Correction

The arthritis spending item yesterday incorrectly stated that the California stem cell agency was spending $17 million on arthritis research. The correct figure is $19.5 million.  The lower figure was based on erroneous numbers on the agency's "arthritis fact sheet," which did not include a $2.3 million award to Schultz in March.

Solid Hook-Up: California Stem Cell Agency and Calibr Connection

Highlights

Creating pathway to clinic

The Calibr approach

Problematic pharma-academic ties

As of today, the California stem cell agency has a $4 million hook into a San Diego research enterprise that also has ties to a glittering array of partners, ranging from Merck to Bristol-Myers Squibb. 

The connections fit with the state stem cell agency’s new goal of creating a clear pathway from the basic research bench to the use of stem cell cures in clinics for millions of people.

The signal event came routinely and quickly this morning when directors of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, approved a $1.7 million award.

The cash is going to the California Institute for Biomedical Research (Calibr) and its director, Peter Schultz.

The funds will be used for pushing into clinical trials a treatment that would -- for the first time -- modify the progress of osteoarthritis, which afflicts 27 million Americans. The therapy could also be used to treat damaged cartilage in knees and elbows.

CIRM has now invested $10 million in Schultz, a reknown chemist and biotech entrepreneuer. Six million of that went for research that was performed at Scripps. All of the funds involve the proposed arthritis therapy. Including today’s award to Schultz and funds to other researchers, the agency has now handed out $19.5 million to find a therapy for arthritis.

Schultz founded Calibr three years ago with up to $90 million, promised over seven years by Merck. The Big Pharma firm has first refusal rights on treatments developed by Calibr. If Merck passes, then other enterprises can make an offer. Calibr has additional partnerships, including a $28.9 million, five-year relationship with the Gates Foundation.

Peter Schultz, catching a big one

Schultz says “our mission is a little bit arrogant.” In a lengthy piece in March by Bradley Fikes of San Diego Union-Tribune, Schultz said Calibr has “a very broad spectrum of interest and we hope to have a significant impact on a number of diseases."

Fikes wrote,  

"'There are a lot of discoveries being made in life science, and many of these discoveries are made in academic institutions and basic research institutions,’ Schultz said. ‘The process of translating those discoveries into new medicines has become somewhat difficult.’

“These institutions have trouble collaborating with big pharma because of differences in culture and regulatory challenges of for-profit and not-for-profit collaboration.

"'That's left the universities try to do drug discovery themselves,’ Schultz said. ‘The problem there is they don't have the knowledge, experience or even the processes to do drug discovery, which is a lot different than a cottage industry approach to basic research."

Fikes continued,

“Meanwhile, big pharma is becoming more risk-averse, looking for validated drug targets and in-licensing compounds. That makes pharma collaboration with basic research centers even more problematical, Schultz said.

"’We have to come up with other ways to really facilitate and accelerate the translation of new research into new medicines,’ Schultz said. ‘Universities are trying to set up their own drug discovery units. Scripps has done that in Florida, Vanderbilt, we see Cornell, Rockefeller and Sloan-Kettering teaming up to do that. They're building something from scratch, and usually without having the experience of having been there and done that. And in some cases what they wind up doing is hiring a lot of people from pharma industry and recreating a pharma-like process.’"

Calibr has 110 employees, Fikes reported, including 60 postdocs. Its annual operating budget for 50 projects totals $25 million. Calibr is still busy hiring with seven positions open on its Web site as of this afternoon.

California Stem Cell Agency Awards $1.7 Million to Help Treat Arthritis

Directors of the California stem cell agency, as expected, this morning approved $1.7 million to help push an arthritis treatment into clinical trials. The funds went to Peter Schultz, director of the California Institute for Biomedical Research. We will have more details later today.

California Spending More than $19 Million on Search for Stem Cell Arthritis Therapy

Stem cell agency summary of Peter Schultz proposal

Highlights
First in class therapy
Avoids risks, costs
Uses drug-like kartogenin
The California stem cell agency tomorrow is set to boost its spending on arthritis to $19.5 million with a new grant to a San Diego researcher who is preparing a clinical trial for his possible therapy.

The agency’s governing board is all but certain to approve a $1.7 million award to Peter Schultz of the Scripps Research Institute in La Jolla on top of the $6 million he has already received.

Meeting behind closed doors, the agency’s blue-ribbon scientific reviewers earlier this summer approved the application on a 12-0 vote. The agency board almost never overturns a positive decision by its reviewers.

The review summary said the proposed therapy would be “first in class regenerative medicine” for osteoarthritis as well as cartilage injury. Currently no disease-modifying drugs are approved for clinical treatment of arthritis, which afflicts 27 million people in the United States. The award is to assist in preparation for a federally approved clinical trial. 

Peter Schultz -- Scripps photo

Schultz, who has close ties to Merck and who is also director of the California Institute for Biomedical Research, laid out some details of his approach in an earlier progress report to the stem cell agency.

