The $2.8 Billion Award Bucket of the California Stem Cell Agency

LOS ANGELES -- Here is the financial state of awards by the $3 billion California stem agency. The effective burn rate is $170 million a year -- the amount of money that can  be awarded -- because of return of funds on grants that have been terminated.

Randy Mills, CEO of the stem cell agency, said that the rate of returns has jumped from 10 percent to 22 percent, which could mean an additional $150 million for future awards, if the rate stays at the level.

A Look at the Portfolio of the California Stem Cell Agency

Look at the status of CIRM funding by disease

LOS ANGELES -- The California stem cell agency this morning presented a fresh breakdown of its spending by disease areas. The largest two components are in the neuro and cancer areas, which account for nearly half of the agency's portfolio.

CIRM Board Meeting Opens

LOS ANGELES -- The meeting of the governing board of the California stem cell agency opened at 9:12 a.m. today.  The public audience is quite small, less than 10 to witness approval of an $890 million expenditure of state funds.

Follow All The News Today on California's New $890 Million Stem Cell Plan

LOS ANGELES -- The California Stem Cell Report will bring you gavel-to-gavel coverage beginnin this morning of today's meeting of the governing board of the California stem cell agency, which is expected to approved an $890 million spending plan for the next five years.

The proposal includes an ambitious, $150 million effort to join next year with a private partner to develop the best of the agency's offerings that do not yet have a private partner. To entice business, the agency is putting up $75 million. It expects the private partner to put up another $75 million.

You can read about all that and more on the California Stem Cell Report as the day progresses. Stories will be filed as warranted.

Today's meeting begins at 9 a.m. PST.

More Info on the $30 Million California Stem Cell Agency Plan for Life After 'Death'

More information emerged this afternoon concerning the California stem cell agency’s $30 million plan for its life beyond 2020, when its funding runs out for new awards.. The agency posted documents late yesterday saying that it had pledges of $7 million from private donors contingent on raising an additional $23 million. One of the presentation slides posted online used the term “wind-down.” Earlier today, the California Stem Cell Report asked the agency for clarification of the sketchy information posted on the agenda for tomorrow’s stem cell board meeting. Kevin McCormack, senior director for communications for agency, responded,

“The $30 million is to help ensure that we have funds to cover the administration of all the awards we make in the next five years. As you know those are multi-year awards so if we can continue making new awards till, say, 2020 we also want to make sure we have enough money in our admin bucket (which is separate fro the research bucket) to cover the supervision and support for those awards.

“We are also but separately working on finding other sources of funding so the agency as a whole can continue funding and administering research after our current money runs out , but that is a separate task.”

Presentation documents posted online made reference to public funding, but had no specifics. Currently the agency survives on money borrowed by the state under the terms of the ballot initiative that created the research program in 2004. However, that $3 billion source is shrinking, and the agency is down to its last $890 million. The online documents made no mention of plans to continue with new awards or loans beyond 2020. Jonathan Thomas, agency chairman, is expected to provide more details tomorrow to the board on the financing plan.

Surviving after 2020: California Stem Cell Agency Reports $7 Million in Private Donations

The California stem cell agency today unveiled the first concrete indication that it will have significant cash after 2020, when its funds are scheduled to run out for new awards.

The news came in a memo quietly posted last night on the agenda for tomorrow’s meeting in Los Angeles. The memo said the agency had received pledges of $7 million in private support that appear to be the first installment in a $30 million, four-year funding plan beyond 2020.

Details were not immediately available. Jonathan Thomas, chairman of the agency, is scheduled to brief board members on the funding plan tomorrow. But based on the memo and a presentation document, Thomas appears to be looking forward to private funding along with some public support, presumably from the state of California. However, the presentation labelled the funding as a “wind-down” operation.

Bill Bowes, UCSB photo

The William K. Bowes, Jr. Foundation is providing $5 million to the agency, and the Franklin and Catherine Johnson Foundation is adding $2 million, the memo by James Harrison, the agency's general counsel said.

The Bowes Foundation in 2012 gave $5 million to the UC Santa Barbara stem cell program. Bowes is the founder of Amgen.

The memo said,

“These gifts are contingent upon CIRM raising an additional $23 million before June 30, 2019 and not having access to additional funds for its administrative costs.”

Currently the agency is financed with money that state borrows (bonds). The cash flows directly to the agency without intervention or control by the governor or the legislature, an arrangement established by voters in 2004 when they approved creation of the agency, formally known as the California Institute for Regenerative Medicine (CIRM).

California Stem Cell Agency: FDA No. 1 Impediment to Stem Cell Therapies, 'Patients Are Dying'

California’s $3 billion stem cell agency this morning made it clear that it is not backing away from taking on the $4.9 billion Federal Drug Administration(FDA).

Randy Mills, MCC photo

“Patients are dying” because the federal government is “being so careful about safety,” Randy Mills, president of the agency, said in an item on its blog, The Stem Cellar.

 “Doing nothing is not okay,” said the headline on the piece, written by Kevin McCormack, senior director for communications for the agency. 

