Wednesday, January 06, 2016

CIRM's Approach to Stem Cell Blogging: The Full Text

The California Stem Cell Report asked the California stem cell agency for a run down on how it approaches its blog, which in December was rated the top stem cell blog of 2015 by The Niche, another stem cell blog published by UC Davis researcher Paul Knoepfler.

Kevin McCormack, senior director for communications, replied,
"It was very flattering obviously to learn that Paul had named us as the #1 stem cell blog. We’ve been working hard to make our blog as engaging and thoughtful, and fun, as possible and this was vindication that at least in his eyes we had succeeded.

"Our is really quite simple. We look for what we think are the best, most interesting stories out there, and then write about them. Obviously we like to highlight stories about research we are funding but more often than not we’re just looking for something new, something fresh, something that sheds a new light on research in general or on tackling a particular disease or problem in particular.

"We try to divide it up so that we all write a blog every week, that way we get different voices and flavors in the mix. I think that’s important for a number of reasons. One, it creates a sense that this is truly a team blog, and two, it allows each of us to take a little bit more time in writing each piece, to make sure we get it right and to do it in a way that is most interesting and accessible for our audience.

"We have a really broad range of people reading us from researchers and scientists to people with no science background (like me), so we are always mindful of trying to write in a way that allows everyone to understand what’s going on. We also try to write in a way that reflects how exciting this research is and the potential it has. But we also try to balance that by reminding people that some of this work was done in animals and needs to be replicated in people before we get carried away.

"One of the new things that Dr. Karen Ring has added, since joining us this year, is more individual profiles of young researchers. These have been popular in helping give a voice to a group of people who are often overlooked, the youngest members of the research teams, the people who represent the future of stem cell research and are the next generation of scientific stars.

"We are always looking to add new ideas, new voices to the blog. So if you have any thoughts or ideas left over from your own, let us know. We’re happy to try anything. At least once."

Readership Numbers on the California Stem Cell Agency's Blog

The California Stem Cell Report asked the state stem cell agency for readership statistics on its blog, named in December as the best stem cell blog in the word. Here is the text of what Kevin McCormack, senior director for communications, sent along.

"We only have stats from May 2014 because that is the date when this blog was switched to Wordpress (that’s also the reason why the viewing figures for May were so low, it took people a while to find the new site). The blog started in 2007 on a site called blogspot.
"Data from 2015:
Home page views: 34,871
Top blog reads: 2,336
Best ever views: Sept 2nd 2015 with 1,454 views
"From May 2014-Dec 2015
Views went from 60  to ~13,000

Months and years





Average per Day
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Overall
2014
2
57
194
235
194
273
381
309
209
2015
356
309
335
251
301
345
268
323
441
440
446
429
353
"Referrers (in order of top views)
1)    Search Engines (google, bing, yahoo)
2)    Facebook
3)    Twitter
"Total # Posts: 1,555
"Total followers: 485 (115 on wordpress and 370 on email subscription)"

Monday, January 04, 2016

From Royalties to Real Products: The Journal Science Looks at the Prospects for the California Stem Cell Agency

The headlines last week in the journal Science spoke of California’s stem cell “end game,” its “a race to the clinic” and its “prospects for new money.”


The article by Kelly Servick provided a quick status report on the Golden State’s $3 billion stem cell agency. The research effort last month approved a plan for spending its last $800 million in an attempt to fulfill the promises of the 2004 ballot campaign that created the research effort.


Servick wrote that the new plan could be critical to survival of the agency. She said,
“(W)hether there will be enough believers in CIRM to keep the agency afloat may depend on how well it can build—and publicize—a track record for moving stem cell discoveries to the clinic.”

The agency has been largely ignored for the last several years by the mainstream media, but its fresh, five-year plan has attracted some modest attention, including  Servick’s piece in Science Jan. 1.


The article largely sprang out of the December meeting at which the board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, approved its strategy for the next five years.


