More Information Available This Morning on Future Direction of $12 Billion, California Stem Cell Program

California's $12 billion stem cell research program, which is embarking on a major new pathway, has posted additional information online that provides some clues to its direction for the next five years. 

The information comes in the form of 33 pages of slides to be used today at a daylong, public meeting of the agency's governing board. The slides were created by Maria Millan, president of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, and other top executives of the enterprise. 

While the slides need considerable explanation, which will be forthcoming later today, they provide a start for those seeking to understand how the 16-year-old agency is planning to spend $5.5 billion in the Golden State over the next decade or so. 

Beyond the 33 pages of slides, other information is being offered as well that deals with a $182 million awards budget for the next six months and new requirements for sharing research data and increasing diversity.  

Still missing is information on the launch of the agency's new effort at dealing with affordability and access questions involving stem cell treatments, a new task created by Proposition 14, the ballot initiative that saved CIRM's financial life. 

The agenda for Monday's meeting contains instructions for participating in the online meeting. Written comments are always useful as well as oral presentations. Written material can provide needed backup for the briefer oral comments and are directly in front of CIRM directors and staff. Comments should be emailed to kmccormack@cirm.ca.gov.

The session starts at 9 a.m. PST today.

Speak Up: Time to Help Shape California's $12 Billion Stem Cell Future

One of the excellent features of California's $12 billion stem cell program has little to do directly with science. The feature does not deal with petri dishes, genetic manipulation or microscopes.

It has a lot to do, however, with the stem cell agency's responsiveness to the public. It involves the persons behind the test tubes and even the Big Pharma companies that are the key to bringing stem cell therapies into widespread use. 

What we are talking about is fundamental to building trust in the California Institute of Regenerative Medicine (CIRM), as the stem cell agency is officially known, and whether CIRM can sustain itself beyond the date when its money runs out again in a decade or so. 

On the surface, it's a simple matter: the ability of the public, scientists and businesses to weigh in on how CIRM spends its next $5.5 billion -- the amount that the people of California are borrowing to pay for the agency's forays. 

Next Monday represents a first-rate opportunity for the public and the myriad interested parties to show up and speak up, both to the board that governs CIRM and its top executives. Some of the matters on the table at Monday's CIRM directors' meeting are, in one form or another:

• Should CIRM spend $100 million for clinical work over the next six months and only $22 million on basic research? 
• Should it change its diversity requirements to require more awards to a more diverse group of scientists?
• Should it require wider research data sharing to improve the quality of work across the field or should it cosset CIRM-financed findings to shield intellectual property?
• How should the state spend up to $155 million to improve stem cell treatment affordability and patient access to therapies and clinical trials? Does such an effort actually represent an unnecessary subsidy to the businesses involved?

Anybody who desires to do so can participate in the CIRM board meeting, which will be online. Questions can be asked. Suggestions can be made. Complaints can be aired. 

The session represents the first big step into CIRM's new world of Proposition 14, the ballot initiative the provided the new, $5.5 billion in bond funding. The measure  also set CIRM on a wider course that offers fresh opportunities that are not without challenges.  

Deciding how to spend $5.5 billion is not a minor matter. It is tiny, however, compared to the dense processes used by another government research organization -- the 27 branches of the National Institutes of Health and their multitude of advisory bodies. In contrast, California's stem cell program is wide open, transparent and accessible to the people most affected. 

What happens beginning Monday and over the next year will fundamentally shape the success or failure of California's stem cell program, the largest such state effort in the nation and the first in California's history. 

CIRM stands open to influence -- for better or worse -- by patients, the general public, researchers and companies that have received nearly $3 billion over the last 16 years. It is now up to all those folks and more to speak up and help CIRM in its efforts to bring to market the much-heralded stem cell therapies and to be a first-rate steward of the people's money. Plus, speaking out is in the best personal and professional interests of those involved.

The agenda for Monday's meeting contains instructions for participating in the online meeting. Written comments are always useful as well as oral presentations. Written material can provide needed backup for the briefer oral comments and are directly in front of CIRM directors and staff. Comments should be emailed to kmccormack@cirm.ca.gov.

