California Stem Cell Report Taking Break

The California Stem Cell Report is on holiday until Jan. 6. Look for a fresh posting then. Happy New Year to all.

Possible Parkinson's Stem Cell Treatment in San Diego, $6.5 Million and Loads of Media Coverage

KPBS 2018 video

A San Diego firm that has $22 million worth of financial roots in the California stem cell agency this month snagged a bonus -- a ton of favorable attention for its efforts to treat Parkinson's disease. 

The fledgling business is Aspen Neuroscience, Inc., which was co-founded by Jeanne Loring, professor emeritus at the Scripps Research Institute, and Andres Bratt-Leal, also formerly of Scripps. 

Earlier this month, Aspen received $6.5 million in seed funding from Domain Associates and Axon Ventures. The announcement of the cash infusion triggered a spate of news articles.

In a piece on the Biocentury web site, writer Elizabeth Eaton quoted Kim Kamdar, a partner at Domain, as saying, 

"Aspen is the only company taking an autologous approach to cell therapy for Parkinson's disease." 

The approach can avoid the immunosuppression necessary for allogeneic therapies. Eaton continued,  

"Such (immunosuppression) treatment, which can last for a year or more to ensure a patient's immune system doesn't react to the transplant, can make patients more susceptible to viral diseases and cancer.

"While companies like BlueRock Therapeutics L.P. are exploring allogeneic treatments, Aspen was able to break into the autologous space thanks to its genomic tools, co-founder and CSO Jeanne Loring told BioCentury.

"Aspen is built on Loring's research at the Scripps Research Institute and the PluriTest, an assay she developed after discovering that pluripotent cells have a distinct genetic signature. The patented test shows whether a cell has achieved pluripotency, which allows researchers to avoid conducting more time-consuming confirmatory tests."

Loring has received nearly $22 milllion from the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), including $4.5 million as a co-PI. She told the California Stem Cell Report, 

"All of my CIRM awards contributed to this project. We used those funds to develop our genomics tools and databases and to develop improved methods for handling the cells.  The only specific CIRM grants supporting this project were DISC2-09073 and the progress award DISC2P-11595."

Loring also credited Summit for Stem Cell Foundation of San Diego for supporting and financing her work as far back as 2011. Joining Domain in the $6.5 million in funding were Alexandria Venture Investments, Arch Venture Partners, OrbiMed Advisors and Section 32.

Here are links to additional stories on Aspen and the $6.5 million in funding: San Diego Union-Tribune, San Diego Business Journal, Endpoints News, FierceBiotech, Xconomy, BioWorld, Parkinson's News Today and BioSpace. 

Aspen Neurosciences video

Latina Cancer Advocate Ysabel Duron Named to California Stem Cell Board

Ysabel Duron

The governing board of the $3 billion state stem cell program has a new member, Ysabel Duron, an award-winning Latina journalist and president of the Latino Cancer Institute.

Her appointment comes as Sherry Lansing, who was the first woman to head a major Hollywood studio, has left the board. Lansing is president of the foundation bearing her name, which is involved deeply in cancer research, and is a member of the University of California board of regents. 

On its blog, the stem cell agency said,

"Ms. Duron was a journalist and TV news anchor for more than 43 years winning numerous awards, including two EMMYS. She has been inducted into the Hall of Fame of the National Association of Hispanic Journalists and given the Living Legacy Award by the Chicana/Latina Foundation.

"As a journalist she covered her own battle against Hodgkin’s Lymphoma, using her reporting to help raise awareness about the disease and the health disparities involved in treating it in communities of color."

The agency quoted Duron as saying,

"Usually I am looking for the best return for the public health! This appointment gives me a new learning opportunity to understand a very complex issue, and, make it bite size so the public, patients and advocates will understand how these scientific revelations will impact lives in the short term and the long run. As a steward of taxpayer dollars, I also want to make sure there is equity for communities across California, and that the research serves all of us."

Lansing served on the agency's 29-member board since its inception in 2004. In her letter of resignation, she said,

"This is just the beginning for stem cell research, and yet we are at a critical inflection point in the life of this organization - with funds coming to an end and promising research that must wait for the next CIRM(the stem cell agency). It is for this reason that I am stepping down now, so that I can dedicate more time to getting the next initiative on the ballot."

State Controller Betty Yee appointed Duron. The agency's board currently has two vacancies.

'Natural Killer' Cancer Cell Treatment Advances; State Stem Cell Agency Pleased

The California stem cell agency this week touted a possible "off-the-shelf cancer killer" that the state enterprise is helping to develop with $4 million.

The company involved in the treatment is Fate Therapeutics, Inc., of San Diego, a publicly traded firm working on induced pluripotent stem cells (iPSC) that have been genetically engineered to enhance their anti-tumor activity. The product is called FT516.

