Monthly Archives: May 2020

The California Stem Cell Research Institute Bond Initiative (#19-0022) may appear on the ballot in California as an initiated state statute on November 3, 2020.

The ballot initiative would issue $5.5 billion in general obligation bonds for the California Institute for Regenerative Medicine (CIRM), which was created to fund stem cell research. The ballot initiative would require CIRM to spend no more than 7.5 percent of the bond funds on operation costs. The remaining bond funds would be spent on grants to entities that conduct research, trials, and programs related to stem cells, as well as start-up costs for facilities.[1]

The official ballot title is as follows:[2]

Authorizes Bonds to Continue Funding Stem Cell and Other Medical Research. Initiative Statute.[3]

The summary provided for inclusion on signature petition sheets is as follows:[2]

Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: (1) stem cell and other medical research, therapy development, and therapy delivery; (2) medical training; and (3) construction of research facilities. Dedicates $1.5 billion to fund research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions. Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years.[3]

The fiscal impact statement is as follows:[2]

State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds.[3]

The full text of the ballot measure is available here.

Californians for Stem Cell Research, Treatments & Cures is leading the campaign in support of the ballot initiative.[4]

Ballotpedia has not identified individuals and entities opposing the ballot initiative. If you are aware of published opposition to the ballot initiative, you may send a reference link to editor@ballotpedia.org.

The Californians for Stem Cell Research, Treatments & Cures PAC was registered to support the ballot initiative. The committee had raised $6.06 million. Robert N. Klein II and Klein Financial Corporation provided $4.63 million to the PAC. The committee had expended $8.72 million (expenditures exceeded contributions due to accrued expenses).[6]

There were no PACs registered to oppose the ballot initiative.[6]

The following table includes contribution and expenditure totals for the committee in support of the ballot initiative.[6]

The following was the top donors to the support committee.[6]

In 2004, voters approved Proposition 71, which was a ballot initiative designed to establish a state constitutional right to conduct stem cell research, create the California Institute for Regenerative Medicine (CIRM), and issue $3.00 billion in general obligation bonds to fund CIRM.[7]

As of October 2019, CIRM had spent $2.91 billion of the $3.00 billion bond issue.[8]

In California, the number of signatures required for an initiated state statute is equal to 5 percent of the votes cast in the preceding gubernatorial election. Petitions are allowed to circulate for 180 days from the date the attorney general prepares the petition language. Signatures need to be certified at least 131 days before the general election. As the verification process can take multiple months, the secretary of state provides suggested deadlines for ballot initiatives.

The requirements to get initiated state statutes certified for the 2020 ballot:

Signatures are first filed with local election officials, who determine the total number of signatures submitted. If the total number is equal to at least 100 percent of the required signatures, then local election officials perform a random check of signatures submitted in their counties. If the random sample estimates that more than 110 percent of the required number of signatures are valid, the initiative is eligible for the ballot. If the random sample estimates that between 95 and 110 percent of the required number of signatures are valid, a full check of signatures is done to determine the total number of valid signatures. If less than 95 percent are estimated to be valid, the initiative does not make the ballot.

On October 10, 2019, Robert N. Klein filed the ballot initiative.[1] Attorney General Xavier Becerra (D) released ballot language for the initiative on December 17, 2019, which allowed proponents to begin collecting signatures. The deadline to file signatures is June 15, 2020.

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On February 13, 2020, proponents announced that the number of collected signatures surpassed the 25-percent threshold (155,803 signatures) to require legislative hearings on the ballot initiative.[9] In 2014, Senate Bill 1253 was enacted into law, which required the legislature to assign ballot initiatives that meet the 25-percent threshold to committees to hold joint public hearings on the initiatives not later than 131 days before the election.

On March 21, 2020, Sarah Melbostad, a spokeswoman for Californians for Stem Cell Research, Treatments, and Cures, reported that the campaign's signature drive was suspended due to the coronavirus pandemic. Melbostad said, "In keeping with the governors statewide order for non-essential businesses to close and residents to remain at home, weve suspended all signature gathering for the time being. ... Were confident that we still have time to qualify and plan to proceed accordingly."[10]

On May 5, 2020, the campaign reported submitting about 925,000 signatures for the ballot initiative.[11] At least 623,212 of the signatures need to be valid. The recommended deadline to file signatures for the election on November 3, 2020, was April 21, 2020. Counties need to validate the signatures before June 25, 2020, for the ballot initiative to appear on the ballot in 2020. Otherwise, the ballot initiative would appear on the ballot on November 8, 2022.