The session starts at 9 a.m. PST Monday. Don't miss an opportunity to help shape the course of California's program to cure untreatable diseases and to lead the way globally on stem cell research. 

How Does $5.5 Billion Become Only Five Bucks? A Question Yet to be Answered

Call it California's five-buck, stem cell mystery. It could be a case of Proposition 14  campaign voodoo or just simply a boring calculation, but no one knows -- at least anyone who is willing to talk. 

As readers may recall, Proposition 14 is a $5.5 billion bond measure (plus a lot of other things) aiming at saving the state stem cell agency from financial extinction. The folks behind the ballot initiative, including Robert Klein, the sponsor of the proposal, are telling California voters to never mind that billion-dollar stuff. 

"Proposition 14 will cost the state an average of less than $5 per person, per year – about the cost of a bottle of aspirin," Klein said way back in July.

He may be right. 

However, Klein, who has already put up millions for the measure and heads the campaign, has not explained how he or his team devised the bottle-of-aspirin figure. The California Stem Cell Report has asked the campaign more than once to explain the figure, most recently just last Wednesday. But so far no explanation has been forthcoming. 

Arriving at such a per capita cost involves a number of assumptions, including population projections over the next 20 to 30 years and interest rates over the same period. Of course, it also should be noted that the five-buck figure is per capita not per taxpayer. That means that taxpayers -- because they now number only about 18 million compared to the total population of about 33 million -- will be paying perhaps twice what the campaign claims. 

Some might say this is no big deal, and they may be right. But a substantial number of persons could believe that this black-box, five-buck number is real because it has been repeated so often, even though it is unsubstantiated. Certainly, the campaign hopes that it will be effective and move a fair amount of voters into the "yes" column.

At this point, the five bucks is no more than campaign voodoo. But, as the California Stem Cell Report wrote in July, such is to be expected in any ballot campaign. The object is to win. Campaigns can be expected to embellish, push the envelope and release information that may not stand up to real scrutiny. 

As mentioned earlier, the California Stem Cell Report has not received a breakdown from the campaign about how it devised its five-buck figure.  If an explanation comes in, we will carry it verbatim. Meantime, the five-buck countdown stands at 27 days since the first inquiry was made. Readers should stay tuned. 

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​Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Buy it on Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

Celularity and $750K from California Stem Cell Agency: Where is the Money Being Spent?

The New Jersey firm that was awarded $750,000 by the California stem cell agency to help finance a Covid-19 clinical trial has four trial sites in two states, but has not identified any in California. 

State law requires that awards from its taxpayer-funded stem cell agency be spent for work in California. 

The firm is Celularity, Inc., which is developing a product that has been fast-tracked by the federal government and which has the support of President Trump's personal attorney, Rudy Giuliani. 

According to the National Institutes of Health website this morning, Clinicaltrials.gov, Celularity has three clinical trial sites in its home state of New Jersey and one in Washington state for the Covid therapy. The information shows that all of those sites are currently recruiting patients. The estimated primary completion date of the work is Nov. 30, 2020.

Although the stem cell agency said on Sunday that a trial site existed in California, it declined to disclose the location. The agency referred questions about a site in California to the company, which has not responded to three requests yesterday and today for information.

Corey Casper, interim president of the Infectious Disease Research Institute in Seattle, is listed as the principal investigator for the trial by Celularity. Casper spoke to stem cell agency directors on May 15 on behalf of the application. Casper also did not respond to inquiries about the location of the California work. 

Six weeks ago, when Celularity's application first came before directors of the California Institute for Regenerative Medicine (CIRM), Casper said the treatment "has a biologic plausibility for being very important and very unique in its treatment for Covid disease."

He continued,

"I think that we have adequate safeguards that have been put into the trial to really assure the safety of the participants."

Safety concerns have been raised by CIRM's grant reviewers as well as by other scientists. The reviewers, who are from outside California, originally rejected the application, giving it a score of 84, one below the cutoff point. After Celularity addressed reviewers' concerns, it scored 85 and was sent to directors who approved it last Friday with no debate.