Writing this week on the agency's blog, Kevin McCormack, senior director of communications at the agency, said,

"Fate Therapeutics has developed an off-the-shelf therapy (thanks to (agency funding) that could, theoretically, be stored at hospitals and clinics around the country and used whenever it’s needed for anyone who needs it."

McCormack said that a CAR-T approach uses a patient's own "re-engineered" cells to kill cancer tumors. He wrote, 

"But the thing that makes it so appealing – using the patient’s own cells – also makes it really complicated and expensive. Creating a custom-made therapy from each patient’s own cells takes time and costs a lot of money. But now (the Fate Therapeutics) approach could change that."

Fate uses NK (natural killer cells). Maxx Chatsko of the Motley Fool financial web site reported,

"It's the first cell product of any kind derived from a clonal master iPSC line to be evaluated in a clinical trial in the United States. The 'clonal master iPSC line' part essentially means it can be manufactured more easily than immunotherapies requiring cells to be extracted from patients. That's why it's called 'off the shelf.'"

McCormack continued, 

"At this year’s meeting of the American Society of Hematology (ASH) Fate announced that the first patient treated with this new approach seems to be doing very well. The patient had acute myeloid leukemia and wasn’t responding to conventional treatments. However, following treatment with Fate’s FT516 the patient responded quickly and...was able to leave the hospital and spend Thanksgiving with his family. 

"Equally impressive is that 42 days after being treated with FT516, the man showed no signs of leukemia in either his bone marrow or blood."

The product is being licensed exclusively to Fate by the Memorial Sloan Kettering Cancer Center

Fate Therapeutics' stock closed today at $18.79, down 13 cents. Its 52-week high was $22.82. The 52-week low was $11.00. Last September it raised $173 million in a stock offering.

LA Times: $5.5 Billion Measure for California Stem Cell Agency Could Actually Be a 'Downfall'

The Los Angeles Times, California's largest circulation newspaper, carried a piece today that called for withdrawal of the proposed, $5.5 billion ballot initiative that would save the financial life of the state's stem cell agency.

The article by Pulitzer Prize-winning business columnist Michael Hiltzik said the measure would perpetuate many of the flaws in the ballot proposition in 2004 that created the agency, officially known as the California Institute for Regenerative Medicine (CIRM). 

In fact, Hiltzik said, the new measure "makes some of them worse."

"That’s dangerous," Hiltzik continued, "because although the measure could fuel the stem cell program for years to come, it might also prompt a repudiation by voters sensitive to its many imperfections. Such an outcome would be tragic for California and the advanced science already supported by CIRM."

Hiltzik's opinion piece was the first extended look at the proposed stem cell initiative by a major media outlet in California. It appeared on the front page of today's business section of the Times. On the paper's web site, the article was featured as a "weekend read" at the time of this writing. 

The Times says it has about 2 million readers on Sunday. It is a go-to source for other journalists when they are researching stories and trying to understand major issues facing the state. 

Hiltzik has followed the $3 billion agency since its inception and has been highly critical. Last spring, however, he wrote that the agency had "proved its value." In today's piece, he had a lot to say about the good work of the agency. 

In his first two paragraphs, Hiltzik declared that CIRM "has made great strides in advancing what’s known as regenerative medicine and placing California at the center of the developing science." Hiltzik also said that CIRM has financed state-of-the-art laboratories, attracted preeminent scientists and "brought scores of promising treatments for severe chronic diseases to the point of clinical trials."

But he also noted that the agency has "has so far failed to yield a single marketable clinical product." He continued, 

"That’s despite the sales pitch for Proposition 71 in 2004 -- that all that stood in the way of 'cures' for Parkinson’s, Alzheimer’s, spinal cord injuries and other maladies was money."

The greatest flaw of the agency, however, has more to do with public policy than science, Hiltzik wrote. And that is the exemption of the agency from the usual oversight by the legislature and the governor, an exemption contained in the measure that created the agency.

Voters provided CIRM with $3 billion in bond funding 15 years ago. 
Today that money has all but run out. Robert Klein, a real estate developer, first chairman of the agency and who sponsored Proposition 71, is now once again sponsoring the latest initiative to give it billions more. 

Hiltzik concluded,

"(Klein) should withdraw his measure, and CIRM’s leadership should write a new one or work with Gov. Newsom and the Legislature to map out the program’s next act. 

"CIRM’s leadership needs to show the public that it’s capable of taking charge of the program’s destiny. If it’s not willing to make its own case for CIRM’s continued existence, how can it persuade voters to give it one cent more?"

San Diego Biotech Reporter Bradley J. Fikes Dies at 61

Bradley J. Fikes, journalist
San Diego U-T photo

When biotech reporter Bradley J. Fikes died last Wednesday at the age of 61, he was described in his newspaper as "part Dr. Dolittle, part Inspector Gadget."

The piece in the San Diego Union-Tribune was a tribute to Fikes, whose family said he died of natural causes at home. The paper said he was "an ever-on-the-move ball of energy" and beloved by his colleagues.

