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Category Archives: Stem Cell Therapy

Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs


Looking for a good job at an
enterprise that is on the cutting edge of biotechnology?

Nine positions are open at the $3
billion California stem cell agency, headquartered in San Francisco.
Some of them could pay more than $200,000 a year.
Several of the new jobs are closely
aligned with the agency's fresh focus on commercializing stem cell
research and driving therapies into the clinic. Scientists and
lawyers are being recruited along with a business development
officer. For some of the positions, travel is required.
One new, high-level position is
described as a senior development officer. The job posting calls for
“expertise in product development for stem cell therapies.” The
person would “directly interact with investigators on CIRM’s
clinically applicable research programs to help provide product
development guidance from preclinical, manufacturing, and first in
human to early phase clinical regulatory perspectives.” An M.D. or
Ph.D. degree in a biomedical science is required. Pay tops out at
$232,891. This person would report to Ellen Feigal, senior vice
president for research and development.
A second, high-level position reporting to Feigal is senior medical officer, who would manage the
agency's portfolio aimed at commercialization of stem cell research,
specifically “focused on IND enabling and clinical development
projects.” This also requires an M.D. or Ph.D. and substantial professional experience in development of biomedical research and
products. Pay also could run as high $232.891 annually.
A third new job at CIRM is
business development officer. That person would help generate
“outside investment in stem cell research in California for both
CIRM-funded and not currently CIRM-funded programs by
biopharmaceutical strategic partners; equity investors (venture
capital and others); and disease foundations.” The salary range
hits $216,270 annually. It wouldn't be surprising if the person in
this job also became involved in developing a funding mechanism for
CIRM after it runs out of state cash in 2017 or so. 
This position reports to Elona Baum,
general counsel and vice president, business development.
And yet another new position is called
director of alliance management. The job deals with the agency's
extensive collaborative funding partnerships, many of which are
abroad. CIRM wants somebody with a law degree, experience in
intellectual property and business law along with strong negotiating
skills. The pay range for the post tops out at $232,891 annually. This position reports to CIRM President
Alan Trounson.
Other open positions include: deputy
general counsel, two science officers and office manager.

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

Posted in Stem Cell Therapy, Stem Cells | Comments Off on Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs

California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards


During the last few months, the $3 billion California stem cell
agency, which is approaching its eight-year anniversary, has chalked up a
number of important firsts.

Most of them came during the July and
September meetings of its 29-member governing board and were related to strenuous efforts by researchers to win approval of awards of up to
$20 million each. Several firsts involved the agency's former
chairman, Robert Klein, who could be considered the father of the
state's stem cell research effort.
So here is the California Stem Cell
Report's
list of firsts at the California Institute of Regenerative
Medicine
(as CIRM, the stem cell agency, is formally known) for the
summer of 2012.
It was the first time that a single
company – in this case, StemCells, Inc. , of Newark, Ca. –
received two awards in the same round.
It was the first time any company has
been awarded as much as $40 million. Again, StemCells, Inc.
It was the first time that Klein has lobbied his former board (see here and here) on
behalf of a particular grant application. That occurred in both July
and September with one of StemCells, Inc.'s application.
It was the first time that the board
has approved an application that has been rejected twice by
reviewers, again the StemCells, Inc., proposal backed by Klein.
It was the first time that board has
received such a large outpouring of appeals by rejected applicants.
It was the first time that the board
has received such lengthy presentations of emotional appeals by
patient advocates on behalf of rejected applicants.
It was the first time that action on a
grant round has been extended over three months(see here and here). The disease team
round began in July. Action will not be completed until the end of
October.
It was the first time that the
governing board has sent so many applications back for re-review –
five, six if the one to be acted on in October is included.
It was also the first time that the
board has ordered a full-blown review of its grant appeal process
with an eye to making making major changes in it.
Several reasons exist for the number of
firsts racked up by CIRM. One is the high stakes involved in the
disease team round that began in July and the low number approved by reviewers – six compared to the 12 approved by the board, as of
today, out of 21 applications. Another reason involves the
increasing understanding on the part of many scientists that they can
appeal directly to the board when reviewers reject their
applications. However, it is also clear that not all applicants
grasp the full range of appeal possibilities. A third reason involves
the agency's muddled appeal process, which has been a problem for
years. And a fourth reason involves the board's push to drive research into
the clinic and commercialization, which applicants are quickly
learning how to exploit.
Readers should feel free to add their
own firsts to this list. They can do so – even, anonymously – by
clicking on the word “comments” at the end of this item.