It is CIRM's 64th clinical trial.

"Emergency" Meeting Tomorrow Morning; California Stem Cell Agency Wants to Expand Scope of its Covid Awards

With only 24 hours notice, California's $3 billion stem cell agency today called a meeting for tomorrow to significantly expand the scope of its Covid-19 round to include vaccine development and to permit "supplemental funding."

If the changes are approved tomorrow, scientists could file their applications up until next Tuesday to be considered in the next application review session, probably within 10 days to two weeks.  They would have an opportunity to submit another application about two weeks later if all the Covid funds have not been awarded.

Agency directors allotted $5 million for the Covid round. They have awarded about $2 million.

Here is what the agency listed this afternoon to describe the proposed changes:

• "Increase scope of early stage opportunities (DISC and TRAN) to include vaccine development studies as a potential vital research opportunity.

 • "Include opportunity for studies on novel ideas and biological mechanisms by opening the DISC1 program announcement.

 • "Allow supplemental funding for active COVID-19 clinical trial awards to expand their efforts.

 • "Include requirement for outreach to underserved populations in all clinical trial proposals 

• "Increase award limit on DISC2 projects and adjust language on 6-month deliverables."

The DISC term generally refers to basic research. The TRAN term refers to translational research.

The full concept plan can be found here.

Normally the agency would not fund vaccine research because it does not involve stem cells. Under the proposal for tomorrow, it would be officially deemed a "vital research opportunity," a loophole in state stem research cell law that allows such funding.  The agency has already invoked the provision in a handful of other instances. 

The supplemental funding change would permit researchers who have already received funding under the Covid-19 round to ask the agency for more cash for their applications. The change would allocate up to $1 million for such awards. 

Under normal conditions the agency's governing board could not meet legally with only 24 hours public notice. The normal legal requirement is 10 days. However, the board is invoking emergency provisions to lift the 10-day notice. 

The 11 a.m. meeting will be available for public participation by the public via phone connections and the Internet. Details are on the agenda.

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

Public Participation Locations for Consideration of $5.5 billion California Stem Cell Finance Measure

Here is the current list of public locations for the Nov. 15, 9 a.m. meeting of the governing board of the California stem cell agency to consider the proposed $5.5 billion ballot initiative that would refinance the agency. 

The measure will also make major changes in the operations of the enterprise. 

The meeting comes only three days before the deadline for making changes in the proposal.

The meeting will be available on the Internet, making it possible for the public to participate remotely. More details are available on the agenda. The list of locations may change. Check the agenda to be sure a location is available. 

The listed locations are generally sites from which a member of the board can participate remotely in the meeting. 

Main meeting site: headquarters of the California Institute for Regenerative Medicine, as the stem cell agency is formally known, 1999 Harrison Street Suite 1650, Oakland, CA 94612

Telephonic locations:
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 San Francisco, 94080
12-231 CHS, David Geffen School of Medicine, UCLA
4005 N Fresno St., Fresno, CA 93726
837 Health Science Road, Irvine, CA 92697600 16th Street, Genentech Hall, S272D, San Francisco, CA 94158

Want to Speak to the Directors of the California Stem Agency? Here is Your Chance.

The $3 billion California stem cell agency meets Oct. 31 to consider applications for $52 million in research funding. Also on the table are issues ranging from its finances to an initiative that would re-fund it with $5.5 billion. The agency expects to run out cash for new awards by the end of the month.

The meeting is open to the public with its main location at its headquarters in Oakland. Here is the current list of locations, which may change. The public can also participate via the Internet as the meeting is streamed live. See the agenda for instructions. 

Here are links to items dealing with issues before the board. "Last Research Awards...." "Competition for $52 Million..."

