Klein, StemCells, Inc., and $31,000 in Consulting Fees for Torres
By Dr. Matthew Watson
The Robert Klein-StemCells, Inc.,
affair has taken another turn with the disclosure that a vice
chairman of the California stem cell agency was paid at least $31,000
over a two-year period by Klein and also voted on behalf of Klein's
effort to win approval of a $20 million award for StemCells, Inc.
consulting fees during 2011 and 2012 from firms controlled by Klein, former chairman of
the agency. In 2012, Torres backed Klein's
efforts to override grant reviewers' rejection of the $20 million
application from the Newark, Ca., publicly traded firm.
 |
| Art Torres, center, with Bob Klein, left, at Klein's last meeting in 2011 as chairman of the California stem cell agency. Incoming chairman Jonathan Thomas is at right. |
The 29-member board of the California
Institute for Regenerative Medicine (CIRM), as the agency is formally
known, narrowly voted 7-5 last September for the award. It was the
first time that the board has approved an application rejected twice
by its scientific reviewers. It was also the first time that Klein
has lobbied the board on behalf of a specific application since
stepping down in June 2011. He was elected chairman in 2005 as the
agency was just beginning its work and is an iconic figure to many in
the California stem cell community.
California Stem Cell Report, Torres said,
"My decision to support an award
to StemCells, Inc. to explore the use of neural stem cell
transplantation to treat Alzheimer's disease was based on the merits
of the application and the hope it offers to patients who suffer from
Alzheimer's, a disease that affects millions, including Bob Klein's
late mother. I have no financial interest in StemCells, Inc. nor does
Bob Klein, and my decision to support the award has no connection
whatsoever to the work I do with Bob Klein."
public communications at CIRM, said that Torres' statement would be
the only comment on the matter from the agency.
declaring that personal issues were occupying his time.
questions to all three dealt with the propriety of Torres' employment
by both CIRM and Klein while Klein was asking the board to award a
business $20 million. The governing board has a code of conduct that
declares members should “maintain the highest standards of
integrity and professionalism.” However, it does not speak to
questions of appropriate employment by CIRM directors outside of the
agency.
are intended “to eliminate even the appearance of impropriety.”
He also referred to CIRM's policy on “incompatible activities”
for employees. It deals with activities that could “discredit”
the agency or that are “inimical” to it. However, it does not
specifically deal with the type of situation involving Torres and
Klein, who is a real estate investment banker and attorney. The policy additionally does not address cases where a
governing board member is also an employee of the agency.
which are required by state law, contain only broad ranges for compensation, and the amount could be significantly higher than
$31,000. Torres reported that in 2011 he was paid between $10,001 and
$100,000 by both Klein Financial Corp. and K CP Cal, which share the
same address as Klein's offices in Palo Alto. In 2012, Torres reported receiving between $10,001 and $100,000 from K CP Cal and
between $1,001 and $10,000 from Klein Ventures LLC, which also has
the same address.
consulting fees and that the firms dealt with real estate. He did not
respond to requests for more details.
arrangement, he works four days a week.
Democratic Party and a longtime state legislator. He was nominated
for vice chairman in 2009 by state Treasurer Bill Lockyer, among
others.
arrangement involving Klein surfaced in connection with the
StemCells, Inc., application. Klein gave the agency $21,000 last May,two months before he pitched the board on the StemCells, Inc.,application. The donation was not reported to the board prior to
Klein's appearances before the panel. The agency's regulations
require such gifts to be reported to the board but do not specify a
time frame. Following inquiries from the California Stem Cell Report,
the agency said it would report the donation at the agency board
meeting next week.
CIRM science officers to Japan for an international stem cell
conference. The agency directed the officers to give special access
to Klein. Two of the officers were heavily involved in the grant
round that included the StemCells, Inc., application, which scientific reviewers scored at 61 on a scale of 100.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7zwWISe_LMA/klein-stemcells-inc-and-31000-in.html
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May 19th, 2013
Patient Advocate Reed Defends Klein Donation to Stem Cell Agency
By Dr. Matthew Watson
received the following email from Don Reed, a patient advocate, who
has long been involved in California stem cell agency affairs. Reed
is vice president of public policy for Americans for Cures
Foundation, a position he has held for some years. Americans for
Cures is the personal lobbying organization created by Robert Klein,
former chairman of the California stem cell agency. Reed said his
opinions below are his own and may or may not reflect those of the
foundation.
“I must take issue with your entry,
'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May
05, 2013.
“When
Bob Klein donated $21,630 to the California stem cell program (to
allow scientists to attend a research conference in Japan) he was
doing exactly what he always does: advancing research to ease
suffering and save lives. The scientists needed a way to attend
a top-level conference. Believing in the benefits of researchers
sharing thoughts, Bob paid for their trip.
“Unfortunately,
your article appears to imply corrupt motivations.
“'A
seemingly innocuous…gift…generated a wave of special favors for
(Klein) that stretched out to include a gold mining multimillionaire
from Canada.'.
A 'wave of special favors?' The article
states that 'Klein wanted to meet with the six science officers…'
and to get their impressions on the conference.
“Is
that not natural? First, would it not be helpful to hear from the
scientists if the trip was worth the time and expense? Second, Bob
Klein works in real estate, a full-time job. He does not have the
scientist’s automatic involvement to keep him up to speed on
everything new in regenerative research. But he wants to know the
latest: what is working, what is not. He is always eager for a chance
to speak one-on-one with an expert.
