California Stem Cell Performance Audits and More: Public Has 16 Golden Opportunities to Weigh In

Californians throughout the state next week will have what appears to be a record number of opportunities to participate -- albeit remotely -- in one of the more important, regular public meetings involving the $3 billion state stem cell agency.

The occasion is the March 13 meeting of the governing board of what is known formally as the California Institute for Regenerative Medicine or CIRM. The meetings of the CIRM governing board are the single most important public events that the agency holds.

The board has 29 members. Fifteen of those members will be participating remotely in next week's session, which means that the public can participate as well from those locations in addition to the physical site of the meeting at CIRM HQ in Oakland. The remote locations range from Fresno to La Jolla  and from Riverside to Elk Grove.

And if you are in New York City, you can weigh in from there as well. One of the agency directors will be hooked up from the Big Apple.

During the meeting, the board solicits public comment on each item under consideration plus general comments as well.

The top item on the agenda is the triennial performance audit of the agency, which in the past has

Graphic by Shopify

reported checkered but improving results in the last two reports. Conflict of interest issues surfaced in the last audit(see below).  In 2012, the audit, required by state law, identified 27 areas where improvements were needed.

The actual audit for this year has not yet been posted on the CIRM web site but is likely to pop up any day now.  The audit, which is required by state law, cost the agency $230,000, bringing to $694,944 the total that the agency has spent on its three performance audits.

If you are interested in attending at the remote locations, check the addresses in advance. Sometimes not enough specificity is provided. But an email to info@cirm.ca.gov will provide full directions.

Here is a link to the 2017 CIRM request for a proposal to conduct the performance audit.

Below are excerpts and links to previous items on the two earlier performance reports. At the end is a comparison of performance audit findings to results from other studies of the agency.

SUNDAY, MAY 17, 2015

Conflict-of-Interest Failings Reported in Application Reviews at California Stem Cell Agency

Conflict-of-interest issues have dogged the $3 billion California stem cell agency since its inception, and they are surfacing once again this week in a report commissioned by the agency itself.

This time the matter is being brought up by Moss-Adams, LLP, of Seattle, a business consulting firm that is being paid $230,000 by the agency to conduct a "performance audit."

In a report to be discussed at a CIRM governing board meeting on Thursday, the firm said it discovered serious problems dealing with the reporting of the interests of the agency's blue-ribbon reviewers.

TUESDAY, MAY 19, 2015

California Stem Cell Audit: Praise for Mills but More Work Needed on IP, Conflicts of Interest

The California stem cell agency this week received good marks for changes made by its new president, but it is also being told that it needs to improve how it tracks potential royalties and how it prevents grant reviewer conflicts of interest.

SUNDAY, MAY 17, 2015

Conflict-of-Interest Failings Reported in Application Reviews at California Stem Cell Agency

Conflict-of-interest issues have dogged the $3 billion California stem cell agency since its inception, and they are surfacing once again this week in a report commissioned by the agency itself.

This time the matter is being brought up by Moss-Adams, LLP, of Seattle, a business consulting firm that is being paid $230,000 by the agency to conduct a "performance audit."

In a report to be discussed at a CIRM governing board meeting on Thursday, the firm said it discovered serious problems dealing with the reporting of the interests of the agency's blue-ribbon reviewers.

THURSDAY, MAY 24, 2012

CIRM Directors Pleased with Performance Audit Findings

The $3 billion California stem cell agency received a "very favorable" performance audit report compared to other government agencies, CIRM directors were told today.

Representatives of Moss Adams, which was paid $234,944 by CIRM for the study, made the comments during a presentation today to the agency's 29 directors. During their comments, CIRM executives and directors focused on the favorable aspects of the findings of the six-month study.

TUESDAY, MAY 15, 2012

IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

The $3 billion California stem cell agency is laboring under a range of problems that include protection of its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month study said yesterday.

The performance audit by the Moss Adams accounting firm of Seattle, Wash., made 27 recommendations for improvements, including more effort to ease strain connected to the agency's controversial dual executive arrangement. The study said that the nearly eight-year-old agency has many "opportunities" to "enhance performance reporting and decision making, strengthen effectiveness and efficiency, retain essential human resources and leverage technology."

In response to the report, the stem cell agency said, "(M)anagement concurs with the findings and recommendations....The recommendations are focused and constructive. CIRM is already implementing many of these recommendations, and we will be investigating the others in the coming months."