CIRM HQ: 1999 Harrison Street Suite 1650, Oakland, CA 94612

Other locations, which are usually hosted by a member of the agency's governing board: 

10901 N. Torrey Pines Road, La Jolla, CA 92037
4005 N Fresno St., Fresno, CA 93726
765 Market Street, #31D, San Francisco, CA 94103
9500 Gilman Drive #0602, La Jolla, CA 92093-0602
291 Campus Drive, Stanford, CA 94305
Medical Sciences 1C, Room 110, Davis, CA 95616

California Stem Cell Board Meetings: A Chance to Meet its Directors and Speak to its Staff

The $3 billion California stem cell agency reports that its governing board will meet 12 times this year, mostly in teleconference sessions that will also have access on the Internet.

The business of the board is largely ratifying awards approved earlier by its grant reviewers. However, its financial survival will be a topic of regular discussion this year. The agency expects to run out of cash for new awards before the end of the year. It is hoping that voters will renew its funding with $5 billion in the fall of 2020.

Four "in-person" meetings are scheduled this year during which most of the board will gather at the agency's headquarters in Oakland. They are scheduled to occur in March, May, September and December. Those will be also accessible on the Internet, both for listening or participating.

The meetings of the board offer opportunities for members of the public, including researchers and business representatives, to speak directly to board members and staff of the agency. The in-person sessions are particularly valuable in that regard because of the informality before and after the meetings, as well as during breaks.  Seating is somewhat limited at the meetings at the headquarters of the agency.

Dates and times of the meetings may change, however, and should be double-checked as the sessions near. The first meeting of the year is scheduled to be conducted via teleconferencing and is set for Jan. 30.

The official name of the board is the Independent Citizens' Oversight Committee. The formal name of the stem cell agency is the California Institute for Regenerative Medicine. 

California Stem Cell Agency Steps Up Public Access to Key Meeting This Week; Brain Cancer and Parkinson's On Tap

Stem cell researchers and the public -- from wherever they are around the world -- will have a chance Thursday to take part remotely for the first time during a meeting of the governing board of California's $3 billion stem cell agency.

The session will include approval of two awards totaling $9.5 million, approval of a $16.8 million operating budget, approval of a revised conflict of interest code along with a quasi-mysterious matter dealing with "programmatic tools."

At the time of this posting, the agency, formally known as the California Institute of Regenerative Medicine (CIRM), had not added online any background material supporting the cryptic, agenda item. However, the general subject deals with decisions that the board makes on applications for funding. In addition to scientific considerations, the board can base its decisions on non-scientific matters, such as whether the application really fits with the CIRM program.

(After this item was posted, the agency added to the agenda a number of slides dealing with the grant-making process and use of programmatic criteria. The California Stem Cell Report will carry an item on those slides tomorrow. Update: That item has now been posted.)

Interested persons will be able -- for the first time -- to make comments not only that matter but others from wherever they are. But they must be logged on to the audiocast/webcast of the session in order to be recognized. The agenda contains directions on how to do that. During the meeting, online participants will be asked if they have a comment. We recommend setting up the connection in advance of the meeting. It may require some tweaking, depending on your computer figuration.

The agency has successfully tested the new public comment feature on a few committee hearings. This will be the first experience with a full board meeting.

The awards expected to be made include a  $5.8 million application for Parkinson's disease and a $3.7 million application for glioblastoma, a form of brain cancer. Reviewers, meeting behind closed doors, have already approved the awards. The board must ratify their decisions in public. (Here are links to review summaries on the Parkinson's application and the glioblastoma application, plus comments by a Scripps Research Institute scientist on the Parkinson's application.

John Zaia of the City of Hope wrote a letter to the board commenting on the public summary of his glioblastoma application, critiquing reviewer comments. He said,

"Based on our experience with two previous FDA-approved pilot trials, we foresee no major hurdles to completing an IND, recruiting patients, manufacturing the therapeutic cell product, and eventually conducting the clinical trial."

The agency does not release the names of applicants until action is taken by the board, but when a letter is written by an applicant, his/her name becomes public along with the letter.

The proposed budget for the 2018-19 year stands at $16.8 million, up 7 percent from an estimated spending of $15.7 million for this fiscal year. The budget for research awards is separate and has been normally set in December. However, some board members have indicated that are are interested in trimming the amount of awards to be given annually in order to extend the life of the agency.