“He met with a Canadian
millionaire? Why is this shocking? The millionaire supports stem cell
research; so does Bob. California is working closely with Canada on
several projects; they pay their scientists, we pay ours; more bang
for the buck. If there is a person with the resources and will to
advance Canadian research, it is natural that Bob would want to
develop a deeper interest in the shared research.
“And why
should Klein be criticized for supporting a research project
attempting to alleviate Alzheimer’s? He saw his own mother die of
the disease, after losing the ability to recognize her own son.
I am familiar with that particular Alzheimer’s project, and
it had some amazing results, restoring memory to laboratory rats.
This was a water maze test, and the rats recovered the memory of a
pathway out of the water, which they had forgotten. To the best of my
knowledge, no one else in the world had achieved memory return, and
the project deserved the most serious consideration. Yes, the
board of directors voted against the Grants Working Group; it is not
only their right but their responsibility to exercise judgment, and
not merely be a rubber stamp for the GWG.
“There is also the
matter of free speech. Anybody else in California can come to the
meetings of the program and voice their opinion—why should Klein be
denied the right to voice his opinion?
“Bob Klein owns no
stem cell stock, no biomedical enterprises. Financially, supporting
stem cell research has cost him a great deal. This is the man who led
the fight to build the California stem cell program, donating roughly
six million dollars, taking out loans on his house to help finance
Proposition 71. And, for six years (without salary) he worked
full-time as Chair of the Board of the oversight committee.
Physically and emotionally, it has been an exhausting decade for him.
He has not profited in any way, except to see the advancement of
research for cure.
“Passing a $3 billion stem cell program
in the midst of a recession was like relocating Mount
Everest—seemingly impossible, but he did it anyway. He moved the
mountain. Thousands of people helped, but one man made it possible.
Without Bob Klein, California would not have the greatest stem cell
program in the world: challenging diseases considered incurable since
the dawn of time. That he should continue to support it, with his
dollars, time, energy and creativity, is commendable.
“Sometimes
a good deed is just that: no sinister motivations, no secret
agendas-- just a positive action which benefits all.”
Source:Stem Cell Therapy
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May 19th, 2013
A Patent War on iPS: One Researcher’s View
By Dr. Matthew Watson
As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.
efforts can surmount barriers that have to do with patents and
ownership of the intellectual property.
Paul Knoepfler discussed some of the problems in a post yesterday. He wrote,
“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.
“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results.
“A search for “cellular
reprogramming produced more than 1,000
results.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..
“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.
“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?
“I don’t think so.
“This could get really messy.”
Source:WARF hESC Patent Update: Seven Years and Challenge Still Underway
By Dr. Matthew Watson
Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.
but she is the key figure in the ongoing challenge to the WARF
(Wisconsin Alumni Research Foundation) patents on human embryonic
stem cells. Her effort began in 2006 but has dropped out of the news.
We asked her for an update on the case.
“Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds.
“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents. Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.
“This is Dan's summary of the current
situation:
"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology."
“The 'narrowing' of the patents has
had an unexpected consequence. Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”
which also involved an interesting discussion of IPS research,
Loring said,
“Patents
on fundamental things --
genes, human embryonic stem cells, iPS cells --
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.
“Patents
are supposed to stimulate investment in development. Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?
“But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells. One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.
“There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs. I’m paying attention to the patent 'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves. It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”
Source:Stem Cell Therapy
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May 19th, 2013
Cash and Favors: Robert Klein Gives $21,630 to the California Stem Cell Agency
By Dr. Matthew Watson
A seemingly innocuous $21,630 gift to
the California stem cell agency has kicked up new questions about a
controversial $20 million research award and generated a wave of
special favors for the donor that stretched out to include a gold
mining multimillionaire from Canada.
 |
| Robert Klein Elie Dolgin/Nature photo |
The gift was made last May by Robert
Klein, chairman of the stem cell agency from 2004 to July 2011, but has never
been publicly reported to the agency's governing board as required by
its own regulations.
reviewers of a $20 million application by StemCells, Inc., of Newark, Ca. The board subsequently asked for a reevaluation of the proposal, which was again rejected by reviewers. Klein persisted at a September meeting, and the 29-member board decided, on a 7-5 vote, to go along with him. It was the
first time in its eight-year history that the board has approved an
application that was rejected twice by its scientific reviewers, who scored the proposal at 61 out of 100.
Klein's donation triggered a number of
special favors from the agency, according to documents provided by CIRM to the California Stem Cell Report under a state Public Records Act request. Klein wanted to meet with the six science officers, who have a wide range of responsibilities, including managing and developing grant and loan programs, participating in reviews of applications and evaluating research progress. CIRM President Alan Trounson obliged. At the meeting in Japan, the six science officers received a memo approved by Trounson instructing them to meet
privately “one-on-one” with their benefactor and to give him special access to their activities. The meetings were
actually scheduled to also include a third person, Rob McEwen, who is one of the 100 richest persons in Canada, a $20 million donor to a stem
cell center in Toronto and CEO of the gold mining company bearing his name.