--

Here is a link to the California state controller's comparison of the findings of the 2012 performance audit to previous findings from a number of enterprises ranging from the National Academy of Sciences to the state's Little Hoover Commission. 

California Makes a $25 Million Kidney Transplant Wager: Its 44th Stem Cell Clinical Trial

The California stem cell agency this week more than doubled down on its bet on a potentially breakthrough treatment for kidney transplants, raising to $25.4 million its support for a project that is entering its final stages.

The hope is that the treatment will not only improve the success rate of kidney transplants but also lead to use in liver, heart and other solid organ transplants. If successful, the therapy would eliminate the need for immunosuppressive drugs in genetically matched kidney transplant patients.

Maria Millan, CIRM photo 

Maria Millan, president of the agency, said in a news release:

“These immunosuppressive drugs not only can cause harmful side effects, but they are also expensive and some patients lose their transplant either because they can’t afford to pay for the drugs, or because their effectiveness is not adequate."

The award also could help save the life of the stem cell agency, which is facing its financial demise as its funding runs out.

The award brings to 44 the number of clinical trials being assisted by the $3 billion agency, formally known as the  California Institute for Regenerative Medicine(CIRM). Clinical trials are the last stages of research prior to certification by the federal government of a treatment for widespread use.

The stem cell agency is hoping that one of its trials will soon produce a therapy that will resonate with California voters who may be asked in 2020 to provide $5 billion more. The agency expects to run out of state funding next year and is attempting to raise more than $200 million privately to tide it over until a bond election in  November 2020.

Action on the award was swift on Thursday. It took less than eight minutes for the agency governing board to unanimously approve an $18.8 million award to Medeor Therapeutics, Inc., of San Mateo, Ca. The award comes on top of a $6.7 million investment in the firm's research in 2016.

Steven Deitcher, Medeor photo

The vote simply ratified a decision on the Phase 3 trial that was already made by the agency's reviewers, who gave the research strong support during a meeting behind closed doors weeks earlier.

Steven Deitcher, co-founder and president of Medeor, said in the agency's news release,

"CIRM funding accelerates our timelines, and these timelines are what stand between needy patients and potential transformative therapies. This CIRM award combined with investor support represent a public-private collaboration that we hope will make a difference in the lives of organ transplant recipients in California, the entire U.S., and beyond."

Tracking the $3 Billion California Stem Cell Agency Month by Month

Directors of the California stem cell agency plan to meet 12 times during the coming year, including four valuable face-to-face sessions that are likely to be based at its Oakland headquarters.

Valuable because those sessions offer an opportunity to chat directly with directors and the agency's staff. The face-to-face sessions are scheduled for March 13, June 28, Sept. 20 and Dec. 13. Topics for the meetings will come later when agendas are posted 10 days before the sessions. But the June and December meetings have often dealt with important financial and strategic issues.

Researchers who have attended the board sessions in the past have benefited from gaining a greater understanding of the application review process and procedures of the board as it ratifies reviewer decisions and hears appeals.

The other eight meetings are telephonic and are scheduled to occur on Jan. 18, Feb. 22, April 26, May 24, July 26, Aug. 23, Oct. 18 and Nov. 29.

To be announced during the year on an ad hoc basis are meetings of the committees of the governing board, which regularly consider important issues and approve policies and actions that are often summarily ratified by the board.

All of the meetings can be tracked by subscribing to notifications from the agency and by reading the California Stem Cell Report, which tries to provide a deeper look at some of the matters facing the stem cell agency.

The public can attend all the meetings at either remote locations and the CIRM headquarters and can address the board directly. If you just want to listen, an audiocast is available. After the meetings, which are also accessible as a recording, transcripts become available a couple of weeks later. 

California Stem Cell Board to Hash Over Cuts, Future Financing Plans Next Week

Directors of the $3 billion California stem cell agency, which is facing the loss of its funding, are scheduled for one of their more consequential meetings late next week -- a session that will deal with cutting the size of awards and planning for life after 2019.

The meeting Dec. 14 will continue a discussion that began last September and that now involves a possible $5 billion bond ballot measure, a private, $222 million fundraising campaign and major  reductions in the size of awards over the next two years.

The agency projects it will run out of cash for new awards in 2019. It is financed by California state bonds but that source is drying up under the terms of the ballot measure that created the effort in 2004.