Fikes occupied a special position in California journalism. He was one of the few daily newspaper reporters who regularly covered the biotech industry and its research community. Fikes was also one of the few who delved into the affairs of California's 15-year-old, stem cell research agency. 

Last month Fikes penned a lengthy piece for the San Diego Union-Tribune that involved the agency, known officially as the California Institute for Regenerative Medicine (CIRM). The story dealt with a blood cancer drug called fedratinib and the relentless, years-long journey before the research, which was partly funded by CIRM, came to fruition. 

Fikes began the story like this:

"Cancer patients hold onto hope the way some people hold onto the lap bars of roller coasters: As if their lives depend on it.

"And then they get ready for the ups and downs."

Kevin McCormack, the stem cell agency's senior director of communications, wrote on the agency's blog that Fikes' story captured the setbacks, twists and turns and the years that it took before the treatment ultimately emerged. 

McCormack said yesterday, 

"Everyone at CIRM was stunned and saddened by the news. Brad was a real character, and a real gentleman. His unique sense of fashion made him hard to miss, even at a crowded conference, but it was his curiosity and his clear love of science that really stood out. He didn’t just report on stem cell research as a job, it was something he loved and that came across in his writing. He had a tremendous gift for taking complex science and turning it into everyday English. He was also great fun to hang out with. He had a wonderful sense of humor and a wry way of seeing the world. I shall miss him. We all will."

One of Fikes' colleagues, Michelle Guerrero, a Union-Tribune illustrator and graphics reporter, said in Fikes' obituary, 

“He had the wonderment of a child, the complexity of a scientist and an artful way of coming up with the words to explain it all.”

Fikes cut a colorful figure as he divined the doings at Scripps and Salk and at the other hallowed halls of science.  The Union-Tribune's piece on Fikes said, 

"Fikes was impossible to miss. By his own admission, he was a walking fashion disaster. He wore odd-colored business shirts that clashed with his suspenders, and slacks that never made contact with an iron. At times, cellphone cables hung out of his pockets like limp licorice."

Fikes was a graduate of San Diego State University where he first began writing the news. The campus newspaper wrote its own account of the life and times of Bradley J. Fikes. The piece carried comments from his colleagues including Gary Robbins who sometimes teamed with Fikes on stories. Robbins praised not only Fikes' journalism but his humanity as well. Robbins said, 

"He had poise, he had professionalism, he was a gentleman.”

Media Coverage: California Stem Cell Agency Receives Slight Whack in Los Angeles Times

California's $3 billion stem cell research program, now down to only $27 million, popped up in the Los Angeles Times this week in a piece that dealt with presidential politics, term limits and dubious ballot measures.

The mention consisted of only two paragraphs. But it demonstrated, at least for the state stem cell agency, the flaws of excessive generalization in P.T. Barnum's famous saying that “Any kind of publicity is good publicity as long as they spell your name right.”

Los Angeles Times columnist Michael Hiltzik wrote yesterday about "crowd pleasing" pitches to voters that actually contain "few virtues."  The starting point was term limits for congressmen and women. Hiltzik noted that such measures, in fact, do not serve the public well because they enhance the power of lobbyists. And then he went on to discuss ballot initiatives in California. 

Hiltzik, a Pulitzer Prize winner and author of "Big Science," wrote, 

"It's not unusual for ballot measures to win the approval of voters despite provisions that work directly against voters’ interests. That includes Proposition 71 of 2004, which created California’s $6-billion stem cell program. (See below for a look at the $6 billion figure and the nominal cost of the stem cell effort.)

"Proposition 71 was sold to voters as a gateway to cures for a host of intractable diseases, a promise hopelessly incompatible with the way science is done. Its promoters also tried to make a virtue out of its nearly total independence from legislative oversight, another artifact of anti-government sentiment. The stem cell program has indisputably supported excellent science, but its lack of legislative oversight remains a flaw."

The lack of legislative oversight will continue under the proposed 2020, $5.5 billion ballot initiative that is now before California election officials. If approved by voters in 11 months, the initiative will save the California stem cell agency from financial extinction. 

The new initiative is sponsored by Robert Klein, the first chairman of the state stem cell agency. Klein's measure does not address a number of sharp criticisms of the program, including those found in a $700,000 study of the agency by the prestigious Institute of Medicine. 

Klein's new initiative is sort of a son of Proposition 71. Klein also directed the writing of the 2004 measure, which did not provide any source of stem cell funding beyond the $3 billion in state bonds. 

As for the $6 billion figure cited by Hiltzik, it originated in a 2004, state ballot analysis of Proposition 71. The figure was an estimate of the total cost, including interest, to taxpayers of the stem cell agency, which is financed by $3 billion borrowed by the state. 

The interest estimate did not anticipate the 2008 Great Recession and the related drop in interest rates. The latest estimate is that the total will be about $4 billion. Read more about that estimate here. 

