Friday, November 30, 2012

Stem Cell Board Members Lubin and Sheehy Honored

A couple of members of the governing board of the $3 billion California stem cell agency were honored for their work this month.

Jeff Sheehy
UCSF Photo
One is Jeff Sheehy, a UCSF communications manager and nationally known HIV/AIDS advocate, who has served on the CIRM board since its inception. He was named by POZ magazine as one of the top 100 “soldiers” in the fight against HIV/AIDS.

CIRM's Amy Adams filed an item on Sheehy on the agency's blog yesterday. She said, 
“Jeff once told me that when he joined CIRM’s board eight years ago, he didn’t see a role for stem cells in an HIV/AIDS treatment. Now, CIRM has committed $40 million toward HIV/AIDS projects and two teams of researchers from City of Hope and UCLA are working toward clinical trials.”
Sheehy was also invited to the White House to commemorate World AIDs day Dec. 1.

Bert Lubin
Childrens Hospital Photo
Also honored was Bert Lubin, CEO of Childrens Hospital in Oakland, where he has worked since 1973, a remarkable achievement in today's world of transitory employment. The San Francisco Business Times named Lubin as the “most admiredCEO” in the San Francisco Bay Area. The newspaper said that since he took charge at Childrens in 2009,
“He recruited a new senior management team, chopped away at the pediatric hospital’s operating deficit and worked to heal relationships with the local community and governmental and political leaders that were deeply frayed...”
On a personal note, a friend who has long volunteered at Childrens gives him high marks as well, citing several encounters where he exceeded the usual CEO effort.
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Correction

The Diane Winokur appointment item yesterday incorrectly stated that she is a current member of the governing board of the Sanford-Burnham Institute. That statement was based on information provided by the California stem cell agency and Golden West ALS chapter. Sanford-Burnham today said, however, that Winokur has not been on the board since last year. She served from 2005 to 2011.


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Thursday, November 29, 2012

Diane Winokur, Veteran ALS Patient Advocate, Named to California Stem Cell Agency Board

Longtime ALS patient advocate Diane Winokur of San Francisco, who has lost two sons to the disease, has been appointed to the governing board of the $3 billion California stem cell agency.

She fills the vacancy left by David Serrano Sewell, who resigned from the 29-member panel earlier this year after serving since the agency's inception. CIRM has 10 patient advocates on its board.

Diane Winokur
Photo -- Legal Momentum
Winokur is well-known in ALS circles. She sat for five years on the governing board of the national ALS advocacy group and currently serves on the board for the California state group, the Golden West chapter. She also served for six years on the board of trustees for the Sanford- Burnham Institute in La Jolla, which has received $37 million from the stem cell agency. She left Sanford in 2011.

Last summer Winokur appeared before the CIRM board to successfully seek approval of an $18 million ALS grant that was rejected by the agency's reviewers. Researcher Clive Svendsen of Cedars-Sinai in Los Angeles appealed the denial to the full board and was supported in emotional testimony by other patient advocates as well, including persons with the affliction.(See here for video of some of the testimony.)
The agency has awarded about $30.6 million, including the Svendsen grant, for research directly related to ALS.

Golden West issued a press release Nov. 21, lauding the Winokur appointment by California Lt. Gov. Gavin Newsom. The release quoted Lucie Bruijn, chief scientist of The ALS Association, as saying,
"Her contributions have been invaluable and she will be a tremendous asset in moving the ALS research field forward through CIRM funding."
The stem cell agency posted a blog item on Winokur's appointment in addition to a press release. CIRM Chairman J.T. Thomas said,
“Her knowledge, expertise and leadership will be a tremendous addition to the ICOC (the stem cell agency governing board) and help guide us in our work.”
Patient advocate Don Reed of Fremont, Ca., described Winokur in a 2008 blog item as “small, elegant, full of energy, an exclamation point of a person.”

(Editor's note: Based on information from CIRM and Golden West, an earlier version of this item incorrectly stated that Winokur is a current member of the Sanford-Burnham board.
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Wednesday, November 28, 2012

Knoepfler Award Update: More than a Baker's Dozen Nominated

As of this week, 14 persons have been recommended for the Knoepfler “Stem Cell Person of the Year” Award.

The total was reported by Paul Knoepfler, the UC Davis stem cell scientist and blogger, who is putting up $1,000 for the winner of the honor.

Knoepfler announced his award plans earlier this month, declaring that he wanted to recognize scientists or others who “truly made a difference” in the stem field. Risk-taking is one important criteria.

Knoepfler said,
“It’s something that I’m hoping I can do every year. It would also be a reward for risk taking, creativity and be breaking with tradition and be something new in that regard.” 
The award has drawn some modest attention outside of Knoepfler's blog. A few days after he introduced the award on his blog, UC Davis decided to put out a press release and video on it. The California Stem Cell Report followed with an item. Then CIRM blogged it as well.

