Randy Mills, the former head of the California stem cell agency who left it in 2017, has resigned as president of a large bone marrow non-profit known as "Be The Match" in Minneapolis.
A brief news release from the organization said he was leaving for "personal reasons." Local news coverage of Mills' departure in Minnesota was scanty. Be The Match reported income of about $418 million in 2018.
Maria Millan, then vice president for therapeutics at California's stem cell agency, succeeded him as CEO and president of the agency and still holds that position. Mills was highly regarded at the agency and has been credited with helping to sharpen its focus and direction.
Wednesday, February 12, 2020
New California Stem Cell Ballot Initiative Hits $1 Million Campaign Spending Mark; Tens of Millions More Needed
The spending was reported by the Californians for Stem Cell Research, Treatments and Cures, the campaign committee led by Robert Klein, a Palo Alto real estate developer who also directed the campaign that created the state stem cell agency in 2004 via a ballot initiative.
The $942,005 in spending covers all of 2019 but not 2020. The report to the California Secretary of State shows that the committee received only $712,254 in non-monetary contributions and had a zero balance as of the end of last year. All of the contributions came Klein Financial Corp. in Palo Alto, Ca., or from Klein, who is president of the real estate investment firm. Klein was the first chairman of the stem cell agency, known officially as the California Institute for Regenerative Medicine (CIRM). The agency is running out of money and needs the additional billions to continue its work. It was funded with $3 billion in state borrowing 15 years ago.
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| Robert Klein addressing CIRM board about the ballot measure in 2017 |
Klein told the California Stem Cell Report in 2017 that he expected that the current stem cell ballot initiative campaign, including signature gathering, campaign advertising, etc., would run this year about $50 million.
In a telephone interview last week, he demurred when asked about campaign finances and fundraising.
Klein has reported to state election officials that the campaign has collected 25 percent of the more than 600,000 signatures needed to qualify for the fall ballot. That benchmark sets the stage for legislative hearings on the proposed initiative.
The legislature cannot modify the initiative but it could offer its own alternative approach. No date has been set for hearings, which must occur 131 days before the Nov. 3 election.
Monday, February 10, 2020
California's Alpha Stem Cell Clinics: A Look at the $50 Million Effort in May
If you want to know what is happening with one of the signature efforts of the $3 billion California stem cell agency, mark Friday May 1 on your calendar.
That's the date of a free, day-long conference in Sacramento dealing with the stem cell agency's statewide Alpha Clinic program, which has its northern most location at UC Davis.
This is the 5th annual review of the Alpha Clinic effort, which was seeded with $50 million by the stem cell agency, formally known as the California Institute for Regnerative Medicine(CIRM). The Alpha clinics specialize in delivering stem cell clinical trials to patients.
(See here for a UC San Diego video involving the Alpha Clinic program. You can skip the ad at the beginning by clicking on the "skip ad" box in the right hand corner of the video screen.)
The Alpha conference represents an opportunity for state policy makers and legislators to get a first-hand perspective on the state's 15-year-old stem cell agency, which is hoping that next November voters will approve an additional $5.5 billion for the program.
The agency expects to phase out its work if the ballot initiative fails.
In addition to UC Davis, other Alpha locations are at City of Hope, UC Irvine/UC Los Angeles, UC San Diego and UC San Francisco.
The agenda for the May meeting is still being developed. But topics currently scheduled include unmet medical needs, cures for rare diseases, cancer clinical trials and the all-important topic of access and affordability.
In addition to researchers, the session includes a number of patients and patient advocates.
Reservations can be made by going to this page on the Internet.
That's the date of a free, day-long conference in Sacramento dealing with the stem cell agency's statewide Alpha Clinic program, which has its northern most location at UC Davis.
This is the 5th annual review of the Alpha Clinic effort, which was seeded with $50 million by the stem cell agency, formally known as the California Institute for Regnerative Medicine(CIRM). The Alpha clinics specialize in delivering stem cell clinical trials to patients.
(See here for a UC San Diego video involving the Alpha Clinic program. You can skip the ad at the beginning by clicking on the "skip ad" box in the right hand corner of the video screen.)
The Alpha conference represents an opportunity for state policy makers and legislators to get a first-hand perspective on the state's 15-year-old stem cell agency, which is hoping that next November voters will approve an additional $5.5 billion for the program.
The agency expects to phase out its work if the ballot initiative fails.
In addition to UC Davis, other Alpha locations are at City of Hope, UC Irvine/UC Los Angeles, UC San Diego and UC San Francisco.