He said,

“Because limited joints are affected in most (osteoarthritis) patients, intra-articular drug injection is an attractive treatment approach that allows high local drug concentration with limited systemic exposure. Targeting resident stem cells pharmacologically also avoids the risks and costs associated with cell-based approaches.”

 Schultz continued,

“Cartilage contains resident mesenchymal stem cells (MSCs) that can be differentiated in vitro to form chondrocytes. This observation suggests that intra-articular injection of a small molecule that promotes chondrogenesis in vivo will preserve and regenerate cartilage in OA-affected joints. Using an image-based screen, we identified a drug-like small molecule, kartogenin (KGN), that promotes efficient and selective chondrocyte differentiation from MSCs in vitro. Intra-articular injection of KGN also shows beneficial effects in surgery-induced acute and enzyme-induced chronic cartilage injury models in rodents, as well as positive effects in incapacitance pain models.”

The agency has already pumped in around $17 million for arthritis research, including funds given earlier to Schultz.

As usual, the award tomorrow involves an institution that has a representative on the agency board. About 88 percent of the money that the agency has handed out since 2005 -- $1.9 billion -- has gone to institutions that have ties to agency directors, according to calculations by the California Stem Cell Report.

The stem cell agency does not identify the winning applicants for awards until after the board acts. However, based on information on the agency's Web site, the California Stem Cell Report was able to verify that Schultz was the applicant up for approval tomorrow.

Tomorrow’s teleconference meeting is scheduled for only one hour beginning at 9 a.m.. The main session will be in San Francisco, which has another location there as well. Other locations where the public can participate include Irvine, San Diego, Napa, Redwood City, two in Sacramento, Los Gatos, San Francisco, Elk Grove, Beverly Hills, Fresno, Los Angeles, Cambridge, Ma., and Ballard, Ca., in Santa Barbara County. Specific addresses can be found on the agenda.

The public can also make comments  on any issue during the board session.

(Editor's note: The figures on CIRM's total spending for arthritis have been increased from an earlier version of this story. The previous figures were based on erroneous numbers on the agency's "arthritis fact sheet," which did not include a $2.3 million award to Schultz in March.)

'Terrorized' -- The LA Times on the StemExpress Story

Highlights
Juggling threats to business
Realistic response by StemExpress

The Los Angeles Times today said anti-abortion activists have  “terrorized and harassed” a small California stem cell/human tissue firm in a heated, national campaign that threatens important medical research.

Pulitzer Prize-winning columnist Michael Hiltzik took on the issue in a column published this morning.

The piece began:

“Last week a small California company that provides human blood, cells and tissues to research scientists bailed on one of its partners, Planned Parenthood.

“Placerville, Ca.-based StemExpress, which had worked with Planned Parenthood to distribute fetal cells and tissues following abortions at the organization's clinics -- with the full consent of the patients undergoing the procedure -- ended its relationship with the healthcare provider ‘due to the increased questions that have arisen over the past few weeks.’ “These aren't questions about the legality or ethics of Planned Parenthood's activities, which haven't been legitimately challenged. They're questions about whether the organization's activities can survive a full-scale political onslaught.”

The headline on the article read:

“A terrorized and harassed corporate partner abandons Planned Parenthood”

 Hiltzik continued,

“StemExpress isn't terminating its relationship with Planned Parenthood because it thinks the relationship led it to do anything wrong. The firm doesn't think Planned Parenthood has done anything wrong, either. We know this because the company says so in a lawsuit it filed last month against the Center for Medical Progress. That's the anti-abortion group that has been releasing edited undercover videos of meetings it conducted, apparently under false pretenses, with Planned Parenthood officials and others.”

He wrote,

“One might think of StemExpress' action as cowardly. But it's more fair to regard it as realistic. In any controversy involving private enterprise, corporate self-interest is the soft underbelly for attack, because economic interest almost always trumps moral steadfastness; the smaller the company the less its defenses against bad publicity, no matter how ill-informed.”

Hiltzik said,

“Among the most disturbing aspects of this affair is its effect on the legal and often necessary use of fetal tissue in biological research. It's true that advances in science have made this less important than it used to be, but it's also true that it's still needed in work toward cures of muscular dystrophy, diabetes, degenerative eye disease and other conditions. CMP's campaign threatens this whole line of inquiry, because any business or nonprofit that serves these researchers will have to ask whether it's worth trying to resist political pressure or the threat to employees' safety.”

For more on StemExpress' problems, see here.

Headquarters Move by California Stem Cell Agency 'Disappointing' to San Francisco

The San Francisco Chronicle today picked up the story about how “a simple state agency” is moving its $3 billion operation east from San Francisco across the Bay to Oakland.

The newspaper carried the article by Victoria Colliver on its front page, one of the few times that news about the state stem cell agency has made such a splash in its hometown paper during the last 10 years. The story followed yesterday's piece on the California Stem Cell Report, which carried the first published details about the move.

Most of what the Chronicle reported was familiar to our readers but Colliver also had this from Kevin McCormack, senior director for communications for the agency.