The memo indicated
that the science officers – all California state employees –
should be helpful by identifying areas of “special importance” to
Klein and “other donors.” The CIRM documents show no objection
from the agency to instructions from another member of the public --
Klein aide Melissa King -- to provide her and Klein with written
summaries about the science officers' activities at the convention
along with “details” about their work at CIRM. Email addresses of
the six were also provided to Klein, who may have additionally
received their cell phone numbers although that is not entirely
clear.
invited McEwen to a closed-door session in Japan involving the
agency's international partners, a session at which presumably
valuable, little known scientific information might be mentioned and
future directions charted. Trounson specifically told McEwen in an
email that it was Klein who asked that the executive be invited to the
session.
wrongdoing in connection with the donation, which was the only
private contribution to CIRM in the 2011-12 fiscal year. Both say
there was no connection between the donation last May 16 and the
StemCells, Inc., application, which was rejected by reviewers one
month earlier during closed-door meetings April 18-20, 2012.
from persons who have applied for funding or who intend to apply for
funding, but the rules do not speak to gifts from persons who lobby
on behalf of funding for others. The rules require that the governing
board of the agency be informed at a public meeting of gifts accepted
by Trounson on behalf of CIRM. Trounson is required to identify the
donor and conditions imposed by acceptance of the gift. Trounson did
neither prior to Klein's appearance last July on behalf of StemCells,
Inc.
recused himself from public discussions of the StemCells, Inc.,
application, although he did not offer an explanation. However, his
action was connected to his relationship with stem cell scientist Irv Weissman of
Stanford University, who founded the publicly traded company, currently sits on its board
and holds 124,608 shares of the firm. Trounson was a guest once at
Weissman's ranch for four days in July 2011, CIRM said in response to
a question this week.
for public communications, said last week that the agency plans to
report the donation to the governing board at its meeting in
the San Francisco Bay Area later this month.
the donation prior to the board's consideration of StemCells, Inc.'s,
application was “due to the lack of additional donations, a
transition in CIRM’s finance office and an oversight."(See thefull text of McCormack's statement here.)
the agency is concerned about the appearance of Klein's donation and
the subsequent board action, McCormack replied,
“No, the two items are entirely
separate with no connection. Item 1 involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research. The science officers had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend. Item 2 is an ICOC (board) decision to fund
a research project that they felt had promise and was important for
the people of California.”
in the wake of his donation, the agency did not respond to inquiries
asking for an explanation.
an email that his donation was not connected to StemCells, Inc. He said that as late as June he had “no idea”
that the its application had been rejected by reviewers. Klein said that he committed to the donation
in “April or May.” (The full text of Klein's comments re the application can be found here and here.)
Prior to leaving CIRM in 2011, Klein was a non-voting member of the CIRM grant review committee, which consists of out-of-state scientists and seven CIRM board members. His service on the committee included the period when it approved a planning grant for StemCells, Inc., to prepare its application for the $20 million.
Klein noted that he did not pick the six science officers for the Japan trip. One of them was the lead science officer on the award round involving StemCells, Inc. A second was also heavily involved, according to the transcript of the July 2012 board meeting. Science officers, however, do not vote on or score applications. Klein characterized the CIRM staff as recommending against approval of the grant so “they were clearly not influenced” by his donation.
science officers were aimed at determining whether they believed the
cost of attending the stem cell convention justified what they
learned at the meeting. He said a second goal was to aid universities
and other researchers, mainly in Canada, “in advancing their
contributions from an existing donor or donors.” Canada is one of
CIRM's research partners.
Klein defended the involvement of
McEwen, who Klein said has contributed to the stem cell group conducting the meeting. Klein said McEwen does not engage in technical
discussions and added,
“On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual.”
employees has stirred up controversy over the years in California.
The most recent example was Gov. Jerry Brown's much-reported trip to
China this spring, which was financed by private donations. Articles
in the Los Angeles Times and The Sacramento Bee both noted that
private funding arrangements have plenty of critics.
wrote,
“It just looks unseemly — a pack of lobbyists and other
favor-seekers paying big bucks to traipse after the governor,
schmoozing and gaining invaluable access.”
from Jock
O'Connell, international trade adviser for the economics
consulting firm Beacon Economics, who said,
“They're donating because they want
to curry favor with the incumbent administration."
donations for trips in the future, McCormack replied that the agency
is “always open to donations from generous supporters” provided
they meet the state's legal requirements.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FefPhO0IEiY/cash-and-favors-robert-klein-gives.html
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May 12th, 2013
The Klein Donation: Text of Stem Cell Agency’s Key Responses
By Dr. Matthew Watson
Here is the text of the key comments
from the California stem cell agency in response to questions from
the California Stem Cell Report (CSCR) concerning the $21,630
contribution by Robert Klein. Here is a link to the full story on the matter.
“Is CIRM concerned about the
appearance created by the donation from Bob Klein to enable scientific
staff to attend the ISSCR meeting in Yokohoma, coming one
month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application
and one month before the July Board meeting that led to the approval
of the award?”(Editor's note: It was actually two months before the board meeting.)
“No, the two items are entirely
separate with no connection. Item 1 involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research. The science officers
had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend. Item 2 is an ICOC decision to fund a
research project that they felt had promise and was important for the
people of California.”
could not finance the trip itself ."
Governor's Office issued an Executive Order requiring state agencies,
under the Governor's direct authority, to reduce out-of-state travel.
Although CIRM was not required to participate, we nevertheless
imposed restrictions on out-of-state travel to meet the intent/spirit
of the Governor's request. Accordingly, we made a decision to
reduce the number of our science staff who would be attending the
conference. Bob Klein's donation made it possible
for those staff to go."
failure to report the Klein donation to the board as required by
agency rules.
“Under the Gift Policy, the President
had the authority to accept Mr. Klein’s generous offer as a 'Direct
payment or reimbursement by third parties for the costs of general
operation or grant management administrative activities.' (Gift
Policy, Sec. III(A)(2).) Because CIRM receives gifts only
infrequently, CIRM staff determined that it would be more efficient
to report gifts to the Board on a semi-annual basis. Mr.