Details of what exactly will be presented next week to the 29-member governing board were not available -- as of this writing -- on the web site of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. More information is expected to be posted in the next few days, but it is likely to resemble closely the matters discussed in late November by the directors. 

Also on tap are changes in the basic research and translational award programs and ratification of reviewer decisions on grant applications in the "Quest" program, which is aimed at development of technology that is uniquely enabled by stem cells. 

The meeting will be based in Oakland with teleconference locations where the public can participate in New York City, Stanford, Santa Cruz and San Diego. The meeting will be audiocast on a listen- only basis. More details can be found on the agenda.  Regarding the New York City site, from time to time teleconference sites have been set up out-of-state when a director is traveling.

The California Stem Cell Report will be covering the meeting live from CIRM's Oakland headquarters.

$75 Million For California Stem Cell Research: Brain Cancer, Sickle Cell, Alpha Clinics and More

OAKLAND, Ca. -- The California stem cell agency yesterday handed out $75 million, doubling down on a couple of efforts to develop a stem cell therapy and a stem cell tool, plus funding an expansion of its Alpha Clinic network with two new, Northern California sites.

The awards bring to $2.34 billion that the nearly 13-year-old agency has committed to stem cell research. The awards also leave the agency with $414 million in uncommitted funds. The state research program, formally known as the California Institute for Regenerative Medicine (CIRM), expects to run out of cash for new awards in less than three years.

The clinical program awards yesterday targeted such afflictions as diabetes, brain cancer and sickle cell anemia. One award of $20 million set a new mark for one CIRM-funded project.

That award went to Viacyte, Inc., of San Diego, bringing to more than $71 million that the agency has pumped into the firm, the largest amount provided to any single project. The firm is seeking to create an implant that would basically be a virtual cure for diabetes.

Also reinforced with more millions was Humacyte, Inc, of North Carolina. It received $14.1 million for its stem cell tool on top of the $10 million it has already received.  The firm is working on a new type of "lifeline" for kidney disease patients undergoing hemodialysis.

The agency's Alpha Clinic Network received a $16 million infusion, split between two new sites, one in Sacramento and the other in the Bay Area. The latter is a joint effort involving pediatric work and UC San Francisco and Childrens' Hospital Oakland. The other award went to UC Davis, whose stem cell program is located in neighboring Sacramento. The Alpha network already has three sites in Southern California at City of Hope, UC San Diego and UCLA/UC Irvine. 

In a CIRM news release,  Abla Creasey, CIRM’s senior director of Strategic Clinical, Regulatory, and Infrastructure Programs, said,

“The Alpha Clinics are a one-of-a-kind network that gives patients access to the highest quality stem cell trials for a breadth of diseases including cancer, diabetes, heart disease and spinal cord injury.” 

Cedars-Sinai in Los Angeles lost out on its bid to be added to the Alpha network. The agency had allotted only $16 million to the expansion under its strategic plan. Directors have been loathe to add more funding to the plan. 

Other clinical stage funding included:

• City of Hope, $12.8 million, PI Christine Brown, a Phase 1 CAR-T trial targeting an aggressive brain cancer called malignant glioma.
• Nohla Therapeutics Inc., Seattle, Wa.,$6.9 million, a Phase 2 trial dealing with neutropenia, a condition that leaves people susceptible to deadly infections after receiving chemotherapy for acute myeloid leukemia.
• Forty Seven Inc., Menlo Park, $5 million, a Phase 1b clinical trial treating acute myeloid leukemia. 
• Stanford, $5.2 million, PI Matthew Porteus, preparatory work for a clinical trial on a genome editing technology to correct the sickle cell disease mutation.

Here are links to summaries of the reviews of each application: UC Davis, UCSF/Childrens' Hopsital, Cedars-Sinai, Viacyte, Humacyte, City of Hope, Nohla, Forty Seven, Stanford.

California Stem Cell Board in Executive Session on New President

OAKLAND, Ca. -- Directors of the $3 billion California stem cell agency this morning opened their meeting at  9:07 a.m. as they were set to award roughly $80 million and name a new president. 

David Martin was introduced as the latest member of the 29-person board.  Martin is chairman and  CEO of  AvidBiotics Corp . of South San Francisco. 

The board immediately moved into executive session to consider the appointment of a new president who left the agency at the end of June.