Servick also quoted Robert Klein, the former chairman of the agency, as saying he hopes to spearhead a new ballot initiative in 2018 to fund the agency beyond 2020, when its cash is expected to run out. At the December meeting, the board specifically avoided approval of a ballot effort and referred the question of future funding to a board subcommittee. No public meetings of that panel have been announced.


Servick began her story like this:

“Born out of discontent with the federal restrictions on research with cells from human embryos, California’s stem cell agency is at a key juncture: Over the past decade, it’s spent a large portion of its $3 billion budget nurturing fledgling disease therapies, but that state money may run out before most ments are ready for the clinic.”


She continued,

“Even if all goes according to plan, however, most CIRM-funded projects will not finish phase II trials in the next 5 years, and may not be ready for an industry partner, (Chairman Jonathan) Thomas told the board. ‘If [CIRM doesn’t] have additional funding at that point, we will have only partially met our obligation to develop therapies and cures.’”


She noted that one funding possibility is “large royalty payments” from CIRM-related research, something that was promised by backers of the stem cell ballot initiative in 2004. However, if any royalties do surface, they will go to the state general fund -- not to the stem cell agency. Lawmakers would have to approve an appropriation for the agency -- one that would also have to be approved by the governor. Currently, the agency is financed by money that the state borrows and which flows directly to the agency without the need for legislative or gubernatorial approval.


At the December meeting, Art Torres, vice chairman of the board and a former, longtime state lawmaker, expressed reservations about dealing with the Legislature.

Servick wrote,

“There are ‘people that don’t believe in what we do, who are members of the legislature,’ Torres warned, and they ‘could invariably impact any [CIRM funding] proposal.’”

The Science article is behind a paywall. If you would like a copy, please email me at djensen@californiastemcellreport.com.

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.

The $2.8 Billion Award Bucket of the California Stem Cell Agency

LOS ANGELES -- Here is the financial state of awards by the $3 billion California stem agency. The effective burn rate is $170 million a year -- the amount of money that can  be awarded -- because of return of funds on grants that have been terminated.

Randy Mills, CEO of the stem cell agency, said that the rate of returns has jumped from 10 percent to 22 percent, which could mean an additional $150 million for future awards, if the rate stays at the level.

A Look at the Portfolio of the California Stem Cell Agency

Look at the status of CIRM funding by disease
LOS ANGELES -- The California stem cell agency this morning presented a fresh breakdown of its spending by disease areas. The largest two components are in the neuro and cancer areas, which account for nearly half of the agency's portfolio.

CIRM Board Meeting Opens

LOS ANGELES -- The meeting of the governing board of the California stem cell agency opened at 9:12 a.m. today.  The public audience is quite small, less than 10 to witness approval of an $890 million expenditure of state funds.

Follow All The News Today on California's New $890 Million Stem Cell Plan

LOS ANGELES -- The California Stem Cell Report will bring you gavel-to-gavel coverage beginnin this morning of today's meeting of the governing board of the California stem cell agency, which is expected to approved an $890 million spending plan for the next five years.

The proposal includes an ambitious, $150 million effort to join next year with a private partner to develop the best of the agency's offerings that do not yet have a private partner. To entice business, the agency is putting up $75 million. It expects the private partner to put up another $75 million.

You can read about all that and more on the California Stem Cell Report as the day progresses. Stories will be filed as warranted.

Today's meeting begins at 9 a.m. PST.

Wednesday, December 16, 2015

More Info on the $30 Million California Stem Cell Agency Plan for Life After 'Death'

