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."

Parkinson's Patients Dismayed by Slow Work at California Stem Cell Agency

OAKLAND, Ca. -- Directors of the California stem cell agency today unanimously approved $40 million for a program to advance or "translate" basic research during a session that was marked by emotional pleas from Parkinson's Disease patients for much faster action.

The contingent from the San Diego area told directors and agency officials they were not moving fast enough to fund a research effort that they supported.

One patient advocate, Jenifer Raub of San Diego, said it was "outrageous" that the effort could not even be considered by reviewers until next March with no funding until about 2017.  Another unidentified patient said,

"Don't let policy, bureacracy and procedures stop this for another year."

Agency officials said that the time is required to meet legal requirements for the competitive grant process and reviews of the proposals that would be submitted.

Individuals appearing at the meeting were largely associated with Summit4StemCell of San Diego and have raised to $2 million to back research by Jeanne Loring, head of the stem cell program at Scripps Research in La Jolla.  The comments appeared spontaneous in reaction to the CIRM staff presentation on the new program. Loring told the California Stem Cell Report she did not organize the comments.

The agency's new, four-round, translation research program promises cash to researchers within nine months of submission. The program says that applications will be accepted in September and March of each year. Asked about the timetable, Mills told the California Stem Cell Report that it will begin in 2016.

Mills later told the board that the agency needed to be responsive to patient needs. He said he would "see if there is anything we can do." He said he would report back to the board on the matter.

(The last paragraph in this item was added about one hour after its initial posting.)

California Stem Cell Agency Approves $53 Million for Basic Research

OAKLAND, Ca. -- Directors of the California stem cell agency this morning approved a $53 million "discovery" research program that is aimed at funding basic research and creating special incentives to help assure that it will lead to a widely used therapy.

Randy Mills, president of CIRM, said a new, $150,000 bonus award will be created as part of the program. He also said recipients will be newly required to explain how their proposal could lead to a therapy, among other things.

Mills told directors that the new requirements would help to prevent past situations in which only 5 percent of basic research awards advanced along a path towards development.

Directors voted unanimously to go forward with the effort following a discussion that focused mainly on technical details of the plan. (See here and here for additional information on the plan.)

UCLA's Kohn Wins $7.4 Million Stem Cell Research Award

OAKLAND, Ca. -- Donald Kohn of UCLA is the recipient of a $7.4 million award from the California stem cell agency to develop a therapy to treat a rare genetic condition called chronic granulomatous disease.

Kohn's proposal was approved unanimously by the directors of the $3 billion agency meeting here this morning. The agency did not identify Kohn as the recipient. However, it was learned shortly after the approval that the Los Angeles investigator had made the application.

See here for more information on his proposal.

$16 Million in Two Grants Approved by California Stem Cell Agency

OAKLAND, Ca. -- Directors of the California stem cell agency today approved $16 million for two clinical trials involving AIDS lymphoma and another involving a rare genetic affliction that creates immune deficiencies problems.

Names of the recipients were not immediately disclosed. See this item for more information on the awards.

$100 Million for Clinical Stage Stem Cell Research in California

OAKLAND, Ca. -- Directors of the California stem cell agency today approved $100 million for clinical stage research for the 2015-16 fiscal year. The funds were allocated on a unanimous vote with no discussion.

The effort extends the CIRM 2.0 program, which began in January of this year. The agency awarded $25 million during the first half of this year out of a $50 million budget.

Oakland Gains HQ of the California Stem Cell Agency

OAKLAND, Ca. -- The California stem cell agency will be moving to new headquarters this fall in Oakland, across San Francisco Bay from its current home near the San Francisco Giants ballpark.

The address of the new headquaters is 1990 Harrison Street in downtown Oakland. Details of the cost and the square footage were not immediately available.

California Stem Cell Agency: 'Lots of Money and Lots of Time"

OAKLAND, Ca. -- The California stem cell agency today said it has committed $1.97 billion during its nearly 11 years of life and anticipates spending about $170 million to $190 million over the next five years.

Agency President Randy Mills presented the figures at a meeting of the agency's board of directors. 

He said he anticipates a "net commitment" of $170 million annually over the next five years.

He said,

 "We have lots of money and lots of time."

California Stem Cell Meeting Begins in Oakland

Directors of the California stem cell agency today began their meeting here at 9:11 a.m. PDT with a report from Chairman Jonathan Thomas.

Looking for Clarity at the $3 Billion California Stem Cell Agency

OAKLAND, Ca. -- Scientists and others seeking the short version of the plans for funding of basic and translational research by the $3 billion California stem cell agency should look no further than an 18-page Power Point presentation.

The explanation is available on the agency’s Web site and in some ways is better than the more prolix description offered in three formal memos. While the presentation offers a fast read, seriously interested parties will need to plow through all three documents. (See here, here and here.)

Critical to understand the direction of the agency, however, is another Power Point presentation -- this one by Randy Mills and which is not supported by a memo or other formal document. But some of what Mills lays out in the slides has been brought up at earlier meetings, the voluminous transcripts of which are available on the agency’s Web site, if you can find them.

A search of the agency’s Web site late yesterday using the term “transcript” turned up 879 results. No transcripts of remarks by Mills or of meetings of the agency’s board of directors were found in the first 14 pages of the results.

