 billion agency was funded through state bond funds, but California Gov. Jerry Brown is trying to reduce the state's long-term debt load, which has skyrocketed in the last decade. 
Thomas told directors this morning that short-term funding comes at "the lowest possible interest rate." He said the arrangement leaves the agency in "very good shape."
The state will provide the funding to CIRM on a month-to-month basis in addition to providing a two month cushion, Thomas said. 
At some point, the short-term debt is likely to covered by state bonds.  As of June 30, CIRM
had $50.9 million on hand, down $42 million from April 30. During the fiscal year ending June 30, the agency paid out $232.7 million compared to $201.4 million in the previous fiscal year. 

Source:
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