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California Stem Cell Research Institute Bond Initiative (2020)

The idea is hard to stomach at first: animal meat grown in a lab.

But proponents of "cell-based meat" say the emerging technology has the potential to tackle two global problems at once. Lab-grown beef patties, chicken cutlets and even exotic proteins could help satisfy the world's growing appetite for meat, they argue. And it could be done in a way that cuts down on the tremendous environmental impact of animal agriculture.

Standing in the way is a long list of challenges including regulatory obstacles, sky-high production costs and the ever-present ick factor.

Still, advocates say lab-grown meat could hit store shelves as soon as 2025 if not earlier.

One proponent is Krijn de Nood, the chief executive of Meatable, a Netherlands-based company that is producing animal tissue by mimicking the cellular growth that typically happens inside rather than outside of living organisms. In an interview, de Nood said Meatable is "mission driven" and that it aims to address issues from climate change to animal welfare.

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The company is among dozens of startups worldwide that are racing to scale technology they claim produces "real meat" not plant-based alternatives from companies such as Impossible Foods and Beyond Meat (Climatewire, Oct. 21, 2019).

That's possible, they say, because most cultured protein products originate as stem cells from real animals. Some companies make a point to say that no animals are harmed in the process.

Here's how it typically works. Engineers obtain an animal stem cell sample and isolate "cell lines" with the strongest genetic material. The cells are then placed in an environment like a petri dish or bioreactor that encourages rapid growth, and later differentiation. The resulting fat and muscle tissue is then harvested, structured and processed to create a final product.

De Nood said Meatable already has produced small quantities of meat using this process. And the whole thing took just three weeks a far faster timeline, Meatable notes, than it takes to raise an animal for slaughter. The company plans to host its first public taste testing of a pork prototype in September.

Several other companies already have allowed outsiders to sample their products. Those include Memphis Meats, Peace of Meat and Mosa Meat, which are based in the U.S., Belgium and the Netherlands, respectively.

In fact, one of the first cultured meat tastings dates back to 2013, when Maastricht University physiologist Mark Post presented the world with a beef patty that was produced in a petri dish.

At the time, that single slab of meat cost a whopping 250,000 to produce; Google co-founder Sergey Brin picked up the tab. Several years later, Post co-founded Mosa Meat.

More recently, in March, Peace of Meat hosted an event where attendees sampled a chicken nugget.

Tasting aside, co-founder David Brandes underscored that the startup has a different ambition than many other companies. Rather than producing consumer-facing products, Peace of Meat aims to eventually grow more than 100,000 tons of pure, cultured fat per year. The startup plans to sell the fat to other companies as a key ingredient to enhance the taste and texture of alternative meat products, including those that are plant-based.

"We don't want to make the most fancy-looking piece of food, we don't want to work on exotic species," said Brandes. "You need to produce massive amounts of meat if you really want to have an impact."

Animal agriculture is responsible for a whopping 14.5% of planet-warming emissions, according to the Food and Agriculture Organization of the United Nations. That figure includes greenhouse gases attributable to meat processing, meat-related transportation and manure storage. Then there's the issue of belching cattle which itself is responsible for 65% of the livestock sector's emissions.

Paul Mozdziak, who serves as Peace of Meat's chief scientific officer, was among those who said a central goal of cellular agriculture is to satisfy the world's staggering, and still rising, demand for animal protein but without relying on supply chains that scientists say are environmentally fraught and highly vulnerable to marketplace disruptions.

As an example, Mozdziak pointed to the novel coronavirus crisis, which in recent weeks has temporarily shuttered meat packing plants, forced farmers to cull tens of thousands of animals and spurred fears of a nationwide protein shortage (Greenwire, May 4).

"I absolutely think the pandemic supports the need for this," said Mozdziak, who also directs North Carolina State University's graduate physiology program.

"It's another way to produce food. It's another way to produce protein. It's another way to increase food security," he added. "What if something [else] happens? ... [W]here's the protein going to come from? How are we going to eat?"

But even Mozdziak, who has pondered cultured meat since the early 1990s, acknowledged the obstacles ahead. Despite entrepreneurs' ambitions, he said, the field remains deep in research and development and far from supermarket shelves.