In his slides today, Mills is covering his thinking on both basic and translational funding and how therapy development should have a continuous and predictable pathway. He likes to talk about it in terms of rail lines, a homely but apt analogy.   

While we are on the subject of Power Point presentations, the agency’s slides have improved greatly since Mills became president of the agency in May 2014.  Nonetheless, Power Point presentations do not necessarily enhance understanding, especially when the presenters do little more than read the notes on the slides. The result is known as “Death by PowerPoint!”

Slides are no replacement for a single, nuanced, written explanation of a proposal, including charts, something more than the agency usually offers in its memos to the board. That said, their memos have also improved and are more comprehensive and straight forward than under the regime of the agency’s former president, Alan Trounson.

Coming Up: Full Coverage of California Stem Cell Meeting Today

The California Stem Cell Report will be on the scene today in Oakland as the Golden State's $3 billion stem cell agency is set to allocate $243 million for a wide variety of research efforts plus a high school training program. News reports will be filed as warranted throughout the day.

The public can participate in the meeting at its physical site in Oakland and at teleconference locations in Beverly Hills, San Diego, South San Francisco, Stanford, Sunnyvale and two in La Jolla. An Internet audiocast is also available. Details are available on the agenda for the meeting, which begins at 9 a.m. PDT.

NDA Appoints Ellen Feigal as Partner

Ellen Feigal, formerly the No. 2 person at the $3 billion California stem cell agency, yesterday was named as a partner in NDA Partners, an international consulting firm to the medical products industry.

Feigal resigned last fall as senior vice president at the stem cell agency, about five months after Randy Mills was named as its new president.

NDA's web site says it is a "a global strategy consulting firm specializing in expert product development and regulatory advice to medical products industries" and that it deals with "emerging biopharma." The web site does not disclose the names of its clients, and it is not known whether any are involved with the California stem cell agency.

Full Coverage of Tomorrow's Stem Cell Meeting

The California Stem Cell Report will provide gavel-to-gavel coverage tomorrow of the directors' meeting of the $3 billion California stem cell agency. Up for consideration are plans for spending $243 million, among other things.

The public can participate in the meeting at its physical location in Oakland and at teleconference locations in San Diego, South San Francisco, Stanford, Sunnyvale and two in La Jolla. An Internet audiocast is also available. Details are available on the agenda for the meeting, which begins at 9 a.m. PDT.

California Ready to Approve $243 Million for New Stem Cell Research

CIRM President Randy Mills uses a railroad analogy for therapy development

The California stem cell agency Thursday is set to approve $243 million to finance everything from testing therapies on patients to exposing high school students to research.

The multi-faceted effort will come before the 29 directors of the agency at their meeting on Thursday at the Oakland Marriot City Center. The initiatives have already cleared the directors’ Scientific Subcommittee.

The effort is the second installment in the CIRM 2.0 program begun earlier this year by the agency’s president Randy Mills. He assumed his post in May 2014 at the California Institute of Regenerative Medicine or CIRM, as the $3 billion agency is formally known.

Mills has described his changes as radical. He says they are aimed at improving the quality of applications and speeding development of therapies. He also has called for deeper involvement by the agency in the direction and work of researchers.

Mills, who has made his entire career in the biotech business, says he wants to provide a relatively smooth track, a “continuous, predictable pathway” from basic research to clinical applications. He uses a railroad analogy to illustrate the desired progression of research(see graphic above).

The $243 million up for approval this week is about 30 percent of the agency's remaining $800 million. However, the money will be spent over the next several years -- not just this year. Under Mills' spending projections, the agency will not run out of cash until 2020. 

The largest program coming before CIRM directors this week is $100 million during 2015-16 for more advanced research related to clinical development. Directors earlier approved $50 million for the effort for the first six months of this year. However, they have awarded only $25 million as of the end of June.

Another $53 million is set for a variety of mostly basic research, which Mills calls “discovery.” Requests for applications are scheduled to begin late this summer or fall. Some of the rounds will have application openings twice a year.  Cash is scheduled to flow to researchers within about 10 months of application.

Mills is also asking the board for substantial delegation of authority to him during the reviews and is calling for an “optimized review process” because of a high anticipated volume of applications in discovery.

Under the $40 million translation research round, Mills would also be delegated authority in the grant review process to pluck out applications and advance them even if reviewers disagreed. Applications will be accepted in September and March. Cash will flow to researchers about nine months after applications are submitted.

Both the discovery and translation rounds are open to both businesses and nonprofit enterprises.

A revised training program called “Bridges 2.0” for college level students is budgeted for $46 million over a five-year period. A training program for high school students, changed and rebranded as “Spark,” will receive $4 million over five years. Applications for that program are due Oct. 1. It is open to colleges, universities and non-profit academic institutions. 

Applications for the Bridges program are also due Oct. 1. They will be limited to “California public universities or colleges or private, nonprofit academic institutions, which did not receive a CIRM-funded Major Facility or Shared Research Laboratory Award (and, hence, do not have a major stem cell research program or a critical mass of stem cell researchers).”

In addition to the Oakland location of the directors' meeting, the public can participate at teleconference locations in San Diego, South San Francisco, Stanford and two in La Jolla. Addresses can be found on the agenda, which includes directions for listening to the Internet audiocast of the meeting.

Email comments for the CIRM directors on items on the agenda may be sent to mbonneville@cirm.ca.gov.