“The lease is up now, and this is now one of the hardest real estate markets in the country. We’re a simple state agency, and we don’t have that kind of money. ... San Francisco is just unaffordable to us.”

McCormack said it would have cost the agency $1.5 million to pay for the equivalent space (20,000 square feet) that it now has in San Francisco. Instead, it found a home in Oakland with 17,000 square feet for $697,560 a year.  The agency has about 55 employees.

Colliver’s story began by saying that the stem cell agency is “the latest victim of San Francisco’s ski-high rents.”

The Chronicle quoted Todd Rufo, head of economic development for San Francisco, as saying, “…(W)e’re disappointed to see them go….”

No coverage has yet surfaced in Oakland area media outlets, according to a Google search this morning.

Legal Setback for California Stem Cell Business Snared in Abortion Flap

A California stem cell/human tissue firm appears to be losing its battle to halt damaging videos that have entangled it in an emotional national controversy about abortion, the Washington Post reported today.

An opinion piece by UCLA law professor Eugene Volokh said that the Los Angeles judge in the case “seems to have been persuaded” by the anti-abortion activists to refrain from blocking further distribution of the videos involving StemExpress LLC of Placerville.

Quoting from the judge’s tentative ruling last week, Volokh noted that the First Amendment issues in the case apparently are carrying the day even if the activists violated state law in making the surreptitious videos. The Washington Post piece provided a link to the response by the Center for Medical Progress, an Irvine organization behind the videos. ­­­­­

California Stem Cell Agency Saying So Long to San Francisco

The new HQ location for the California stem cell agency

The city of Oakland does not have the same snap and sizzle as San Francisco, but it will soon have something that the famed city-by-the-bay will not have – the headquarters of an internationally known, $3 billion, stem cell research agency.

California’s taxpayer-financed program, which is arguably the largest, single source of stem cell research funding in the world, is leaving San Francisco this fall and moving across the bay to the sunnier and cheaper climes of Oakland.

The reason is that the agency is no longer the beneficiary of free space in San Francisco and can’t afford to pay sky-high rent to stay there.

Red bubble shows location of new CIRM HQ -- Google map

The new address for the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, will be 1999 Harrison St. in Oakland.  CIRM will be housed on the 15th and 16th floors of a granite-clad building overlooking Lake Merritt in the downtown area.

In San Francisco, the agency’s neighbors included Happy Donuts, which also sold Louisiana fried chicken, and the San Francisco Giants baseball park.  In Oakland, its neighbors will include the FBI and Cerexa, Inc., a biotech firm owned by Forest Laboratories of New York. If CIRM workers are missing Happy Donuts fare, Oakland's famous Chicken&Waffles restaurant is only 15 minutes away on the bus.

The stem cell agency enjoyed its rent free location as the result of a bidding war in 2005 among cities in California to acquire the agency headquarters. San Francisco offered a package that it calculated at $18­­­­­­­ million. It also helped San Francisco that Bob Klein, the first chairman of the agency, lived on the San Francisco peninsula.

The agency and its auditor estimate that CIRM saved $12 million in rent and related benefits during the 10 years it has been in San Francisco. That money, however, will ultimately be spent on research or agency expenses.

That includes the rent for the new digs that will run $697,560 annually. The base rate for the 17,097 square feet is $3.40 a foot. The agency will have 14,411 square feet on the 16th floor of the 27-story building and 2,686 on the 15th. 

In response to a query, Kevin McCormack, CIRM’s senior director for communications, said,

“The term for the 16th floor is five years; the term on the 15th floor is three years, with an option to extend by two years to be coterminous with the term on the 16th floor.  This will provide CIRM with the flexibility to reduce its space and rent burden, depending upon the circumstances.”

The agency is expected to run out of cash for new awards in less than five years but will have ongoing functions related to its existing awards.

Costs for tenant improvements are still being calculated along with costs for the move.

Under the San Francisco lease, the owner provided free parking, a significant benefit for the agency employees, which number about 55.  Parking can run to $15 to $20 a day in the agency's current neighborhood, according to sanfrancisco.bestparking.com.

In Oakland, employees will have to pay for their own parking, but the agency is looking into government assistance programs. The location is near a BART station, a mass transit overhead rail system that runs through much of the San Francisco Bay Area.

Over the years, Oakland has presented a changing face to the public. In World War II, it was part of what was described as a “second gold rush” as the result of defense plant operations. In 1966 , the city was the headquarters of the Black Panthers, whose co-founder, Huey Newton, attended high school there. Today Oakland is involved in a wave of gentrification that has created tension­­ within the community.

It may be fitting for the agency to return to what is known as the East Bay area in California. Its first, temporary headquarter was located in Emeryville, just three miles up the road from its new space. 

Text of StemExpress Statement on Cutting Ties to Planned Parenthood

Here is the text of the full statement from StemExpress as provided to the California Stem Cell Report by a spokesman for the firm. 

"StemExpress statement Regarding Termination of Agreements With Planned Parenthood

"StemExpress at its core is a small life sciences company committed to accelerating research, advancing medicine, and saving lives. We partner with organizations also seeking to help researchers find solutions to some of life's most significant medical conditions and diseases. Our commitment to quality defines us and is demanded by our customers in the research community. 