De Nood, of Meatable, highlighted that same issue. "It's all about the scalability of the process," he said, noting that his company is working to drive down costs and move its operations from "small environments" to large bioreactors that would require major processing factories.

Peace of Meat's Brandes agreed. But he said that even if production costs fall, there's the possibility that cultured meat would not meaningfully impact the carbon footprint of the global food system.

"When it comes to greenhouse gas emissions, I think there is a big potential," said Brandes. But producing large quantities of cultured meat would inevitably require substantial amounts of energy, too, "so it really depends where you draw the energy from," Brandes said.

Despite those obstacles and more, some projections have named cultured meat as a key driver of a revolutionary shift away from animal agriculture. Independent think tank RethinkX, for instance, predicts that cell-based meat and plant-based alternatives could render industrial cow farming "obsolete" in the U.S. entirely.

Ermias Kebreab, who is a climate and animal agriculture expert at the University of California, Davis, disagreed with that assessment.

Even as the world becomes more invested in exploring alternatives to conventional protein, Kebreab said, researchers and traditional farmers are actively developing strategies like feeding seaweed to cows to cut the sector's environmental footprint.

In his eyes, sustainable agriculture, rather than cellular agriculture, is what will ultimately enhance food security in developing countries where most future population growth is predicted to occur.

"I'd rather have beef" from cows, said Kebreab, adding that cell-based meat also raises other issues for him, like the products' overall nutritional value. He said he's wary of "highly, highly processed food."

Mozdziak, of Peace of Meat, agreed in part. He doesn't see cellular agriculture putting meat companies out of business.

But "at the same time," he said, "let me vehemently state that I think cultured meat is really important. ... [I]f we're going to have a billion more people on the planet in 30 years, we're going to have to find a way to feed them."

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BUSINESS: Can lab-grown meat save the planet and dinner? - E&E News

Today I would really like to keep most of the focus on regular NCI business. Im really eager, in fact, to be talking about cancer research and concepts the NCI would like to release. And these will spur interest in cancer research and priority areas. But there is a pandemic going on and we do have some coronavirus items to address as well.

We just had a board meeting on this topic almost entirely devoted to COVID-19. We dont have to do a whole lot on that topic today. But I will just use a few slides to summarize that presentation from the joint board meeting, and remind you of how the NCI has been taking a critical role in an unprecedented response to this pandemic. Also, since things are moving so fast around here right now, there actually have been a few significant developments in the coronavirus spacesince even the joint board meeting just a few weeks ago. Ill briefly summarize that news as well.

In particular, related to those developments, including a new and correct congressional appropriation. There are some COVID items that we do need, and Dinah Singer will direct that discussion at the end of todays meeting.

But let me start out our short COVID discussion by repeating a statement I made last month at the joint board meeting, which is that the primary focus of the National Cancer Institute is, and always will be cancer research and cancer care. Thats a message Ive been delivering in just about every presentation Ive given, in every email and blog post and other materials Ive written during this pandemic response.

And its one that Dinah Singer spoke to at her virtual presentation at AACR two weeks ago on April 28. If you havent seen this, I encourage you to check it out. Dinah also wrote a great post for our Bottom Line blog on the topic, which includes a link to the presentation.

So, this slide summarizes why the NCI is important to the pandemic response. It shows the disproportionate impact of COVID-19 on cancer patients, and patients with cancer whove survived cancer. Additionally, as I illustrated at the joint board meeting, the NCI has unique research expertise and capacity related to Frederick National Lab and our great extramural networks.

Therefore, we have to be involved in the pandemic response. And then, lastly, I think given the nature of this crisis, it has had a tremendous effect on public health. The NCI has a moral obligation to work in this area.

I want to call your attention though to the decrease in care delivery to cancer patients related to the coronavirus pandemic. And this is something, frankly, Ive been worrying about a lot lately, and Ive been hearing from a lot of you and other extramural leaders.

Ive been looking at the statistics about decreases in screening and deferred care, and I am getting very worried about this issue. The data regarding delayed diagnosis and delayed therapy are very clear from cancer research over the decades.

Delayed diagnosis and deferred care leads to worse outcomes for patients with cancer. The things we do to prevent cancer and to diagnose cancer and to treat cancer well, they work, and they cant be put off indefinitely.

And if we do, we will lose ground, and we will give up hard-won progress. And heres a very specific fear I have, in this regard. Every spring, the National Cancer Institute, with the CDC and the ACS and NAACCR, puts out our Annual Report to the Nation on our progress against cancer.