Klein’s donation was the first gift CIRM had received in some
years. Due to the lack of additional donations, a transition in
CIRM’s finance office, and an oversight, CIRM staff has not yet
presented a report including Mr. Klein’s gift. Staff plans to
report Mr. Klein’s gift as part of the finance report at the May
Board meeting. Because the President had the authority to
accept the gift pursuant to section III(A)(2) of the Gift Policy, it
did not require a commitment letter. (See Gift Policy, Sec.
III(C)(1) ['A Commitment Letter is not required for gifts described
under III.A.2., 3. and 4.'].) However, consistent with the
policy, Dr. Trounson sent Mr. Klein a letter of appreciation, a copy
of which we have already provided you.”
Source:Stem Cell Therapy
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May 12th, 2013
The Klein Donation: Text of Robert Klein’s Comments on Special Treatment by CIRM
By Dr. Matthew Watson
Here is the text of comments from
Robert Klein, former chairman of the California stem cell agency,
concerning his $21,630 donation to the agency and subsequent actions
by the agency. Klein's comments May 1 came in response to questions
from the California Stem Cell Report(CSCR) on April 30. The text of
the inquiry from CSCR precedes Klein's response. Here is a link to the story on the matter.
"I have sent the following to CIRM
asking for their response and am offering the same opportunity to
you. Here is what I sent the agency:
'The documents that I have received so
far show that after Klein gave CIRM $21,000 the agency instructed six
of its science officers to give him special access to their
activities and apparently did not object to additional instructions
from another member of the public, Melissa King, to provide Klein and
her with written summaries about their activities at the ISSCR
convention and “details” about their work at CIRM. Email
addresses of the six were also provided to Klein, who may have
additionally received their cell phone numbers although that is not
entirely clear. The CIRM documents show that the six were told to
engage in one-on-one sessions with Klein, which actually included a
third person, a wealthy Canadian mining company executive. One
document indicates that the science officers should assist in
fundraising for CIRM by identifying areas of “special importance”
to Klein and 'other donors.'
"'Additionally, Alan Trounson, at
Klein's request, invited the mining executive to a closed door
session involving the agency's international partners, a session at
which presumably valuable, little known scientific information would
be discussed and future directions charted. Trounson specifically
told the executive that it was Klein who asked that executive be
invited to the session, adding to Klein's clout in any business or
other dealings that Klein might have with the executive.'
My questions to CIRM deal with the
special treatment that was provided in connection with your donation.
I would ask you if you think that state agencies should provide this
sort of extraordinary treatment for individuals who donate to the
agency. At the very least, doesn't this raise questions about the
integrity of the agency and doubts in the public mind about whether
it can be fair and even-handed in its activities?
"In April or May of 2012 I committed
to contribute a charitable donation to CIRM to cover the travel costs
for 5-7 additional science officers to attend the International Stem
Cell Conference in Japan. It is important to CIRM that their
science officers understand the cutting edge research being developed
around the world so that CIRM does not fund redundant research; but,
to the contrary, the science officers understand how to create
networks between California scientists and scientists in other
foreign countries who are doing complementary research that can
potentially accelerate the advancements of therapies for patients. I
do not hold any financial interest in biotech companies. I have
historically been involved in encouraging international collaboration
to advance medical therapies; for patients, every day of delay in the
development of a therapy is a delay they cannot afford. To
conceptually document the value of additional scientists traveling to
these meetings, it was discussed that there should be conceptual,
bullet point summaries about the value for CIRM obtained through the
scientists discussions at the international conference. The
idea was to create bullet points of information about a few of the
most meaningful scientific concepts and contacts the science officers
benefitted from each day of attendance at the conference. I did not
participate in the selection of the science officers who attended and
I did not play any part in determining what activities they
participated in. There were two fundamental goals to the very short
one-on-one sessions that were arranged at "down time" that
would not conflict with their other activities. The first goal was to
conceptually understand if each of the science officers believed that
the benefit to the agency was sufficient to justify the cost of their
attending, when considering the learning and contacts they had gained
which might accelerate research and therapies for patients. The
second goal was to assist universities and non-profits, principally
in Canada - a research partner of CIRM - in advancing their
contributions from an existing donor or donors."The Canadian mining executive had an
important history in contributing to the International Stem Cell
Society and to Canadian non-profit research institutions. This
individual has an expert background in mining and a passionate
personal commitment to medical research; but, he does not engage in
technical discussions of research. On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual grants. The value of international
collaboration and the benefits of collaborating with new
international partners is discussed. Scientific theories and
individual grants are not discussed and new scientific information is
not presented. I attended this session of international partners to
support international collaboration; again, I do not hold any
financial interest in any biotech organizations. Additionally, I do
not have any business or financial relationship with the Canadian
mining executive. The Canadian executive, based upon family and
friends who have had chronic disease, is a significant donor to
non-profit research institutions in Canada. All of my activities, the
donation and the encouragement to develop information to validate the
future benefits of science officers traveling to international stem
cell conferences were focused on benefitting California patients with
chronic illness or injury and the agency formed through Proposition
71."
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SBGFem2qPWo/the-klein-donation-text-of-robert.html
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May 12th, 2013
The Klein Donation: Text of Robert Klein’s Response re StemCells, Inc.
By Dr. Matthew Watson
Here is the text of the initial
response from Robert Klein, chairman of the California stem
cell agency until July 2011, to questions from the California Stem Cell Report (CSCR)
concerning his $21,630 donation to the agency. The questions posed by
CSCR on precede the response by Klein. Here is a link to a story on
the matter.