Under current spending rates, the agency expects to run out of money for new awards by the end of next year. It is pinning its hope for survival on a private fundraising effort now underway and voter approval of a proposed $5 billion bond measure in November 2020.  An update on the fundraising effort may be presented Thursday by CIRM board chairman J.T. Thomas.  

New Tool for Wading Through California's $2.5 Billion in Stem Cell Spending

The $3 billion California stem cell agency this week added a valuable feature that is aimed at giving better access to information concerning its active research portfolio, which currently runs to more than 160 projects.

The feature is called the Active Awards Portfolio Dashboard. Its development was overseen by Karen Ring, the agency's social media honcho. Writing on the agency's blog, she said,

"This interactive tool makes it easy to search through the active research projects that we’re currently funding, and filter these projects by disease focus, technology type or stage of research."

The new dashboard is a companion to the clinical awards dashboard, also engineered by Ring. The agency's website contains vast quantities of information. The dashboards provide tools that help readers wade through it and ferret out what is most relevant to their individual needs.

The California Institute for Regenerative Medicine(CIRM), as the agency is formally known, has funded 969 projects costing nearly $2.5 billion during its 13-year history . It is slated to run out of cash in 2019 unless ambitious fundraising plans fulfill their promise. 

Advancing Science, Avoiding Harm: New Fed Rules to Raise Curtain on Clinical Trial Results

The Wall Street Journal today carried a piece about sweeping, new federal research disclosure rules aimed at beefing up the public accessibility of findings of clinical trials backed by billions in public dollars.

The regulations are targeting what Francis Collins, head of the National Institutes of Health (NIH), has called a "disappointing" record of publishing clinical trial results.  He said that "both real and potential harm can result from failure to fully disclose the results of clinical trials."

The regulations are scheduled to roll out somewhat slowly but have been more than 20 years in the works. The Journal reporters, Daniela Hernandez and Amy Dockser Marcus, wrote online today,

"The new rules are part of a push for greater transparency and accountability for the NIH's huge investment in biomedical research. In the past, many organizations have failed to properly register studies and report their findings, actions that NIH officials say result in misspent funds, potential human harm and a lack of public trust in science. The NIH spends roughly $3 billion annually on clinical trials."

Violation of the rules carries the possibility of fines running up to thousands of dollars a day plus endangerment of future funding from the NIH.

Already at one California university, the requirements have increased the workload. The WSJ reported,

"Stanford University School of Medicine is 'adding five or six full-time employees to our overall infrastructure for human research,' said Mark Cullen, senior associate dean for research.

"Dr. Cullen said many of his researchers are still worried and confused about how the new policies will affect their work; the new hires are meant to add to an existing support system made up of roughly 100 staffers."

The NIH is particularly interested in reporting research that has negative results. The WSJ wrote,

"Under the old rules that required publication in journals, negative results often remained undisclosed because journals prefer to publish positive findings.

"'The release of negative results not only prevents duplication and potential unnecessary risk to human volunteers, it also advances our understanding of the science,' said NIH’s Dr. (Carrie) Wolinetz (NIH's associate director for science policy).

In 2015, Collins and Kathy Hudson, then NIH's deputy director for science, outreach and policy and now executive director of the People-Centered Research Foundation, wrote in JAMA,

"If the clinical research community fails to share what is learned, allowing data to remain unpublished or unreported, researchers are reneging on the promise to clinical trial participants, are wasting time and resources, and are jeopardizing public trust.

"The scientific community has a disappointing track record for dissemination of clinical trial results.

California Pumping $19 Million More into Stem Cell Effort to Improve Kidney Transplant Success

The California stem cell agency is set to make a nearly $19 million bet next week on a treatment that is aimed at significantly improving the success of  kidney transplants and helping to reduce healthcare costs.

The agency's board is expected to ratify a decision to award $18.8 million to Medeor Therapeutics, Inc.,  of San Mateo, Ca., for a phase 3 clinical trial, the last stage before its proposed product can be widely used.