Thanks to advances in screening and prevention and treatment and survivorship, that document has become an annual feel-good story for the NCI. Every year Ive been here, the report has been good news.

Its been a couple of percent drops in cancer mortality each year, and thats been going on, in fact, for decades. But with all this deferred and delayed care and postponed surgeries and later, reduced chemotherapy, and canceled appointments for mammography or a Pap smear or colonoscopy, this is going to have an impact on cancer outcomesan impact that I think well see play out over years to come.

So, Im becoming worried that, because of the pandemic, that in 2021 or 2022 or 2023, we will have the first Annual Report to the Nation since 1993 that shows an increase in cancer mortality. And I know exactly what the statistics will mean for patients. I know that that represents more cancer suffering and more bad outcomes, and more deaths. And lets all agree, we dont want that to happen, and we wont let that happen. I know COVID has caused many changes to how we care for patients.

And we have a legitimate need to be careful during the pandemic in order to protect the public health. But we need to get back to work of caring for our patients. We need our hospitals and our clinics and our infusion centers to start doing what they do best, which is care for our patients who need this. Of course, we have to do this in a manner that is smart, that is careful, that protects patients and staff alike from the coronavirus.

But we need to get back to work. The cost of deferred cancer care will be significant. Neglecting cancer will produce a negative impact on the public health, and one that may trouble our patients for years to come. I plan on talking a lot more about this in the coming weeks. And I havent even spoken about the debilitating impact on cancer science, by having these labs closed and postponedtremendous impact as well.

Just to remind you something that Dinah spoke about, and that is on the blog post as well, is the number of NCI COVID-19 funding opportunities that are somewhat new and recently posted, and still open. This is summarized here. I wont spend a lot of time on them, other than to say were taking both administrative supplements and competitive revisions.

We also had a good discussion at the joint board meeting about allowing a change of scope of certain grants, and we have received a small number of requests to do that, and are working through that. But I think that we are still considering administrative supplements and competitive revisions, and we will be making funding decisions related to these very soon.

Now with the COVID part of the discussion behind us, at least for the next few hours, lets return to regular NCI business. Frankly, I am really excited, as I said, to be able to spend most of our time today on advancing cancer research and cancer science. Getting these concepts that the BSA will see today is really a lot of work getting these things together.

I think you will be impressed or youll be really shocked by how much the NCI has been able to get done during a period of complete telework. I think this is a testament to the really extreme efforts of the trained professionals in the NCI to get this work done, no matter what the situation.

As always, its good to mention where we are in the appropriations outlook. Theres really not a lot to report. At this stage right now, much of Congresss focus has been on supplemental funding related to the coronavirus pandemic, and the work on the 2021 budget has been a little a bit behind that.

But Congress has been busy and has already passed these supplemental fundings, and as is widely reported, is working on a fifth emergency appropriations bill. At the same time, appropriators are starting to take up their work on the regular FY21 appropriations bill, and I suspect well be hearing more about that soon. So, stay tuned.

Some really wonderful news during the joint board meeting last month, I was able to share some news about Dan Gallahan assuming the permanent role as director of NCIs Division of Cancer Biology. And today Im very pleased to share that Phil Castle will soon take the helm at NCIs Division of Cancer Prevention.

Those of you who know, Phil is replacing Barry Kramer in this role, but DCP has been led for over a year now by Debbie Winn, serving in an acting capacity. Debbie has done a spectacular job in this rolevery hard to be an acting in this roleand I want to thank her for taking this on for the benefit of the NCI. I would like a virtual round of applause for Debbie. Yay Debbie!

Phil is joining us from Albert Einstein College of Medicine in New York, where he served as professor in the Department of Epidemiology and Population Health. He was also the executive director and co-founder of the Global Coalition Against Cervical Cancer.

Phil is no stranger to the NCI. He was a senior tenured investigator and tenure-track investigator in the Division of Cancer Epidemiology and Genetics from 2003 to 2011. While at NCI, he was the lead investigator on several epidemiologic studies, including the Mississippi Delta project, the HPV Persistence and Progression Cohort, and the guidelines cohort and cancer at Kaiser Permanente, Northern California, and the Anal Cancer Screening Study.

Im thrilled Phil is joining the NCI in this key role, and Im really excited to have him join and provide vision for the DCP mission regarding cancer prevention, screening and early detection. So, welcome, Phil.