The FDA is too slow, too concerned about safety and needs to remove rules that are “bad for patients and regulators,” said the item.

Mills has been beating a drum concerning the FDA for a number of months, citing a non-scientific survey of agency stakeholders that showed 70 percent of them identified the FDA as the No. 1 impediment standing in the way of CIRM’s goals. 

Significantly, McCormack’s piece comes one day before the board of the California Institute of Regenerative Medicine (CIRM), as the agency is formally known, meets in Los Angeles to approve a plan that includes 50 new clinical trials over the next five years. All of those trials require FDA approval. 

In the proposal, Mills identifies FDA foot-dragging as one of the risks to successful completion of the $890 million effort.

 McCormack’s item said CIRM is “caught between a rock and a hard place. And CIRM is going to try and help them get out from under that.”

He quoted Mills’ speech to the World Stem Cell Summit last week. Mills said,

“We have had the current FDA regulatory structure for cell therapy in place for 15 years, and in that 15 years not one stem cell therapy has been approved. The scoreboard is not lying, there’s a zero on it. Not one therapy has been approved. There is an issue here, we can’t ignore that fact and so we made it part of our proposed new Strategic Plan to try and remove this burden. 

“There is an excessively long translational pathway to get an Investigational New Drug (IND) approval from the FDA (a necessary step to proceed with testing a therapy in a clinical trial). For non-cell therapies it takes 3-4 years to get an IND. For cell therapies it takes 6-8 years, twice as long.” 

Mills continued,

“We are not anti-regulation, we are not anti-FDA, and we are not calling for the removal of rules and regulations around stem cell therapies, that would be bad for patients and research. These therapies have risks and we are not proposing any strategy that puts things on the market without any testing or safety data. But right now we are being so careful about safety to ensure patients are not put at risk while those same patients are dying from their disease.”

In addition to Mills, one of the speakers at the World Stem Cell Summit was from the FDA. He said the primary mission of the FDA is safety. On the other hand, the mission of the California stem cell agency has long been “to accelerate stem cell therapies.” 

Full Coverage Thursday of California's New Stem Cell Direction

For all the latest doings by the $3 billion California stem cell agency, follow the California Stem Cell Report on Thursday for on-the-scene reporting as the agency officially approves its new course for the next five years.

Directors of the agency are scheduled to meet in Los Angeles to ratify a spending plan for its last $900 million. Also on tap is a risky, $75 million venture aimed at pushing the best of CIRM's research into the marketplace. 

The California Stem Cell Report will provide gavel-to-gavel coverage, but avid followers of the agency can listen in on the Internet or from two telephonic locations in San Diego and at Stanford. Details are on the meeting agenda.  

The Klein Legacy: Vestiges of California's Stem Cell Past to be Scrubbed This Week

No doubt exists that Bob Klein left his mark on the $3 billion California stem cell agency. Sometimes he is described as the father of the agency. He was its first chairman and led the drive to win voter approval of the research effort in 2004.

Bob Klein, Elie Dolgin photo

The agency has been under new leadership since 2011. And this Thursday some of the marks left by Klein are going to be erased.

Minor stuff now, but they recall some of the issues that rumbled through the agency in earlier days.

For example, the agency’s rules currently restrict to 12 the number of employees in the chairman’s office out of an agency total now of 55-56. The restriction is almost certainly to be removed on Thursday by the agency’s governing board. A memo by agency general counsel James Harrison said mildly that “disagreements” existed during the Klein regime about staff resources, leading to the limitation.

Those disagreements were actually sufficiently harsh that the stem cell board at one point in 2007 felt compelled to strip six employees from Klein’s office of chair, limiting him to four.

During Klein’s tenure, he also scheduled board meetings with jam-packed agendas that often took two days. The lengthy sessions tested the patience of board members, some of whom fled for the doors in an effort to catch their flights home as the hours wore on. The result was that the supermajority, legally required quorums required to do business were lost.. (See here and here for
more on quorum problems at the agency.)

To help avoid those unseemly situations, rules allowing telephonic attendance by key members of the board were enacted. Nowadays, the meetings proceed with dispatch, often ending early, much to the satisfaction of board.

So the board on Thursday plans to expand the use of telephonic meetings, which could well be a plus and a minus. The move will increase the number of offsite locations where members of the public and researchers can weigh in remotely with comments during meetings, a feature that has been lightly used. On the other hand, there will be less face-to-face contact between members of the board, something that is an important aid in finding solutions to touchy problems.

Head of NIH Troubled by Flagrant Violations of Law Requiring Public Disclosure of Research Results

The headline read “Failure to Report: Law Ignored, Patients at Risk.” The story this week began,

"Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found.

"The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer

"The worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 95 percent of the time since reporting became mandatory in 2008."

Francis Collins, head of the NIH, said he finds the failure to report "very troubling."

The story was written by Charles Piller, West Coast editor of STAT, which is a new online news operation dealing with the life sciences. It was started by the owner of the Boston Globe. The STAT web site says it reports "from the frontiers of health and medicine."