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

Posted in Stem Cell Therapy, Stem Cells | Comments Off on California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards

StemCells, Inc., Discloses How it Will Generate $40 Million in Matching Funds


StemCells, Inc., said yesterday that it
will come up with the $40 million needed to match loans from the California
stem cell agency through “existing infrastructure and overhead”
and will not be issuing stocks or warrants to the agency.

In a statement to shareholders, Martin
McGlynn
, CEO of the publicly traded firm, discussed the $40 million in loans awarded by agency this summer, including $20 million last
week. The stem cell agency's governing board, after it emerged from
an executive session on the matter, last Wednesday night adopted a
motion requiring the company to demonstrate that it has the matching
funds.
CIRM Chairman J.T. Thomas, a Los Angeles bond financier, said that
concerns were expressed during the executive session that the agency
“would account for such a large part of the assets of the company.”
At his suggestion, the board approved the loan on the condition that
“it show it has access” to the $20 million in matching funds that
company offered during the application process. StemCells, Inc., also
offered a $20 million match on another loan approved in July by CIRM.
The latest financial reports from
StemCells, Inc., which is based in Newark, Ca., show that it had
assets of $17 million as of June 30 and liabilities of $11.6 million.
The company reported net income for the second quarter of $833,522
compared to a loss of $4 million for the same period a year ago.
In its filing with the SEC, the company
said,

“We have incurred significant
operating losses since inception. We expect to incur additional
operating losses over the foreseeable future. We have very limited
liquidity and capital resources and must obtain significant
additional capital and other resources in order to provide funding
for our product development efforts....”

In his statement yesterday, McGlynn
said the California stem cell agency had “doubled down” on
StemCells, Inc., in approving the two loans. He said the company is
not concerned about meeting the matching requirements. McGlynn said, 
Martin McGlynn
StemCells, Inc., Photo

“To be clear, we do not interpret the
diligence requirement as an obligation to raise a specific amount of
money in a particular period of time, and we wish to correct the
misstatements made by some uninformed third parties that the ICOC is
requiring us to raise $20 million in matching funds. In
point of fact, we expect that a substantial amount of our
contribution towards these projects will come from existing
infrastructure and overhead, salaries for our existing personnel, and
other contributions in kind. Furthermore, we will soon be
reviewing the budgets for both projects in detail with CIRM
staff. Because each disease team budget was prepared on a
stand-alone basis, we expect to see significant economies and
efficiencies now that the company has in fact been awarded funding
for both.”

McGlynn also said,

"Under this particular CIRM
program (RFA 10-05), funding for companies will be in the form of
unsecured, non-recourse, interest-bearing, term loans, which will be
forgivable in the event the funded research fails to result in a
commercialized product. On the other hand, should the product be
successfully commercialized, CIRM would earn milestone payments
depending on how successful the product becomes. Because CIRM
shares the downside risk, and could participate handsomely on the
upside, the structure makes the loan about as close to 'equity' as one could, without having to dilute existing shareholders in order
to gain access to significant amounts of capital.  The company
will not issue stock, warrants or other equity to CIRM in connection
with these awards. 

"Of course, we realize that CIRM
prefers that applicants from industry provide evidence of their
ability to secure whatever additional funds may be needed to complete
any CIRM-funded project, in this case the filing of an IND for each
indication. This is stated in the text of RFA 10-05 itself and
was repeated in various comments by CIRM staff during the application
process. When making the second award on September 5, the
ICOC naturally recognized the sizeable commitment it was making
to StemCells, so it instructed CIRM staff to satisfy themselves
of the company's ability to access the capital needed to fund the
project, namely the Alzheimer's program through to the filing of the
IND.”

