Friday, April 10, 2020

Covid-19 and California Stem Cell Agency: Plasma Research to be Funded in $5 Million Round

California's stem cell research agency, in an "emergency" move this morning, joined the search for a plasma treatment for Covid-19, stressing the importance of extending access to minority communities. 

It was only the second time in the 15-year history of the agency that its governing board invoked its "vital research opportunity" clause, which gives it authority to divert funding from stem cell research to other purposes.

Maria Millan, CEO and president of the agency, said in a statement,
“The intent behind this amendment is to be responsive to this COVID-19 crisis by leveraging CIRM’s funding programs, processes and infrastructure within the scientific ecosystem that it has supported to date.
"By providing an opportunity for the medical and scientific community to gather important data while using convalescent plasma treatment protocols on an emergency basis, CIRM is joining the global effort to  expedite treatments to patients in need in the midst of this global pandemic."
This morning's action, approved unanimously, adds plasma research to a $5 million grant round aimed at the coronavirus.  The round has rolling application deadlines. The first was last Tuesday and drew 19 applications. The next deadline is expected in about two weeks.

The board unanimously added a provision to the plasma proposal aimed at ensuring that it would reach into minority and medically under served areas of the state. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), is speeding its award process and expects winning applicants to be ready to begin their work within 30 days of approval of an award.

The use of plasma in treating Covid-19 has attracted international attention as well as here in California.   

CIRM directors also approved additional members to its panel of grant reviewers, all of whom come from out-of-state. The agency selects reviewers from the panel depending on the nature of their expertise.  Sphere: Related Content

Thursday, April 09, 2020

California Stem Cell Agency Set to Finance Anti-Covid-19 Plasma Research

In a rare move, California's stem cell agency is set to expand beyond its traditional scope and finance research involving the use of blood plasma for treatment of Covid-19 patients. 

It would be only the second time that the agency, known formally as the California Institute for Regenerative Medicine (CIRM), has invoked the "vital research opportunity" clause in the 10,000-word ballot initiative that created the agency in 2004. 

Under the initiative, CIRM is restricted to using its $3 billion for stem cell research -- not the vast array of possibilities for the entire field of biomedical research. But a little-noticed provision also allowed for exceptions in the case of "vital research opportunities."  

The proposed action tomorrow would include plasma research in a new, $5 million effort approved two weeks ago to support stem cell research involving Covid-19. On Tuesday, the agency received 19 applications for funding under that fresh, ongoing effort. Another deadline for applications is expected in about two weeks. 

The expansion to include plasma will be presented to the CIRM governing board tomorrow at 11 a.m. PDT during a public, online meeting. It includes funding "proposals to study convalescent plasma or its derivatives (e.g., immunoglobulin) for the treatment of patients with COVID-19."

The plan also said,
"Clinical studies of convalescent plasma may propose use of the FDA’s single-patient emergency IND (eIND investigational new drug) pathway to satisfy the (agency's) CLIN2 eligibility requirements for a traditional IND."
CIRM's $5 million coronavirus effort might seem skimpy to those used to thinking of the agency as a $3 billion program. It was a $3 billion effort 15 years ago. Today the agency is running out of cash and is down to its last $27 million, which is largely committed to a sickle cell round. 

CIRM is hoping that a proposed, $5.5 billion ballot initiative will qualify for the November ballot, be approved by voters and give it at least another 10 years of life.  

The first occasion for invoking the "vital research" clause involved gene therapies. 

The public can listen in on tomorrow's meeting and make comments. Instructions for online access can be found on the meeting agenda. 

Here is a look at a national plasma effort already underway. Here are federal recommendations concerning such research. 

Sphere: Related Content

Wednesday, April 08, 2020

$5 Million Allotted: California Stem Cell Agency Receives 19 Applications for Research Targeting Covid-19

Nineteen scientists seeking to crush the coronavirus submitted applications this week for research grants from the California stem cell agency, which has set aside $5 million for the job. 

Details on the nature of the proposed work were not disclosed by the agency, known formally as the California Institute for Regenerative Medicine (CIRM). That's in keeping with its usual practice concerning applications that are yet to be reviewed or approved. 

The research must involve a stem cell or a drug or antibody targeting stem cells. The agency said that only research involving "development or testing of a treatment for Covid-19 (is) eligible."

The "emergency" coronavirus round was established by the agency just two weeks ago. CIRM plans to deliver funds quickly to the winning applicants. The researchers are expected to be ready to begin work within 30 days of approval of the awards. 

The agency allocated the $5 million on March 27. Yesterday was the first deadline for applications. The next is expected in about two weeks.  The agency has said it would fund all stages of research from basic to clinical. Maria Millan, president and CEO of the agency, said earlier in a statement
“These are clearly extraordinary times and they require an extraordinary response from all of us.... California researchers have made us aware that they are pursuing potential stem cell based approaches to the COVID-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."
Some scientists have expressed doubt that a stem cell approach can generate the results needed. In posting Sunday on The Niche stem cell blog, Sean Morrisonchairman of the Public Policy Committee at the International Society for Stem Cell Research and director of Children’s Research Institute at University of Texas Southwestern, responded to a question that asked about "potential roles for cellular therapies for COVID-19? Is there something unique they might be able to achieve that other approaches like anti-viral drugs could not?"