"We value our various partnerships but, due to the increased questions that have arisen over the past few weeks, we feel it prudent to terminate activities with Planned Parenthood. While we value our business relationship with Planned Parenthood, that work represents a small percentage of our overall business activity and we must focus our limited resources on resolving these inquiries.

"StemExpress works tirelessly to accelerate the speed of helping patients globally: 7.6 million people die of cancer each year, another 7.4 million of heart disease, over 4.6 million from lung cancer, AIDS and diabetes and every 12 minutes another name is added to the national transplant waiting list. These numbers drive our work and the research community. StemExpress looks forward to the swift resolution of all inquiries and audits so we can focus our full attention on helping the medical and research community improve and save lives."

California's StemExpress Cuts Links with Planned Parenthood in Anti-Abortion Flap

A California stem cell/human tissue firm has severed its ties with Planned Parenthood in the wake of a national, anti-abortion controversy, the Politico Web site reported late today.

Politico writer Jennifer Haberkorn cited a statement from StemExpress LLC of Placerville, which said,

“We value our various partnerships but, due to the increased questions that have arisen over the past few weeks, we feel it prudent to terminate activities with Planned Parenthood. While we value our business relationship with Planned Parenthood, that work represents a small percentage of our overall business activity and we must focus our limited resources on resolving these inquiries.”

The statement has not been posted on the company’s Web site as of this writing.  (Shortly after this item was published, a spokesman released the text of its statement, which can be found here.)

The company has said in court that it has suffered damage and its executives have been threatened with violence as a result of Internet videos that were made surreptitiously by anti-abortion activists. The activists used fake names and a fake company to gain access to Planned Parenthood officials. StemExpress was identified as one of the purchasers of fetal tissue from Planned Parenthood.

Investigations into the company and Planned Parenthood have been launched by the Senate and the House. The issue has come up in the 2016 presidential race. The U.S. Department of Justice and the California attorney general are looking into whether privacy laws were violated by the anti-abortion activists.

The company has been vilified on the Internet. The latest posting involved a video of a former employee of StemExpress, Holly O’Donnell, who said that “she once saw another technician appear to obtain fetal tissue without a patient’s consent,” Politico reported. StemExpress “unequivocally” denied the claim two days ago.

The firm said,

“Like all of their previous material, (the) video by (the activists) is deceptively edited and falsely worded to suggest impropriety or illegality where none exists. (Their) continued efforts to malign StemExpress—a life-sciences company that predominantly supplies adult cells, blood and tissue to the nation’s leading researchers—will only serve to slow the pace of life-saving medical research aimed at curing disease and extending quality of life for millions of Americans.”

Earlier this week, the activists lost a bid to overturn a temporary restraining order against them. StemExpress said they also “refused to produce witnesses for depositions or respond to document requests previously ordered” by the Los Angeles superior court.

A California Stem Cell Clinical Trial, Eye Disease and Willie Brown

The $3 billion California stem cell agency today reported the kickoff of treatment in another clinical trial and managed to wrap a famous California politician into the story as well.

The research in the trial has been supported by the state at a nominal amount of $19 million. The cost to taxpayers roughly doubles, however, because of interest on the funds, which are borrowed by the state.

Willie Brown

The politician is Willie Brown, former mayor of San Francisco and former speaker of the California Assembly, the second most powerful position in state government, certainly when Brown was in the post.

Brown, now 81, has retinitis pigmentosa(RP), the disease that is targeted by the clinical trial.

­­­­­­­­

Writing on the agency’s Stem Cellar blog, Kevin McCormack, senior director of communications for the agency, said,

“The trial is the work of Dr. Henry Klassen at the University of California, Irvine (UCI). Dr. Klassen just announced the treatment of their first four patients, giving them stem cells that hopefully will slow down or even reverse the progression of RP.”

McCormack continued,

“The patients were each given a single injection of retinal progenitor cells. It’s hoped these cells will help protect the photoreceptors in the retina that have not yet been damaged by RP, and even revive those that have become impaired but not yet destroyed by the disease. 

“The trial will enroll 16 patients in this Phase 1 trial. They will all get a single injection of retinal cells into the eye most affected by the disease. After that, they’ll be followed for 12 months to make sure that the therapy is safe and to see if it has any beneficial effects on vision in the treated eye, compared to the untreated one.”

McCormack said that Klassen's work offers hope to all those afflicted by disease, including the former mayor. Brown is not believed to be in the trial, but identities of patients are not usually revealed. He has said very little publicly about his condition, but recently talked about it during a speech at a conference held by the Everylife Foundation for Rare Diseases.

McCormack reported,

“He described how people thought he was being rude because he would walk by them on the streets and not say hello. The truth is, he couldn’t see them.