The agenda for the May meeting is still being developed. But topics currently scheduled include unmet medical needs, cures for rare diseases, cancer clinical trials and the all-important topic of access and affordability.
In addition to researchers, the session includes a number of patients and patient advocates.
Reservations can be made by going to this page on the Internet.
Thursday, February 06, 2020
California Stem Cell Agency Okays Major, Publicly Financed Conference During Ballot Campaign for $5.5 Billion More
OAKLAND, Ca. -- California's financially strapped stem cell agency this morning approved a $250,000, two-day public conference on the state of stem cell research that would be held in the midst of a ballot campaign to provide the agency with an additional $5.5 billion from taxpayers.
The proposal was approved on a unanimous vote after a brief discussion.
The conference is expected to be held prior to the Nov. 3 election involving the proposed, $5.5 billion measure. Details and location are yet to be worked out.
Known formally as the California Institute for Regenerative Medicine (CIRM), the agency was created by voters in 2004 who provided it with $3 billion in bond funding. It is now down to its last $27 million for awards. The agency has additional cash to continue its administrative operations this year and wind down later if the proposed ballot initiative fails to win approval.
CIRM has held a number of large, public events over its 15-year life to bring together scientists and the public as part of its public information efforts to report on its activities and encourage collaboration among researchers. The conference approved today falls in that category, the agency says.
The meeting, however, is likely to be targeted, sooner or later, by opponents of the agency as an improper use of public funds. The state has legal restrictions on use of public funds during ballot campaigns that involve many gray areas. But normal public information efforts are permitted.
No member of the public spoke today against the conference, which was available live online and at a number of public teleconference locations throughout the state.
The agency told the California Stem Cell Report earlier this week,
The proposal was approved on a unanimous vote after a brief discussion.
The conference is expected to be held prior to the Nov. 3 election involving the proposed, $5.5 billion measure. Details and location are yet to be worked out.
Known formally as the California Institute for Regenerative Medicine (CIRM), the agency was created by voters in 2004 who provided it with $3 billion in bond funding. It is now down to its last $27 million for awards. The agency has additional cash to continue its administrative operations this year and wind down later if the proposed ballot initiative fails to win approval.
CIRM has held a number of large, public events over its 15-year life to bring together scientists and the public as part of its public information efforts to report on its activities and encourage collaboration among researchers. The conference approved today falls in that category, the agency says.
The meeting, however, is likely to be targeted, sooner or later, by opponents of the agency as an improper use of public funds. The state has legal restrictions on use of public funds during ballot campaigns that involve many gray areas. But normal public information efforts are permitted.
No member of the public spoke today against the conference, which was available live online and at a number of public teleconference locations throughout the state.
The agency told the California Stem Cell Report earlier this week,
"CIRM has conducted four grantee meetings since the agency’s inception. These meetings are opportunities for grantees to share information about their progress, discuss bottlenecks in the field, and identify potential partnership opportunities. This grantee meeting will be no different. The meeting will comply with state laws governing the use of public funds in connection with ballot measure campaigns and will not include any advocacy for or against the ballot measure."The CIRM conference proposal said that the public, CIRM grantees, interested funding organizations, patient advocates and stakeholders would be invited to the two-day session. An estimated 300-400 participants are expected. CIRM said the goals of the meeting are to:
- "Provide a public forum to learn about the most recent advances in stem cell research in California.
- "Encourage the sharing of information and data among CIRM grantees to foster collaboration and learning.
- "Timely presentations to address and overcome key bottlenecks and challenges in the field to help advance existing projects.
- "Showcase promising stem cell-based projects for partnership opportunities with investors, funders, or companies."
"Communications about a ballot measure should be delivered through CIRM’s ordinary communication methods, like its website, blog, newsletter, emails to interested persons, and public meetings, in the style CIRM normally uses to communicate other information. CIRM should avoid passionate or inflammatory language and modes of communication that it does not regularly employ, and should not encourage voters to vote in a particular manner."Harrison drafted portions of the 2004 initiative that created the agency. He was also heavily involved in drafting the current proposed initiative.
California Stem Cell Agency Approves $1.8 million to Speed Promising Research
OAKLAND, Ca. -- The California stem cell agency today approved the use of $1.8 million in newly recovered funds to help researchers move promising basic research into products that would be available to the general public.
The action targeted acceleration of work from what the agency calls its Quest program. The agency said it had eight possibilities for awards in the pipeline.
The money for the awards comes from $2.8 million that has been recovered from other CIRM-funded research that has not met its milestones.
The agency expects to report on the status of any additional recovered funds in May.