McGlynn also said firm's bid for
another $10 million from CIRM could come in the form of a grant
instead of a loan. He said,

"Finally, I can confirm that in
June of this year the Company applied for up to $10
million under CIRM's Strategic Partnership I program
(RFA 12-05). Unlike the disease team awards under RFA
10-05, if companies are approved for funding under RFA 12-05, they
may elect to take such funding in the form of a grant, not a
loan. Our application under RFA 12-05 is for a controlled Phase
II clinical trial of HuCNS-SC cells in Pelizaeus-Merzbacher disease
(PMD), a rare myelination disorder. StemCells completed a Phase
I study in PMD in February 2012 and in April announced that
all of the patients from that study showed evidence of cell-derived
myelination and three of the four patients in the study showed
measurable gains in motor and/or cognitive function.”

According to CIRM, the awards in the strategic partner round will be approved either next month or in December. 
StemCells, Inc. stock was trading at
$1.85 at the time of this writing. Last week, it rose to $2.43.
During the last 12 months, its high was $2.67 and its low was 59
cents.

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

Posted in Stem Cell Therapy | Comments Off on StemCells, Inc., Discloses How it Will Generate $40 Million in Matching Funds

Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs


Looking for a good job at an
enterprise that is on the cutting edge of biotechnology?

Nine positions are open at the $3
billion California stem cell agency, headquartered in San Francisco.
Some of them could pay more than $200,000 a year.
Several of the new jobs are closely
aligned with the agency's fresh focus on commercializing stem cell
research and driving therapies into the clinic. Scientists and
lawyers are being recruited along with a business development
officer. For some of the positions, travel is required.
One new, high-level position is
described as a senior development officer. The job posting calls for
“expertise in product development for stem cell therapies.” The
person would “directly interact with investigators on CIRM’s
clinically applicable research programs to help provide product
development guidance from preclinical, manufacturing, and first in
human to early phase clinical regulatory perspectives.” An M.D. or
Ph.D. degree in a biomedical science is required. Pay tops out at
$232,891. This person would report to Ellen Feigal, senior vice
president for research and development.
A second, high-level position reporting to Feigal is senior medical officer, who would manage the
agency's portfolio aimed at commercialization of stem cell research,
specifically “focused on IND enabling and clinical development
projects.” This also requires an M.D. or Ph.D. and substantial professional experience in development of biomedical research and
products. Pay also could run as high $232.891 annually.
A third new job at CIRM is
business development officer. That person would help generate
“outside investment in stem cell research in California for both
CIRM-funded and not currently CIRM-funded programs by
biopharmaceutical strategic partners; equity investors (venture
capital and others); and disease foundations.” The salary range
hits $216,270 annually. It wouldn't be surprising if the person in
this job also became involved in developing a funding mechanism for
CIRM after it runs out of state cash in 2017 or so. 
This position reports to Elona Baum,
general counsel and vice president, business development.
And yet another new position is called
director of alliance management. The job deals with the agency's
extensive collaborative funding partnerships, many of which are
abroad. CIRM wants somebody with a law degree, experience in
intellectual property and business law along with strong negotiating
skills. The pay range for the post tops out at $232,891 annually. This position reports to CIRM President
Alan Trounson.
Other open positions include: deputy
general counsel, two science officers and office manager.

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

Posted in Stem Cell Therapy | Comments Off on Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs

California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards


During the last few months, the $3 billion California stem cell
agency, which is approaching its eight-year anniversary, has chalked up a
number of important firsts.