“Why did you give the agency the
money?
“Did you place on conditions on its
use?
“Did anyone connected with the agency
indicate in advance that your donation would be desired? If so
who? Who did you deal with primarily on the donation -- Trounson,
Thomas or...?
“The donation came one month after
grant reviewers rejected StemCells Inc.'s Alzheimer's application. Do
you think it was appropriate to make the donation and then ask the
board twice to override its reviewers?
“Do you think the donation and
subsequent action on StemCells, Inc.'s Alzheimer's application will
negatively color the perception of future efforts by CIRM at private
fundraising?”
approximately $20,000 as a contribution to CIRM to cover the travel
expenses of staff to the International Stem Cell Society
meeting in Japan. My commitment to ensure scientific staff can
participate in international meetings dates back many years. In 2011
I wrote the following explanation of its importance in obtaining the
knowledge to accelerate the drive of scientific research to reach
patients with chronic disease.
Leading Edge Science
“Travel by CIRM staff members and leadership permits CIRM to stay
in contact with, and understand, the leading edge advances of
scientists all over the world, and to leverage those advances by
creating a platform for collaborations between these leading
scientists and their peers in California. Currently, CIRM has
collaboration agreements with 15 foreign governments pursuant to
which these governments have pledged $134,380,000 in commitments to
fund the work of their scientists on join teams with California
scientists to develop therapy candidates and to advance therapies to
human trials. Although a significant amount of this commitment is
currently pending scientific peer review and not all of it will be
awarded as part of a successful application, every dollar in
funding by a foreign government magnifies the scientific impact of
California’s taxpayer dollars. If just $40 million is awarded each
year over ten years, it would provide California with $400 million of
scientific leverage.
- It
is critical to understand that there are unpublished scientific
discoveries in progress in each of these nations. Often, publication
may trail a scientific discovery by nine months or more. - The
travel requested by CIRM provides a critical link for the timely
transmission of valuable new information. California cannot afford to
lose the opportunity to harness discoveries in other countries to
advance the development of therapies in California and to capture the
opportunity to advance therapies for patients instead of using
California taxpayer dollars to duplicate discoveries already mastered
in other countries. - While
CIRM’s scientific staff works with scientists in other countries to
capture the scientific knowledge for the benefit of California’s
therapy development teams, the Chairman’s Office works with
international finance ministers, the premiers of international
states, and foreign funding agencies to ensure funding allocations
for these bilateral funding agreements. These discussions often
involve face-to-face negotiations in foreign nations and states, in
addition to meetings at international conferences, all of which are
supported by extensive staff work in California. - CIRM
issued its first co-funding awards early in 2009. Over the last two
years, these agreements have yielded $57 million in international
funds actually approved through peer review. This $57 million
represents participation by only the first five countries and one
international state with which CIRM established a collaboration. Now,
CIRM has agreements with nine countries and two international states
and an additional three countries will be added in the near future. - Even
if CIRM were only to obtain $30 million per year in international
matching funds, the ratio of return on CIRM’s $206,920 travel
expenditures would be approximately 145 to 1. - Proposition 71 specifically anticipated
and directs CIRM to develop leverage and global leadership to capture
the benefit for patients.
Cell Science
science officers on the grant review staff at CIRM reach out
nationally and internationally through conferences that may include
10-20 meetings per day and workshops of 8-12 hours per day to grasp
the leading edge of this pre-publication, dynamic
revolution in medical knowledge. In order to ensure that the
every research dollar is optimally deployed to advance therapies to
save lives or rescue the quality of life for patients, it is critical
that CIRM staff remain on the cutting edge of new discoveries.
International conferences and workshops provide a critical
opportunity for massive and decisive transfers of information, which
ensures that California is funding the right research.
Trounson on the issue covering the travel expenses for the staff for the reasons stated above. I had no input into the selection
of scientific staff. In May and even in June when the conference
occurred I had no idea that there would be any disagreement on the
Alzheimer’s application of Stem Cells Inc. in August. At the Board
meeting I asked that there be consideration for the fact that three
other peer reviews had found the work leading up to this application
to be outstanding and they had ranked it highly. In addition, the
current peer review had not been briefed on the fact that they
downgraded the applicant for following the directions on material
points by the prior peer reviews. Finally, the standard deviation on
the 2012 peer review was extremely high and the re-review by the
three member committee resulted in a split decision. It is
particularly appropriate with a huge standard deviation,
demonstrating both strong support and opposition within the peer
review group, for the Board to make its own independent decision.
Please recall that the staff recommended against approval so that
they clearly were not influenced by my commitment to a contribution
to the Agency, months before, for the benefit of scientific staff to
be able to attend an international science conference. Additionally,
Dr. Trounson, I believe, recused himself from the review of the Stem
Cells Inc. application, for unrelated reasons, so he was not
involved. I personally had served on the three prior peer reviews,
including one in the prior year that recommended this application for
a Disease Team approval. I know how strongly the scientists on those
three prior peer reviews supported funding this scientific research,
with the 2011 review specifically recommending this Disease Team for
approval. I believe it was extremely important for me to provide a
voice to those three scientific panels who disagreed with a portion
of the scientists on the 2012 scientific panel. Supporting the
scientific movement to human trials for Alzheimer’s has to be
eventually approved by the FDA; but, this loan will move the science
and the potential for clinical trials forward significantly and
hopefully obtain FDA approval. I believe all three of the Board’s
overrides of the peer review recommendations on the Disease Team
round in 2008 are leading directly to human trials in the United
States and/or United Kingdom. 92% of the all of the funds awarded by
CIRM have followed the recommendations of the peer review committee;
but, in those significant cases where the Board has made an
independent decision, there has been an extremely high success rate
particularly when there has been a high level of disagreement within
the Peer Review Board that was overridden and prior peer reviews
recommended and/or approved the scientific approach and concepts of
the applicant.”