Rare Media Coverage of $5.5 Billion California Stem Cell Ballot Measure

The journal Science is carrying an article about the "delicate negotiation" involving the California stem cell agency and the man who is sponsoring a ballot measure that would keep the research effort alive with $5.5 billion in cash. 

The piece by Kelly Servick followed a two-hour meeting last Friday of the governing board of the agency, formally known as the California Institute for Regenerative Medicine (CIRM). Klein was in attendance and agreed to additional changes in the measure beyond those he announced to the California Stem Cell Report. 

There was no disagreement between Klein and the agency concerning the amount of money involved, which is much needed by CIRM. It has only $27 million left, compared to the up to $300 million annually that it normally spends on awards. The $27 million is earmarked for sickle cell anemia. 

The piece in Science represented rare national or even California media attention to refinancing the agency, which has pumped $2.7 billion into stem cell research in the Golden State in the last 15 years. Beyond the refinancing, the Klein initiative would make sweeping changes in the agency and governance. It also does not deal in a significant way with some areas that have been the focus of sharp criticism over the years, such as conflicts of interest.

Servick's article captured some of the highlights of last Friday's CIRM board meeting. She also reported, 

"In July, Americans for Cures conducted a poll of about 1150 likely voters and found a 65% approval rating for re-funding CIRM, Klein says."

Servick wrote, 

"Many researchers credit the agency with creating a strong infrastructure for stem cell research in the state and shepherding dozens of experimental treatments into human trials. But no CIRM-funded stem cell therapy has yet won FDA approval, leading critics of the agency to ask whether the initial 2004 initiative, born from opposition to a ban on federal funding for embryonic stem cell research, promised 'cures' it couldn’t deliver." 

Klein has until 5 p.m. today to file his amended initiative with state election officials. If it qualifies for the ballot with more than 600,000 signatures it will be brought to voters next November.

$5.5 Billion Stem Cell Ballot Measure: Questions in California but Apparently No Foot-Dragging

Some directors of the California stem cell agency this morning expressed a number of reservations about a $5.5 billion ballot initiative to stave off its financial demise, but none appeared likely to oppose the proposal 

In a special, two-hour meeting of the agency's governing board, questions were raised about provisions that would restrict the board or mandate programs, ranging from training to lab equipment. A provision to increase the size of the board from 29 to 35 was criticized and supported. A new effort to deal with the affordability of stem cell therapies was praised. But some aspects were questioned.   

The topic of the day was a complex, 30-page, proposed ballot initiative sponsored by Robert Klein, the first chairman of the agency, who has already announced changes in his proposal. More alterations appeared to be in the works as the result of today's hearing, including elimination of some language dealing with pricing. The meeting did not go into details about that subject.

In addition to requiring the state to borrow $5.5 billion for stem cell and other "vital" research, Klein's proposal would expand the scope of the agency and alter its governance. It would be required to develop and finance efforts at making stem cell research more affordable. Brain disease research would receive special attention with a dedicated $1.5 billion out of the $5.5 billion. Training programs would be mandated and expanded at community and state colleges and much more.

(The CIRM summary of the initiative can be found here. A summary by the California Stem Cell Report can be found here.)

(Here is the text of the initiative as filed in October. Here is the text of the measure with Klein's proposed changes as of Nov. 14.)

The agency began its life in 2004 with $3 billion in state bond funding, authorized by California voters through a ballot initiative.  Known formally as the California Institute for Regenerative Medicine(CIRM), it is down to its last $27 million, which is devoted to a sickle cell program with the federal government. At its peak, the agency was giving away up to $300 million a year.

Today's meeting began with several of the board members declaring that the public should not perceive their questions and comments as indicating they did not support the effort to refinance the agency. Some had expressed concerns that opponents might use board comments to defeat the initiative next November. 

Steve Juelsgaard
CIRM photo

The board moved rapidly through the initiative during the morning meeting. CIRM director Steve Juelsgaard and others raised questions about the size of the board, declaring that large boards become disengaged from an enterprise. Os Stewart, who has served on the board since 2004, said he initially thought 29 members were excessive but feels differently after 15 years. 

Several members expressed concern about mandates that would tie the hands of the board. CIRM Director Francisco Prieto said, 

"The science can surprise us."

Klein told the board that "we have fundamental obligation to give the voters an idea where their money is going." He also said that the mandates do not have legal timetables.

Today's meeting was very lightly attended, according to an agency spokesman, mostly by CIRM staffers. Only one member of the public addressed the board, Don Reed, a longtime patient advocate and supporter of the board.

Questions about the measure arose publicly this month after longtime director

Jeff Sheehy
CIRM photo

Jeff Sheehy authored a 3,300-word critique of the Klein measure, declaring it amounted to "too little and too much."  At the end of today's meeting, Sheehy did not express reservations that would prevent him supporting the measure. 

