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Category Archives: Stem Cells

Deadline This October: California Stem Cell Agency Seeking Detailed Public-Private Plan for its Future

The $3 billion California stem cell
agency, which is currently scheduled to go out of business in a few
years, hopes to come up with a detailed plan by this fall for a novel
public-private arrangement that would extend its life.

The rough outlines of the proposal
assume $50 to $200 million in “public investment,” although it is
not clear whether that would be a one-time figure or an annual amount
from presumably the state budget or perhaps another state bond
measure. The concept includes additional private funding of a
yet-to-be-determined nature. (The agency later said that the public investment figures would be a one-time event.)

The broad sketch of the agency's latest
thinking about how to regenerate itself was found in an RFP posted four days ago on its website.

CIRM is seeking a consultant who would
flesh out the general concepts that it has offered. Work would
begin in mid June and be completed in four months, close to the ninth
anniversary of the agency, formally known as the California
Institute for Regenerative Medicine. The RFP did not contain a figure
for the cost of the study, but said that the price would be part of
the criteria for evaluating bids.

CIRM was created in November 2004 when
California voters approved Proposition 71, a ballot initiative. Since
then it has awarded $1.8 billion to 595 recipients. It is funded by
money borrowed by the state (bonds), but cash for new grants is
scheduled to run out in 2017. Interests costs on the bonds raise the
total cost of the agency to roughly $6 billion.

CIRM said in the RFP that the plan for
its future should provide

“...an in-depth analysis of various
public-private funding models with potential to attract private
sector investment to, and facilitate further development of the most
promising CIRM-supported research projects; and recommend a single
preferred approach for achieving this goal, complete with details
relating to the recommended structure and an operational plan.”

The RFP also contained a just-released,
$31,750 study by CBT Advisors of Cambridge, Mass, that examined
mechanisms for financing translational research, which is the key
focus nowadays at the stem cell agency. Such research is aimed at
pushing laboratory findings into the marketplace.

Among other things, the CBT report,
whose lead author was Steve Dickman, said,

“The nature of CIRM as a state agency
is perhaps the biggest weak point (and) has to be addressed politically
and cleared up as soon as possible or raising money will be
unnecessarily challenging.”

The CBT study did not address how that
might be done, which could be a considerable task. Proposition 71
modified the state constitution and state law and can be altered only
by a super, super majority vote of the legislature or by another
ballot initiative.

California is the first state to
provide billions for stem cell research by using borrowed money. It
also is unique in California state government in that its funding
flows directly to the agency and cannot be altered by the governor or
the legislature.

Translating all that into some sort of
public-private arrangement would be novel among state government
departments and could well require legislative or voter approval.

The California Stem Cell Report has
queried the agency concerning the frequency of the assumed “public
investment” and CIRM's budget for the RFP. We will report that
information when we receive it. (The agency later declined to disclose what it was prepared to pay for the study.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bdJQjlhAoPM/deadline-this-october-california-stem.html

Posted in Stem Cell Therapy, Stem Cells | Comments Off

California Stem Cell Agency Budget Up 4.6 Percent, Topping $17 Million

During the past couple of years, the California stem cell agency has vastly improved the way it
budgets the relatively tiny amount it spends on operational expenses.

At one point a few years back, its
operational budget was often all but incoherent to the public and to
at least some members of its governing board. (See here, here and
here.) But times have changed. The process for its operational
budget, which amounts to about $17 million for the 2013-14 fiscal
year, is now more transparent and better organized.

The long overdue improvements can be
credited to the hiring of Matt Plunkett in December 2011 as its first
chief financial officer in its eight-year history, as well as the
efforts of CIRM directors Michael Goldberg and Marcy Feit. Goldberg,
a venture capitalist, is chairman of the board's Finance Subcommittee
and Feit, CEO of Valley Healthcare in Pleasanton, Ca., is vice chair. Plunkett, however,
left the agency suddenly last summer and the agency has no plans to
replace him. CIRM Chairman J.T. Thomas says Plunkett put new
financial systems in place that can be operated without a CFO.