Wednesday, February 05, 2020
$5.5 Billion California Stem Cell Initiative Moving Quickly to Qualify for November Ballot
The effort to place a $5.5 billion stem cell research initiative on the November ballot hit a key milestone this week, chalking up at least 25 percent of the signatures needed.
In an interview yesterday with the California Stem Cell Report, Robert Klein, chairman and founder of Americans for Cures, said that he expects to have about one million signatures in hand by the end of April.
To be be placed before voters, the initiative must have valid signatures from 623,212 voters. To achieve that number, many more signatures are gathered because a number of them are disqualified by elections officials. The deadline for signatures for the measure is June 15.
Klein sounded optimistic about the pace of the signature-gathering effort. He said it was running slightly ahead of 2004 when he led the effort for the ballot measure that created the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known.
"We're gaining momentum actually," Klein said in a phone interview.
CIRM needs a major cash infusion this year because it is running out of money. The agency was provided with $3 billion in bond funding by voters 15 years ago. It is now down to $27 million for research awards.
Klein sent a letter Feb. 1 to the California secretary of state, the state's top election official, declaring that the effort had acquired at least 25 percent of the signatures needed. The milestone triggers legislative hearings on the initiative.
The hearing or hearings must be held no later than 131 days before the Nov. 3 election. The legislature cannot alter the proposal, but it can offer its own version. Supporters of a proposed measure can also withdraw it.
"This means the legislature can offer alternative legislation as a compromise in an effort to convince petitioners to withdraw certified initiatives," according to Ballotpedia.
Klein declined to discuss specific costs of the signature gathering effort. However, it is largely done in California through firms that are paid by a measure's supporters. In 2018, the average cost of a signature was about $6.00 and ran as high as about $9.00, according to Ballotpedia. The average total cost in 2018 was $2.6 million for qualifying an initiative.
Klein is a real estate developer based in Palo Alto. He directed the writing of both the original initiative and the latest one and was the agency's first chairman. Americans for Cures is the stem cell advocacy group that he founded.
(The information on costs of signature gathering was not contained in an earlier version of this item.)
In an interview yesterday with the California Stem Cell Report, Robert Klein, chairman and founder of Americans for Cures, said that he expects to have about one million signatures in hand by the end of April.
To be be placed before voters, the initiative must have valid signatures from 623,212 voters. To achieve that number, many more signatures are gathered because a number of them are disqualified by elections officials. The deadline for signatures for the measure is June 15.
Klein sounded optimistic about the pace of the signature-gathering effort. He said it was running slightly ahead of 2004 when he led the effort for the ballot measure that created the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known.
"We're gaining momentum actually," Klein said in a phone interview.
CIRM needs a major cash infusion this year because it is running out of money. The agency was provided with $3 billion in bond funding by voters 15 years ago. It is now down to $27 million for research awards.
Klein sent a letter Feb. 1 to the California secretary of state, the state's top election official, declaring that the effort had acquired at least 25 percent of the signatures needed. The milestone triggers legislative hearings on the initiative.
The hearing or hearings must be held no later than 131 days before the Nov. 3 election. The legislature cannot alter the proposal, but it can offer its own version. Supporters of a proposed measure can also withdraw it.
"This means the legislature can offer alternative legislation as a compromise in an effort to convince petitioners to withdraw certified initiatives," according to Ballotpedia.
Klein declined to discuss specific costs of the signature gathering effort. However, it is largely done in California through firms that are paid by a measure's supporters. In 2018, the average cost of a signature was about $6.00 and ran as high as about $9.00, according to Ballotpedia. The average total cost in 2018 was $2.6 million for qualifying an initiative.
Klein is a real estate developer based in Palo Alto. He directed the writing of both the original initiative and the latest one and was the agency's first chairman. Americans for Cures is the stem cell advocacy group that he founded.
(The information on costs of signature gathering was not contained in an earlier version of this item.)
Tuesday, February 04, 2020
California's Stem Cell Agency Considers Mounting Major Public Forum During Upcoming Ballot Campaign for $5.5 Billion in Refinancing
California's stem cell agency has recovered $2.3 million from unsuccessful research awards and today proposed to split the amount between more research and a public forum later this year to discuss progress in the field.
The forum would be held after a proposed ballot initiative to refinance the agency with $5.5 billion is likely to have qualified for the November ballot. The proposal for the two-day event is the sort of conference that opponents of the agency are likely to raise questions about.
Legal restrictions exist in California exist concerning how public funds may be used during a ballot campaign. In response to a question, a spokeswoman for the agency, formally known as the California Institute for Regenerative Medicine (CIRM), said this morning that the grantee conference would comply with state law and would not involve advocacy for the ballot initiative.