Klein unofficially modified his measure this week. He has until Monday at 5 p.m. to actually file the changes with state elections officials. The official comment period for the initiative is closed. But Klein said yesterday that interested parties can send comments and suggestions to him through Saturday at this email address: castemcell2020@gmail.com. 

Comments filed directly with Klein are not a public record. If a reader would like to share his/her comments with the public, please send a copy of them to the California Stem Cell Report at djensen@californiastemcellreport. We will carry them verbatim.

Here is a link to a guide to the stem cell initiative information maze, which is updated as other key information surfaces.

California Stem Cell Agency's Summary of $5.5 Billion Measure to Save its Financial Life

The California stem cell agency late yesterday posted its own summary of a proposed $5.5 billion ballot initiative to keep it from basically going out of business next year.

The summary is about 1 1/2 pages long compared to the 30 pages of the actual initiative, which is the subject of a hearing this morning by the governing board of the agency. 

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, is down to its last $27 million. It came into being in 2004 with $3 billion in state bond financing. 

Also posted on the meeting's agenda is a five-page memo from 2017 discussing what the agency can and cannot do in connection with election activities such as a ballot initiative campaign.  Last month the board was given a seven-page memo about such activities. Both memos confirm that the agency may use public funds to draft its own initiative.

Neither of the memos discuss the pros and cons of the ballot measure sponsored by Robert Klein, who ran the ballot campaign that created the stem cell agency 15 years ago this month.

Here is an updated guide to the key documents and information concerning the initiative.

Robust Defense of $5.5 Billion California Stem Cell Measure; State Hearing Scheduled for Tomorrow Morning

The man behind the $5.5 billion California stem cell initiative this afternoon vigorously defended the measure and released details of fresh changes in the proposal, which will be scrutinized tomorrow morning by the directors of the financially strapped state stem cell agency.

Robert Klein file photo by California Stem Cell Report

Despite the fact that agency faces its fiscal demise next year, the initiative is the only proposal around to continue the agency's funding. It ran afoul last week of questions from some of the agency's directors. One of those directors wrote a 3,300-word critique of the proposal by Robert Klein, the first chairman of the agency and who directed the writing of the 2004 ballot initiative that created the agency. A special meeting was called for tomorrow morning.

In addition to providing $5.5 billion in state bonds, Klein's proposal would significantly expand the reach and change the governance of what is formally known as the California Institute for Regenerative Medicine(CIRM). The measure would require the agency to launch a major effort to make "affordable" what are extremely expensive stem cell and genetic treatments. The proposal would also enlarge its governing board from 29 to 35. The board has been criticized sharply for the size of its board.

Klein said in an emailed statement that the changes he made in the wake of CIRM directors' concerns basically follow the outlines of what he released yesterday. He stoutly defended the agency's current work and his plans to expand its scope.

He said in an eight-page statement to the California Stem Cell Report.

"Patients and their families should not have to suffer more delays because of ill-conceived agendas that obviously do not fit into the new initiative, with a scope that has already been court validated."

Klein added,

"The federal government remains a threat to scientists and physicians investigating the best cell sources for developing therapies for patients. Just within the last nine months there have been new restrictions imposed by the federal government based upon ideological grounds."

Klein, a Palo Alto, Ca., real estate developer, is under a state deadline of 5 p.m. on Monday to make any changes. As sponsor of the 2020 initiative, he is the only person legally entitled to make changes. The measure then will go through a lengthy state elections process. More than 600,000 registered voters will have to sign petitions for the measure if it is to make it onto the November 2020 ballot.

Klein noted that the state deadline has passed for officially making public comments. But he said suggestions and comments can be sent to him through Saturday Nov. 16 at this address: castemcell2020@gmail.com.  Any such comments are not a public record. If a reader would like to share his/her comments with the public, please send a copy of them to the California Stem Cell Report at djensen@californiastemcellreport. We will carry them verbatim.

The public can listen in and participate in tomorrow's meeting via the Internet or at telephonic locations throughout California. An updated list of those locations is here. Information on Internet access is on the meeting agenda.

Below is the text of the statement Klein sent this afternoon to the California Stem Cell Report. In it, he says the full text of the current version of the actual initiative is available on the Americans for Cures web site, a stem cell patient advocacy group that he founded and chairs.

   2020 Update – the California Stem Cell Research, Treatments, And Cures Initiative of 2020 11.14.19 by Anonymous 2ZGCBei on Scribd

A Guide to Information on the $5.5 Billion California Stem Initiative

Trying to wade through the information maze surrounding the proposed, $5.5 billion California stem cell initiative? Here are links to key documents, online postings and information dealing with the proposal and the ballot initiative process.

This list of information sources was updated Nov. 14, 2019, at 8:54 PM PST.