“He was famous for driving fancy cars like Bentleys, Maseratis and Ferraris. When he stopped doing that, he said, ‘people thought I was broke because I no longer had expensive cars.’ The truth is his vision was too poor for him to drive.”­­

Brown sponsored a stem cell symposium in 2004 backing the ballot initiative that created the $3 billion stem cell agency. The news media have not reported any recent comments by him on the agency’s work, according to a Google search.

Here are links to the agency’s press release on the trial, an earlier progress report on Klassen’s research and the NIH clinical trial site with enrollment information for the trial.

California's Stem Cell Research Performance; Agency Schedules More Awards

Overview of applications and funding outcomes in CIRM 2.0 as of July 23 -- CIRM chart

Highlights

One contract signed

17 applications received

Demand leveling off

Mills says 'metrics' good

The governing board of the $3 billion California stem cell agency is scheduled to meet on Aug. 20 to give away more millions for late stage preclinical research as part of its ambitious and "radical" overhaul of its funding effort.

The one-hour teleconference meeting will have its­­­ main location in San Francisco. Seven other offsite locations are also available for the public, ranging from Napa to San Diego.

The only item on the agenda is consideration of an unspecified number applications for funding work leading up to a clinical trial. (See here for the request for proposals -- PA15-01.)

The number of applications to be considered and their review summaries are not yet available on the Web site of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. However, they are part of what CIRM President Randy Mills calls CIRM 2.0, what he terms a “radical” change in the way the agency handles applications.

Deadlines for applications in this late-stage research round, funded at $100 million for this fiscal year, come up at the end of every month. The goal is to generate better applications and speed the cash to researchers.

The program began Jan. 1. So far, only one contract has been signed for a research project, Mills reported to the CIRM governing board on July 23. ­­­ However, four have been approved by the CIRM governing board out of 17 that applied between January and June. 

Mills told the board last month,

“The demand is leveling down more closely to what we thought it would be. So in May we received three applications, in June we received two applications.

“The review team was very worried in April when we had five applications because that's more than we actually anticipated we would have, but it seems to be normalizing down around the two or three a month area which is closer to what we had predicted.

 “One other thing I want to point out here -- which was neat in April -- is we sent three programs for what we call budget review. And that's before we send these things to the grants working group for actual scientific adjudication, we send them for external budget review to make sure that the budgets are appropriate for the scope of work being offered.

“We actually had one fail. And I like that because that says that system is working. And if something is going to go through the process and have a budget that's not justifiable, we're able to catch it, and we're able to kick it out. In this case we made them go back and think through their budget a little more closely.

“With all that said, it seems to be working well from a metrics standpoint. We're very pleased. Only in January did we have the one delay, and we haven't had an off mark since.”

In addition to San Francisco, Napa and San Diego, locations where the public can participate in the meeting and lobby for or against a specific research application can be found in Irvine, Redwood City, Sacramento and Los Gatos. Specific addresses can be found on the agenda.

Skirting the Courts to Air Anti-Abortion Videos Attacking California Human Tissue Firm

Conservative organizations are exploring ways to sidestep judicial actions that have put a halt to some of the anti-abortion videos dogging a California stem cell/human tissue firm.

One proposal calls for Congressional committees to place the videos on the public record as a result of a Congressional request. The argument goes that the judges cannot prevent a Congressional hearing at which the videos are presented.

The company involved is StemExpress of Placerville, which was identified in videos taken surreptitiously by anti-abortion activists who used false names and a fake company to win the confidence of Planned Parenthood officials.

Both Senate and House committees are looking into the videos, deploring what was said about obtaining human tissue by the Planned Parenthood employees. Federal and state officials are looking into possible criminal violations by the anti-abortion activists who failed to get legal consent for recording the comments by Planned Parenthood officials.

StemExpress has won a temporary restraining order against further distribution of the videos, arguing that the firm has already been harmed and could be irreparably damaged. The firm also said violence has been threatened against company employees as a result of the videos.

Lawyers with the Heritage Foundation, Hans von Spakovsky and Elizabeth Slattery, wrote last week about the order in an item headlined,

“How Lawmakers Can Beat Planned Parenthood’s Stalling Tactics.”

They said, 

“No federal or state judge has the authority to prevent a congressional committee from holding a hearing at which witnesses … testify about their experiences or where the committee presents evidence it has obtained such as the undercover videos, which could also be posted on the committee’s website.” 

The WND website today picked up the lawyers’ suggestion. Bob Unruh wrote that the issue will escalate despite the current Congressional break. He quoted the Family Research Council as saying,

“The political pressure cooker will only get hotter back home when members hear from unhappy voters firsthand.”

The Congressional ploy would additionally­­ involve the National Abortion Federation, which has also won a restraining order on the videos. Hearings on both temporary restraining orders are scheduled for later this month in San Francisco and Los Angeles.

In a related development, another California tissue firm, Advanced Bioscience Resources of Alameda, surfaced on the Politico Web site in connection with the controversy.

Jennifer Haberkorn and Brett Norman wrote,

“One of the companies (Advanced Bioscience)­­­­­­­­­­­­­­­­­­­­­­ identified as a fetal tissue supplier in sting videos of Planned Parenthood counts two federal health agencies among its customers, earning at least $300,000 for material used in research of treatments for HIV and eye disease….” 