Morrison replied,  
"I’m afraid I’m skeptical about cellular therapies for Covid-19. Some have suggested that transplantation of immune effector cells, such as NK cells, into patients might promote a more effective immune response. I worry it will take too long for the transplanted cells to engraft and mount an effective immune response against a virus that often kills patients within days of hospitalization. 
"Others have suggested that mesenchymal stem cell (MSC) transplants might provide a benefit by attenuating the hyper-inflammation that occurs in late stage patients. While there has been some evidence that MSCs can attenuate pathological immune responses in some contexts, most clinical trials that tested this strategy failed. The other red flag is that all of the cell therapies I have seen proposed for Covid-19 have been repurposed from very different indications.
"To some extent that’s to be expected when dealing with a novel pathogen. However, it gives one pause when a cell therapy under development for cancer is suddenly touted as also having anti-viral activity. Immunologically, these are two very different problems that require very different kinds of pre-clinical testing."
The next step in CIRM's Covid-19 round is for the agency to convene a panel of scientists from out-of-state to review the applications behind closed doors and make the de facto decisions on whether to fund them. Their decisions then go to the CIRM governing board for ratification. 

At that point, summaries of the anonymous reviewers' comments on the applications become public. 

Five of the applications were from private companies and the rest from nonprofits. 

The reviewers do not publicly disclose their financial or professional conflicts of interest. Members of the governing board are barred from voting on applications involving their institutions. The research is required to be performed in California.  Sphere: Related Content

Tuesday, April 07, 2020

A Grim Picture? Nuts and Bolts of California's Ballot Petition Pinch and $5.5 Billion for Its Stem Cell Research Program

Here is a not-so-hypothetical question: In these days of the coronavirus crisis, is it safe to touch a mailed-in petition to place a $5.5 billion stem cell research proposal on the November ballot?

While some may consider the question dubious, it is in, in fact, a real question for enterprises attempting to win a position on the ballot next fall. And it illustrates the difficulties facing backers of the proposed stem cell ballot measure, which is aimed at saving California's stem cell agency from financial extinction. 

The agency is running out of money and will begin to close its doors next fall unless more cash is coming in.

Lisa Renner wrote yesterday about California's ballot petition pinch for Capitol Weekly, a respected online news service that follows state governmental and political affairs. She said,

"It’s never easy to get initiatives qualified for the ballot, but this year of the COVID-19 pandemic is the worst ever....
"While organizations technically have until April 21 to turn in signatures to qualify for the November ballot, the shutdown effectively means that those that didn’t collect enough signatures by mid-March probably won’t make it. At best they can hope for possibly qualifying for November 2022."
Renner painted a vivid picture of the nuts-and-bolts of the petition business. She quoted Fred Kimball, owner of Kimball Petition Management.
"Kimball is faced with the challenge of confirming the signatures to make sure they are from unique registered voters. In a normal year, he said he has 75-100 people crammed in his office checking signatures. But this year, he has only six workers in house while the rest are looking at petitions from home.
"'I haven’t done this ever,' he said. 'Usually the petitions never leave the site of the office. There’s a lot of trust you put into the workers. It’s very difficult.'
"Some employees have quit because they don’t want to touch papers that have been handled by so many people and thus could be contaminated with the virus. To deal with that concern, Kimball has set a new rule that new signatures pages that come in his office must sit for one week before anyone touches them again. He also requires employees in house to wear masks and gloves."
Kimball's firm is working on the ballot proposals dealing with kidney dialysis and medical negligence. But his comments bear on any proposed initiative. 

In the case of the stem cell measure, it needs 623,212 valid signatures of registered voters to qualify for the ballot. Backers say they have 915,000 and need another 35,000 in order to account for disqualified signatures. They have launched an ambitious and "unprecedented" effort to circulate petitions via the Internet.

"Proponents usually seek at least 50 percent more than the legal minimum number of signatures to compensate for possible duplicate or otherwise invalid signatures," according to Wikipedia.

Capitol Weekly's Renner also reported on the stay-at-home orders facing county elections officials.

"Most have shut down all offices, requiring initiative supporters to set up appointments to drop off petitions. Much of their staff is also working at home, which sets up the new burden of getting the petitions to employees."
She continued,
"Joseph Holland, the Santa Barbara County clerk, recorder, assessor and registrar of voters, said his office hasn’t even finished certifying the March 3 election and is facing employees out sick and suddenly charged with taking care of their children after schools closed. “We are operating with a skeleton crew,” said Holland, who also serves as president of the California Association of Clerks and Elections Officials. 
"While his employees are considered essential under the shut-down order, figuring out logistics about where they sit is an issue. They can no longer sit side by side at cubicles as that would violate the 6-foot social distance rule. “It has reduced our capacity by half.” 
"For petition signatures that come in on a single page, the county is able to scan them and electronically send them to employees working at home for validation. But the county is not able to scan petitions that come in booklet form. Those must still be validated by employees at the office, Holland said."
The verification process involves random samples, which can trigger a full check of each signature, slowing the process considerably. There is a possibility that the current legal requirements could be modified, but that change would likely involve the governor and the legislature. 

The campaign for the stem cell measure has set for itself a deadline of this Saturday to finish collection of signatures. 
Sphere: Related Content

Friday, April 03, 2020

Final Cyberspace Dash Underway for $5.5 Billion California Stem Cell Initiative

Above is the instructional video from the stem cell initiative campaign web site. 