(Editor's note: The applications in this round were reviewed once in April 2012 by CIRM's full grant review group. StemCells, Inc.'s application was subject to a reevaluation after Klein's appeal in July 2012 and rejected again, but it was not a full review. Klein may be referring also an earlier round that provided grants for planning to apply for the full $20 million.)
Source:Stem Cell Therapy
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May 12th, 2013
hESC Research Totals $458 Million out of $1.8 Billion from California Stem Cell Agency
By Dr. Matthew Watson
The California stem cell agency today
said that it has awarded $458 million to fund research involving
human embryonic stem cells (hESC) out of a total of $1.8 billion it
has given away during the past eight years.
the key reason that the agency now exists is the perceived
need in 2004 to fund hESC research in the wake of the Bush
Administration restrictions on federal funding in that area. The
restrictions created a national uproar in the scientific and patient
advocate community, which feared that promising therapies would never
be developed.
create the agency focused hard on hESC research to the virtual
exclusion of any mention of adult stem cell research. Opposing the
effort were such forces as the anti-abortion movement and the
Catholic church. But this month LifeNews.com carried a mildly
approving item that pointed to the agency's turn towards adult stem
cell research.
the Bush restrictions, some questions were raised about the need for
the California effort, which is costing state taxpayers $6 billion,
including interest. But those concerns received little public
attention and quickly died out.
state bonds. Cash for new awards is scheduled to run out in 2017. The
agency is looking at developing a public-private effort for thefuture that would need a $50 to $200 million “public investment”
and major private funding.
manager, provided the $458 million figure following publication of
this item yesterday on the California Stem Cell Report.
Source:Stem Cell Therapy
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May 5th, 2013
‘Praise’ for California Stem Cell Agency from Unlikely Corner
By Dr. Matthew Watson
The California stem cell agency this
month received what some might consider a gesture of approval from a
longtime foe – LifeNews.com.
anti-abortion efforts and information and is sharply opposed to research
involving human embryonic stem cells.
read a tacit endorsement of recent CIRM activities in an April 22 piece written by Gene Tame out of Sacramento. It said the most recent
$32 million grant round from CIRM “demonstrates – again – where
the future of stem cell reserch lies.”
“CIRM has been steadily moving away
from its original mission to give preferential
treatment to funding for human embryonic stem cell research
(hESCR). Instead, after adopting a renewed
emphasis on translating research into clinical trials, CIRM
has more and more shifted the bulk of its grants towards funding
research utilizing adult stem cells and other alternatives to hESCR,
such as induced
pluripotent stem cells (iPSCs).”
“(T)he lack, once again, of funding
for hESCR only serves to highlight how old and dated that approach to
finding treatments and cures increasingly seems.”
the stem cell agency has moved a considerable distance from its
reason for being – research involving human embryonic stem cells.
In 2004, the ballot campaign to create the agency pitched voters hard
on hESC research and made no real mention of adult stem cells.
Instead, it focused on the threat from the Bush Administration with its
restrictions on hESC research, which have been lifted by the Obama
Administration. .
academic, Aaron Levine, reported that through 2009 only 18 percent of California's dollars went for grants that were "clearly" not eligible for federal funding under the Bush restrictions.
publicly disclosed statistics on its funding of hESC research.
those 240 awards, but it has given away a total of $1.8 billion. (Following publication of this item, the agency told the California Stem Report that it has funded $458 million in hESC research.)
blue-ribbon Institute of Medicine panel that recommended sweeping
changes at CIRM.
Source:Stem Cell Therapy
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May 5th, 2013
Stem Cell Agency Provides More Cost Detail on Future Plans
By Dr. Matthew Watson
The California stem cell agency today clarified the size of the assumed "public investment" in its rough outline of its plan for future activities.
"This hypothetical range of public investment ($50 million to $200 million) is thought of as a one-time investment, with hope of private investments in multiples of that with the fund recharging to some extent based on revenue."
"We have not wanted to post the budget range because we want honest estimates of what folks think the budget should be rather than having them penciling estimates that max out the budget."
Source:Stem Cell Therapy
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April 28th, 2013
California Stem Cell Agency Seeks Lobbyist Bids
By Dr. Matthew Watson
out a bid for a private lobbyist to watch out for its interests in
Sacramento, perhaps severing a longtime relationship with one of the
Capitol's more prestigious power brokers.
a contract since 2005 with Nielsen Merksamer Parrinello Gross &
Leoni LLP of Sacramento, which reported lobbying revenue last
year of more than $5 million. That made it one of the top revenue producers among California lobbyists.
It started at $49,900 for five months in 2005 on a no-bid contract with Nielsen, although the annual figure is now $49,999. The agency's request this month for bids calls for a boost to $65,000 annually.
health care lobbying. Its biotech/pharmaceutical clients have included Genentech, Merck &
Co. and Pfizer. The firm also played a role in the drafting of and
campaign for Proposition 71 in 2004. In 2009, at the behest of
Robert Klein, then chairman of the agency, it produced a legal memo
that Klein used to help box in the agency governing board on taking a
position on the Little Hoover Commission report recommending major
changes at the enterprise.
agencies that hires a private lobbyist, which has raised some
eyebrows. Nearly all agencies handle legislative relations
internally.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/0HfVYv0XVQg/california-stem-cell-agency-seeks.html
Stem Cell Therapy
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April 28th, 2013
Deadline This October: California Stem Cell Agency Seeking Detailed Public-Private Plan for its Future
By Dr. Matthew Watson
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.