In addition to a House committee, the chairman of the Senate Judiciary Committee has requested information from StemExpress, Advanced Biosciences and Novogenix Laboratories, LLC, of Los Angeles, about their policies, practices and revenue.

Three California Human Tissue Firms Targeted by House Committee

A Republican-dominated Congressional committee today zeroed in on three California human tissue firms entangled in the national flap over abortion and the Planned Parenthood Association.

All three were sent letters today seeking to determine whether the companies were in compliance with laws dealing with the distribution of fetal material.  They were given a deadline of Aug. 21 to provide a briefing to the House Energy and Commerce Committee.

Questions include procedures involving informed consent from donors, fees for fetal tissue, the amount of revenue from fetal tissues in 2014 along with policies and practices for handling fetal tissue.

StemExpress of Placerville, east of Sacramento, and its president Cate Dyer, received one of the letters. The stem cell and tissue firm has been much in the news about the controversy. The flap was triggered by Internet videos with Planned Parenthood officials that were taped surreptitiously by anti-abortion activists using false identities and false company credentials.

Both the federal and California departments of justice are investigating whether the anti-abortion activists violated the law when they made the undercover videos. 

The other two letters went to Linda Tracy, president of Advanced Bioscience Resources, Inc., of Alameda, and Ben Van Handel, executive director of Novogenix Laboratories, LLC, of Los Angeles. (See the letter to Advanced here, the letter to Novogenix here.)

The letters to StemExpress and the Advanced Bioscience referred to a July 27, New York Times article that included them. The House committee letter quoted from the piece.

The article by Denise Grady and Nicolaus St. Fleur said, 

"(F)etal tissue is a uniquely rich source of the stem cells that give rise to tissues and organs, and that studying how they develop can provide clues about how to grow replacements for parts of the body that have failed.

“'Think of fetal tissue as a kind of instruction booklet,' said Sheldon Miller, the scientific director of the intramural research program at the National Eye Institute.

"Stem cells derived from adult tissue may eventually replace fetal ones, researchers say, but the science is not there yet."

All three companies were told by the House committee,

“Under the NIH Revitalization Act of 1993, it is "unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the
transfer affects interstate commerce." While this provision prohibits the sale or purchase of fetal
tissue itself, the term "valuable consideration" does not include reasonable payments associated
with the transportation, implantation, processing, preservation, quality control, or storage of
human fetal tissue. As the committee with legislative jurisdiction over the NIH Revitalization
Act of 1993, we have an oversight responsibility and interest in determining whether there is
adequate compliance with the law, and/or whether the law is adequately meeting ethical and
moral concerns." 

A Reuters story said that none of the companies has responded to a request for comment.

Text of Court Documents in the StemExpress-Daleiden Case

Coming up on Aug. 19 in Los Angeles will be the next court hearing on the temporary restraining order obtained by StemExpress against David Daleiden. (See here for a related story.)

Here is the text of the July 2015 request by StemExpress for the order.

  StemExpress Filing for Restraining Order Against David Dalaiden by DavidJensen

Here is the actual text of order that was granted.

   Temporary Restraining Order Obtained by StemExpress Against David Daleiden by DavidJensen

California Stem Cell Firm Fighting Anti-abortion Onslaught

Protest this week at StemExpress headquarters -- Channel 10 image

Highlights: 

Controversy threatens to embroil stem cell research 

Trump jumps in 

Strangulation threat

Loss of business

A small stem cell/tissue firm in California’s Gold Rush country is battling hard as it fears “irreparable damage” from a wave of vitriol and harmful publicity about its business.

The firm is StemExpress, LLC, of Placerville, which has become entangled in a national, abortion ruckus that could escalate and spill over more broadly into stem cell research across the country.  

David Daleiden
CMP photo

In fact, the key anti-abortion player behind the controversy, David Daleiden, said he received the inspiration for his campaign when he attended a stem cell conference some years ago.

The latest flap started three weeks ago and shows no signs of abating. Daleiden and his backers have targeted Planned Parenthood, which Daleiden says is “trafficking (in) and selling baby parts for profit.” StemExpress, which supplies stem cells and human tissue to researchers, surfaced in the secretly made videos as a client of Planned Parenthood.

The controversy has entered the 2016 presidential race, triggered Congressional investigations, generated a major story out of the U.S. Senate yesterday and could play a role in a possible government shutdown come October.

The company says it will pursue “all available legal remedies” against Daleiden and his Sacramento-based Center for Medical Progress (CMP). On July 28, StemExpress was granted a temporary restraining order against release of further videos. It said in its court filing that “irreparable damage” could result, including violence against the firm and its executives. (See here for the full text of the filings.)

A story later in the San Francisco Chronicle said,  

Cate Dyer -- StemExpress photo

“After the videos were released, an anonymous Internet post disclosed the address of StemExpress’ chief executive (Cate Dyer) and said the executive should be strangled with piano wire….”