Most of them came during the July and
September meetings of its 29-member governing board and were related to strenuous efforts by researchers to win approval of awards of up to
$20 million each. Several firsts involved the agency's former
chairman, Robert Klein, who could be considered the father of the
state's stem cell research effort.
So here is the California Stem Cell
Report's
list of firsts at the California Institute of Regenerative
Medicine
(as CIRM, the stem cell agency, is formally known) for the
summer of 2012.
It was the first time that a single
company – in this case, StemCells, Inc. , of Newark, Ca. –
received two awards in the same round.
It was the first time any company has
been awarded as much as $40 million. Again, StemCells, Inc.
It was the first time that Klein has lobbied his former board (see here and here) on
behalf of a particular grant application. That occurred in both July
and September with one of StemCells, Inc.'s application.
It was the first time that the board
has approved an application that has been rejected twice by
reviewers, again the StemCells, Inc., proposal backed by Klein.
It was the first time that board has
received such a large outpouring of appeals by rejected applicants.
It was the first time that the board
has received such lengthy presentations of emotional appeals by
patient advocates on behalf of rejected applicants.
It was the first time that action on a
grant round has been extended over three months(see here and here). The disease team
round began in July. Action will not be completed until the end of
October.
It was the first time that the
governing board has sent so many applications back for re-review –
five, six if the one to be acted on in October is included.
It was also the first time that the
board has ordered a full-blown review of its grant appeal process
with an eye to making making major changes in it.
Several reasons exist for the number of
firsts racked up by CIRM. One is the high stakes involved in the
disease team round that began in July and the low number approved by reviewers – six compared to the 12 approved by the board, as of
today, out of 21 applications. Another reason involves the
increasing understanding on the part of many scientists that they can
appeal directly to the board when reviewers reject their
applications. However, it is also clear that not all applicants
grasp the full range of appeal possibilities. A third reason involves
the agency's muddled appeal process, which has been a problem for
years. And a fourth reason involves the board's push to drive research into
the clinic and commercialization, which applicants are quickly
learning how to exploit.
Readers should feel free to add their
own firsts to this list. They can do so – even, anonymously – by
clicking on the word “comments” at the end of this item.

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

Posted in Stem Cell Therapy | Comments Off on California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards

'Bubble babies' immune systems restored

LOS ANGELES UCLA stem cell researchers have found that a gene therapy regimen can safely restore immune systems to children with so-called "bubble boy" disease, a life-threatening condition that if left untreated can be fatal within one to two years.

In the 11-year study, researchers were able to test two therapy regimens for 10 children with ADA-deficient severe combined immunodeficiency (SCID), which has come to be known as "bubble boy" disease because some of its victims have been forced to live in sterile environments.

During that time, the researchers refined their approach to include a light dose of chemotherapy to help remove many of the blood stem cells in the bone marrow that were not creating the enzyme adenosine deaminase (ADA), which is critical for the production and survival of healthy white blood cells, said study senior Dr. Donald Kohn, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

The refined gene therapy and chemotherapy regimen proved superior to the other method tested in the study, restoring immune function to three of the six children who received it, said Kohn, who is also a professor of pediatrics and of microbiology, immunology and molecular genetics in UCLA Life Sciences Division. An even further-refined regimen using a different type of virus delivery system will be studied in the next phase of the study, which already has enrolled eight of the 10 patients needed.

The study appears today (Sept. 11) in the advance online issue of the peer-reviewed journal Blood.

"We were very happy that in the human trials we were able to see a benefit in the patients after we modified the protocol," Kohn said. "Doctors treating ADA-deficient SCID have had too few options for too long, and we hope this will provide them with an efficient and effective treatment for this devastating disease."

Children born with SCID, an inherited immunodeficiency, are generally diagnosed at about 6 months old. They are extremely vulnerable to infectious diseases and don't grow well. Chronic diarrhea, ear infections, recurrent pneumonia and profuse oral candidiasis commonly occur in these children. SCID occurs in about one of every 100,000 births.

Currently, the only treatment for ADA-deficient SCID calls for injecting patients twice a week with the necessary enzyme, Kohn said, a lifelong process that is very expensive and often doesn't return the immune system to optimal levels. These patients also can undergo bone marrow transplants from matched siblings, but matches can be very rare.

About 15 percent of all SCID patients are ADA-deficient. Kohn and his team used a virus delivery system that he had developed in his lab in the 1990s to restore the gene that produces the missing enzyme necessary for a healthy immune system. To date, about 40 children with SCID have received gene therapy in clinical trials around the world, Kohn said.

Two slightly different viral vectors were tested in the study, each modified to deliver healthy ADA genes into the bone marrow cells of the patients so the needed enzyme could be produced and make up for the cells that don't have the gene. Four of the 10 patients in the study remained on their enzyme replacement therapy during the gene therapy study. There were no side effects, but their immune systems were not sufficiently restored, Kohn said.

Continued here:
'Bubble babies' immune systems restored

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