Tap into Stem Cell Agency's Meeting Tomorrow

Several new, teleconference locations have been added to the list of those where the public can take part in tomorrow's meeting of the governing board of the $3 billion California stem cell agency.

On the agenda is appointment of a new president for the agenda and the award of roughly $80 million to California researchers.

Here is the latest list of locations apart from the meeting site at the agency's headquarters in Oakland. The agenda has more information regarding internet and audiocast access on a listen-only basis.

1. 1156 High Street, 200 Kerr Hall, Santa Cruz CA 95064 - Location available 9:00 to 11:30
2. 291 Campus Drive, Stanford, CA 94305 - Location available 9:15 to 11:00
3. 500 Hayes Street, San Francisco, CA - Location available 9:00 to 12:00
4. 9500 Gilman Drive and Meyers Leichtag Bldg. Room 284 La Jolla, CA 92093
5. 8700 Beverly Blvd 2015, Los Angeles, CA 90048
6. 700 Tiverton Avenue, Los Angeles CA 90095
7. 10996 Torreyana Road, Suite 200 San Diego, CA 92121

Thinking About Its Demise: California Stem Cell Agency Launches Examination of Alternatives

California's $3 billion stem cell research agency, which is facing its financial demise in a few short years, has formed a team of its directors to tackle transition planning and examine possible alternatives, including ones that would extend its life.

The first meeting of the group of directors is tentatively scheduled for Sept. 18. Jonathan Thomas, chairman of the governing board of the California Institute for Regenerative Medicine(CIRM), as the agency is formally known, said earlier this summer:

"The legislature has asked that we put together and start thinking about a transition plan, which can contemplate a variety of factors."

In response to a question last week, a spokesman for the agency, Kevin McCormack, said that a notice with more details would be posted 10 days prior to the meeting.

At a meeting in June, Thomas laid out the need for the transition team. He said all options are on the table including asking the legislature for cash or to place a measure on the ballot for more bond funding.

The agency's only real source of money is state bonds, authorized by voters in 2004. It has roughly $600 million left. The agency has projected it will run out of cash for new awards in mid 2020, although that could vary, depending on whether it slows down the pace of awards.

Several directors at the board meeting in June expressed a "sense of urgency" about dealing with the fate of the agency. CIRM Director Jeff Sheehy, a member of the San Francisco board of supervisors and an HIV/AIDS patient advocate, voiced concern about the uncertain nature of the agency's future.

Sheehy said,

"It seems to me that we will be talking about a substantial scaling back of the organization in 2020....We've kind of created this expectation that we were going to go to 2018 and come back with new money."

Sheehy referred to talk that a new bond initiative might be launched in 2018, a move that the board's former chairman, Robert Klein, has publicly advanced. Sheehy said, however, that he spoke with Klein, who told him that he was now considering 2020 instead.  Klein's method would require the gathering of hundreds of thousands of valid voter signatures to place the proposal on the ballot and would bypass the legislature. 

The year 2020 includes a presidential election, which has higher voter turnout and generally is considered a better time to win approval of bond measures. Presumably, the agency might be able to secure extra funding to span any financial gap or, alternatively, lower the frequency of awards to stretch out the cash. 

The members of the transition group are Thomas, Sheehy, Art Torres, Steve Juelsgaard, Joe Panetta, Kristiina Vuori, Linda Malkas, Diane Winokur, Shlomo Melmed, Al Rowlett and Judy Gasson. Short bios on each of them can be found via this page. 

The California Stem Cell Report will carry an item with the date and location of the September meeting when it becomes available. 

California Stem Cell CEO Search: Lid Still on Until Late September

The  governing board of the $3 billion California stem cell agency, which is seeking a new president, does not plan to have another meeting of its presidential search committee until possibly this fall.

The committee has held only one meeting since May 2, when Randy Mills announced he would be leaving at the first of July.  Maria Millan, formerly vice president for therapeutics, has been serving since July 1 as interim president. She has the backing of Mills to fill the slot permanently. 

The meeting of the search committee occurred July 17. And the agency has remained virtually mum on the process of selecting a new president to oversee what some call the final stage of its life. It is scheduled to run out of cash for new awards in about three years. 

Last Monday (July 31) , the California Stem Cell Report carried an item on the dearth of information about the process of selecting a new president, including the lack of a public timetable and addressing such questions as whether a search firm would be involved. The position carries a salary of up to $575,000.