The proposal, if approved by voters, would save CIRM from financial extinction. The agency is running out of money and needs more billions to continue its work. CIRM was created in 2004 by voters who provided $3 billion in state bond funding. It is now down to $27 million for awards.
At its meeting on Thursday, the CIRM governing board is scheduled to be asked to allocate $1.8 million of the recovered funds for "progression" awards to help advance more basic level research into possible clinical use. A CIRM document said that two applications have already been received and another six appear to be in the pipeline.
Another $250,000 would be allocated for a public conference in the latter part of the year "to discuss advances and progress in the field of stem cell research in California."
The event would occur after the proposed initiative qualifies for the ballot. Efforts to gather more than 600,000 signatures of registered voters are already underway. The deadline for qualification falls in June.
State law bars agencies from spending public funds for activities that are strictly for ballot campaigns. However, the agencies are permitted to continue their regular public information practices.
James Harrison, former general counsel to the agency and a well-known expert on campaign law, briefed the CIRM governing board last fall on the complex restrictions and gray areas. He said,
In response to a query from the California Stem Cell Report, Maria Bonneville, a spokeswoman for the agency, said,
The forum would be held after a proposed ballot initiative to refinance the agency with $5.5 billion is likely to have qualified for the November ballot. The proposal for the two-day event is the sort of conference that opponents of the agency are likely to raise questions about.
Legal restrictions exist in California exist concerning how public funds may be used during a ballot campaign. In response to a question, a spokeswoman for the agency, formally known as the California Institute for Regenerative Medicine (CIRM), said this morning that the grantee conference would comply with state law and would not involve advocacy for the ballot initiative.
The proposal, if approved by voters, would save CIRM from financial extinction. The agency is running out of money and needs more billions to continue its work. CIRM was created in 2004 by voters who provided $3 billion in state bond funding. It is now down to $27 million for awards.
At its meeting on Thursday, the CIRM governing board is scheduled to be asked to allocate $1.8 million of the recovered funds for "progression" awards to help advance more basic level research into possible clinical use. A CIRM document said that two applications have already been received and another six appear to be in the pipeline.
Another $250,000 would be allocated for a public conference in the latter part of the year "to discuss advances and progress in the field of stem cell research in California."
The event would occur after the proposed initiative qualifies for the ballot. Efforts to gather more than 600,000 signatures of registered voters are already underway. The deadline for qualification falls in June.
State law bars agencies from spending public funds for activities that are strictly for ballot campaigns. However, the agencies are permitted to continue their regular public information practices.
James Harrison, former general counsel to the agency and a well-known expert on campaign law, briefed the CIRM governing board last fall on the complex restrictions and gray areas. He said,
"Communications about a ballot measure should be delivered through CIRM’s ordinary communication methods, like its website, blog, newsletter, emails to interested persons, and public meetings, in the style CIRM normally uses to communicate other information. CIRM should avoid passionate or inflammatory language and modes of communication that it does not regularly employ, and should not encourage voters to vote in a particular manner."Harrison drafted portions of the 2004 initiative that created the agency. He was also heavily involved in drafting the current proposed initiative.
In response to a query from the California Stem Cell Report, Maria Bonneville, a spokeswoman for the agency, said,
"CIRM has conducted four grantee meetings since the agency’s inception. These meetings are opportunities for grantees to share information about their progress, discuss bottlenecks in the field, and identify potential partnership opportunities. This grantee meeting will be no different. The meeting will comply with state laws governing the use of public funds in connection with ballot measure campaigns and will not include any advocacy for or against the ballot measure."The CIRM conference proposal said that the public, CIRM grantees, interested funding organizations, patient advocates and stakeholders would be invited to the two-day session. An estimated 300-400 participants are expected. CIRM said the goals of the meeting are to:
- "Provide a public forum to learn about the most recent advances in stem cell research in California.
- "Encourage the sharing of information and data among CIRM grantees to foster collaboration and learning.
- "Timely presentations to address and overcome key bottlenecks and challenges in the field to help advance existing projects.
- "Showcase promising stem cell-based projects for partnership opportunities with investors, funders, or companies"
Monday, February 03, 2020
California's New Stem Cell Initiative and Its $7.8 Billion Cost, Including Interest
The price tag for refinancing California's unique and ambitious stem cell research program could run to close to $7.8 billion, give or take a few hundred million dollars or more.
So says the state's legislative analyst in a financial analysis of a proposed ballot initiative that is likely to be on next November's ballot. The measure would provide $5.5 billion more for research awards to California scientists by the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is formally known.