The campaign to save California's stem cell research program from financial extinction is making an "unprecedented," electronic sprint to gather the final signatures to qualify its $5.5 billion rescue measure for the November ballot. 

In the next eight days, the campaign says it needs 35,000 more signatures to be sure that the multi-billion-dollar ballot initiative is presented to voters next fall. 

The stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM), is running out of money. It will begin closing its doors in November without more funding.  The campaign's web site says, 
"Over 915,000 voters have already signed petitions to help qualify our initiative for the November 2020 ballot. In the last full week before public signature gathering was shut down due to the coronavirus, over 120,000 voters signed – a tremendous response. But we need at least 950,000 signatures to secure a place on the California ballot this fall. 
"Help us meet our goal by signing and returning a petition today. The campaign must gather the last 35,000 signatures through mail-in submissions by April 11th."
In response to questions from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad described the online move as "unprecedented." She said,
"What’s happening right now across the world is unprecedented, which means the innovative changes we’re making to gather signatures through a mail-in option are unprecedented as well." 
The campaign's unusual Internet pitch is aimed at putting petitions in the hands of its supporters. The effort requires downloading documents, reading detailed instructions on filling them out and then returning them by regular mail. Normally, paid signature gatherers take care of all that.

The process is not simple and is likely to be daunting for some.  The campaign's web site mentions "wet signatures," the importance of printing out the 16 pages of the petition and the need to complete the "circulator declaration." A seven-minute instructional video has also been posted by the campaign (see above). 

The campaign's message stresses speed. 
"Time is of the essence; a fast response is needed to preserve our opportunity to guarantee our ballot position."
The legal minimum of valid signatures of registered voters is 623,212. The extra hundreds of thousands of signatures are needed because many are disqualified by election officials during the certification process.

The campaign's online pitch also includes a schedule of 30-minute webinars aimed at building support and answering questions. They begin tonight at 6:15 p.m. PDT and continue on April 5, 7 and 11. 
Sphere: Related Content

Wednesday, April 01, 2020

Backers of a $5.5 Billion California Stem Cell Measure Claim 915,000 Signatures, Ballot Qualification at Stake

The campaign to place a $5.5 billion, stem cell measure on the California ballot this fall says it has gathered more than enough signatures to bring it before voters. 

In response to questions from the California Stem Cell Report, a campaign spokeswoman said,
"In our last full week of signature gathering, we received 120,000 signatures, showing the tremendous support from California voters. With 915,000 signatures in hand and a new sign-from-home option that allows individuals to mail in their signatures, we’re confident that we will be able to gather the final signatures we need while, most importantly, keeping Californians safe." 
The proposal needs 623,212 valid signatures of registered voters to qualify. Because so many signatures are disqualified in the verification process, many more than the bare minimum are required. 

The next step is for the campaign to submit the signatures to election officials for verification, a process than can take a month or more under normal government operating conditions. 

The entire process has a deadline of June 15 to be completed.  

Campaign spokeswoman Sarah Melbostad said, "Voters can go to our website to sign the petition and ensure the continuation of treatments and cures that could save or improve the lives of millions."  

(Editor's note: An earlier item on this subject that was briefly up this afternoon  incorrectly said that the campaign had not responded to a question concerning the current number of signatures. That post has been deleted.) Sphere: Related Content

Tuesday, March 31, 2020

California Pumps $5 Million into Search for Stem Cell Treatment for Covid-19

California's stem cell agency, in an emergency action, has allocated $5 million for research into treatments for Covid-19 and set the deadline for the first applications for one week from today. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), approved the funding last Friday during an emergency meeting of its governing board. 

In an item yesterday on the CIRM blog, Maria Millan, CEO and president, said,
"California researchers have made us aware that they are pursuing potential stem cell based approaches to the Covid-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."
The agency set accelerated timetables for action, both by the agency and applicants. It said it would expect winning applicants to begin work within 30 days of being approved. 

CIRM's move comes as itself is facing a mortal financial threat. It was created by voters CIRM in 2004 with $3 billion. It is now down to its last $27 million and is hoping voters will approve $5.5 billion more via a proposal that is yet to qualify for the November ballot. Otherwise CIRM's doors will begin to close in the fall. 

Presumably, billions of private and public dollars are already pouring globally into the search for various aspects of Covid-19, so the $5 million is a relatively tiny amount. CIRM has developed a speedy process, however, for bringing funds to bear on research and is acting to accelerate that even further. 

Jonathan Thomas, chairman of the CIRM board, said, 
"The coronavirus is creating an unprecedented threat to all of us and, as one of the leading players in regenerative medicine, we are committed to doing all we can to develop the tools and promote the research that will help us respond to that threat." 
The campaign to qualify the $5.5 billion initiative for the ballot released a statement heralding the action by CIRM. Robert Klein, the Palo Alto real estate developer behind both the original ballot measure and this year's funding initiative for CIRM, said, 
"The investment by California’s stem cell institute to combat Covid-19 highlights the remarkable potential of this research and therapy development to impact the lives of every Californian. ...We urge Californians to think back on this moment, when they decide the fate of future life-saving stem cell discoveries and treatments come November."
The campaign said 10 days ago that it has suspended the gathering of signatures. It is not clear whether it has enough to qualify for the fall ballot. More than 600,000 valid signatures are required. 