Next week's award will bring to $25.4 million that the state has invested in the work. The agency awarded $6.7 million for the research in 2016.

The company's chief medical officer, D. Scott Batty, Jr.,  said last spring that its product, dubbed MDR-101, "has the potential to address the two most critical transplant patient needs: preventing organ rejection and mitigating anti-rejection treatment-associated toxicities. " He added that the technology could potentially be used in all solid organ transplant patients.

Fierce Biotech reporter Phil Taylor wrote last April,

"Patients who undergo organ transplants may no longer have to rely on lifelong immune-suppressing drugs, if Medeor Therapeutics has its way."

Taylor continued,

"More than 30,000 Americans get an organ transplant every year, and while success rates for these procedures are improving, it is estimated that up to a third of the most common transplants—such as heart, kidney, and liver—fail within 5 years."

The Medeor treatment uses adult stem cells to create a condition in which the transplanted kidney "is no longer viewed as foreign by the recipient," according a summary of the closed-door review of the company's application (CLIN2-10411). 

The agency's reviewers, who do not have to publicly disclose if they have  potential conflicts of interest, voted 11-1 to fund the research. The agency's board almost never overturns the decisions of its reviewers, who come from out-of-state. The names of persons reviewing specific applications are not disclosed by the agency, which also does not disclose the name of applicants until after board action. The California Stem Cell Report identified the firm from public records.

Samuel Strober, Stanford photo

Last November, Medeor announced it had raised $57 million in Series B financing, "led by RA Capital Management. Additional new investors included Sofinnova Ventures and 6 Dimensions Capital, who were joined by existing investors Vivo Capital and WuXi Healthcare Ventures."

The scientific founder of the firm is Samuel Strober, a professor of medicine at Stanford and who is a member of its scientific advisory board. 

The estimated date of completion of the trial is January 2022, according to clinicaltrials.gov. The governing board of the $3 billion stem cell agency is scheduled to meet Jan. 18 to approve the award. No other action is scheduled.

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. 

Probing California's Stem Cell Trials: New Tool Helps Public Navigate the Multi-Million Dollar Maze

Here's how the new clinical trial dashboard looks. You can slice and dice
the information by clicking on the black and blue boxes on the CIRM
website at the top of the page.

California's $3 billion stem cell agency this week is debuting a new, online guide to its burgeoning network of clinical trials aimed at  developing therapies ranging from acute myeloid leukemia to X-linked severe combined immunodeficiency (X-linked SCID).

The new tool is called the clinical trials dashboard. It is a major improvement in making information on the all-important trials more easily available to the public, patients, researchers and policy makers.

Clinical trials, which have three stages and can last years, are the final step before a therapy can be approved for widespread use by the Food and Drug Administration. The agency plans to spend about $400 million on clinical ventures from 2017 to 2020.

The new dashboard cuts through the online maze and allows readers to sort by disease areas, investigator and institution, among other things. It also shows quickly the status of each trial, whether it is recruiting and takes the reader to a contact if he or she is interested in participating in a trial.

As the main dashboard page shows, the agency, formally known as the California Institute for Regenerative Medicine (CIRM), has funded 40 trials. The dashboard allows you to see which are still active and which are still recruiting. If you are interested in cancer and solid tumors, filtering them out is simple. Just click on the blue box on the dashboard.

Want to know which institution has the most CIRM-backed trials? The answer is UCLA with five, a figure easily arrived at by using the new CIRM tools. That goes for investigators as well. The dashboard can show you that Donald Kohn of UCLA has the highest number of trial awards with three. A bunch of others have two each.

CIRM has long had a vast array of information on its website. As with any website, that presents a challenge in terms of making the information available to public. First, the public needs to know it is there. Next, they need to be able to actually find the relevant information and find it relatively easily. Removing barriers to online access is critical. The online tools also must fill a wide range of information needs.  A cancer patient or researcher is not likely to be interested in plowing through reams of eye disease information in order to gain access to the relevant cancer data.