So far we have not detected any stories about the award in the mainstream media, but things could change.

Deadline for entries is Dec. 17.
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Wednesday, November 21, 2012

California Stem Cell Agency Still in Talks on $40 Million for StemCells, Inc.

The California stem cell agency and StemCells, Inc., are still trying to reach agreement on a deal in which the company would receive $40 million from the state's taxpayer-funded research effort.

The sticking point is the $40 million in matching funds required from the Newark, Ca., firm under the terms of the two awards approved in July and September. The latter award was okayed on a 7-5 vote by the governing board after it was rejected twice by the agency's reviewers.

On Monday the California Stem Cell Report queried the agency about the status of the awards. Kevin McCormack, the agency's spokesman, replied,
“We are still in talks with them over the terms of the funding. Hopefully, we'll have an agreement soon.”
He did not elaborate further.

CIRM staff normally reviews applications after they are approved by the agency's governing board to be sure that all conditions are being met. However, in the case of the September award to StemCells, Inc., CIRM's governing board took the unusual step of publicly stating that the firm must demonstrate it has the $20 million in matching funds before it receives any payments from CIRM. The board did not take that sort of public position on the $20 million grant approved earlier in the summer, although matching funds are required in that case as well.

The former chairman of the $3 billion stem cell agency, Robert Klein, appeared twice before the board to lobby for approval of the second award to StemCells, Inc., which is a publicly traded firm.. It was the first such appearance by Klein before his former colleagues since leaving the agency in June 2011.

Action on the StemCells, Inc., awards attracted attention from the Los Angeles Times last month. Pulitzer Prize-winning columnist Michael Hiltzik wrote that the process was “redolent of cronyism.” He said a “charmed relationship” existed among StemCells, Inc., its “powerful friends” and the stem cell agency.

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Texas Flap Looms Over California Stem Cell Agency's Grant Appeals

In nine days, the California stem cell agency plans to take another crack at finding ways to curb its free-wheeling appeal process involving scientists whose applications for millions have been rejected by reviewers.

It is a matter of considerable interest to researchers who need the cash to keep their labs running and remain in good standing with their host institutions.

The stem cell agency's governing board this fall created a task force to deal with the appeals issue after a record-breaking number of researchers made public appeals featuring emotional patient advocates. Even the former chairman of the agency, Robert Klein, made a two-time pitch for one applicant. Board members later complained publicly about “arm-twisting,” lobbying and“emotionally charged presentations.”

The agenda for the Nov. 30 task force meeting in Oakland -- with teleconferencing sites in San Francisco, Irvine, Palo Alto, Seattle and Rochester, N.Y. -- contains few clues on what the panel is hoping to specifically accomplish in next week's 90-minute session.

But interested researchers can check the transcript from the Oct. 24 meeting, during which CIRM President Alan Trounson described the problem as “very critical.” He said,
“I think this is a very serious matter that could really bite us very hard in a similar way to what's happened in Texas. Unless we come up with some kind of process that really addresses the science, it's a very large concern.”
Trounson's Texas reference was to the mass resignations of reviewers at that state's $3 billion cancer research effort. Questions have been raised about integrity of its grant review process and the program's political and biotech industry relationships. James Drew of the Dallas Morning News produced a bit of an overview this week. In another piece, Eric Berger of the Houston Chronicle provided quotes from emails from the infighting on a controversial $18 million grant.

Changes in California's grant appeal process may well be also discussed at the agency's board meeting Dec. 12 in Los Angeles. The board hopes to wrap up its action by late January.

Here is a link to an item with more specifics on material presented to the task force in October. Here is a link to an August 2012 list of articles and documents related to the CIRM appeals process.

Interested parties can address comments to the agency at info@cirm.ca.gov.   

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Tuesday, November 20, 2012

Pomeroy Moving On, Will Leave Stem Cell Board

Claire Pomeroy, one of the longtime members of the governing board of the $3 billion California stem cell agency, will be leaving her position at UC Davis and the stem cell board next June.

Pomeroy yesterday announced her departure from Davis as vice chancellor for human health services and dean of the medical school. In a telephone interview, she told the California Stem Cell Report that she is examining a “few select opportunities” to work at a national level on health reform and health policy issues.

Claire Pomeroy
UC Davis photo
Pomeroy, 57, will be spending time in Washington, D.C., working on health issues on behalf of the University of California during the transition period before she leaves her position in California.

Pomeroy came to UC Davis 10 years ago, shortly before the Golden State's stem cell agency was created in 2004. At that time, UC Davis had what she called a “fledgling” stem cell research effort. Today the school has chalked up $128 million in grants from the stem cell agency, ranking fifth among institutions funded by the agency.