StemExpress said that release of more videos “will draw StemExpress and Dyer deeper into the vortex of public animosity stirred up by CMP’s crusade to brand everyone associated with Planned Parenthood as evil criminals, which will not only have (and already has had) a detrimental impact on StemExpress’s business reputation and relationships, but more importantly, it presents a real threat of danger to Dyer’s personal safety.”

StemExpress has lost at least one customer, Colorado State University. But more of the firm's wide-ranging clients are likely to be rethinking their connection because of the controversy.

StemExpress said in a court filing that its customers include nearly every major medical research institution in the country, major pharmaceutical companies, medical schools, overseas firms and federal agencies.

Headlines involving StemExpress have rattled around cyberspace for the last few weeks. A search this afternoon of  Google News using the term “stemexpress” turned up 61,400 results. They included such headlines as:

“Bombshell: Investigators says StemExpress bought intact dead babies from Planned Parenthood.”

“Gruesome video reveals how a lab technician was recruited to draw blood; next thing she knew she was handling the limbs of an aborted baby”

Yesterday, the company was the target of a protest at its headquarters by demonstrators who told it to “get Stem out of Hangtown,” the Gold Rush name for Placerville.

In the company's court filings,  it said that Daileden used a fake named (Robert Sarkis) and pretended to work for a fake company, BioMax Procurement Services, in order to meet privately with Planned Parenthood officials.

The company said the recordings were “a clear violation of California’s Invasion of Privacy Act, which criminalizes the non-consensual recording of confidential communications.”

The company noted that the U.S. Department of Justice and the California attorney general, Kamala Harris, have both launched criminal investigations into the matter.  

Yesterday the company released a statement that said,

“Ninety percent of our work is with adult, healthy, living donors and 100% of our samples are collected according to the highest ethical standards and in strict adherence to the law.  StemExpress has never requested nor received an intact fetus.

"StemExpress performs extensive work to test, isolate and purify the donated cells so that researchers can use them to help find cures and treatments for life’s significant medical conditions. It is for this work that we are paid.

"We would all benefit from a dialogue about how rare and important human materials are collected, how stem cell research works and the incredible power of regenerative medicine to improve the quality of life of so many people stricken with disease."

Bits and pieces have surfaced on the Internet about Daileden from a variety of sources. He grew up in Davis, about 57 miles west of StemExpress' headquarters.  

Patti Armstrong of the National Catholic Register reported on July 22, 

“It was while majoring in government at Claremont McKenna College in California that Daleiden received his first hint that the abortion industry was selling parts from aborted babies.

“I was working as a research assistant and attended a stem-cell conference as part of my job,” he said. “The presenter mentioned using cells from an aborted baby for research. That got my attention. I thought, ‘Wait a minute — what?’” 

Armstrong reported that Daleiden was prepped for his undercover work by Theresa Deisher, who holds a Ph.D. from Stanford and is "president of Sound Choice Pharmaceutical Institute and CEO of AVM Biotechnology; both (Seattle) companies have a mission to end the use of aborted babies in biomedical research."

No. 2 Exec at Salk Institute Leaving, Move Follows Retirement of President

Another top executive at the Salk Institute is leaving under circumstances that indicate that the move is not entirely voluntary, the San Diego Union-Tribune is reporting.

Left to right, Irwin Jacobs, chair of Salk
 board; William Brody, president; Marsha
Chandler, executive vice president
Salk photo

She is Marsha Chandler, who was executive vice president and chief operating officer of the La Jolla, Ca., enterprise and who also once served as a director of the $3 billion California stem cell agency.

Gary Robbins reported her departure effective Aug. 31, saying that Salk released a statement that “suggests that Chandler's exit was not voluntary.”

The statement said:

"In order to provide the future Salk president with the greatest flexibility to determine the institute’s ideal executive management structure going forward, the executive committee of the board of trustees and the institute’s leadership have decided to restructure the executive team. Therefore, with respect to this decision, Marsha Chandler will be leaving…”

William Brody, president of Salk, announced last week that he would be leaving at the end of the year.

Robbins wrote,

“Chandler, 70, helped Brody to roughly triple the institute's endowment to $370 million and to help recruit a greater mix of scientists at the Salk, whose basic research has led to drugs to treat cancer, and improved treatments in diabetes, inflammation and obesity.”

Chandler served on the stem cell agency board from 2007 to 2009. She was replaced on the board by Brody, who left the position in 2012. Since then Salk has had no representative on the 29-member panel. Nearly all of the institutions that receive awards from the agency have representatives on the agency board.

'Best of Times, Worst of Times' -- A Tale for Stem Cell Fans

Highlights:

Sinking stock prices vs. $40 billion market

Profits drive therapies

Test for the California stem cell agency

During the past week, followers of the stem cell world have been treated to sharply contrasting perspectives on the likely success of therapies involving regenerative medicine.

One perspective was bleak; the other robustly optimistic.

One borrowed slightly from the “Tale of Two Cities,” with a headline that said “Tale of seven stem cell stock woes….”