The increase in the price tag is caused by the fact that the $5.5 billion would be borrowed money -- bonds that would be issued by the state. The legislative analyst estimated that the interest costs could total $2.3 billion, bringing the actual expense to taxpayers to $7.8 billion.
Significant caveats exist, however. The legislative analyst, who prepares these sorts of analyses for all ballot measures, cautioned that the $7.8 billion estimate could rise or fall depending on how interest rates rise or fall. Another unknown involves the length of the payback period.
What the legislative analyst has to say is a significant matter for the proposed initiative, whose success will determine the financial survival of the agency. CIRM is running out of cash. It was funded by voters 15 years ago with $3 billion. If the proposed initiative fails, CIRM will wither away over the next two to three years.
Should the initiative qualify for the ballot, the seven-page financial overview of the measure would be delivered, via the state's official voter's guide, to about 20 million California voters prior to the election. The overview would also serve as the basis for news stories in virtually all of the media, which is always looking for bottom line figures.
Beyond the interest costs, the analysis carried other financial bits of interest. It said that over an initial, five-year period the agency would use some the bond proceeds to pay the interest on the money it is borrowing. The analyst said,
The new initiative stipulates that the agency improve access to stem cell therapies, funding that effort with up to 1 percent of the $5.5 billion, a change from the current law involving CIRM. Other changes from the current situation: 1.5 percent for starting "community care centers" for new clinical trial sites, $1.5 billion for research into brain and nervous system diseases and up to 0.5 percent for a shared lab program.
Royalties from any therapies financed by CIRM research would go to the agency and not the state general fund, as currently is the case. So far, royalties have totaled only about $200,000. Larger amounts are likely to appear in the next decade as the therapies emerge from the research that was financed years ago.
Regarding possible savings as the result of more cost-effective therapies, the analysis said,
In 2004, the legislative analyst prepared an interest cost estimate of $3 billion on the original amount for awards, also $3 billion. However, the projections did not anticipate the recession of 2008, which resulted in a long-term drop in interest rates. Today, the interest on the original $3 billion is expected to be about $1 billion.
Here are links to more information on proposed initiative and related matters:
So says the state's legislative analyst in a financial analysis of a proposed ballot initiative that is likely to be on next November's ballot. The measure would provide $5.5 billion more for research awards to California scientists by the California Institute for Regenerative Medicine (CIRM), as the state stem cell agency is formally known.
The increase in the price tag is caused by the fact that the $5.5 billion would be borrowed money -- bonds that would be issued by the state. The legislative analyst estimated that the interest costs could total $2.3 billion, bringing the actual expense to taxpayers to $7.8 billion.
Significant caveats exist, however. The legislative analyst, who prepares these sorts of analyses for all ballot measures, cautioned that the $7.8 billion estimate could rise or fall depending on how interest rates rise or fall. Another unknown involves the length of the payback period.
What the legislative analyst has to say is a significant matter for the proposed initiative, whose success will determine the financial survival of the agency. CIRM is running out of cash. It was funded by voters 15 years ago with $3 billion. If the proposed initiative fails, CIRM will wither away over the next two to three years.
Should the initiative qualify for the ballot, the seven-page financial overview of the measure would be delivered, via the state's official voter's guide, to about 20 million California voters prior to the election. The overview would also serve as the basis for news stories in virtually all of the media, which is always looking for bottom line figures.
Beyond the interest costs, the analysis carried other financial bits of interest. It said that over an initial, five-year period the agency would use some the bond proceeds to pay the interest on the money it is borrowing. The analyst said,
"Were the state to begin issuing bonds shortly after approval of the measure, CIRM would likely make interest payments totaling in the low hundreds of millions of dollars from bond proceeds by the end of 2025."The proposed initiative also places a 6.5 percent cap on total funding for certain operational expenses including administration and grant oversight. Other changes would give more freedom to the agency, which originally had a 50-person cap on staff. That cap was later removed by state legislation. The new initiative would set the cap at 70 with a provision for more employees beyond that number, under certain conditions involving, among other things, compensating them with cash raised privately.
The new initiative stipulates that the agency improve access to stem cell therapies, funding that effort with up to 1 percent of the $5.5 billion, a change from the current law involving CIRM. Other changes from the current situation: 1.5 percent for starting "community care centers" for new clinical trial sites, $1.5 billion for research into brain and nervous system diseases and up to 0.5 percent for a shared lab program.