She said that creation of the stem cell agency “catalyzed development of our program,” which she said has risen to “national prominence.”

Pomeroy's service on the stem cell agency board was also instrumental in attracting a $100 million grant from the Moore Foundation to start a new school of nursing at UC Davis in 2009. Through her service on the board, she met Ed Penhoet, who also served on the board and was one of the co-founders of Chiron and then president of the Moore Foundation. Subsequently, Penhoet called her for lunch to discuss her thoughts on nursing education, and developments moved on from there.

The $100 million commitment was the nation's largest grant for nursing education, according to the Moore Foundation.


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'The Knoepfler Award:' Recognizing Risk and Those Who Make a Difference

A UC Davis stem cell researcher-blogger has announced a “stem cell person of the year” award complete with a $1,000 cash prize that he is putting up himself.

Paul Knoepfler, who may be the only stem cell scientist in the U.S. actively blogging on the subject, said he has decided to put his money where his mouth is. 

Since announcing the contest in a Nov.13 blog item, Knoepfler has already received eight nominations, including one for a scientist. Three days after the item aappeared, UC Davis featured Knoepfler in a press release that included a video of Knoepfler explaining the effort.

Paul Knoepfler
UC Davis photo
He said he wanted to go beyond “old fashioned awards” given by “stodgy committees.” Knoepfler said he is seeking to recognize that stem cell research is “transcending the lab.”

The goal of the award, Knoepfler said, is “to advance the stem cell field and give credit to those who make a real difference.”

Knoepfler wrote,
“The criteria are that the person made a truly outstanding difference in the stem cell field for 2012. The winner could be a scientist, a patient advocate, someone in industry, a student, a physician…really anyone who has made the field better. For non-scientist nominees I’m particularly interested in those who took personal risks or gave of themselves to help others. For scientists I am looking for outstanding scientific achievement and in particular out-of-the-box thinking. Folks in any country are eligible.”
Deadline for nominations is Dec. 17. Self-nominations are permissible. Knoepfler plans to pick five finalists and interview them by phone. He also plans an online vote that he said  “may” influence his decision.

Complete details are available on Knoepfler's blog
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Monday, November 19, 2012

California Stem Cell Agency Blogs on Geron Clinical Trial

The California stem cell agency published an article online last week concerning the hESC clinical trial that Geron abandoned last year, dealing mainly with one of the participants in the program.

The piece was studiously non-committal about whether the $3 billion research program is likely to fund the trial once again, should BioTime, Inc., of Alameda, Ca., be successful in acquiring the assets of once was the first hESC clinical trial in the United States. The agency loaned Geron $25 million a few months before the company cancelled the trial.

Amy Adams, CIRM's communications manager, simply wrote,
“They (BioTime) would need to apply for a loan if they want CIRM to financially support the continued trial.”
The latest round of funding that BioTime could apply for has a deadline of Dec. 18 for letters of intent. In addition to a loan, a grant is also a possibility.

Adams focused on Katie Sharify, who was enrolled in the clinical trial shortly before Geron said it was dropping the effort for financial reasons. Adams interviewed Sharify before an audience of scientists.

Adams wrote,
“Katie told me that it would be impossible not to hope that a trial would help her, but that by the time she made the decision to participate she knew she was doing it to further science, not necessarily to further her own recovery. She told the audience, 'I was part of something that was bigger than me, and bigger than all of you.'”
Stem cell scientist Paul Knoepfler of UC Davis also wrote about the BioTime-Geron deal last week. Noting that Geron's decision a year ago left many “upset to put it mildly,” Knoepfler said the “idea of BioTime buying the Geron stem cell program is a great one that provides new hope on many levels.”


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Researcher Alert: Keeping Tabs on the Stem Cell Exchequer

The California stem cell agency has posted the dates for meetings of its board of directors for 2013 with most of the sessions scheduled for the San Francisco Bay Area.

One is expected to take place in San Diego in August, and another in Los Angeles 13 months from now. The other five are in Northern California. Not yet on the schedule is a board workshop in early January that will be open to the public.

Why is this of interest to researchers and others? The  board controls the purse strings to $3 billion for research grants and determines what areas are to be funded. Astute scientists would do well to take in the sessions. They offer insights into board thinking and opportunities to deal with the agency staff and directors on an informal basis. Only a handful of researchers – or less – attend the meetings on a regular basis, but have been well-served by the time spent. 
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Friday, November 16, 2012

BioTime Will Have to Compete for California Cash for Geron's Dormant Clinical Trial

The California stem cell agency said today it does not plan to reactivate the $25 million loan to assist in Geron's spinal injury clinical trial despite an impending deal that would turn the effort over to BioTime, Inc.

Kevin McCormack, senior director for public communications for the agency, said BioTime will have to compete in an upcoming award round if it wants to win California dollars.

