CIRM Application Shutdown: Text of Robert Klein's Comments

Here is the text of comments by Robert Klein, chairman of Americans for Cures, on the shutdown of applications at the California stem cell agency. Klein was responding to questions from the California Stem Cell Report.

"When Californians learn of the remarkable progress from the California funded stem cell and genetic therapies FDA approved human trials in restoring major function to paralyzed patients, to save the lives of children with severe immune diseases, to restoring sight to patients that are blind, the support for stem cell research and therapy development exceeds 70% in recent polls.

"California’s leadership in cellular and genetic therapies, through its state funded research and human trials, currently supports 51 human trials for a range of chronic disease and injuries, and 24 more human trials are in progress by biotech companies based upon California’s funded research.

"The life-changing and life-restoring work of California’s scientists and physicians will predictably earn the chance for renewed funding. Polls indicate that California voters want the opportunity to vote in 2020 on continuing this visionary California initiative, originally funded in 2004 through Proposition 71, the California Stem Cell Research and Cures Act. The gap in available state funding from the fall of 2019 through November 2020 will hold back additional critical human trials for new life saving and/or disease mitigating therapies; but, I have faith that Patient Advocates and California voters will back new funding at the polls in 2020 and continue California’s remarkable contribution to this medical revolution that effects every one of our lives.

"In advancing the research and therapies, the California research funding agency has also gained broad financial support for its portfolio of research and human trials based on the strength of more than 2850 peer reviewed published medical discoveries and the 75 human trials directly funded or separately funded supporting the California funded discoveries. The matching funds from donors, institutions, private companies and non-profit organizations have already exceeded $3,250,000,000, more than a 100% match on the $3,000,000,000 originally approved in state funding.

"This medical revolution holds the promise of restoring health and quality of life for many of California’s individuals and families suffering from chronic disease and injury. However, the last tactical mile to bring this broad spectrum of therapies to patients will require more funding and the thoughtful support of California’s public as the human trials and discoveries are refined and tested, overcome numerous obstacles or complications, and ultimately serve to improve the life and reduce the suffering of every one of us."

CIRM Application Shutdown: Text of Jeanne Loring's Comments

Here is the text of comments by Jeanne Loring on the application shutdown at the California stem cell agency. Loring was responding to questions by the California Stem Cell Report. She also filed a comment separately on the initial story. 

"CIRM has built an enormous resource of stem cell expertise in California over the last 14 years. They had a big impact on my lab; over the years I was awarded 10 grants on which I was PI or co-PI and several more as a co-investigator, we trained hundreds of researchers in pluripotent stem cell technology through CIRM’s Shared Labs and Training Center grants, I mentored 32 students through the Bridges program, and we published 71 scientific papers with CIRM support (so far). While I also obtained funding from the NIH and private donors, CIRM was by far the dominant supporter of my research.  When I obtained my first grant on human embryonic stem cells from the NIH in 2002, I could not have predicted that I would be able expand on that work so spectacularly. I was in the right place at the right time.

"While I am grateful for CIRM’’s support of my work, I have also been deeply troubled by some of  their decisions. This is not the time or place to dissect their judgments, but if they are rejuvenated by another bond measure, I hope they will call on some of us to share our experiences as they develop their strategy for the future of stem cell research and development in California."

California Application Shutdown: Text of Comments by Steve Peckman

Here is the full text of comments by Steve Peckman on the shutdown of applications by the California stem cell agency. Peckman was responding to questions from the California Stem Cell Report. 

"The inevitable announcement by CIRM serves to highlight the impressive success of Proposition 71 as a catalyst for scientific discovery and the clinical application of stem cell research and regenerative medicine.  Since 2005, CIRM’s trailblazing initiatives from science and ethics training to basic scientific research, biomedical tool development, infrastructure, pre-clinical testing, and clinical trials have made California an international leader in the field.  The pool of scientific knowledge is constantly growing because of the public’s trust and investment in the future.  The forward thinking of California voters through the passage of Proposition 71 has gifted the world with critical biomedical breakthroughs, such as a cure for ADA-SCID (developed by UCLA physician-scientist Dr. Donald Kohn and his team), whose broad impact will inform science and medicine for generations to come.

"As you noted, talk of CIRM’s death is a bit premature as it will still be awarding pre-clinical and clinical research grants in the near term and overseeing research grants and clinical trials for at least four more years."