How ballot initiatives work in California

• Ballotpedia on initiative law
• Wikipedia overview of California initiative process
• How changes can be made in an initiative

Text of the 30-page, proposed $5.5 billion measure

Text of the revised version of initiative as of Nov. 14, 2019

A summary of the measure from the California Stem Cell Report

A summary of the measure from the stem cell agency

A critique of the proposal by CIRM board member Jeff Sheehy

A critique of the proposal by CIRM grant recipient Jeanne Loring

An eight-page statement from Robert Klein, author of the initiative, to the California Stem Cell Report.

Proposed changes in the initiative offered by its sponsor, Robert Klein

How CIRM can write its own initiative

An article on CIRM board reaction to the initiative, complaints about "handcuffs"

Delays on Details of Changes in Proposed, $5 Billion California Stem Cell Initiative

The details of the changes in the proposed 2020 California stem cell initiative that were promised by its sponsor yesterday have not been received as of this writing. The California Stem Cell Report will carry them when they are received.  The governing board of the state stem cell agency is scheduled to meet at 9 a.m. tomorrow to consider the initiative.

Changes Afoot in $5.5 billion California Stem Cell Initiative: Sponsor of the Measure Reacts to Suggestions and Questions

The proposed $5.5 billion California stem cell initiative is being altered in the wake of questions raised by some members of the governing board of the state stem cell agency, which is facing its financial demise unless the measure is approved by voters next fall.

In a phone conversation and email this evening, Robert Klein, sponsor of the initiative, said a "substantial amount of disinformation and misperceptions" exists concerning the measure. He said he was altering three key areas dealing with ethics and conflicts of interest, affordability and creation of a new scientific advisory board. 

Klein is the only person at this point who can modify his initiative. The state-imposed deadline is Monday at 5 p.m.  The governing board of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), is scheduled to meet at 9 a.m. on Friday to consider the Klein initiative. This week's meeting was scheduled following a testy board discussion last week. 

Klein directed the writing of the 2004 initiative that created CIRM with $3 billion in state bond funding. Only $27 million is left, and it is earmarked for sickle cell research. Klein also directed the 2004 ballot campaign and was the agency's first chairman. 

Klein said he has received hundreds of comments about the proposed initiative, which makes sweeping changes in CIRM and the way it works. Klein's initial email about the changes in the measure is brief. The full text is  below. He said he would send more details about the changes later this evening and was open to more suggestions as they come in. (Update: As of 5:49 a.m. PST today Nov. 14, Klein had not delivered the details of his changes, which will be carried on the California Stem Cell Report when they are received.)

Here is Klein's email to the California Stem Cell Report.

"There is a substantial amount of disinformation and misperceptions being spread about the 2020 Initiative. I have addressed 3 areas of clarification below. Later today I intend to complete a more in-depth statement that covers a large number of points, which I will send to you upon completion. I hope the information below will provide a starting point for clarifying the understanding of a number of provisions.

"Amendments

"Although counsel assured me that the original wording in the 2020 initiative, as to any adoption of National Academy of Science standards for ethics or conflicts, was discretionary for the board, there will be posted on the Americans for Cures website, and distributed to CIRM, revised language that specifically states that the adoption of any part of the National Academy standards would be discretionary for the board. The requirements for open meetings to change any standards has not been modified. It remains in place.

"In addition, I have received helpful comments on the Accessibility and Affordability Working Group; and consequently, I have modified those sections to make it clear that the focus of this group is to work with designated experts on achieving early public and private insurance coverage for therapies derived from CIRM funded research. Please read the language in this section (sec. 7, 125290.75) which also provides more description of the expertise and experience qualifications of the Working Group members recruited outside of the CIRM board members on this Working Group.

"For clarity of purpose, the provision that addressed a potential advisory board, selected by the President and the Chair, has been revised and relabeled as a “task force” authorizing section, for specialized objectives. The membership of any task force has been restricted to California residents. These task forces will not have any function in evaluating grants, which must be reviewed and evaluated by the “Grants Working Group,” as clearly required by the Initiative.

"As additional comments are received, further modifications will be considered.

"Thank you."

Americans for Cures is a stem cell advocacy group that Klein founded and chairs. Here are links to the actual initiative and also to a summary prepared by the California Stem Cell Report. 

From Royalties to 'Vital' Research Opportunities: A Summary of California's $5.5 Billion Stem Cell Measure

The proposed 2020 stem cell initiative for the California stem cell agency is much more than the $5.5 billion it provides to continue the operations of the state's stem cell enterprise. 

It would also make sweeping changes in the California Institute for Regenerative Medicine (CIRM), which is down to its last $27 million. They range from expanding the scope of the agency to restructuring its governance.

This article is an initial attempt to summarize the measure’s more important changes. It does not capture all of the implications and alterations that could affect CIRM. Readers may see other sections of the initiative that are of interest. If so, please email the California Stem Cell Report at djensen@californiastemcellreport.com. 

The CIRM governing board is scheduled to consider the proposal at a meeting Friday at 9 a.m. The public can participate online and by other means. 