The clinical trial dashboard was built by Karen Ring, CIRM's website manager and a former stem cell researcher, along with contributions from numerous others on the agency's team. It is a major step forward in the agency's effort to tell the CIRM story and how it has spent the billions provided by California taxpayers.

Here is a video that turned up this morning as I navigated my way through the clinical trial dashboard. Another note: I did not encounter any bugs this morning, but Ring says she will be tweaking the dashboard and improving it in the next couple of weeks.

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

Alpha Clinic Session Streaming Live Today

The symposium on Thursday dealing with California's Alpha stem cell clinics will be available online or via a phone connection that day and also later on YouTube later.

Here is the information provided by the City of Hope, which is hosting the one-day event, on accessing the proceedings, which involves a $40 million effort by the California stem cell agency. You can find the agenda here for some idea on the timing of each segment and speakers.

Click the link below Thursday to join the webinar:

https://cityofhope.zoom.us/j/193680670

Or iPhone one-tap (US Toll): +14086380968,193680670# or +16465588656,193680670#

Or Telephone:

Dial: +1 408 638 0968 (US Toll) or +1 646 558 8656 (US Toll)

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More Than $300 Million to be Awarded: California Schedules 12 Stem Cell Agency Board Meetings This Year

California's $3 billion stem cell agency has scheduled governing board meetings every month this year as it plans to give away more than $300 million.

The board has two types of meetings: telephonic, which are usually routine, ratifying earlier decisions on individual grant applications, and face-to-face meetings, of which there are only four. The face-to-face meetings often involve approval of concepts for new award rounds or significant changes in rules or policies.

Readers interested in the agency should think about taking in one of the four face-to-face sessions. They provide an opportunity to chat informally with board members along with the top staff of the agency.

The telephonic sessions are run out of the agency's Oakland headquarters, another opportunity for face-to-face encounters with some CIRM board members and staff. 

In addition to board meetings, subcommittees meet off and on during the year, sometimes by telephone and face-to-face. But there is no set schedule.

In both types of meetings, they can be listened to via the Internet and also participated in via remote locations at board member sites. All the meetings can be found at this Web site, which provides transcripts of the sessions. Readers can sign up for automatic notifications at that site. 

Here is the rundown.

January 19th, 2017, Telephonic
February 23rd, 2017 Bay Area, face to face
March 23rd, 2017, Telephonic
April 27th, 2017, Telephonic
May 25th, 2017, Telephonic
June 29th, 2017, Bay Area, face to face
July 20, 2017, Telephonic
August, 24th, 2017, Telephonic
September 21st, 2017, Bay Area, face to face
October 26th, 2017, Telephonic
November 30, 2017, Telephonic
December 14th, 2017, Bay Area, face to face

Meeting dates and locations are subject to change

California Stem Cell Agency Says Companies Seeking "Better Deal" in Unique, $150 Million Plan

Highlights
Five responses to plan
Application process is not a negotiation
Protection of state taxpayers paramount
More talks with companies planned

The president of the California stem cell agency, Randy Mills, yesterday said that the firms that responded to an ambitious proposal to create a $150 million public/private partnership were seeking to make a "better deal" than the agency had offered.

Mills said that the agency was "not going to give away something that is not in the best interests of the people of California."

Randy Mills, FDA photo

Mills was responding to questions raised earlier this week as a result of a report on this web site that
the proposal has hit a significant snag. The plan is aimed at creating a unique enterprise to speed development of stem cell therapies and to help establish California as a global stem cell powerhouse. The new company would be backed by a $75 million state loan (discounted to 50 percent payback)  with a matching $75 million coming from a successful applicant. The company would have the pick of agency research that did not already have a commercial partner.

The deadline for applications was Oct. 31. Up until yesterday, the agency had not even disclosed the number of responses to the request for applications(RFA). Nor had it gone beyond vague expressions of the issues troubling the proposal.

In a telephone interview with the California Stem Cell Report, Mills said that five responses were received on Oct. 31. But he said none were eligible for consideration because they did not meet the requirements of the RFA. He said the responses indicated that the companies viewed the application process as a "negotiation." Mills said "all kinds of terms" were proposed that were "different than in the RFA." He said,

"We put forward what we thought was a very good deal. The heads of the companies wanted to make a better deal."