Following publication of the item, Kevin McCormack, senior director for communications at the agency, sent the following email. 

"Just to be absolutely clear, this is exactly the same process we followed when we were looking for a replacement for Alan Trounson. Then, as now, we did not disclose the results of the closed session meetings of the Presidential Search Subcommittee nor described the contents or outcomes.  From the very beginning of this process, and we mentioned this at the last board meeting, the intention was for the subcommittee to meet and evaluate the options for finding a replacement for Randy and then for the matter to be taken up at the very next meeting of the full ICOC (the governing board). There is no 'lack of information' nor is there any intention of holding another Presidential Search Subcommittee meeting before the full board meeting in September."

The agency, however, has a record of difficulty in recruiting new presidents, including rejected offers and board discord on the desired qualities in a CEO.  It also has in the past disclosed such things as timetables and search firms and more. (See here, here and here.)

Zipped Up in Oakland: California Stem Cell Agency Mute on Search for New CEO

More than mum -- a good description for the $3 billion California stem cell agency this morning as it wrestles with what is likely its most important decision of 2017.

And that is finding a new president to oversee what some call the "last stage" of its life and its search for a stem cell therapy that will fulfill the expectations of the voters who created the research program in 2004.

The governing board of the California Institute for Regenerative Medicine (CIRM), as the Oakland-based agency is formally known, has held one meeting of its presidential search committee since Randy Mills announced his resignation May 2.

No public utterances emerged, however, from the July 17 session. Did the panel set a timetable for selecting a new president? No response. Will the board hire a search firm to help recruit? No response. Is the search committee going to meet again? No response. Simple questions that have been dealt with openly in past presidential searches at CIRM.

The search for a replacement for Mills has special significance. The agency expects it will run out of cash for new awards in three years or less. In the world of stem cell research, that may not be a nanosecond but it is a very short period of time.

Maria Millan, CIRM photo

It raises the likelihood of an exodus of staff from the program, which has also lost another linchpin in the organization, general counsel James Harrison. Without some certainty and confidence about the next three years, some CIRM employees, of which there are only about 50, may look to other enterprises for their professional futures. The likelihood of more departures could increase unless the board moves to shore up stability and to help retain the energy that Mills brought to the program.

Maria Millan, formerly the vice president for therapeutics, is interim president. Mills publicly endorsed her to fill his slot, which carries an annual salary of up to $575,000. She has been in place for one month. She too may be wondering about the stability of her position and whether she should be looking elsewhere for a position.

The next meeting of the governing board of the agency is set for Aug. 24. CIRM Chairman J.T. Thomas usually gives a report to the board at many meetings. He skipped that at the board meeting in July. Will he will brief the board at the August meeting on the presidential search? That has not yet been publicly disclosed.

Former USC Med School Dean Loses Board Seat at $3 Billion California Stem Cell Agency

Former USC medical school dean Carmen Puliafito, who reportedly led a secret life involving drugs and prostitution, is no longer a member of the governing board of the $3 billion California stem cell agency.

In response to a query last week from the California Stem Cell Report, Evan Westrup, press secretary to Gov. Jerry Brown, said,

"This individual is no longer on the board."

Carmen Puliafito
Photo by Tibrina Hobson, FilmMagic

However, as of this writing, the web site for the agency listed Puliafito as a member of the governing board, carrying a short biography and a photo.

In response to a question this morning, Kevin McCormack, senior director for communication for the agency, said,

"If the governor says he is not in the board then he is not on the board. We will change the web page."

The governor's office did not respond to requests last week for more details concerning Puliafito's departure. But his term expired last December. Agency board members may continue to serve until a replacement is named.

The position that Puliafito held on the board of the California Institute for Regenerative Medicine(CIRM), as the agency is formally known, is required to be filled by an executive from a California university. Since the inception of the agency in 2004, the seat has been filled by the dean of the USC School of Medicine.

Puliafito (far left) at ceremonies opening stem cell center at
USC. CIRM provided $27 million for the $80 million project.
 Then CIRM board chairman Bob Klein is second from right.
Then Gov. Schwarzenegger stands next to Puliafito, who he
appointed to the CIRM board. 

It is not clear whether the governor will replace Puliafito with another representative from USC. Brown may look askance at the school in the wake of reports about how USC handled the Puliafito affair over a period of more than a year. 