Royalties from any therapies financed by CIRM research would go to the agency and not the state general fund, as currently is the case. So far, royalties have totaled only about $200,000. Larger amounts are likely to appear in the next decade as the therapies emerge from the research that was financed years ago.
Regarding possible savings as the result of more cost-effective therapies, the analysis said,
"To the extent the measure results in new treatments that are more cost-effective than existing treatments, state and local governments could experience savings in some programs such as Medi-Cal, the state’s subsidized health care program for low-income people. The magnitude of these and other indirect effects is unknown."The stem cell agency, which was created by voters in 2004, has yet to finance research that has led to stem cell treatments that are approved for general public use.
In 2004, the legislative analyst prepared an interest cost estimate of $3 billion on the original amount for awards, also $3 billion. However, the projections did not anticipate the recession of 2008, which resulted in a long-term drop in interest rates. Today, the interest on the original $3 billion is expected to be about $1 billion.
Here are links to more information on proposed initiative and related matters:
SUNDAY, DECEMBER 08, 2019
LA Times: $5.5 Billion Measure for California Stem Cell Agency Could Actually Be a 'Downfall'
FRIDAY, NOVEMBER 15, 2019
$5.5 Billion Stem Cell Ballot Measure: Questions in California but Apparently No Foot-Dragging
MONDAY, NOVEMBER 04, 2019
California Stem Cell Agency Chalks Up its 60th Clinical Trial as Funds Dwindle
Thursday, January 30, 2020
Federal Stem Cell Regulation Setback in California; Case Involves Treatments with Fat Cells
Dubious stem cell clinics in California were in the news again this week with a piece in the Los Angeles Times declaring that a federal judge had dealt a blow to regulators trying to crack down on the much-criticized enterprises.
The column by Michael Hiltzik said,
The column by Michael Hiltzik said,
"A Los Angeles federal judge has rejected a government motion that could have shut down a network of clinics offering customers allegedly unauthorized stem cell treatments.
"The ruling by Judge Jesus G. Bernal potentially deals a setback for the Food and Drug Administration’s campaign against treatments using stem cell preparations that the FDA has not approved.
"In the ruling published late Monday, Bernal denied the government’s motion for summary judgment in its lawsuit against the Rancho Mirage-based California Stem Cell Treatment Center, the Cell Surgical Network, and the latter’s founders, Mark Berman and Elliott Lander. Bernal ruled that the case was suitable for trial."UC Davis stem cell researcher Paul Knoepfler also wrote about the case on his blog.
"The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of the medical science here as a stem cell biologist.
"Unfortunately, this all leaves the door potentially still open for hundreds of clinics to sell the unproven fat stem cell product at the heart of this case called 'stromal vascular fraction' or (SVF)."
This lawsuit was first filed in May 2018 and is likely to continue for some time, possibly involving lengthy appeals.
The controversy over unregulated clinics is of concern to those who support refinancing California's stem cell agency with $5.5 billion via a hoped-for voter approval of a ballot measure in November. The fear is that the flap could create voter confusion and besmirch the entire field.
The agency was created in 2004 by voters who provided it with $3 billion. It is now down to its last $27 million for research grants. That figure is likely to increase next week as agency directors hear a report on the amount of cash recovered from awards that did not meet benchmarks.
Monday, January 27, 2020
Calfornia's Stem Cell Pie for 2020: State Agency to Slice Up Nearly Final Millions Next Week
It ain't over yet -- at least that's the word from what could be deemed the financial center of stem cell research in California.
The governing board of the California stem cell agency is scheduled to meet Feb. 6 to allocate unspecified additional millions for stem cell research and peer down the road that awaits it beginning Nov. 4 of this year.
That is the day after California voters are expected to deliver their judgment on whether the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, should continue and receive an additional $5.5 billion.
The agency is running out of money. Its initial $3 billion is now down to $27 million for awards. A ballot initiative to give the agency the additional billions is expected to be on the ballot this fall, Nov. 3 to be precise.
But in just 10 days, the CIRM board will reveal the amount of cash that has been recovered from research awards that failed to meet milestones during 2019. The board is scheduled to make decisions on how that money, which is likely to run into tens of millions, is to be allocated during the remainder of this year.
Also on the agenda is a three-word topic: "strategic plan themes." This is likely to involve possible directions of the agency should it receive additional funding from the ballot initiative. That proposed measure substantially expands the scope of the agency and specifies it move into in certain new areas, including attempting to assure the affordability of agency-financed therapies whose costs could run upwards of $2 million.
The agenda includes an update on most major programs involving CIRM, information that will come widely into play as the next fall's election receives more attention.