More information emerged this afternoon concerning the California stem cell agency’s $30 million plan for its life beyond 2020, when its funding runs out for new awards.. The agency posted documents late yesterday saying that it had pledges of $7 million from private donors contingent on raising an additional $23 million. One of the presentation slides posted online used the term “wind-down.” Earlier today, the California Stem Cell Report asked the agency for clarification of the sketchy information posted on the agenda for tomorrow’s stem cell board meeting. Kevin McCormack, senior director for communications for agency, responded,
“The $30 million is to help ensure that we have funds to cover the administration of all the awards we make in the next five years. As you know those are multi-year awards so if we can continue making new awards till, say, 2020 we also want to make sure we have enough money in our admin bucket (which is separate fro the research bucket) to cover the supervision and support for those awards.
“We are also but separately working on finding other sources of funding so the agency as a whole can continue funding and administering research after our current money runs out , but that is a separate task.”
Presentation documents posted online made reference to public funding, but had no specifics. Currently the agency survives on money borrowed by the state under the terms of the ballot initiative that created the research program in 2004. However, that $3 billion source is shrinking, and the agency is down to its last $890 million. The online documents made no mention of plans to continue with new awards or loans beyond 2020. Jonathan Thomas, agency chairman, is expected to provide more details tomorrow to the board on the financing plan.

Surviving after 2020: California Stem Cell Agency Reports $7 Million in Private Donations

The California stem cell agency today unveiled the first concrete indication that it will have significant cash after 2020, when its funds are scheduled to run out for new awards.

The news came in a memo quietly posted last night on the agenda for tomorrow’s meeting in Los Angeles. The memo said the agency had received pledges of $7 million in private support that appear to be the first installment in a $30 million, four-year funding plan beyond 2020.

Details were not immediately available. Jonathan Thomas, chairman of the agency, is scheduled to brief board members on the funding plan tomorrow. But based on the memo and a presentation document, Thomas appears to be looking forward to private funding along with some public support, presumably from the state of California. However, the presentation labelled the funding as a “wind-down” operation.
Bill Bowes, UCSB photo

The William K. Bowes, Jr. Foundation is providing $5 million to the agency, and the Franklin and Catherine Johnson Foundation is adding $2 million, the memo by James Harrison, the agency's general counsel said.

The Bowes Foundation in 2012 gave $5 million to the UC Santa Barbara stem cell program. Bowes is the founder of Amgen.

The memo said,

“These gifts are contingent upon CIRM raising an additional $23 million before June 30, 2019 and not having access to additional funds for its administrative costs.”

Currently the agency is financed with money that state borrows (bonds). The cash flows directly to the agency without intervention or control by the governor or the legislature, an arrangement established by voters in 2004 when they approved creation of the agency, formally known as the California Institute for Regenerative Medicine (CIRM).

California Stem Cell Agency: FDA No. 1 Impediment to Stem Cell Therapies, 'Patients Are Dying'

California’s $3 billion stem cell agency this morning made it clear that it is not backing away from taking on the $4.9 billion Federal Drug Administration(FDA).

Randy Mills, MCC photo
“Patients are dying” because the federal government is “being so careful about safety,” Randy Mills, president of the agency, said in an item on its blog, The Stem Cellar.

 “Doing nothing is not okay,” said the headline on the piece, written by Kevin McCormack, senior director for communications for the agency. 

The FDA is too slow, too concerned about safety and needs to remove rules that are “bad for patients and regulators,” said the item.

Mills has been beating a drum concerning the FDA for a number of months, citing a non-scientific survey of agency stakeholders that showed 70 percent of them identified the FDA as the No. 1 impediment standing in the way of CIRM’s goals. 

Significantly, McCormack’s piece comes one day before the board of the California Institute of Regenerative Medicine (CIRM), as the agency is formally known, meets in Los Angeles to approve a plan that includes 50 new clinical trials over the next five years. All of those trials require FDA approval. 

In the proposal, Mills identifies FDA foot-dragging as one of the risks to successful completion of the $890 million effort.

 McCormack’s item said CIRM is “caught between a rock and a hard place. And CIRM is going to try and help them get out from under that.”