A headline on a column last week by Los Angeles Times columnist Steve Lopez said,

"USC bosses flunk the leadership test amid shocking allegations about former medical school dean"

USC ranks 6th among California institution in the amount of awards it has received from CIRM, collecting a total of $110 million.

Correction

Two items today and yesterday on the California Stem Cell Report incorrectly said that Carmen Puliafito was reappointed as a member of the stem cell agency's governing board in 2010 by Gov. Jerry Brown. The re-appointment was made by then Gov. Arnold Schwarzenegger. Brown was elected in 2010 but did not take office until 2011.

'Secret Life' Flap: Former USC Med School Dean-Stem Cell Agency Board Member on Leave from School

The former dean of the USC medical school, who is also a member of the governing board of the $3 billion California stem cell agency, is on leave and no longer seeing patients, the Los Angeles Times is saying today.

The news came after the Times reported yesterday that Carmen Puliafito had a "secret life" involving illegal drug activity, some of which was captured on video.

Puliafito was appointed in 2008 to the 29-member board of the California Institute for Regenerative Medicine (CIRM), as the agency is officially known,  by then Gov. Arnold Schwarzenegger and reappointed by him in 2010. Puliafito's term expired last fall but he is permitted to serve until a replacement is named.

The governor's office has not responded to requests yesterday by the California Stem Cell Report for a comment about the matter.

Puliafito has made no comment about the Times' reports.

(Editor's note: An earlier version of this item incorrectly said that Puliafito was reappointed by Gov. Jerry Brown. Brown was elected in 2010 but did not take office until 2011.)

LATimes: 'Secret Life' of Former USC Med School Dean and California Stem Cell Agency Director

Carmen Puliafito (right), a member of the governing board of the California
stem agency, and Robert Klein, then chairman of the agency. USC photo 2009

The headline in the Los Angeles Times this morning said:

"An overdose, a young companion, drug-fueled parties: The secret life of USC med school dean"

Put together by a team of five reporters, the article called Carmen Puliafito a "towering figure," a "renowned eye surgeon" and a prodigious fund raiser, bringing in more than $1 billion for USC by his own estimate. And then it said, 

"During his tenure as dean, Puliafito kept company with a circle of criminals and drug users who said he used methamphetamine and other drugs with them, a Los Angeles Times investigation found.

"Puliafito, 66, and these much younger acquaintances captured their exploits in photos and videos. The Times reviewed dozens of the images."

Puliafito resigned his $1.1 million position as dean in March 2016, declaring he wanted to pursue outside opportunities. He still serves, as a gubernatorial appointee, on the board of the California Institute for Regenerate Medicine (CIRM), as the stem cell agency is formally known. The board position pays $100 a day for meeting attendance. The board meets 10 to 12 times a year. 

USC has received $110 million from CIRM since 2004, ranking No. 6 among all California institutions that have won stem cell awards from the state agency. USC has had a representative on the board since its inception in 2004.

Paul Aisen, San Diego UT photo, Howard Lipin

Puliafito remains on the USC faculty and continues to accept patients. He is a "central witness" in a $185 million, legal wrangle involving UC San Diego researcher Paul Aisen. Puliafito has described himself as the "quarterback" in the effort to hire Aisen away from UC San Diego. The Times wrote,

"Curing Alzheimer’s is a top priority for government agencies and pharmaceutical companies, and Aisen’s lab was overseeing groundbreaking research, including drug trials at 70 locations around the world. More than $340 million in funding was expected to flow to his lab, according to court records.

"UC contended in its suit that its private school rival went beyond the bounds of academic recruiting by targeting professors and labs based on grant funding. The suit accused USC of civil conspiracy, aiding and abetting breach of fiduciary duty and other misconduct."

Puliafito's current term on the stem cell agency board term expired Nov. 3, 2016, according to a governor's office document. However, members of the board may serve until a replacement is named. He was appointed in 2008 by then Gov. Arnold Schwarzenegger and reappointed in 2010, also by Schwarzenegger, according to the governor's office document.

In response to a query, Kevin McCormack, senior director of communications for the agency, said via email,

"We were surprised to read the allegations about Dean Puliafito in the Los Angeles Times. Since being appointed to the CIRM Board by Governor Arnold Schwarzenegger, in late 2008, Dean Puliafito has served with distinction, bringing knowledge, expertise and deep commitment to our mission."