The meeting will be based at CIRM's headquarters in Oakland. But it will also be available electronically at a number of other public locations throughout California and via the Internet. Members of the public will be able to comment and ask questions through the Internet. Details are available on the agenda.
Thursday, January 23, 2020
Tiny Poll Heartens Backers of California's Financially Beleaguered Stem Cell Agency
The first public opinion poll of 2020 is out concerning the financial fate of California's $3 billion stem cell agency, and the result is "upbeat."
However, there is one caveat that is as consequential as the failure of a phase 1 clinical trial. That is the go, no-go stage at which the safety of a stem cell therapy is tested in humans.
The poll covers only 83 people out of the roughly 20 million California voters.
The testing of public sentiment was conducted in the past week or so by UC Davis stem cell scientist Paul Knoepfler, who well knows the weakness of the non-scientific sample. But he still thinks it is something of a promising sign.
Writing on his blog, The Niche, Knoepler reported that 48 percent of his self-selected respondents, who filled in the poll on the blog, believe that the agency will be refinanced with $5.5 billion from California voters come November.
Sixty-three percent of those polled also said it should be.
The agency is now down to its last $27 million, which is only a relative drop in the stem cell research bucket.
Knoepfler described the poll results as "upbeat." He said that he thought that the 63 percent figure was an especially good sign for the agency, known formally as the California Institute for Regenerative Medicine (CIRM). Knoepfler wrote,
However, there is one caveat that is as consequential as the failure of a phase 1 clinical trial. That is the go, no-go stage at which the safety of a stem cell therapy is tested in humans.
The poll covers only 83 people out of the roughly 20 million California voters.
The testing of public sentiment was conducted in the past week or so by UC Davis stem cell scientist Paul Knoepfler, who well knows the weakness of the non-scientific sample. But he still thinks it is something of a promising sign.
Writing on his blog, The Niche, Knoepler reported that 48 percent of his self-selected respondents, who filled in the poll on the blog, believe that the agency will be refinanced with $5.5 billion from California voters come November.
Sixty-three percent of those polled also said it should be.
The agency is now down to its last $27 million, which is only a relative drop in the stem cell research bucket.
Knoepfler described the poll results as "upbeat." He said that he thought that the 63 percent figure was an especially good sign for the agency, known formally as the California Institute for Regenerative Medicine (CIRM). Knoepfler wrote,
"I actually thought this one might swing the other way since we have many readers here on The Niche who run stem cell clinics or are fans of the clinics, and seem to have a dislike or skepticism for organizations such as CIRM, ISSCR (an international group of stem cell researchers), etc."
Backers of the agency are currently in the process of gathering more than 600,000 voter signatures to qualify the $5.5 billion ballot measure for the fall ballot.
The results of that signature drive, which is being handled by professional signature-gathering firms, may not be known until June.
Tuesday, January 14, 2020
Global Growth in 2020 for Regenerative Medicine While California's Stem Cell Program Faces Extinction
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| ARM graphic |
Just 11 miles away across the famed San Francisco Bay, however, was another sort of stem cell scene. It could be found in the not-so-posh, Oakland headquarters of the state stem cell program, known officially as the California Institute for Regenerative Medicine (CIRM) .
CIRM is going broke. Its original $3 billion has shrunk to $27 million over the last 15 years.
On the other hand, global financing for therapies and treatments in the regenerative medicine field totaled nearly $10 billion in 2019, marking the second highest year ever, the leading U.S. industry group reported at the session at the Parc 55 hotel.
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| Janet Lambert, CEO of ARM -- ARM photo |
Lambert said,
"The pipeline is robust, with several next-gen technologies entering the clinic and an increase in clinical trials for indications with large patient populations."Her comments came as CIRM faces a financing shortfall that could mean its virtual extinction.
The agency, created in 2004 by state voters, is down to its last $27 million of uncommitted cash. CIRM has often spent close to $300 million a year. The agency is hoping voters next November will provide it with $5.5 billion more under the terms of a ballot initiative yet to qualify for the ballot. CIRM's only significant source of funding is bonds issued by the state.
Lambert's organization has more than 350 members, including CIRM. The largest percentage of ARM's membership comes from cell and gene therapy companies. The global financing it reports is almost entirely private.
ARM's 2019 survey tracked nearly 1,000 companies globally, including 534 in the United States. The second largest number, 237, includes Europe and Israel. Lambert said the fastest growing area is Asia, which has 180.
ARM counted 94 phase three clinical trials globally, the last stage before a therapy is approved for widespread use by the federal government.