Here are links to additional CIRM information on its Covid-19 program:
Sphere: Related Content

Friday, March 27, 2020

Covid-19 Break for California Stem Cell Report

The California Stem Cell Report, at least this writer, has tested positive for covid-19.  The symptoms are such that it makes it make difficult to compose even short postings. We are following the usual precautions and hope to return to regular publication soon. Sphere: Related Content

Saturday, March 21, 2020

California's $5.5 Billion Stem Cell Initiative: Signature Gathering Suspended Due to Coronavirus

Backers of a $5.5 billion stem cell research initiative in California have suspended their efforts to gather signatures to place it on the November ballot, but are expressing confidence that the proposal will qualify.  

In response to questions from the California Stem Cell Report, the campaign said it had run afoul of statewide bans on public gatherings. Voter signatures on petitions to place the initiative on the ballot generally require small gatherings in public places. 

The proposal is intended to refinance the California stem cell agency, which has spent nearly all of the $3 billion it was provided by voters in 2004. It will begin to close its doors next fall unless more funding is provided. 

Sarah Melbostad, a spokeswoman for Californians for Stem Cell Research, released a statement that said, 
"In keeping with the governor’s statewide order for non-essential businesses to close and residents to remain at home, we’ve suspended all signature gathering for the time being."
The statement continued, 
"We’re proud of our team and proud of the promising and significant number of signatures we’ve gathered to date – demonstrating strong support amongst voters. We’re confident that we still have time to qualify and plan to proceed accordingly."
To qualify for the ballot, the valid signatures of 623,212 registered voters are needed. Large numbers of signatures are usually disqualified during the certification process. So tens of thousands of signatures or more beyond the minimum are invariably necessary. 

The campaign originally expected to have the signatures gathered by the end of April. The campaign did not respond to a question concerning the number of signatures that it has on hand now. 

The California Stem Cell Report understands that petition circulation companies throughout the state are calling in their signatures next week. At that point, reliable figures may be available. The halt to signature gathering affects other potential ballot measures this fall. 

Here is the full text of the campaign's statement:
"In keeping with the Governor’s statewide order for non-essential businesses to close and residents to remain at home, we’ve suspended all signature gathering for the time being.
"As the COVID-19 issue is updating daily, if not hourly, we at the campaign are monitoring the situation very closely and will comply with all statewide, regional and local ordinances.
"We’re proud of our team and proud of the promising and significant number of signatures we’ve gathered to date – demonstrating strong support amongst voters.
"We’re confident that we still have time to qualify and plan to proceed accordingly.
"When faced with this current situation, we’re reminded every day how important this initiative is to save and improve the lives of millions of Californians living with chronic diseases and conditions, such as cancer, Alzheimer’s, heart disease, HIV/AIDS, kidney disease and more."
Sphere: Related Content

Friday, March 20, 2020

Coronavirus Fallout: New and Bigger Hurdles Now Face $5.5 Billion California Stem Cell Measure

California's intensifying battle against the coronavirus is creating ever larger obstacles and uncertainty concerning the proposed $5.5 billion ballot initiative to refinance the state's stem cell research program, which is running out of money.

The new, statewide ban on public gatherings is certain to hamper the gathering of the 600,000-plus signatures needed to place the measure on the November ballot. No one knows how long that ban will be in place. Signature gathering in California largely occurs in public places using paid workers. 

The financial fallout from the crisis also raises questions about whether funds can be raised to support the petition drive -- not to mention a fall ballot campaign that could cost in the neighborhood of $50 million. The usual contributors to such an effort are likely to feel financially squeezed, plus they may be refocusing on new and higher priorities dealing with health care, if they have cash they are willing to contribute.

The impact of the coronavirus crisis has already knocked off one ballot measure in Palo Alto, a wealthy Silicon Valley enclave.  The school board there this week removed a $16-million-a-year property tax measure from its May ballot.  An article in the Palo Alto Daily Post said, 
"'In order to do even a high-polling ballot initiative … the committee doing it needs to have a certain amount of resources, including money raised and feet on the street,' (school) trustee Melissa Baten-Caswell said. 'It is really not conceivable that they’re going to have enough to run the rest of the campaign in this time frame.'
The financial squeeze is also being reported nationally. Some big national political donors backed the measure that created the stem cell program 15 years ago.  Politico wrote just this morning,
"Campaigns across the country have canceled face-to-face fundraisers for the foreseeable future and are scrambling to figure out how to raise enough money to stay solvent. Big donors' stock portfolios are tanking. And small-dollar, online contributors — who have never been more important to campaigns — are facing sudden financial uncertainty and the real possibility of unemployment."
Backers of the $5.5 billion stem cell initiative have until June 15 to complete the qualification process, which goes beyond simply gathering signatures. They must be verified by election officials as valid signatures of registered voters which can take some time. 

The campaign had expected to submit more than enough signatures by late April. The California Stem Cell Report has queried the campaign for comment, but has received none. 

The stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), was created in 2004 by voters with $3 billion in funding. It is now down to it last $27 million for awards.  Sphere: Related Content

Wednesday, March 18, 2020

Autism and Stem Cells: Live Online Event Tomorrow from California Stem Cell Agency

The California stem cell agency wrote this week about the "definitely strange" and challenging times, but it is making a move tomorrow to stay on balance with an online Q&A exploration of autism and stem cell research. 