Responding to a question from the California Stem Cell Report, McCormack said,
“That (earlier) loan was specific to Geron and when the trial was ended the loan ended too. Of course if Biotime and Geron do complete their deal then Biotime would be free to apply to us for a new disease team grant.”
McCormack later added that BioTime could also compete in other appropriate rounds, including the strategic partnership round just posted by CIRM. It provides for four awards of up to $15 million. Funding could come as early as October of next year. The strategic partnership round is a business-friendly effort that is aimed at attracting “industry engagement and investment.” The deadline for letters of intent is Dec. 18.

The stem cell agency made its $25 million loan to Geron in 2011 just a few months before the Menlo Park firm abandoned its human embryonic stem cell trial for financial reasons. (The full text of the loan agreement can be found here.) The company has repaid the loan with interest.

The company has tried to sell the assets associated with the clinical trial since last November. The only public interest that has surfaced has come from BioTime, Inc., of Alameda, Ca. Michael West, founder of Geron, is the CEO of BioTime. Tom Okarma, CEO of Geron from 1999 to 2011, is CEO of the BioTime subsidiary that would assume the clinical trial.

News from clinical trial is expected to be published soon, according to a story in the San Francisco Business Times by Ron Leuty. He quoted CIRM President Alan Trounson as saying that “some findings” from the trial would be published next month in a medical journal.

Geron's stock traded at $1.24 at the time of this writing today, up from $1.21 yesterday. BioTime's stock stood at $2.99, up from $2.97.


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Geron, BioTime Deal Moves Forward with Letter of Intent

Geron Corp., which once pioneered human embryonic stem cell research, is close to selling off its hESC business in a complicated deal involving two former CEOs of the company and BioTime, Inc., of Alameda, Ca.

The two publicly traded firms yesterday announced a “letter of intent” involving a transaction in which BioTime would acquire the assets of Geron's hESC clinical trial that the company suddenly abandoned last year. The firm also laid off 66 people, about 40 percent of its staff.

Abandonment of the program came only a few months after the $3 billion California stem cell agency loaned Geron $25 million to assist in the trial. The agency could restore the loan for the trial, but the Geron-BioTime announcement did not mention that possibility. The California Stem Cell Report has asked the agency for comment.

The letter of intent came one year and one day after Geron announced that it was giving up the hESC spinal injury trial because of financial reasons. The Menlo Park, Ca., firm has been trying to sell its hESC assets since then. BioTime has been the only firm to express public interest. The Geron trial was the first hESC trial approved by the FDA.

The proposed deal involves Michael West, who founded Geron and is now head of Biotime, and Tom Okarma, who was CEO of Geron from 1999 to 2011. Okarma is now head of BioTime Acquisition Corp.,(BAC) a subsidiary of BioTime.


Here is how yesterday's press release described the deal in which BioTime would acquire Geron's “intellectual property and other assets related to Geron’s discontinued human embryonic stem cell programs.”
“ BioTime would contribute to BAC $5 million in cash, $30 million of BioTime common shares, warrants to purchase eight (8) million common shares of BioTime at a pre-specified price, rights to use certain human embryonic stem cell lines, and minority stakes in two of BioTime’s subsidiaries. In addition, a private investor would invest $5 million in cash in BAC. 
“Following consummation of the potential transaction, Geron stockholders would receive shares representing 21.4% of the common stock of BAC as well as warrants to purchase 8 million shares of BioTime common stock at a pre-specified price. BioTime would own approximately 71.6%, and a private investor would own approximately 7.0% of the outstanding BAC common stock for their $5 million investment. BioTime would also receive warrants that would enable it to increase its ownership in BAC by approximately 2%, which would reduce the Geron stockholders’ ownership in BAC to 19.2%. BAC would also be committed to pay to Geron royalties on the sale of products that are commercialized in reliance upon Geron patents acquired by BAC.”
Prior to release of the letter of intent, an article earlier this week by Vickie Brower in The Scientist said,
“The offer couldn’t come at a better time for Geron, which in recent months has started to feel pressure from its shareholders to boost its stock price and move products through the pipeline. Since last November, when the company announced its decision to shutter its hESC and regenerative medicine business and funnel its resources into developing telomerase-related treatments for cancer, the stock price has dropped more than 50 percent to $1.30 a share. Geron claimed the move was simply to save money, but many took the decision—which effectively terminated a clinical trial of an hESC treatment for spinal cord injury—as a setback for the entire field." 
News coverage of yesterday's announcement was light. Here is a link to a piece by Ryan McBride on Fierce Biotech.

Geron's stock price closed at $1.21 yesterday and rose to $1.24 in after hours trading. BioTime closed at $2.97. No after hours trading was reported for BioTime.

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