Tuesday, December 22, 2015

Taking Some Stem Cell Time Off

The California Stem Cell Report is going dark for the holidays and will resume during the first week of January 2016, a year that also will bring us the Chinese year of the red fire monkey.

We wish all of you fine readers out there a wonderful holiday and a happy new year!

Monday, December 21, 2015

Media Coverage: The Scientist Weighs In on CIRM's New Plans

The $3 billion California stem cell agency has scored another modest media victory with a small article in The Scientist about its plans for spending $890 million during the next five years.

The piece by Bob Grant appeared in the Dec. 21 edition of the magazine and was headlined,
"CIRM Ups Translational Velocity."

Randy Mills, CEO of the agency, was quoted. The California Stem Cell Report was cited as well.

The Scientist is aimed at life science professionals. It says it has 409,000 unique monthly online visitors.

See here and here for other articles on the media coverage of the agency's new spending plan. 

Profitability in a $50 Billion Market: Fujifilm Projections and Cellular Dynamics

A Japanese firm that is the beneficiary of a $16 million award from the California stem cell agency was the subject yesterday of a piece in the Wisconsin State Journal.

The article by Judy Newman involved Fujifilm and Cellular Dynamics International (CDI) of Madison, Wis. The Japanese business bought Cellular Dynamics last April for $307 million. By that time, Cellular Dynamics had received the California cash to help create the world's largest public stem cell bank at the Buck Institute north of San Francisco. 

The stem cell agency has pumped more than $32 million into the project.

The occasion for the Wisconsin story was an interview with Kazuyoshi Hirao, CDI’s new chairman and CEO, and Chris Parker, executive vice president and chief business officer. The story also reported that Jamie Thomson, the famed University of Wisconsin researcher who founded the firm, is no longer employed by it. The newspaper did not elaborate.

Here are some highlights from the Q&A.

Parker said that Fujifim intends to bring to bear large-scale manufacturing practices on cellular production. He continued,
"Fujifilm believes regenerative medicine (using stem cells to treat diseases) will be a $50 billion market by 2025. Manufacturing will have to ramp up with it. We will have to look at leveraging other technologies to scale the business.
"The concept is that some day, we’ll each have our own iPS cells made and banked. So that when you need heart cells after a heart attack or you have eye damage from age-related macular degeneration, you pull your own cells out of the stem cell bank. Or you can use them to test drugs for toxicity before you take them.
"We’re envisioning replacing existing cells that will stay in the body and not be sloughed off later."
Hirao said, 
"We have a very aggressive target: 60 percent growth in revenue each year, for the next five years. We want our cells to be used for drug research and screening and for cell therapy — treating diseases."
Parker said, 
"CDI already has three cell therapy programs going — for age-related macular degeneration; Parkinson’s disease; and to replace scarred heart muscle after a heart attack — all using our iPS-derived cells. We anticipate being profitable by the end of 2017.
"CDI has 160 employees, about 120 of them in Madison. We expect to hire another 15 to 20 by the end of 2016, at least 10 of them in Madison.
Hirao said,
"We are trying to change the model. Current drug testing is performed, mostly, using animal cells. By 2019, we want the majority of drug testing to use iPS cells instead.
"Once the market is created, there will be a big jump in sales. That’s why Fujijilm has great expectations for this."

Sunday, December 20, 2015

A Stem Cell Offering to 4 Million Readers in Southern California

The Los Angeles Times today carried an article on the California stem cell agency and its far-reaching plans to create an industrial stem cell powerhouse in the Golden State.

Why is that particularly significant? Because the Times has a Sunday readership of roughly 4 million online and in print. The Times also rarely carries "straight" news coverage of the agency, although L.A. institutions are awash in more than half-a-billion dollars in cash from the agency.

The agency has been largely ignored by the mainstream media in recent years, a subject of some concern to some members of its governing board. They would like to see much more favorable coverage of the agency's efforts.

The Times gave the stem cell story some online prominence with better display than many others. However, that sort of display changes as the day wears on and editors refresh Web pages.

The story originally appeared Friday in San Diego Union-Tribune and was written by Bradley Fikes. The Los Angeles Times and the San Diego paper are owned by the same company and share stories from time to time. Fikes traveled more than three hours from San Diego to cover the story at a meeting of the agency's governing board. The meeting was only 30 minutes away from the Times newsroom.

See here for an earlier piece about media coverage of the agency's $890 million spending plan.

Friday, December 18, 2015

A Look at News Coverage of California's New Plan to Create a Stem Cell Powerhouse

The California stem cell agency received modest news coverage today of the official launch of its five-year plan for spending its last $890 million.

Articles appeared in The Sacramento Bee, the San Diego Union-Tribune and on Southern California public radio. California Healthline also carried a piece that summarized most of the coverage.

The number of stories may seem insignificant to some, but it is much more than the agency usually receives. It has all but vanished from the public eye. Rest assured, however, that situation can change in a flash when something truly bad or good surfaces.