The deadline for the sponsor of the measure to make changes in the proposal is Monday at 5 p.m. Only the sponsor, who is Robert Klein, the first chairman of the agency, can make changes. 

Bond Financing and Interest Costs

The $5.5 billion would be provided through bonds (state borrowing) sold over a 10-year period. The interest on the bonds increases the cost to taxpayers as opposed to an annual appropriation. 

Expansion of Scope of Work 

The initiative’s purpose is “to support stem cell research to mitigate and/or cure chronic disease and injury” and also to finance “other vital research (opportunities) to develop treatments and cures for serious diseases and conditions like diabetes, cancer, HIV/AIDs, heart disease, paralysis, blindness, kidney disease, respiratory illnesses, and many more.” It also would “promote” accessibility and affordability of treatments by ensuring that more Californians have the opportunity to participate in clinical trials. (p.2)

“Other vital research opportunities” mean “scientific and medical research and technologies, includinq but not limited to qenetics, personalized medicine, and aqinq as a patholoqy, and/or any stem cell research not actually funded by the institute under paragraph (3) of subdivision (c) of Section 125290.60 which provides a substantially superior research opportunity, vital to advance medical science as determined by at least a two-thirds vote of a quorum of the members of the Scientific and Medical Research Funding Working Group and recommended as such by that working group to the ICOC (CIRM governing board), or as determined by the vote of a maiority of a quorum of members of the ICOC.” (p. 29) 

The measure would also: 

• Expand the agency’s Alpha Clinic program and create “centers of excellence” to expand clinical trial locations based on geographic diversity.(p. 3) The measure prescribes specific criteria for decisions by the board. 
• Require the board to establish and oversee affordability programs for CIRM-funded treatments. 
• Create a new, 17-member affordability group (p. 5, p. 6, p. 20) to deal with a wide-range of affordability issues including development of financial models and funding of patient and caregiver expenses 
• Require the agency to create new training and fellowship programs to help create a stem cell work force, including programs at the community and state college levels. (p. 4) 
• Re-establish the “shared research laboratory” program to provide more training and equipment and to create lab access for neighboring institutions. (p. 5)  

Conflicts of Interest 

Conflict of interest provisions would be be guided by the National Academies of Science (NAS), an out-of-state organization with no requirement for open meetings. (p.18)

The NAS is a widely respected and 156-year-old, non-profit based in Washington, D.C. 

The initiative language says that standards must “be qenerally aliqned with those adopted by the National Academy of Sciences to the extent that such standards are consistent with constitutional and statutory requirements applicable to the institute.” (p. 15)

No conflict standards would be required in connection with discussion or enactment of strategic and concept plans and “research budgets.” (p. 13)

Grant Reviews and Selection of Reviewers 

The measure alters the composition of the grant review group that makes the de facto decisions on awards. The measure would continue the current practice under which reviewers are not required to disclose publicly their economic or professional conflicts of interest.   (p.22)

Reimbursement of expenses of research participants and caregivers would be permitted. (p. 16) 

New Scientific Advisory Board 

Creates a 10-member scientific advisory board with 50 percent from out of state. Five of the total would be appointed by the chair of the agency and five by the president. (p.7) 

Expansion of Board from 29 to 35 

In addition to adding six members to the governing board, the chancellor of UC San Francisco would get one additional appointment. Two nurses also would be added to the board. Representatives from the state college system would be eligible for appointment. (p.7, p. 9)

The proposal additionally:

• Adds as criteria for selection of some board members “other vital research opportunities, therapy development, or therapy delivery,” “nursing” and “mental health” patient advocacy. Criteria for the board chairman would be expanded to include a “documented history” in “other vital research opportunity (sic) in therapy development and/or therapy delivery advocacy.” 
• Allows for ouster of some board members with a half of a term left at the time of the passage of the measure when a new appointment is made. (p. 10) 

Public Openness and Transparency 

The proposal: 

• Makes more information confidential including “progress reports” currently filed publicly by applicants. (p. 12)
• Includes “applications” as confidential, although that is current practice. Currently the agency is excluded from some transparency requirements that apply to other state agencies. (p. 12)

Royalties and License Revenues 

Royalties, including interest on them, shall be, to “the extent permitted by law...appropriated for the purpose of offsettinq the costs of providinq treatments and cures arisinq from institute-funded research to California patients who have insufficient means to purchase the treatment or cure, includinq the reimbursement of patient-qualified costs for research participants.” Currently the royalties flow to the state's general fund. (p. 14)

Number of CIRM Employees/Budgeting 

The measure would allocate at least $1.5 billion, with conditions, for awards dealing brain diseases, including Alzheimer’s disease, Parkinson's disease, stroke, dementia, epilepsy, schizophrenia, depression, traumatic brain injury, brain cancer and autism. (p.2)