The California Stem Cell Report also asked Brown's office for comment. When it responds, the full text of the comments will be carried.

The reporters who put together the story are Paul Pringle, Harriet Ryan, Adam Elmahrek, Matt Hamilton and Sarah Parvini.

(Editor's notes: An earlier version of this item said that Puliafito was reappointed by Brown in 2010. The re-appointment was by Schwarzenegger. Brown was elected in 2010 but did not take office until 2011.
(This article was picked up Capitol Weekly, a news and information service devoted to California public policy issues. The Capitol Weekly version can be found here.)

CIRM Directors Open Morning Meeting

BURLINGAME, Ca. -- Directors of the $3 billion California stem cell agency opened their meeting this morning at 9:06 a.m. with  introduction of the newest member of the board, Linda Malkas of the City of Hope, and a report from Chairman Jon Thomas.

Diabetes to Arthritis: California Awards $33 Million for Clinical Stage Stem Cell Work

The California stem cell agency today approved nearly $33 million for clinical stage research projects testing treatments for type 1 diabetes, arthritis of the knee, ALS and an immunodeficiency affliction.

The awards were quickly approved with little discussion during a meeting at the Oakland headquarters of the California Institute for Regenerative Medicine or CIRM, as the agency is formally known.

The award likely to have an impact on the most people -- if it is successful -- is a relatively small, $2.3 million award to the Cellular Biomedicine Group,  a Chinese firm with operations in Cupertino, Calif. The stem cell agency by law only finances work in California. The research would also be supported by $572,993 in co-funding.

The project is aimed at treating osteoarthritis of the knee. More than 51 million people in the United States suffer from arthritis, which is particularly common in the knee.

The goal of the research is to regenerate knee cartilage through the use of a mesenchymal progenitor cell treatment, according to the agency's application review summary. The funding would go to manufacture the product and complete work to secure Food and Drug Administration approval for a phase one safety trial. A treatment for the public would likely be years in the future.

Here are the other winners today of California stem cell cash with links to the summaries of the reviews.

Caladrius Biosciences of New Jersey won $12.2 million for a clinical trial for young people ages 12-17 for newly diagnosed type 1 diabetes. The firm plans to use regulatory T cells from the patients themselves to treat the disease. Caladrius has a California location in Mountain View. (Caladrius' press release can be found here.)

St. Jude's Research Hospital in Memphis, Tenn., was awarded $11.9 million for a phase one/two trial to treat infants with X-linked severe combined immunodeficiency. The trial would aim at enrolling at least six patients suffering from the catastrophic affliction. The treatment would use the patients own bone marrow stem cells after the cells were specially handled. The agency said in a press release that St. Jude's is working with UC San Francisco. (St. Jude's press release can be found here.)

Cedars-Sinai Medical Center in Los Angeles was awarded $6.2 million for a phase 1/2A trial to test a treatment for ALS, which has no treatment or cure. The CIRM review summary said a "huge unmet need" existed. About 20,000 persons in the United States suffer from the affliction.

CIRM's press release did not identify the researchers involved in any of the awards.

The agency is on a push to support more clinical trials, which are the last and most expensive research prior to the possibility of winning federal approval for widespread use of a therapy.

Currently the agency is participating in 27 trials and is planning on adding 37 more in the next 40 months. The agency is expected to run out of funds for new awards in June 2020 and has no source of future financing.

The awards were previously approved behind closed doors by the agency's out-of-state reviewers, who do not disclose publicly their economic or professional interests. The agency's directors rarely overturn a positive decision by the reviewers.

All of the winners have links to two or more members of the 29-member CIRM governing board. Those members are not allowed to vote on applications where they have conflicts of interest.
About 90 percent of the funds awarded by the board since 2005 have gone to institutions that have ties to members of the board, past or present, according to calculations by the California Stem Cell Report.

(Editor's note: An earlier version of this item incorrectly said the total amount of awards was $37 million.)

California Stem Cell Agency Ends Today's Session

Directors of the California stem cell agency concluded their meeting at about 3:10 p.m. PST today. The California Stem Cell Report will carry an item a little later today on the awards made at the session.

First Time: California Stem Cell Directors Open Session in CIRM HQ in Oakland

CIRM graphic showing state of its administrative budget as of today 

The governing board of the $3 billion California stem cell agency this morning opened its meeting at 9:10 a.m. PST at its Oakland headquarters, the first time such a meeting has been held at the physical offices of the 12-year-old enterprise.