Interested readers can get a glimpse of
what is upcoming for CIRM spending beginning in July in documents prepared for the Monday meeting of the governing board's Finance
Subcommittee meeting. The agenda, however, lacks a much-needed
explanation and justification for the spending. All that is presented
now for the public are raw numbers and a PowerPoint presentation,
which is no substitute for a nuanced, written overview.

Nonetheless, here are the basics. The
budget proposed for 2013-14 stands at $17.4 million, up 4.6 percent, according to California Stem Cell Report calculations, or $771,000 from forecast expenditures for the current year. The
budget represents the cost of overseeing $1.8 billion in grants and
loans and preparing new proposals and reviews of applications for
hundreds of millions of dollars in additional awards.

The largest budget component is for
personnel – $12.1 million, up from $10.7 million. Second largest
is outside contracting at $2 million, down from $2.9 million for the
current year, continuing a trend away from outside contracts, which
once were burgeoning.

One interesting area includes “reviews,
meetings and workshops,”- which are expected to cost $1.8 million
this year. Next year, they are budgeted for $2 million. Some might
look askance at those sorts of expenditures for “meetings.”
However, that includes the fees and expenses for scientific reviewers
for multi-day meetings in the San Francisco area, which is a high
cost area, and other large gatherings. However, the figure does not
include travel for reviewers, who come from out of the state and even
from overseas.

Examples of the meeting costs include a
three-day grant review session last September at the Claremont Hotel
in Oakland that cost $44,019. A two-day meeting at the same hotel for
the 29-member CIRM governing board cost $34,424. (These figures and others involving outside contracts can be found on the agenda of the
board's Governance Subcommittee meeting April 10.)

The agency also dissected the budget
from different perspectives on expenditures. The spending plan
includes $2.0 million for the office of Chairman Thomas and $1.6
million for the office of President Alan Trounson. Comparable
figures for actual spending this fiscal year were not provided,
however, by CIRM for the Finance Subcommittee meeting. The size of
the chairman's budget reflects the controversial dual executive nature of management at CIRM, which has come under repeated
criticism, including from the recent blue-ribbon report by the
Institute of Medicine.. However, the arrangement is locked into state
law as the result of the ballot measure, Proposition 71, that created
the stem cell agency in 2004.

Legal expenses are budgeted at $2.2
million with public relations and communications running slightly
more than $1 million. The scientific office, as one might expect,
consumes much larger amounts, with basic research, translational
research, grants review and grants administration budgeted at $4.7
million. The development side of the scientific office, which
focuses on pre–clinical and clinical research, is slated for $3.4
million. The agency did not offer comparable figures for the current
year.

Under Proposition 71, the agency can
legally spend only 6 percent of its $3 billion in bond funding for operational
expenses. At one time the agency had a 50-person staff cap, but that
was altered several years ago by the legislature. The most recent
figures show it has 54 employees. However, this month's budget
documents did not list the number of staff for this year or next.

The stem cell agency also reported that
it expects to spend an additional $1 million a year for rent
beginning in 2015, when a free rent deal provided through the city of
San Francisco expires. The city put together a $18 million package to
attract the CIRM headquarters in a bidding war with other California
cities. The agency has never produced a public accounting of whether
it has received full value on the package.

The proposed budget is likely to be
approved by the Finance panel next week without significant changes
and then by the full board late in May.

The public can participate in the
Finance meeting at two locations in San Francisco one each in Irvine,
Pleasanton, La Jolla and Berkeley. Specific locations can be found onthe agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4WgoKJd8w08/california-stem-cell-agency-budget-up.html

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Meager California Biotech Representation in Governor's China Trip

California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

Some 90 persons were involved in the governor's delegation, but representation was meager from California's renown biotech sector and none at all from the $3 billion California stem cell agency, which has a collaboration underway with Chinese scientists. It may have been the only state agency with a formal collaboration agreement with China prior to Brown's visit.

According to many reports, the Chinese government regards growth of its biotech industry as one of its core economic efforts. Within that sector, biomedicine ranks as the most important and fastest growing, according to an Italian Trade Commission report. Stem cell research is especially important, according to this Canadian study. Indeed, some scientists in China are eyeing a Nobel Prize in the field (See here or here.)