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.)
thinking about how to regenerate itself was found in an RFP posted four days ago on its website.
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.
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.
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.”
$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.
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.”
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.
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.
public-private arrangement would be novel among state government
departments and could well require legislative or voter approval.
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:Stem Cell Therapy
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April 28th, 2013
California Stem Cell Agency Budget Up 4.6 Percent, Topping $17 Million
By Dr. Matthew Watson
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.
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.
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.
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.
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.
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.
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.
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.)
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.
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.
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.
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.
approved by the Finance panel next week without significant changes
and then by the full board late in May.
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:Stem Cell Therapy
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April 21st, 2013
Meager California Biotech Representation in Governor’s China Trip
By Dr. Matthew Watson
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.
“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.”
(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.)
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/x57uSahTPNI/meager-california-biotech.html
Stem Cell Therapy
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April 21st, 2013
StemCells, Inc., Nails Down Controversial, $19 Million Award from California Stem Cell Agency
By Dr. Matthew Watson
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..
cash was withheld until the financially strapped company could
demonstrate that it could match the size of the loan, as promised in
its 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.
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."
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.
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.”
and the stem cell agency did not answer a question about whether
those funds are being used to back the award from California
taxpayers.
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.”
million. We have queried the agency about the smaller figure
announced today.
$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.
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 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.
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.
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.”
two points higher than the one from StemCells, Inc. Reviewers also did not recommend funding that application.
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 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.
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:Stem Cell Therapy
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April 14th, 2013
Modest Approval from Long-time Stem Cell Agency Critic
By Dr. Matthew Watson
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.
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.
“Stem cell agency finally addresses
potential for conflicts”
chairman of the agency, “has taken important steps in
reducing the potential for conflicts within this agency.”
“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.”
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.
“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:Stem Cell Therapy
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April 14th, 2013
StemCells, Inc., Rejects $20 Million from California Stem Cell Agency
By Dr. Matthew Watson
When does a financially struggling
biotech company turn down a $20 million “forgivable loan?”
Ca., and the cash is being offered by the $3 billion California stem
cell agency. The research program has handed out nearly 600 awards, and it is the first time that a recipient has rejected funding.
cell saga that began publicly last July and that involved unusual personal lobbying by the former chairman of the Golden State's stem cell research agency. The high point of the saga may have come in
September when the agency's governing board finished awarding
StemCells, Inc., $40 million in two different awards. But there was a
catch. StemCells Inc., had to match that figure with $40 million of
its own.
in the towel on the $20 million awarded on its cervical spinal cord
injury application. In comments to analysts March 21, Rodney Young,
chief financial officer of the publicly traded company, said:
“The funding would have been in the
form of a forgivable loan, however, we have elected not to borrow
these funds from CIRM(the stem cell agency).”
“You may also recall that last
September, CIRM approved a separate application under the same
disease team program for Alzheimer's disease, which was also for up
to $20 million in the form of a loan. We remain in confidential
negotiations with CIRM regarding the terms and conditions that would
attach to this loan.”
rejecting the cash, either in the conference call transcript or in
its press release.
Inc., reported continuing losses. For 2012, net losses totaled $28.5
million compared to $21.3 million in 2011. Revenue for 2012 was $1.4
million compared to $1.2 million in the previous year.
Inc., founded by Stanford's eminent researcher Irv Weissman, stirred
up a bit of a ruckus. The spinal injury award was handed out
routinely in July. Scientific reviewers gave it a score of 79 and
recommended funding. It was another matter on the Alzheimer's
application. It was scored at 61. Reviewers said it did not merit
funding. But the company publicly appealed to the full board, which sent the
application back for more examination. It was rejected again.
Nonetheless, in September, the 29-member board approved the award on
a 7-5 vote, bypassing a rival Alzheimer's application scored at 63.
It was the first time in the eight-year-history of the agency that
its board approved an application that was rejected twice by
reviewers.
lobbying by Robert Klein, former chairman of the board. Klein was
also chairman of the ballot campaign that created the agency, and
Weissman, who holds stock in StemCells, Inc., and sits on its board,
was a major fundraiser for the campaign.
Prize-winning columnist, Michael Hiltzik, wrote 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.
Martin McGlynn, CEO of StemCells, Inc., expects “quick” action on
finally securing the cash.
the March conference call between McGlynn and analyst Kaey Nakae of
Ascendiant Capital Markets.
Nakae: “Okay. Just 2 more questions.
I guess the first one, as it relates to CIRM.
In deciding to decline the funding for spinal cord yet continuing to
pursue the funding for Alzheimer's, is there a difference in what
you're getting from them in terms of potential terms and conditions
that allow you to proceed on one and not the other, or is it the fact
that you're already in human with -- in spine, and still very
preclinical with Alzheimer's?”
McGlynn: :”I think you're very
definitely -- you're getting at some important criteria when one
considers how to fund programs whether you use debt or equity,
etcetera. So I wouldn't disagree with anything that you've outlined
or surmised. But I just would pray your indulgence until we're
finished, the negotiations with CIRM, which are coming to a close and
we expect those to resolve pretty quickly with regards to the
Alzheimer's program. And then quite frankly, we can be way more
forthcoming and way more disclosive with regards not only to our
decisions, but to our thinking.”
day. Its 52-week high is $2.67 and its 52-week low $0.59.