The specific matter is a Facebook Live event called "Ask the Stem Cell Team About Autism" at 12 p.m. tomorrow.  The agency said on its blog:
"The event features Dr. Alysson Muotri from UC San Diego. We have written about his work with stem cells for autism in the past. And CIRM’s own Associate Director for Discovery and Translation, Dr. Kelly Shepard."
Kevin McCormack, senior director of communications at the agency, said that some people had asked why the agency was going ahead with the program.
"It’s a good question. And the answer is simple. Because there is still a need for good, thoughtful information about the potential for stem cells to help families who have a loved one with autism. And because we still need to do all we can to dispel the bad information out there and warn people about the bogus clinics offering unproven therapies.
"In many ways Facebook Live is the perfect way to deliver this information. It allows us to reach out to large numbers of people without having them in the same room. We can educate not contaminate."
McCormack noted,
"If you can’t tune in while we are live, not to worry, you’ll be able to watch it again afterwards when it gets posted to our CIRM Facebook page."
Sphere: Related Content

Tuesday, March 17, 2020

Coronavirus Shutdown Hits California's Stem Cell Agency; Effort to Re-finance Research Program Hampered

California's $3 billion stem cell agency closed its physical doors this morning to avoid being considered, along with thousands of other San Francisco Bay Area enterprises, an "imminent threat to public health" under the terms of strict, new government orders. 

Maria Millan, CEO and president of the Oakland-based agency, told her 34 employees yesterday that the action was being taken in compliance with legal orders issued by six Bay Area counties. The agency's staff will continue their work from home or elsewhere.

The stringent directives affect seven million people and businesses ranging from retail to entertainment. But many enterprises were exempted because of the services or goods they provide, such as supermarkets and banks. 

Violation of the orders is deemed to be "an imminent threat to public health," a formidable piece of legalese that can be enforced by police. 

The orders generally ban public gatherings, which would seem to mean effectively a ban in the Bay Area on public gathering of signatures to qualify a $5.5 billion stem cell research measure for the November ballot. The agency is running out of money and hopes to stave off its financial demise with approval of the measure next fall. 

The deadline for completing the tedious qualification process for the ballot measure is June 15. Backers of the measure had hoped to have more than enough signatures by the end of April. 

Yesterday's orders are in effect until at least April 7.

As a practical matter, the process of soliciting signatures for ballot measures in California was already encountering barriers because of safe distance and other concerns. 

The campaign  has not yet responded to questions concerning the impact of coronavirus situation. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), had already allowed its employees to work from home. The agency funds research but does not actually perform it. 

Americans for Cures, a Palo Alto patient advocacy group supporting the measure, said it would be working remotely in compliance with the new orders. The group was founded by Robert Klein, who oversaw preparation of the proposed stem cell initiative.

The agency says that none of its current portfolio, which includes 60 clinical trials, has specific application to the coronavirus. Here is the text of the note that Maria Millan, CEO and president of CIRM. sent to the agency's team yesterday.
"As we enter week two of our agency-wide telecommute, the COVID-19 crisis continues to intensify, resulting in additional containment measures with an increasing number of school, university and business closures, cancellation of gatherings, and severe travel restrictions. In addition, a three week 'shelter in place' order has just been issued for six counties in the Bay Area- San Francisco, San Mateo, Santa Clara, Alameda, Marin, Contra Costa. As stated last week, this situation remains fluid, we are monitoring it closely and I am remaining in close contact with the LT, HR and our Board so we can continue to take appropriate action as needed.

"We are committed to working with our community to deploy containment measures in order to 'flatten the curve' of this outbreak and, as always, we are committed to the health and well-being of our employees and their families. In this spirit, and taking into account the containment response timing in our local communities, we will extend the CIRM agency-wide telecommute plan to April 13 . We will be in constant contact and will notify you of any additional changes. To date, there have been no documented or reported COVID-19 cases or exposure in CIRM employees.   "Thank you for continuing our important work at CIRM, for your responsive support of our programs/grantees/patient advocates during this crisis and for continuing to execute our strategic goals. I’d like to acknowledge our IT department who have armed us with the technological tools to work remotely, our project managers for coordinating us and keeping the schedules on track and leadership for enabling their teams to remain productive. "Please feel free to contact your manager, HR, Maria B or me if you have any questions related to CIRM’s COVID response or if you need assistance in transitioning to the agency-wide CIRM telecommute plan. "Take good care & look forward to working with you from a distance (for now)."
Sphere: Related Content

Monday, March 16, 2020

Fresh Hurdles for $5.5 Billion Stem Cell Measure: Coronavirus and Safety Distance

Signature gathering -- Too close for safety?  Photo Hero Images
The current coronavirus emergency and the practice of social distancing are likely to put a crimp in gathering signatures to qualify a $5.5 billion stem cell initiative for the November ballot in California.

The situation is already troubling much smaller petition efforts in New York State where state legislative candidates need as few as 500 signatures to qualify for the ballot.

One candidate going door-to-door reported that a resident shouted through a window, 
“I don’t want to talk to anybody or open the door!” 
In California, 623,212 valid signatures are needed to put the $5.5 billion stem cell proposal on the ballot. Backers had hoped to have well over that by the end of April.

Without voter approval of the measure, the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), will go out of business. It was created by voters in 2004 with $3 billion but is running out of money.