He quoted Mills’ speech to the World Stem Cell Summit last week. Mills said,
“We have had the current FDA regulatory structure for cell therapy in place for 15 years, and in that 15 years not one stem cell therapy has been approved. The scoreboard is not lying, there’s a zero on it. Not one therapy has been approved. There is an issue here, we can’t ignore that fact and so we made it part of our proposed new Strategic Plan to try and remove this burden. 
“There is an excessively long translational pathway to get an Investigational New Drug (IND) approval from the FDA (a necessary step to proceed with testing a therapy in a clinical trial). For non-cell therapies it takes 3-4 years to get an IND. For cell therapies it takes 6-8 years, twice as long.” 
Mills continued,
“We are not anti-regulation, we are not anti-FDA, and we are not calling for the removal of rules and regulations around stem cell therapies, that would be bad for patients and research. These therapies have risks and we are not proposing any strategy that puts things on the market without any testing or safety data. But right now we are being so careful about safety to ensure patients are not put at risk while those same patients are dying from their disease.”
In addition to Mills, one of the speakers at the World Stem Cell Summit was from the FDA. He said the primary mission of the FDA is safety. On the other hand, the mission of the California stem cell agency has long been “to accelerate stem cell therapies.” 

Tuesday, December 15, 2015

Full Coverage Thursday of California's New Stem Cell Direction

For all the latest doings by the $3 billion California stem cell agency, follow the California Stem Cell Report on Thursday for on-the-scene reporting as the agency officially approves its new course for the next five years.

Directors of the agency are scheduled to meet in Los Angeles to ratify a spending plan for its last $900 million. Also on tap is a risky, $75 million venture aimed at pushing the best of CIRM's research into the marketplace. 

The California Stem Cell Report will provide gavel-to-gavel coverage, but avid followers of the agency can listen in on the Internet or from two telephonic locations in San Diego and at Stanford. Details are on the meeting agenda.  

Monday, December 14, 2015

The Klein Legacy: Vestiges of California's Stem Cell Past to be Scrubbed This Week

No doubt exists that Bob Klein left his mark on the $3 billion California stem cell agency. Sometimes he is described as the father of the agency. He was its first chairman and led the drive to win voter approval of the research effort in 2004.

Bob Klein, Elie Dolgin photo
The agency has been under new leadership since 2011. And this Thursday some of the marks left by Klein are going to be erased.

Minor stuff now, but they recall some of the issues that rumbled through the agency in earlier days.

For example, the agency’s rules currently restrict to 12 the number of employees in the chairman’s office out of an agency total now of 55-56. The restriction is almost certainly to be removed on Thursday by the agency’s governing board. A memo by agency general counsel James Harrison said mildly that “disagreements” existed during the Klein regime about staff resources, leading to the limitation.

Those disagreements were actually sufficiently harsh that the stem cell board at one point in 2007 felt compelled to strip six employees from Klein’s office of chair, limiting him to four.

During Klein’s tenure, he also scheduled board meetings with jam-packed agendas that often took two days. The lengthy sessions tested the patience of board members, some of whom fled for the doors in an effort to catch their flights home as the hours wore on. The result was that the supermajority, legally required quorums required to do business were lost.. (See here and here for
more on quorum problems at the agency.)

To help avoid those unseemly situations, rules allowing telephonic attendance by key members of the board were enacted. Nowadays, the meetings proceed with dispatch, often ending early, much to the satisfaction of board.

So the board on Thursday plans to expand the use of telephonic meetings, which could well be a plus and a minus. The move will increase the number of offsite locations where members of the public and researchers can weigh in remotely with comments during meetings, a feature that has been lightly used. On the other hand, there will be less face-to-face contact between members of the board, something that is an important aid in finding solutions to touchy problems.

Head of NIH Troubled by Flagrant Violations of Law Requiring Public Disclosure of Research Results

The headline read “Failure to Report: Law Ignored, Patients at Risk.” The story this week began,
"Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found.
"The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer
"The worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 95 percent of the time since reporting became mandatory in 2008."
Francis Collins, head of the NIH, said he finds the failure to report "very troubling."

The story was written by Charles Piller, West Coast editor of STAT, which is a new online news operation dealing with the life sciences. It was started by the owner of the Boston GlobeThe STAT web site says it reports "from the frontiers of health and medicine."

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