California Stem Cell Agency Pitches for Support; Los Angeles Event Scheduled Tuesday

Just one day before the California stem cell agency announced it was cutting off applications for more research funding, it made an ardent pitch to the public for increased support. 

The appeal concerned a public event that the agency, formally known as the California Institute for Regenerative Medicine (CIRM), is staging on Tuesday in Los Angeles. 

In an item on the agency's blog, The Stem Cellar, Kevin McCormack, senior director of communications, briefly recounted the $3 billion agency's work. And then he wrote,

 "We still have a lot to do. The problem is we are quickly running out of money. We expect to have enough money to fund new projects up to the end of this year....Some may get funding from other sources, but many won’t. We don’t want to let that happen."

Stem researchers, CIRM leaders and others will be there. McCormack said,

"It’s going to be an opportunity to learn about the real progress being made in stem cell research, thanks in no small part to CIRM’s funding."

On the web page for the event, there was also this:

"You'll hear from a woman whose infant daughter was cured of a fatal immune-system disorder, from the doctor who developed that treatment and from stem cell champions who are worried what will happen to the most promising research if CIRM no longer exists."

 The free, public event will be in the Los Angeles Convention Center, 1201 South Figueroa St., Petree Hall C. The event begins at 6 p.m. but McCormack said CIRM staffers will be there at 5 p.m. to answer questions.

Interested persons can RSVP here. But it is unlikely that anyone will be turned away.

Money Running Out: California's Stem Cell Agency Shutting Down Applications for Research Awards

The $3 billion California stem cell agency, which is running out of cash, today served notice that it would stop accepting applications for more research awards beginning next month.

The low key announcement is another step towards the looming demise of the 14-year-old agency, created by voters in November 2004. Its hopes for continued life are pinned on a proposed bond measure for the November 2020 ballot.

A memo to the governing board from leadership of the agency, formally known as the California Institute for Regenerative Medicine (CIRM), said that it currently has $88 million worth of requests for cash but only $33 million available for awards.  

The memo said, 

"Given the status of applications in the system and expected applications this month, we intend to close application submissions after this month. In the unlikely event that funds continue to be available after processing of all applications in the queue, we may temporarily re-open the submission window as needed."

The matter was taken up this morning at a meeting of the board that approved an $11 million clinical award for a rare disease. 

During a brief discussion, board member Os Steward of UC Irvine said that "shutting off the spigot could be highly disruptive." 

He indicated that he would prefer to call it a suspension of applications. 

Board member Jeff Sheehy said the move is "abrupt but that is kind of where we are."

Under the ballot initiative that created the agency, the only significant source of funding is bonds issued by the state of California. The authority for issuing the bonds is expiring. 

The agency has been trying for months to raise $200 million in private funding. No announcement of any progress, however, was made at today's session. 

The agency has on hand enough funds to handle administration of existing awards for a couple of years. 

Here is the full text of today's memo. 

"For 2019, the ICOC allocated $93 million for clinical program applications (CLIN1, CLIN2, CLIN3) and $30 million for the CIRM/NHLBI collaboration on sickle cell disease. As of June 2019, the available budget for non-sickle cell disease applications is $45 million.  

"Currently, we have one application recommended for funding by the GWG and pending approval this month for $12 million. There are two applications slated for GWG review later this month and three applications that have received a score of “2” by the GWG that are pending reassessment by the GWG next month. We have also received five applications that are undergoing eligibility review. The total request for all clinical applications currently in our system is about $88 million. We are expecting two to three additional application submissions for this month’s deadline, which falls on June 28, 2019. The budget request for these is still unknown. We expect that not all applications will achieve a funding recommendation, but there may be enough to deplete the annual allocation.

"Given the status of applications in the system and expected applications this month, we intend to close application submissions after this month. In the unlikely event that funds continue to be available after processing of all applications in the queue, we may temporarily re-open the submission window as needed. 

"We intend to inform all prospective applicants submitting an application this month that there is no guarantee of an availability of funds and that review of their application may be halted if funds are depleted prior to the completion of their review. We also intend to post notice that application submissions will close after the June deadline until further notice.Ap 

"This action does not affect application submissions for sickle cell disease that are accepted under the CIRM/NHLBI collaborative program."