CIRM is helping to finance 60 clinical trials, including three that are still active in phase three. It has yet to back research that has led to a widely available product.
Here are links to CIRM's phase three trials: BrainStorm Cell Therapeutics, $16 million, ALS, PI Ralph Kern; Humacyte, Inc., $10 million, kidney failure, PI Jeffrey Lawson; Medeor Therapeutics, $11 million, kidney failure, PI Karen Smith.
Here is a link to Lambert's slides. In the near future, ARM expects to mount online a video of her presentation including two additional panel sessions that examine the current and future outlook for regenerative medicine.
Monday, January 13, 2020
Gold-Plated Stem Cell Treatments, Multi-billion Dollar Benefits and Potential Industry Profits
One of the nation's leading regenerative medicine industry groups is touting multi-billion dollar savings that may be achieved with the type of stem cell and gene therapies that are being developed with cash from California's financially beleaguered stem cell program.
The industry group is the Washington, D.C.,-based Alliance for Regenerative Medicine (ARM). It is tackling one of the major issues facing development of commercial stem cell therapies -- sticker shock at their expected prices, running upwards of a $1 million or more.
Without a willingness from health care insurers to cover the costs and provide a pathway to profit, it is unlikely that the biotech industry will embrace production of the therapies.
In a study released last Friday, the group said,
California's stem cell agency was not mentioned in the study, but it has funded research in all three areas. The agency is a member of ARM.
The study, backed by ARM and performed by the Marwood Group, said,
The agency, funded with $3 billion in 2004, is down to its last $27 million. A new, proposed ballot initiative is focusing hard on affordability of stem cell treatments. The initiative has no specific solutions but stipulates that a new version of CIRM -- if the ballot measure is approved -- should devise some ways to come up with answers for insurers who are not likely to warm easily to $1 million therapies.
The industry group is the Washington, D.C.,-based Alliance for Regenerative Medicine (ARM). It is tackling one of the major issues facing development of commercial stem cell therapies -- sticker shock at their expected prices, running upwards of a $1 million or more.
Without a willingness from health care insurers to cover the costs and provide a pathway to profit, it is unlikely that the biotech industry will embrace production of the therapies.
In a study released last Friday, the group said,
"Advances in molecular biology and genetics are leading to new treatments for rare diseases that require new ways of assessing value. CGTs (cell and gene therapies) are directed at the underlying cause of a condition and offer durable, potentially curative, or near-curative benefits. These transformative therapies create challenges for current reimbursement frameworks as they (the therapies) require significant upfront costs but are expected to provide a lifetime of benefits. The recurring treatment costs of chronically-managed patients can be greatly reduced and even eliminated with a one-time administration or short course of these novel therapies.
"As CGTs arrive on the market, payers need new models for assessing their value. These treatments could potentially end the patient’s burden of illness, resulting in cost offsets (eliminating or reducing the need for long-term treatment, hospitalizations, and other care) and productivity gains that span a lifetime. Manufacturers incur a high per-patient development cost for these therapies and payers who bear the cost of treatment may not realize the long-term financial benefits due to health plan switching."The ARM study predicted cost savings of as much as $33.6 billion over about a decade in connection with three afflictions: sickle cell disease (SCD), multiple myeloma (MM) and hemophilia A (Hem A).
California's stem cell agency was not mentioned in the study, but it has funded research in all three areas. The agency is a member of ARM.
The study, backed by ARM and performed by the Marwood Group, said,
"Access to CGTs for even a modest number of patients with MM, SCD, and Hem A each year can reduce overall disease costs by nearly 23% over a 10-year period. The savings from lowering healthcare costs and raising productivity are considerable, approaching $34 billion by 2029. Of the savings, $31 billion are from a reduction in healthcare costs and $3 billion are from productivity gains."The model used by ARM assumed CGT prices as high as $2 million. The study said,
"The model has tested more than 180 different prices across the three potential CGTs that ranged from a minimum test price of $150,000 and up to a maximum price test of $2,000,000. The prices entered into the model created 60 different cost savings curves for all three of drugs in this model. Prices were distributed with more than 50% of test prices in the $100,000-$600,000 price per administration range."The discussion of the costs of stem cell therapies has special resonance in the Golden State where voters are likely to be asked next fall to give $5.5 billion more to its stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM).
The agency, funded with $3 billion in 2004, is down to its last $27 million. A new, proposed ballot initiative is focusing hard on affordability of stem cell treatments. The initiative has no specific solutions but stipulates that a new version of CIRM -- if the ballot measure is approved -- should devise some ways to come up with answers for insurers who are not likely to warm easily to $1 million therapies.
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