LOS ANGELES -- Directors of the $3 billion California stem agency this morning began discussion of its spending plans for the next five years, an $890 million effort that is designed to "transform regenerative medicine."
Jeff Sheehy, chairman of the Science Subcommitte of the board, praised the effort, especially the "metrics" that measure the agency's teams performance at all levels. He said the staff developed metrics within each area.
David Higgins of San Diego, another board member, said that CIRM's plan is much different than other strategic plans that are "boring" and "go into a desk drawer." He said the CIRM plan is "much different" and creates a pathway to success.
Thursday, December 17, 2015
The $2.8 Billion Award Bucket of the California Stem Cell Agency
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
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| Look at the status of CIRM funding by disease |
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.
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.
Wednesday, December 16, 2015
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.
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| 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).
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| 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.”
Tuesday, December 15, 2015
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.
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