Id like to give a brief update on the Childhood Cancer Data Initiative. We are anxiously anticipating an upcoming working group report for the joint board meeting in June. As some of you know, Jaime Guidry Auvil kicked off the BSA working group on March 27 and provided an overview of its activities, as well as its relationship with ongoing NCI pediatric initiatives.

While we await the report, its important to note that we are using the FY20 CCDI funding to support foundational aspects of childhood cancer research and data related to those efforts, from which to build CCDI in years FY21 to FY30. So, we are working on this at a good speed with the already appropriated funds and are eagerly awaiting more advice from the working group on the shape of this initiative.

Ill just mention that the cell-based therapy and vector production efforts at Frederick National Lab are proceeding apace. As I mentioned though at the joint board meeting, we have actually had our first trial, using a CAR T-cells prepared at Frederick, open. The virus production facility will soon come online. And well evaluate potential viral production projects proposed by the extramural community.

So, we envision Frederick will have capacity to make viral vectors as needed for extramural searchers. This will include both developmental and clinical trial proposals.

Needless to say, Im thrilled with the progress and ramping up of this facility. In fact, this summer we will begin accepting applications. Weve dedicated space to produce viral projects, so those of you who will need help producing virus for, say, a CAR T trial or some other related efforts, stay tuned for the announcement about the acceptance of applications.

I think many on this board are aware of the interesting pattern of prostate cancer statistics over the last few years, regarding incidence and mortality, with changing recommendations related to PSA screening. The NCI has been following this area carefully. We had a very large internal NCI meeting, spanning the gamut from basic researchers to clinical trialists, to population health science researchers, to discuss where our prostate cancer research portfolio ought to be, in light of these changing statistics, and we decided a good way to go forward would be to have a lot of advice from the extramural community.

And for that reason, were working towards a workshop next spring to bring in extramural perspective to convene the best folks to try and understand where the NCI should be focusing its research mission related to prostate cancer now. Bill Dahut and others are leading this effort at the NCI.

I thought Id mentioned a few quick research updates that we found exciting. I always like to try and at least note some of the great science that NCI has done, either intramurally, or funded extramurally, and always try and bring up a few recent items.

This is work from the DeNardo lab at Washington University, published recently in Cancer Cell, related to dendritic cells in tumor immunotherapy. It proposes that the number of dendritic cells in a tumor may explain why immunotherapy works for some cancers, but not others, and work in miceboosting dendritic cell number triggered an immune response in pancreatic cancer, which has been traditionally difficult in terms of immunotherapy. So exciting research proposals to follow.

Work from the Richard Kitsis lab at Albert Einstein tries to better understand the relationship between daunorubicin and doxorubicin and cardiomyopathy, and developed an experimental drug to prevent this chemotherapy-induced heart toxicity. It does so without interfering with the chemotherapys therapeutic ability to kill cancer cells in mice. So, interesting work for a long-standing problem related to the use of these agents at extended doses for patients.

In some microbiome research from Marcel van den Brink at Memorial Sloan Kettering in people with blood, hematologic malignancies, the health of their gut microbiome appears to affect the risk of dying after receiving allogeneic stem cell transplant, according to this NCI-funded study, published in the New England Journal of Medicine that got tremendous attention in the press. An exciting development to help improve outcomes for patients who need allogeneic transplantation.

Finally, in addition to our grantee blog, Bottom Line, which is now widely read, and our research enterprise blog, which is Cancer Currents, I also also want to remind everyone about an important resource on our cancer.gov site. This site is specifically designed for researchers with questions. And it is updated frequently with new information as it becomes available.

To date, weve tracked over 20,000 visits to these blogs and other researcher-focused web content. I wanted to stress that we know all too well that the extramural community, as is the case in nearly every sector of the nation, things are really hurting out there.

And regardless of how the back-to-business plan does roll out at various institutions, it will really take some time to bounce back. We know, for instance, that universities and institutions have begun furloughing staff and laying off researchers. We know clinical trials accrual is down, especially for non-treatment trials.

All of this will slow the pace of research, but beyond that and equally important, the public health crisis represents a real hardship for our families, our communities, and patients with cancer. NCI has not lost sight of this. Well do all we can help to recover from these significant setbacks.

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Sharpless: COVID-19 threatens to reverse long-running trend of decreasing cancer mortality - The Cancer Letter