Costs of CIRM “working” and advisory groups, application reviews, consultants and research conferences would be designated as “research funding,” meaning that they would not come out of the agency’s administrative budget, which is capped at 6.5 percent of $5.5 billion. (p. 23, p. 28)

The proposal also:

• Caps the number of employees nominally at 70 but allows the addition of 15 agency employees to deal with affordability issues. Also allows the addition of “employees funded throuqh sources other than bond proceeds or the (state) General Fund." (p. 19)
• Enacts formulas that restrict the use of bond funds in various categories, including new clinical programs, affordability, buildings and research equipment. (p.23)
• Establishes new rules and limits on indirect, administrative costs in grant awards, an important consideration for recipient institutions. (p.24, p.27)

Sacramento Biotech Interests Eyeing Proposed $5.5 Billion California Stem Cell Measure

The proposed $5.5 billion California stem cell initiative attracted some media attention this week in Sacramento in an article that said the area's biotech researchers and companies "are keeping a close eye on where those dollars go."

The piece by Felicia Alvarez in the Sacramento Business Journal outlined the impact of the state stem cell agency in the area and addressed the future should the measure win approval in November 2020. UC Davis has used $143 million from the agency to build its stem cell program. 

The article said more funding would dovetail nicely with plans for a development called Aggie Square by UC Davis at its Sacramento complex, which currently houses its stem cell program.  David Lubarsky, UC Davis Health CEO, said, 

“We believe many companies and life science manufacturers will gravitate to Sacramento and Aggie Square to align themselves with this technology."

Alavarez also wrote, 

"Aggie Square could eventually be expanded into a nationwide manufacturing site for stem cell-based medicines, and an eventual distribution hub, Lubarsky said."

However, Cate Dyer, CEO of StemExpress, expressed a desire for changes in the proposal. Dyer sits on the board of the UC Davis Institute for Innovation and Entrepreneuership. She said, 

“I would like to see some changes made to this bill in what Californians intended it to be — directly benefiting health care in California and returning the royalties and fees back to the state.”

Dyer also said some stem cell-related start up efforts out of UC Davis have struggled. Dyer said, 

“Students contact me all the time that are tied up in these agreements with the university that they can’t get out of. They can't get their business external enough that investors would want to come in.”

The Sacramento Business Journal article is a rare news story dealing with the proposed initiative, which would make sweeping changes in the state stem cell agency, formally known as the California Institute for Regenerative Medicine. 

Not all of those changes are beloved  by all members of its 29-member governing board, which has scheduled a meeting Friday morning to consider the proposal. (See here for a 3,300-word critique by one board member here. See here for an article on last week's sometimes testy discussion of the measure.)

Directors could, at Friday's meeting, make recommendations for alterations. The deadline for actually changing the terms of the measure is Monday at 5 p.m. The only person who can make changes in the proposal is Robert Klein, the sponsor of the measure and the first chairman of the stem cell agency. Directors of the agency have the choice of writing their own initiative as an alternative to Klein's or taking other alternative steps.

The meeting is open to members of the public, who can comment as well, at a number of locations throughout the state.  It is also scheduled to be available online. 

Have Your Say on $5.5 Billion California Stem Cell Measure; Locations, Internet Access to Public Meeting Friday

The public can participate and listen in on the stem cell agency's meeting on Friday dealing with the proposed, $5.5 billion ballot initiative that could lead to changes in the measure. Some of the agency's board members have already expressed reservations. 

The session is scheduled for two hours beginning at 9 a.m. It will be available via the Internet and also at telephonic locations throughout the state. Here is a current list of the locations, including the stem cell agency headquarters in Oakland.  The locations could change. Instructions for Internet access can be found on the agenda. 

• State stem cell agency -- 1999 Harrison Street Suite 1650, Oakland, CA 94612

Other Locations (updated Nov. 14, 2:36 p.m. PST):

• 10901 N. Torrey Pines Road, La Jolla, CA 92037
• 1001 Health Sciences Rd., Irvine, CA 92697
•  291 Campus Drive, Stanford, CA 94305
• 8700 Beverly Blvd 2015, Los Angeles, CA 90048
• 583 Mrak Hall, 1 Shields Ave., Davis CA  95616
• 100 Kimball Way, South SF, 94080
• 12-231 CHS, David Geffen School of Medicine, UCLA
• 4005 N Fresno St., Fresno, CA 93726
• 837 Health Science Road, Irvine, CA 92697
• 769 Evans Hall, University Dr, Berkeley, CA 94720
• 8170 Laguna Blvd., Elk Grove, CA 95758
• Marina Village Conference Center - 1936 Quivira Way, San Diego, CA 92109
• 765 Market St. Apt 31D, San Francisco, CA 94103
• 15775 Gum Tree Lane, Los Gatos, CA 95032
• 10850 Gold Center Drive, Suite 325, Rancho Cordova, CA. 95670
• 600 16th Street, Genentech Hall, S272D, San Francisco, CA  94158