The coverage mirrors that of most state agencies, which operate in obscurity until a dramatic issue flares up.

We should mention that the only news outlet in the state that pays reasonably regular attention to the stem cell agency is the San Diego Union-Tribune. It has assigned Bradley Fikes to its biotech beat. He was the only reporter from the mainstream media at the meeting yesterday of the stem cell agency board.

Also of note was the agency's own blog piece, written by Kevin McCormack, senior director for communications. Here is how his item began.
"The poet T. S. Eliot once wrote: 'If you aren’t in over your head, how do you know how tall you are?' Well, everyone at CIRM, California’s stem cell institute, is about to find out how tall we are."
Here are links to the other pieces: The Bee (written by yours truly), the San Diego Union-Tribune, Southern California public radio (Stephanie O'Neill did two stories, see here and here) and California Healthline. The Bee piece may get picked up the other Bee newspapers in Fresno and Modesto.

(McCormack later reported the KQED radio station in San Francisco carried an item as well.)

Will There Be Life After 2020 for the California Stem Cell Agency?

LOS ANGELES -- Directors of the California stem cell agency, which is due to run out of funds for new awards in five years, have begun what is likely to be a drawn-out public discussion of how to finance the agency's work beyond 2020.

The subject of life-after-death -- death being defined as termination of the agency's $3 billion in bond funds -- arose yesterday during a meeting of the agency's governing.

Options ranged from another bond issue to seeking private, philanthropic funds. However, unless the cash comes in the form of state bonds, it is not likely to amount to the $300 million-a-year the agency was authorized to spend during the last 11 years. California Gov. Jerry Brown has also more than once deplored the amount of state debt generated by state bonds.

The agency is funded through the bonds, money that the state borrows, that were authorized by a ballot initiative in 2004. Additional bonds could be provided through the initiative process, which requires millions of voter signatures, or by the state legislature placing another bond measure on the ballot. Then a campaign must be mounted. In 2004, the stem cell campaign cost more than $30 million.

No conclusions were reached yesterday other than referring the subject to the directors' legislative subcommittee, which is chaired by Art Torres, a former state lawmaker and chairman of the state Democratic Party.

One director, Jeff Sheehy, a communications manager at UC San Francisco, said it would be "weird" to have "somebody else control our fate by going out and collecting signatures." Sheehy did not mention it, but another initiative could also require changes in the agency itself, changes that the board might not welcome. Going to the legislature poses the same possibility of unwelcome changes.

The bond issue approach has been backed by Bob Klein, who directed the 2004 campaign and was the first chairman of the agency, largely as the result of specific, narrow qualifications for the post that he wrote into state via the initiative. In 2011, Klein left his post and the governing board.

Klein has talked about raising $5 billion for the agency through a bond measure, although not recently in publicly reported accounts. Last September, his stem cell advocacy group, which is headquartered in his real estate offices in Palo Alto, rose from hibernation with a Webinar highlighting "milestones" from Proposition 71, the measure that created the agency and which Klein has claimed credit for writing.

The California Stem Cell Report queried CIRM in September about the Webinar. Kevin McCormack, senior director for communications for the stem cell agency, replied that it was not asked to participate in the Webinar and would not have done so if asked.

CIRM director Sherry Lansing, former chair of the UC regents, urged a broad discussion of financing possibilities "the sooner the better." A number of other CIRM directors weighed in as well, indicating a general interest in moving forward on a path to future funding. No date for a meeting of the legislative committee was set.

The question of financial life after 2020 came up when CIRM Chairman Jonathan Thomas discussed a $30 million, "wind-down" fund for administrative expenses should the agency have to close its door because of a lack of funding. Thomas has secured $7 million in private donations as a start, but that money will not be available unless it is matched with an additional $23 million.

Randy Mills, CEO of the agency, presented an inscribed "game ball" to Thomas for raising the $7 million. It was the second game ball awarded at yesterday's meeting, apparently the beginning of a new tradition at the agency to recognize superlative performance. (For technically oriented readers, the award is a baseball -- not a football.)

Thursday, December 17, 2015

Link to CIRM's News Release on Its New Spending Plan

The California stem cell agency this afternoon posted a news release about his new, $890 million plan for the next year, describing it as bold, innovative and ambitious.

Here is a link to what the agency has to say.

Fifty New Clinical Trials, a $150 Million Partnership and Much More: California's Coming Stem Cell 'Powerhouse'


Highlights
50 new clinical trials
$150 million public-private partnership
"Long overdue," says venture capitalist
$30 million end plan

LOS ANGELES -- Directors of the California stem cell agency this morning approved an $890 million plan for the next five years as it surges forward with a risky and ambitious effort to build an “industrial stem cell therapeutic powerhouse” in the Golden State.