Other major ballot proposals are also caught in the safety distance pinch. The include ones dealing with sports betting, dialysis clinics, packaging waste reduction and a measure to modify Prop. 13, the property tax law of 1978.

Whether they are affected in a significant way depends on individual deadlines and how many signatures they have to date.
Gathering signatures for a ballot measure is an expensive proposition that requires hiring signature gathering firms that, in turn, hire the "gatherers" to be in places with high pedestrian traffic. The signing process also requires what some persons might regard as less than safe physical distances in supermarket parking lots and other locations. Shoppers may well be more focused on stocking up rather than signing up. 

In New York state, Gov. Andrew Cuomo has sharply reduced the amount of signatures required for candidates to qualify for the ballot.  

In a statement, Cuomo said,
"Public health experts have been clear that one of the most common ways to communicate COVID-19 is through direct person to person contact, and we are doing everything in our immediate power to reduce unnecessary interactions.

"This executive order modifies the election process in a way that both protects public health and ensures the democratic process remains healthy and strong regardless of the ongoing pandemic."

Any impediments to gathering signatures in California are likely to mean increased expense. In 2018, costs ran as high as $9 a signature. 

It is not clear that the California governor or other state officials can do anything to deal with the slowdowns in signature gathering, which affect other efforts besides the stem cell initiative. However, state lawmakers might be able to make an immediate change in state law with a two-thirds vote of both houses and the agreement of the governor. 

To make the November ballot, the stem cell initiative campaign must clear the certification process by June 15.  The campaign did not immediately respond to a request for comment.  Sphere: Related Content

Friday, March 13, 2020

Does the Failure of a Big Bond Measure Earlier This Month Mean Bad News for $5.5 Billion Stem Cell Proposal?

Tax fatigue: A problem for bond measures?
Was voter rejection of a $15 billion school bond measure a bad omen for another bond measure that would save the California stem cell agency from financial extinction? 

The question arises because the failure of the school bond proposal shocked its backers. The measure was considered nearly a certainty by some. However, it turned out to be the first state school bond measure to be rejected by voters in nearly three decades, despite almost non-existent organized opposition.  

Some attribute its March 3 downfall to "bond/tax fatigue," along with confusion. If so, the rejection of measure may not augur well for the proposed, $5.5 billion bond measure to refinance the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known. 

CIRM began life in 2004 with $3 billion provided by voters. It is now down to its last $27 million. The doors will begin closing in November if fresh financing is not found.  

CIRM's backers say there is a significant difference between what happened earlier this month and what may happen in November with the stem cell measure. 

In response to a question from the California Stem Cell Report, stem cell campaign spokeswoman Sarah Melbostad released a statement that said, "California voters did not have an emotional connection to Proposition 13," the school bond measure.

On the other hand, the statement indicated that the stem cell measure has emotion in abundance.
"Investing in the future health of our families and loved ones is one of the most important investments we can make today," the statement said.  "In the November 2020 election, California voters will have the opportunity to continue forging a pathway for life-saving treatments and cures." (Underlining by this writer)
The statement acknowledged the several reasons bandied about for Proposition 13's loss, including confusion.
"As many experts have noted, voters likely confused the ballot number with the well-known Proposition 13 from 1978 and voted no as a result." 
(Proposition 13 limited increases in property taxes, which stirred much concern in the 1970s and which continues to this day.)

Confusion could play a role as well in November on the stem cell measure. That is, confusion involving the research financed by CIRM and the dubious activities of unregulated clinics that purport to sell "stem cell" therapies that can cure everything from sexual dysfunction to bad knees -- all with the same product. 

The federal government has attempted to crack down on the "snake oil" clinics with mixed success. In California, both state medical regulators and legislators have not moved significantly on the clinics, whose treatments have led to lawsuits and accusations of physical and financial harm.  

That said, headlines also appear regularly on the Internet and elsewhere dealing with "miraculous" stem cell cures from the clinics. Many of claims are related by celebrities, including William Shatner (Capt. Kirk of Star Trek fame), sports figures and even a former Trump administration cabinet member/former Texas governor, Rick Perry

That attention could cut two different ways. One side could conceivably help build support generally for stem cell therapies by telling stories of success. The other side could lead to concern that all stem cell work is questionable. Ultimately, the old P.T. Barnum saying -- "I don't care what the newspapers say about me as long as they spell my name right." -- may come into play.

The election this month was also politically different than the presidential election next fall. Major elections, with their higher turnout, generally are regarded as more favorable for bonds. Plus the California voters have a 34-year, overall history of approving about 90 percent of the bond measures on the ballot. 

Here is the full text of the statement from Californians for Stem Cell Research, Treatments and Cures.
"Public polling data from PPIC consistently showed that Proposition 13 had only a very slim margin of support among likely voters.
"As many experts have noted, voters likely confused the ballot number with the well-known Proposition 13 from 1978 and voted no as a result.
"California voters may have also experienced school bond fatigue with the number of different school bonds passed in recent years — and are looking to the Governor and state legislature for other options.
"California voters did not have an emotional connection in regards to Proposition 13. Proponents of the ballot measure failed to demonstrate how funds would effect local communities and school districts.
"Investing in the future health of our families and loved ones is one of the most important investments we can make today—in the November 2020 election, California voters will have the opportunity to continue forging a pathway for life-saving treatments and cures.
"California voters’ breakthrough investment in 2004 firmly established the state as the global leader of stem cell research, we must continue to support these efforts in researching and developing new therapies, treatments and cures for chronic diseases, conditions and injuries.
"Patient advocates, leaders in medical research, revered medical practitioners and Nobel Prize winners support this Initiative because they all agree it is the most viable path to real treatments and cures for diseases that touch nearly all Californians – from cancer and diabetes to Alzheimer’s and Parkinson’s."
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Tuesday, March 10, 2020