Source:Stem Cell Therapy
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April 7th, 2013
More about Funding for Personalized Medicine Research
By Dr. Matthew Watson
A post entitled Funding for Personalized Medicine Research, dated January 31, 2012, provided information about the participation of the Cancer Stem Cell Consortium (CSCC) in the Large-Scale Applied Research Project Competition of Genome Canada, in collaboration with the first phase of the Personalized Medicine Signature Initiative of the Canadian Institutes of Health Research (CIHR).
On March 26, 2013, it was announced that 17 projects will be supported. A list of these project is available (PDF). One of the 17 projects is entitled "Innovative chemogenomic tools to improve outcome in acute myeloid leukemia". The Project leader is Guy Sauvageau of the Institute for Research in Immunology and Cancer (IRIC) at the Université de Montréal. The Project co-leader is Josée Hébert of the Centre de Recherche Hôpital Maisonneuve-Rosemont, Montréal. One of the aims of this project is to develop new models for tracking cancer stem cells that are left behind after a patient is treated.
Source:
http://cancerstemcellnews.blogspot.com/2013/03/more-about-funding-for-personalized.html
Stem Cell Therapy
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March 31st, 2013
Cyberspace Makeover at California Stem Cell Agency
By Dr. Matthew Watson
California's $3 billion stem cell
agency has performed a well-done makeover on its most important
public face – its web site, which is chock-a-block full of useful
information for researchers and the unwashed alike.
words of its directors as they wrestle with everything from grant
approvals to conflicts of interest. Scientists can be seen telling
the story of their accomplishments. Money can be followed, and
summaries of reviews of grant applications read, both those approved
and those that did not pass muster.
Institute of Regenerative Medicine (the formal name of the agency) is the place where the stem cell program
really meets the public. News stories are important, but infrequent.
Day to day, however, thousands of interested persons seek out
information that the folks at CIRM HQ, just a long throw from the San
Francisco Giants ballpark, bring to cyberspace.
of the web site, 15,000 to 17,000 “unique viewers”
visit online. She told the California Stem Cell
Report in an email,
“We're up about 25 percent year over
year in unique viewers to the site. A lot of that growth comes from
search, and the rest is from traffic driven through our blog and
Facebook.”
those chalked up by major media sites. But they are significant
given that there are only a few thousand people worldwide who are
deeply and regularly interested in stem cell research. Many more,
however, are stimulated to look into the subject from time to time,
either because of news stories, personal, disease-related concerns or simple interest in cutting edge science. Engaging those
readers, who can spread the CIRM story, and winning their approval is
critical for the agency as it faces the need to raise more millions
as it money runs out in the next few years.
its short life. So much that good tools are needed to navigate the
site. Decisions about what should go on the home page are critical.
With the makeover, the agency now has a long-needed, home-page link to its
meetings , especially those of its governing board, which are the
single most important events at the agency.
new, white background makes it easier to read and is comfortable for
readers long conditioned to the black-on-white print of the books,
newspapers and magazines. The video image on the home page is larger,
which helps attract viewers. The site has long had a carload of
videos, some of which contain powerful and emotional stories from
patients.
new features. She reported,
“I've had people inside CIRM (who
have been beta testing this site) tell me that they are finding
content they'd never seen before because the site is so much easier
to navigate.”
also have pulled together important information on each grant on a
single page, including progress reports. You can find a sample here on a $1 million grant to Stanford's Helen Blau.
“Now people can not only
read about what our grantees are hoping to accomplish, they can read
about what has actually been accomplished with our funding.”
downloadable spread sheets of information that can be manipulated by
readers offline. She said,
“Most places on the site where you
see tables, you can now download those tables to Excel. You'll notice
the small Excel icon at the lower left of the table. This feature has
long been available for the searchable grants table. Now you'll see
it on all the tables of review reports (see here for
example http://www.cirm.ca.gov/application-reviews/10877)
on the disease fact sheets (see
here http://www.cirm.ca.gov/about-stem-cells/alzheimers-disease-fact-sheet)
and other places throughout the site. This is part of an effort to
make our funding records more publicly available.”
still needs work. A search using the term “CIRM budget 2012-2013”
did not produce a budget document on the first two pages of the
search results. A search on the term “Proposition 71,” the ballot
initiative that created CIRM, did not provide a direct link to its
text on the first two pages of search results.
as I can tell, is a list of the persons who appointed the past and
present board members as well as the dates of the board members'
terms of office. The biographies on some of the 29 governing board
members come up short. In the case of Susan Bryant, her bio does not
mention that she is interim executive vice chancellor and provost at
UC Irvine. Links also could be added to board members statements of economic interest. A list of CIRM staff members (only slightly more than 50
persons) and their titles could be added.
uses Google Analytics tools. Adams said,
“A unique visitor is Google's
definition (it's one of the metrics they provide). It's a visit from
a unique IP (internet protocol) address. So, if you visit our site
multiple times from one IP address during a day, you count as a
single unique visitor. (Editor's note: It is possible to have
more than one visitor from the same IP address.)
“We get ~23,000-25,000 visits per
month, or ~16,000-18,000 unique visitors. Page views are on the order
of 65,000 a month.”
is a worthy effort and enhances CIRM's relationships with all those
who come looking for information. The agency is to be commended and
should continue its work to improve the site and its connections with
the public.
Source:Stem Cell Therapy
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March 17th, 2013