California would seem to be well placed to take advantage of that situation, given its substantial biotech industry and community, which is only rivaled by Massachusetts. Add to that the existence of the unique California stem cell agency, which has funded a $1.5 million study by Holger Willenbring at UC San Francisco that also involves research by Lijian Hui at the Shanghai Institutes for Biological Sciences, which is separately funded by that country to the tune of nearly $1 million.

A look at the list of those traveling to China with the governor showed two representatives who could be considered from biotech: Joe Panetta, head of BioCom, a life science industry organization in Southern California, and Michel Baudry, dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences in Pomona, Ca..

We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

(Following the posting of this item, Ron Leuty of the San Francisco Business Times gave us a heads up on the latest on the site. He reported in March that Joinn Laboratories, a Chinese contract research organization, purchased the site. Leuty said that its plans are vague about future development, but that it may lease some of the space.)

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/x57uSahTPNI/meager-california-biotech.html

Posted in Stem Cell Therapy, Stem Cells | Comments Off

Meager California Biotech Representation in Governor’s China Trip

California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/x57uSahTPNI/meager-california-biotech.html

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StemCells, Inc., Nails Down Controversial, $19 Million Award from California Stem Cell Agency

The stock price of StemCells, Inc.,
price today jumped as much as 9 percent after the company disclosed
it had finally concluded an agreement with the California stem cell
agency for a $19.3 million forgivable loan for research twice rejected by the agency's scientific reviewers..

The stem cell agency governing board seven months ago approved the loan to the Newark, Ca., firm. But the
cash was withheld until the financially strapped company could
demonstrate that it could match the size of the loan, as promised in
its application.

The StemCells, Inc., (SCI) application
was nixed two times in 2012 by the agency's scientific reviewers who gave it a
score of 61. In a controversial move, the 29-member board approved the award in early September on a 7-5 vote after former agency
chairman Robert Klein intervened publicly on behalf of the firm. It was the first time that Klein had lobbied the board publicly on behalf of an application. It was also the first time that the board
approved an application that was rejected twice by its reviewers, a
panel of internationally recognized stem cell scientists.

In a press release, Martin McGlynn,
CEO of StemCells, Inc., said,

"With CIRM's support, we are now
able to lay the groundwork that could result in the world's first
neural stem cell trial in Alzheimer's patients."

Both the company and the $3 billion
state research agency were tight-lipped about the nature of the
matching funds from the company, which reported losses of $28.5
million in 2012 on revenues of $1.4 million.

In a brief response to questions from the
California Stem Cell Report, McGlynn said,

“At this time, we
do not intend to elaborate any further on the contents of our press
releases or public filings pertaining to the SVB (Silicon Valley Bank) or CIRM(the stem cell agency) loans.”

Earlier this week, the company reported receiving a $10 million loan from Silicon Valley Bank. Both McGlynn
and the stem cell agency did not answer a question about whether
those funds are being used to back the award from California
taxpayers.

The agency confirmed that the firm was
providing $19.3 million in matching resources. But Kevin McCormack,
senior director of public communications, did not provide any
specifics on the nature of the match. He only said,

“The matching requires
them to demonstrate they have enough funds necessary to
fund SCI’s share going forward as well as their own
operations and other commitments.”

The award was originally for $20
million. We have queried the agency about the smaller figure
announced today.

The company's stock price rose as high as $1.87 earlier today after closing at $1.71 yesterday. It stood at
$1.77 at the time of this writing. Its 52 week high is $2.67, and its
52 week low is $0.59. The loan from Silicon Valley Bank gives the
bank warrants to purchase 293,531 shares of the company at $1.70 over
the next 10 years.

The 10-year loan from CIRM is low risk for the
company, which said its “obligation to repay the loan will be
contingent upon the success” of the research. If a product is
developed, it will take years before it could hit the market.

The award to StemCells, Inc., put
the stem cell agency in a touchy situation involving the company's decision last month to reject an additional $20 million award from
the agency.( It was the first time a recipient has rejected an award.) Neither the company nor the agency would give a reason for
the rejection of the loan for a spinal injury project . However, the
award also required a $20 million match, which undoubtedly tested the company's resources.