Checking in on Skimpy Media Coverage of the $3 Billion California Stem Cell Program

The Capitol Weekly website, a must read for state policy makers and legislators, published an article yesterday involving California's stem cell agency. The article began like this,
"A small firm in Menlo Park is probably the only company in the nation that is named after the number of a particular human protein. It is a small number too, only 47. But it has large implications for California’s financially strapped state stem cell agency."
The piece pulled together the events of last week involving the purchase of Forty Seven, Inc., a grantee of the stem cell agency, by Gilead Sciences, Inc., for $4.9 billion. It was the lead story on Capitol Weekly for much of yesterday.

The political and governmental news website is a case where California stem cell news reaches an important audience not normally attuned to what emanates from the stem cell agency's headquarters in Oakland.  

While regular readers of the California Stem Cell Report are familiar with many aspects of the Forty Seven deal and its significance, that is not necessarily the case with the readers of Capitol Weekly. They consist of "elected officials and staff, political professionals, activists, academics and regular state employees," according to its web site. Capitol Weekly is also something of an institution and has been publishing, first in print and then online, since the 1980s.  

As our readers are aware, news coverage of the California Institute for Regenerative Medicine (CIRM) in the mainstream media is virtually non-existent, which poses a challenge for the agency as it hopes for voter approval of a proposed ballot measure next fall to give it an additional $5.5 billion. 

Mainstream coverage of the agency and the ballot measure will step up next fall, but the news media has severe financial and staffing limitations. Most of their efforts will go to cover the presidential race and matters that have more perceived, immediate impact on California. 

Capitol Weekly has a special niche that reaches influential folks and opinion leaders in the state Capitol. The California Stem Cell Report has an arrangement with Capitol Weekly in which it often picks up items from this site after they are published here. This writer also sometimes writes a piece for Capitol Weekly that is tailored to its audience, which does not necessarily want or need as much detail as many of the readers of the California Stem Cell Report. Yesterday's story on Capitol Weekly is one example. 

The media environment is tough right now for coverage of science-oriented stories or small state agencies, with the exception of such things as the coronavirus. But it is a reality that confronts the campaign on behalf of the $5.5 billion initiative to keep CIRM alive.  Sphere: Related Content

Sunday, March 08, 2020

Inside California Stem Cell IP: A Look at the Royalty Money Trail

The $4.9 billion purchase last week of a California immunology firm is a rich deal for Forty Seven, Inc., but it is no immediate cash cow for the state's stem cell agency, which backed the firm's "don't-eat-me" research with upwards of $45 million.

CIRM's intellectual property (IP) regulations, which have received little public attention, are key to determining who gets what out of the arrangement. However, at this point, nobody knows how much or when any cash will come back to the state. 

The IP rules are currently aimed at financing more research and production of  therapies as opposed to generating the most income possible for the state. It is a balancing act, according to CIRM. 

At the request of the California Stem Cell Report, the agency last week answered a number of questions concerning some of the details that come into play in cases such as Forty Seven. The upshot is that a grant, which is what Forty Seven received, can be converted to a loan, paid off and thus end any obligation to pay royalties. 

Here is how the agency's intellectual property rules work, starting with the sale of Forty Seven. 

The per share price to be paid for Forty Seven is $95.50, up 1,600 percent since last October's low of $5.53. The agency does not share in that run-up. State agencies are barred by the State Constitution from owning stock. 

The stem cell agency has awarded Forty Seven directly $15 million for its cancer-fighting trials. Noted Stanford researcher Irv Weissman separately has received $30 million from the agency, much of which went for the basic research behind Forty Seven. Weissman, who co-founded the firm and is on its board of directors, stands to gain $191 million. Stanford is set to receive $67 million.

Any payout for the agency, known formally as the California Institute for Regenerative Medicine (CIRM), is down the road. If a profitable treatment ultimately emerges, the state -- not the agency -- might get some royalties through the company or Stanford.  In that case, state lawmakers could spend the funds for anything from salaries at the Department of Motor Vehicles to purchase of office furniture. 

Or Gilead Sciences, Inc., the new owner of Forty Seven, could convert the CIRM grant to a loan, which then could be paid off with interest, ending the possibility of extended royalties from the company. In that case, the payoff would go to CIRM for research purposes -- not the state's general fund. 

In 2015, when CIRM directors approved the loan conversion provision, Randy Mills, then president of the agency, said the mission of the agency is to produce therapies -- not to generate large profits. He said loan conversions would recycle CIRM cash with interest into more research faster than royalties. 

Here is the text of our questions and CIRM's responses concerning IP rules,  with more details on how it all works.  

California Stem Cell Report: Can you refresh me on the date of the changes in the IP rules related to the loan conversion and the justification? .... My recollection is that conversions were authorized because of pressures from grantees. 