The other carried a headline that said “global stem cell market predicted to reach $40 billion in five years….”

One was a story about hard-eyed investors backing away from stem cell research. The other was about a bright, near-term future for the field.

Don Gibbons, chief communications officer at California’s stem cell agency, wrote about that bright global market on his agency’s blog. He said that the $40 billion figure was generated by the worldwide consulting firm Frost and Sullivan, which was promoting its study of the field. The 2014 report is going for as much as $7,500, a price tag that helps illustrate one of the features of the stem cell field: It needs a lot of cash.

Indeed, Gibbons noted that Frost and Sullivan cautioned that funding for early stage, clinical stem cell work is not abundant.

Which brings us to Paul Knoepfler’s tale of stem cell stock “woe.” He is a stem cell researcher and blogger at UC Davis, which has benefited mightily from cash from the $3 billion California stem cell agency.

He wrote,

“Lately, stem cell companies have not been doing so well financially to put it mildly and their stock prices have generally been going down, down, and down further. A lower stock price and market capitalization are not just a headache for investors and bad for the companies, but they also strongly interfere with the progress of the clinical science.”

And he asked,

“To be blunt, why are their stocks doing so miserably?”

Knoepfler did not really attempt to answer that question. However, it is clear that stem cell stock prices are down because nobody wants to buy them. The reason? Investors do not expect to make money any time soon by purchasing shares in those firms, which struggle perennially to raise cash.

That is a financial reality that the $3 billion California stem cell agency needs to fully integrate into its plans for spending its last $800 million, which is slated to run out in less than five years.

The agency’s goal is to produce a stem cell therapy as promised to California voters 11 years ago when they approved creation of the agency, which will cost the state about $6 billion, including interest, before the effort expires.

Without backing of industry, there will be no therapies. But the priorities of a business are not necessarily the same as the agency’s. Profits necessarily come first with a business. Otherwise it will vanish into a financial abyss. Witness the dumping of the nation’s first hESC clinical trial by Geron, in which the agency invested $24 million only three months before the trial was summarily terminated by the company for financial reasons. 

The California stem cell agency’s president, Randy Mills, should understand the vagaries of all this better than most. He made his career as a biotech business executive, not as a researcher. Over the last year, he has done much to sharpen the focus of the agency and begin to create a clear path for emergence of a therapy, a “radical” change he has dubbed CIRM 2.0.

Whether he can successfully put together the needs of business and the needs of science and medicine is perhaps the key question for the California stem cell agency between now and 2020. 

California's Salk Institute Looking for New CEO

San Diego is a hotbed of biomedical research, so when one of the leaders of its top institutions leaves, it is significant news.

William Brody, Salk photo

William Brody, head of the Salk Institute and a former director of the California stem cell agency, will be retiring at the end of the year, the San Diego Union-Tribune reported yesterday.

Brody, 71, came to Salk in 2009 and has wrapped up a $300 million fundraising effort that has stabilized the nonprofit after a period of financial uncertainty, Gary Robbins reported in the newspaper’s story.

Robbins wrote,

"'Salk has always had a much smaller endowment than other comparable institutions, but with decline in funding for biomedical research we needed a buffer and that is what Bill achieved,' said Terry Sejnowski, a Salk neuroscientist. 'None of his predecessors were able to do this. We don't have wealthy alumni or grateful patients, just the best basic science.'

"But if you compare where we are today with Scripps (Research) and medical schools around the country that are bleeding faculty and debt we are solvent if not plush, and continue to recruit the best young faculty. Looking to the future we need to find another Bill Brody."

Brody served on the governing board of the $3 billion state stem cell agency from August 2009 to the end of 2012. His predecessor at Salk, Richard Murphy, also served on the board and as interim president of the agency. Salk has not had a representative on the board since Brody left. 

Salk had received $52 million from the agency, which ranks the institute 12th on the list of recipients of awards. When Brody left the agency board in late 2011, Salk had chalked up $37 million in stem cell agency awards.

Salk officials said they will launch a nationwide search for a replacement. Scripps Research, also located nearby in the San Diego suburb of La Jolla, is also looking for a new CEO with top notch fundraising abilities. 

California Stem Cell Agency Ends Today's Session

OAKLAND, Ca. -- Today's meeting of the governing board of the California stem cell agency has concluded. We will have more on its proceedings during the next few days. Here is a link to the agency's press release on the meeting. It identifies the other recipient of an award ($8.5 million) made today as Mehrdad Abedi of UC Davis. Donald Kohn of UCLA received the other award ($7.4 million). 

Concerning the changes in the basic research and translation award programs, the press release said,,

"By scheduling both the Discovery and Translational awards more regularly CIRM is creating a system that helps move the most promising projects along a pipeline and also provides predictability to the grant system, making it easier for researchers to know when they can apply for funding.

"The stem cell agency estimates that each year there will be up to 50 Discovery awards worth a total of $53 million; 12 Translation awards worth a total of $40 million; and 12 clinical awards worth around $100 million."