The spinal injury application was
scored at 79 by agency reviewers and was routinely approved by the
board. With its withdrawal by the company, the agency, which prides
itself on funding only the best science, was left supporting research
(StemCells, Inc.'s Alzheimer's project) judged significantly inferior
by reviewers with its score of 61.

In response to a question about that
situation, CIRM's McCormack said,

“Our goal is to always fund the best,
most promising science. This is not the first time that our board has
voted to fund a project that the Grants Review Group had not
recommended (this has happened in around 2% of cases) The board did
so for a number of reasons, not the least of which is that this was
the first disease team application that had a goal of moving a
promising stem cell therapy for Alzheimer's towards clinical
trials.”

The round in question, however, had another application dealing with Alzheimer's which was scored at 63,
two points higher than the one from StemCells, Inc. Reviewers also did not recommend funding that application.

The action last September by the
agency board came only after it publicly said the funds would not be
distributed until the StemCells, Inc., could show it could provide
the match, still another first for the agency.

The award triggered a column in
the Los Angeles Times by Pulitzer Prize winning writer Michael
Hiltzik, who said in October that the
process was “redolent of cronyism.” He said a “charmed
relationship” existed among StemCells, Inc., its “powerful
friends” and the stem cell agency.

StemCells, Inc., was founded by
Stanford researcher Irv Weissman, who was a major fundraiser for
Proposition 71, which created the stem cell agency in 2004. Klein
headed the ballot campaign, which spent more than $30 million to win
voter approval. Weissman sits on board of directors of StemCells,
Inc., and holds 124,608 shares in the firm, including 8,630 he reported this month receiving.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/34J6wy7wpLY/stemcells-inc-nails-down-controversial.html

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Modest Approval from Long-time Stem Cell Agency Critic

Of all California's newspapers, The
Sacramento Bee, the only daily paper in the state capital, has long
been the most critical – editorially – of the Golden State's $3
billion stem cell research agency.

Today, however, the newspaper gave a
modest nod of approval to the agency's modest efforts to clean up its
built-in conflicts of interest, which have been cited as a major flaw
by the prestigious Institute of Medicine.

The headline on the Bee's editorial today said,

“Stem cell agency finally addresses
potential for conflicts”

The piece said that Jonathan Thomas,
chairman of the agency, “has taken important steps in
reducing the potential for conflicts within this agency.”

The editorial continued,

“He hasn't
gone as far as we would like, or that independent outside reviewers
have recommended....But he's achieved what's possible, at least for
now, and the board may empower him to go further.”

The Bee referred to action last month
in which the agency's governing board decided, among other things,
that 13 of the 15 board members linked to recipient institutions
could not vote on any grants, although they could participate in
discussion of applications. Twenty-nine persons sit on the board. In
a $700,000 report commissioned by the agency, the Institute of
Medicine recommended a fully independent board.

The Sacramento newspaper said,

“We
think Thomas and the oversight board should go further and adopt the
Institute of Medicine recommendations. But that is politically
unlikely. As is now obvious, it will be up to the Legislature to
fully remove representatives of funding-eligible institutions from
being involved in decisions about grants that could come back to
them.

“Thomas, to his credit, recognizes
that his compromise may not be the perfect solution. He wants to test
out the new policy for a year, and see how it works. There's a lot
riding on the outcome. CIRM is expected to run out of funds in 2017,
and while philanthropy and foundation money could extend that for a
few years, supporters of California stem cell research clearly want
to go back to the ballot to seek additional funding. To make that
case, CIRM supporters can't afford any more scandals about insider
dealing. The next year will reveal whether it is on the right track.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/NowG2d8N5CM/modest-approval-from-long-time-stem.html

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Category Archives: Stem Cells

Deadline This October: California Stem Cell Agency Seeking Detailed Public-Private Plan for its Future

California Stem Cell Agency Budget Up 4.6 Percent, Topping $17 Million

Meager California Biotech Representation in Governor's China Trip

Meager California Biotech Representation in Governor’s China Trip

StemCells, Inc., Nails Down Controversial, $19 Million Award from California Stem Cell Agency

Modest Approval from Long-time Stem Cell Agency Critic

The Future Of Nano Technology

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