The agency proposes 50 new clinical trials on top of 15 already underway. Next year it expects to set up a $150 million partnership with private investors to turn research into cures. Investors would have first pick of the best research that CIRM has to offer that currently lacks a partner. 

Other ventures and goals for what could be the agency's last five years of life include:
  • Introduction of 50 new therapeutic or device candidates into development
  • Working to create a more favorable federal regulatory environment
  • Reduction by 50 percent the time it takes basic research to move into a clinical trial
  • Creation of two centers at $15 million each to assist in much of the "backroom" work needed for clinical trials
  • Creation of an online, hook-up center for researchers looking for collaborators to advance their work
Directors of the agency, formally known as the California Institute 71 for Regenerative Medicine (CIRM), approved the plan unanimously at a meeting here. (Here is a link to its press release.)

Arlene Chiu, former director of CIRM's scientific programs and now with the City of Hope, told the agency board that the plan was audacious and bold. CIRM board member Sherry Lansing, former chair of the UC board of regents, praised the plan's "sense of urgency."  Another board member, Steve Juelsgaard, former executive vice president of Genentech, said the plan contained projects that he had never seen before in the biotech industry.

Asked for comment, CIRM board member Al Rowlett, who is chief executive officer of the Turning Point mental health program in Sacramento, said,
“It’s ambitious, but then isn’t that what the people of California were when they approved Proposition 71. They wanted to create something that was going to change the face of medicine. That’s what we hope to do….”
Proposition 71 was the ballot initiative that created the $3 billion agency in 2004. The campaign led voters to believe stem cell therapies were close on the horizon. None has been produced, and the agency's state bond funding is expected to run out in 2020.

CIRM directors later today will be briefed on a $30 million “wind-down” plan that has attracted $7 million in private donations. More funding is being sought. One source may be the state legislature.

The agency’s plan for the next five years says it would benefit the people of California by creating  “an industrial stem cell therapeutic powerhouse that expands the tax base, adds high quality jobs and increases the likelihood of the commercialization of stem cell treatments for patients with unmet needs.”

Randy Mills, CEO of the agency since May 2014, said the plan was devised to have "the greatest possible impact for our patients. We didn’t want something ‘good enough.’ We wanted something transformational."

He acknowledged the risk and size of the task, which he said is aimed at transforming regenerative medicine. But he remains optimistic that the agency’s tiny team of about 55 persons can pull it off. He gave his team full credit for developing the spending proposal. 

The CIRM plan calls for spending $620 million on clinical work and “translational” research, which is aimed at taking basic discoveries beyond the most preliminary stage. Basic research would receive $170 million. Educational programs total $50 million. Another $50 million would go for “infrastructure.” 

One of the riskier elements of the proposal may be the agency’s plan to offer $75 million to private investors to begin a partnership in which they would have access to the best of the CIRM-funded research that doesn’t already have a private partner. 

The investors, who could be a Big Pharma firm, an existing smaller company or venture capitalists, would have to add $75 million of their own money. The agency would also continue to support the selected research, thus minimizing the risk to the private investors.

For months, Mills has been commenting on the reluctance of private investors to engage in stem cell therapy development, which is expensive and novel. “De-risking” is important in attracting business interest, Mills says.

Competition for the $75 million is scheduled to begin behind closed doors early next year. But questions have been raised about the risk that no private investors would find any CIRM research attractive.

Gregory Bonfiglio, managing partner of Proteus Regenerative Medicine, a Portola Valley, Ca., a venture capital firm, said in an interview, however, such efforts by the agency are long overdue.

He said, 
“There are risks inherent in the development of new, disruptive technology. The bigger risk is failing to deliver on their underlying promise to bring new regenerative therapies to patients…. The bigger risk is not doing anything.”
Another important element of the plan involves creation of accelerating and “translating” centers, funded at $15 million each, beginning next year. The agency is also likely to expand its Alpha Clinic effort, which is aimed at providing one-stop treatment centers.

The translating and accelerating centers would work with the Alpha clinics and other researcher to provide much of the “backroom” work needed to negotiate federal rules and regulations and win ultimate approval of a therapy. 

California's $30 Million Stem Cell 'Pitching Machine'

LOS ANGELES -- Above is a look at the California's stem agency's plan to support efforts to advance research into clinical trials. Two, $15 million centers are planned. They would perform the "back room" work that does not have appeal to research scientists.

Transforming Regenerative Medicine: Discussion Begins on California's $890 Million Approach

LOS ANGELES -- Directors of the $3 billion California stem agency this morning began discussion of its spending plans for the next five years, an $890 million effort that is designed to "transform regenerative medicine."

Jeff Sheehy, chairman of the Science Subcommitte of the board, praised the effort, especially the "metrics" that measure the agency's teams performance at all levels. He said the staff developed metrics within each area.

David Higgins of San Diego, another board member, said that CIRM's plan is much different than other strategic plans that are "boring" and "go into a desk drawer." He said the CIRM plan is "much different" and creates a pathway to success.

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