CIRM: The interim loan conversion policy was implemented in May 2015. Our then President and CEO Randy Mills recommended the changes, and the CIRM Board approved them, to try and bring in more for-profit applications. He felt the existing policy added complications on the commercial development path for therapies, making it less attractive for for-profit companies to apply to us for funding. Engaging with for-profit companies is key to delivering on our mission so we made the changes, not because of pressure from existing grantees or anyone else. 

Transcript of Intellectual Property Subcommittee May 19, 2015
Transcript of CIRM governing board meeting May 21, 2015 
(The meetings involved approval of the current IP regulations.)

California Stem Cell Report: Is it accurate to say that a company can escape any obligation to pay royalties by unilaterally converting a grant to a loan? Can CIRM do anything to prevent the company from such a conversion? (See here for language from an federal document filed by Forty Seven.)

CIRM: Our goal is to always give every project we fund the greatest chance of success and that often means creating the easiest path for companies we fund to partner with other commercialization partners that have the capital to successfully bring the program through the necessary steps to move the given therapeutics to market and to patients. If a project is successful, and clearly that’s why CIRM was created, the company is still obligated to repay the funding we provided it but it has the option of doing so in a lump sum or to allow that repayment through potential, but still uncertain, future royalties.

As these policies were discussed and approved by our Board it does not make sense for us to try and prevent a company from following our rules.

California Stem Cell Report: Does the proposed new initiative do anything to prevent that from occurring or affect it in any way? 

CIRM: The new initiative does not address this issue. Our Board has, as it always has had, the flexibility to change the IP policy if it so chooses.

California Stem Cell Report: Can you please clarify the language concerning the interest rate on the loan? 
Does the interest take effect retroactively beginning with the date of the award? In other words, let's say the award was made in 2016. The company converts to a loan in 2026. Does it have to pay interest for all of those 10 years? 

CIRM: Yes, the interest takes effect retroactively but only to the date of each individual payment. Since the grant is paid out over the life of the Award, each payment is treated individually in determining the compounded interest up the conversion date. The specific interest rates are determined by the stage of clinical development at the time of election.

California Stem Cell Report:  Can you also clarify the following language from the SEC document related to how the total interest amount is calculated. It raises a possibility that interest could be as much as 30 percent in year in some cases. The phrase I am referring is "plus zero to 30% per annum that varies depending on the stage of the research and the stage of development at the time the election is made."

CIRM: The election point at the time of conversion as well as the starting point of the CIRM-Funded Project affects the return. Please see page 29 of the CIRM GAP linked here for the chart.

California Stem Cell Report: If a unilateral conversion is allowed, doesn't that adversely affect the interests of the state of California by providing a relatively inexpensive way to avoid paying potentially many more millions to the state?

CIRM: There is a balancing act between the CIRM’s mission - accelerating stem cell therapies to patients with unmet medical needs - and a financial return back to the State. In the interests of funding for-profits, who are generally better prepared to advance clinical projects to cure patients, this loan conversion policy was adopted by the CIRM Board. Since it is a loan, the money returns to CIRM for further reinvestment in other projects. Indeed, without the adoption of the conversion option by our Board it is possible that companies like Forty Seven Inc. might not have applied to CIRM for funding. Before these new regulations were introduced CIRM had few for-profit companies applying for our funding.
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Friday, March 06, 2020

Bloomberg News: $191 Million Payout for Stanford Researcher in Immunotherapy Deal

Renowned stem cell scientist Irv Weissman of Stanford University stands to gain $191 million from the sale of a Menlo Park, Ca., immunotherapy firm that he co-founded to develop a cancer treatment, Bloomberg News reported this afternoon.

The firm is Forty Seven, Inc., whose scientific underpinnings were developed in Weissman's lab. Gilead Sciences, Inc., of Foster City, Ca., announced Monday that it is buying Forty Seven for $4.9 billion which amounts to a price of $95.50 a share.

Weissman serves on the company's board and holds 4.2 percent of the company's stock, according to the article.

Weissman was not immediately available for comment on the report.

The article by Devon Pendleton said,

"Stanford’s payout from the sale is $67.1 million. Other winners from the deal include billionaire Stanley Druckenmiller’s Duquesne Family Office and the Rockefeller family’s venture capital firm Venrock Associates. The entities, which own stakes of 0.8% and 1.2%, respectively, acquired their holdings in the last quarter of 2019, filings show, when the shares traded for as low as $5.53 and as high as $45.39."
Pendleton wrote that Weissman "credits the support of the nonprofit Ludwig Institute for Cancer Research and the state-funded California Institute for Regenerative Medicine (CIRM) with funding Forty Seven’s early clinical research and development."

CIRM, commonly known as the state stem cell agency, awarded Forty Seven directly and Weissman $30 million for earlier research. The agency does not stand to benefit from the sale unless the proposed therapies reach the marketplace and generate a profit. That could trigger royalties to the state.  However, the agency has said that the deal validates its efforts to successfully stimulate research that leads to a product and fills an unmet medical need.

Bloomberg said,

"Biotechs saw it as too dicey to invest in at an early stage, Weissman said. So he and (Ravindra) Majeti formed Forty Seven, with Stanford getting an equity stake and future royalties that it agreed to share with the state."
Majeti is a professor of medicine at Stanford, a director of Forty Seven and also held stock. The Bloomberg piece did not identify his gain.

(A slightly earlier version of this story attributed the initial report to the Los Angeles Times. It was a Bloomberg News story that was picked up by the Los Angeles Times.) 
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