Mills added,

"The deal is as good as the deal is going to get."

He said the $3 billion agency, known formally as the California Institute for Regenerative Medicine (CIRM), has to be willing to walk away if the deal is not appropriate.  He said the agency had a fiscal responsibility to taxpayers. "My investors are the people of California," Mills said.

Mills said, however, he was going to discuss the proposal further with those who responded to determine whether it was a matter of "terms or time." He said the proposal was innovative and unusual, posing challenges for both the companies and the agency.

Mills comments came as he was responding to questions raised by a reader of the California Stem Cell Report, Ed Snively, of El Centro, Ca. Snively is a longtime participant in local affairs in his area in Imperial County and has long followed stem cell agency matters.

He wrote in an email to California Stem Cell Report,

"Thank you, David, for this interesting observation on selective transparency by the agency. The comments by Mills regarding state regulatory compliance and taxpayer procedure acceptance were curious to me. I think Mills owes an explanation of his remarks to taxpayers. If this 'bold' plan violates the terms of the agency contract with the state and stakeholder/taxpayers then Mills needs to explain why that is. What he has done is make me think that something right on the legal edge is going on behind closed doors. I hate that in public agencies."

The California Stem Cell Report emailed the comments to the agency, asking if it would like to respond.

In the subsequent telephone interview, Mills said that he did not want the agency to be perceived as selectively transparent and that he had "no problem" in answering any questions.  He said that if his earlier comments were not clear that it was his fault, and he elaborated on the issues involved.

But under the agency's longstanding rules, it does not disclose the names of applicants nor does it disclose their applications -- only a review summary when they come before the agency's governing board for final action.  However, the terms of contracts with successful applicants are a public record.

California's Stem Cell Research Spending Up for Review Next Week

If you are interested in how the state of California is going to spend its final $800 million or so on stem cell research, you should catch a key meeting next Tuesday in Oakland, which also can be heard online.

The session involves the 29-member, governing board of the $3 billion California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is formally known.

The agency was created by California voters in 2004 with voters' expectation that stem cell therapies were all but just around the corner. So far, no therapies have been developed by the agency that are available for widespread use.

Nonetheless, the agency, which runs out of money in 2020, is pushing hard. It has more than 20 clinical trials underway, which is the last step in bringing a therapy to market. However, those trials can take years with no guarantee that a proposed product will emerge successfully.

On tap on Tuesday will be a look at the agency's research plans for the next three years with a review of how it has performed so far in 2016. The agency's proposal for research spending in 2017 is likely to have a significant impact on the hundreds of stem cell researchers in California. The proposal is not yet available online, however, with only two business days left before the meeting.

CIRM is also hinting that there will be some surprises at the meeting, but it is unlikely that a product announcement will be forthcoming.

Additionally on tap are applications for a total of $14.9 million for two early-stage clinical trials. One is for $6.7 million (CLIN2-09439) to test using stem cells and T cells to eliminate the life-long need for immunosuppresive drugs by kidney transplant recipients. The other (CLIN2-09698) is for $8.3 million for a mid-stage trial (2b) for a therapy for retinitis pigmentosa.

The applications were approved for funding by the agency's grant reviewers, who meet behind closed doors and do not publicly disclose their economic or professional interests. Ratification of the reviewer decisions is a formality for the agency. although the names of the recipients are not generally disclosed prior to board action.

The board is expected to re-elect Jonathan Thomas as chairman of the panel. Thomas was elected to the position in 2011. He has sent a  two-page letter to the board detailing his work during the last five years. Also scheduled to be re-elected is Art Torres as vice chairman.

Thomas receives $400,000 annually for his "80 percent effort" in the part-time position. Torres, a former state lawmaker, receives $225,000, also for an "80 percent effort."

Instructions for listening to the meeting online can be found on the agenda. In addition to main meeting site in Oakland, public telephonic locations exist in San Diego and La Jolla. Specific addresses can be found on the agenda.