In the past, the 29-member board has held meetings at hotels and university campuses. Those sessions cost thousands of dollars for room rental, audio services and more. Today's meeting is a face-to-face session of the board. About half of the directors' meetings are currently conducted via telephone and are much less expensive than the face-to-face sessions, which were standard earlier.  About 12 meetings are scheduled each year. 

Reducing administrative costs is critical for the agency, which has a lifetime, operational budget that is capped by law at $180 million, 6 percent of the $3 billion in bond funding that voters allotted when they created the California Institute for Regenerative Medicine (CIRM) in 2004. 

Its staff numbers slightly more than 50 persons and was in the 20s during its early days, not much more than it takes to staff a 24-hour Burger King, if that. 

The agency projects it will run out of cash for grants sometime in 2020 but will need to fund operational expenses beyond then as multi-year awards wind down.

(The CIRM graphic was not included in an early version of this item.)

California to Hand Out $32 Million for Stem Cell Research Next Week

The California stem cell agency next week is expected to award as much as $32 million for late stage research and clinical trials involving therapies for arthritis of the knee, type 1 diabetes, an immunodeficiency affliction and ALS. 

Also on tap for the Feb. 23 governing board meeting are concept proposals for expansion of the Alpha Clinic program along with unspecified changes in the $3 billion agency's discovery, translation and clinical plans. 

Four awards are already approved by the agency's reviewers and are scheduled for routine ratification by the board. Their review summaries can be found on the agenda. The reviewers also rejected one proposal for research involving Parkinson's disease. That summary can also be found on the agenda.

More details on the concept plans are expected to be posted soon. The meeting will take place in Oakland with public teleconference locations in in San Diego, Los Angeles and two in La Jolla. Addresses can be found on the agenda. 

Latest Targets of the California Stem Cell Agency: $26 Million for Zika, Heart Disease and Much More

The California stem cell agency next Thursday expects to award nearly $26 million to 14 scientists to seek therapies for afflictions ranging from cystic fibrosis to Zika.

The awards have all been approved by the agency's out-of-state reviewers in a round called "Quest." The $3 billion agency's board is scheduled to ratify reviewers' decisions at a telephonic meeting next week. The board almost never overturns its reviewers' decisions.

The expected outcome of a Quest award is "a candidate therapeutic, medical device, diagnostic or tool that is ready for translational stage activities."

The application receiving the highest score, 95, is seeking to develop "CRISPR/Cas9 mediated FOXP3 gene editing in patient-derived hematopoietic stem cells as a cure for IPEX syndrome."

The review summary on the $1.1 million proposal said,

"Using CRISPR/Cas9 gene editing, we will insert a wild type copy of the FOXP3 gene into patient derived HSCs, enabling pre-clinical proof of concept data for clinical trials that could reduce IPEX patient pathologies. This work will the first-in-man demonstration of the curative potential of edited HSCs and will help maintain California’s lead position in stem cell research and cure."

IPEX syndrome is a rare disease that can lead to diabetes and severe enlargement of secondary lymphoid organs.

The Zika award received the second highest score, 93. It is aimed at determining the "the impact of the Zika virus during human neurodevelopment and to test a FDA-approved therapeutic candidate to treat Zika infection." The research is budgeted for $2.1 million. 

The largest award, $2.4 million, is aimed at a gene therapy to "regenerate heart muscle for the 23 million adult and pediatric patients with heart failure, for whom there are currently no disease-modifying therapeutic approaches."  It received a score of 88.

The cystic fibrosis application was scored at 85, which was right at the cutoff line for funding. The proposal is aimed at "genome editing to correct cystic fibrosis mutations in airway  stem cells."  The application sought $2.2 million.

The reviews of 14 applications can be found here along with the reviews of unsuccessful applicants who scored from 84 to 65. None of the names of the applicants have been released yet by the agency, which withholds the information until after the board ratifies the reviewer decisions. 

Here is a link to the agenda for the meeting, which includes remote locations throughout the state at which the public can participate in the meeting and speak to the board. The meeting is also expected to be available through an audiocast. 

Remote locations include Oakland, San Diego, Napa, Irvine, Los Gatos, Elk Grove and San Francisco. Specific addresses can be found on the agenda.