Tuesday, June 27, 2017

Seeking a CEO: $3 Billion California Stem Cell Agency Faces Critical Leadership Challenges

California's 12-year-old stem cell research effort is expected to give away tens of millions of dollars in public this week, but its most important matters -- issues that deal with its survival and future -- likely will be discussed behind closed doors at a meeting Thursday of its governing board

On the table is the leadership of the $3 billion organization, which is scheduled to run out of cash in just three years, which amounts to a mere tick of the clock in the world of biomedical research. Beginning next week the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, will be minus its chief executive officer and its longtime counselor, who even predates the organization's actual creation in 2004.

CIRM directors are scheduled to meet Thursday at the San Francisco Marriott hotel in Burlingame, Ca., to confirm the appointment of Maria Millan, CIRM's vice president of therapeutics, as interim president of the agency. She will assume the duties of Randy Mills, who is leaving CIRM next week to head the National Marrow Donor Progam. 

Mills, who was paid $573,00 last year, also made it clear to the California Stem Cell Report in May that Millan is the appropriate person to take over the agency on a permanent basis after he leaves.

However, the decision is up to the 29-member board, which has scheduled an executive session Thursday to discuss the interim replacement for Mills. He joined the agency only three years ago but has left an impressive mark.

CIRM directors have also scheduled a July 17 meeting of their presidential search subcommittee to deal with the agency's leadership during what could be the last years of its life.

CIRM has a checkered record  in recruiting new presidents for a variety of reasons (see herehere and here). Some candidates have rejected offers. Other search efforts have been excessively prolonged.

Finding a new president from outside CIRM poses difficulties that would not have been in place, for example, five years ago. They include the tenuous future of CIRM along with the time needed for a normal executive search, plus the learning curve for a new CEO.

While CIRM is a small enterprise in some ways (less than 50 employees), it is an unusual mix of government, biotech business and academia, unlike any other state agency.  The combination has raised hurdles in the past.

The clock is running out fast at the agency. Any alterations in the plan put in place by Mills, Millan and company could slow its efforts to fulfill voter expectations that the agency would actually generate a widely available therapy. CIRM is helping to finance 27 current clinical trials, which are the last stages in research prior to a product reaching the market. The agency hopes to add 38 more trials over the next three years. But there are no guarantees that any will be successful.

Millan can step in and pick up the job relatively seamlessly.  Bringing in a CEO from outside could well take six months or more, including relocation. But serving as the head of  an organization that could be out of business in three years may not be appealing to many and could prolong recruitment.

If Millan is bypassed by the board, she may well leave the agency, triggering a cascade of departures as other CIRM employees also look to their own professional futures. An employee drain would hamper the agency's drive to come up with a commercial therapy.

James Harrison, the longtime counsel to the agency, is also leaving at the end of this week, returning to other pursuits at his private practice. Harrison has been a cornerstone of CIRM and has influence well beyond the not-so-simple legal matters involving the agency. He was also one of the authors of the 10,000-word ballot initiative that created the agency in 2004.

Scott Tocher, a longtime veteran of the agency, will replace Harrison. An announcement of the appointment is expected at the Thursday meeting.

Looming in the background is a gossamer plan for another ballot initiative to fund CIRM  beyond 2020. Bob Klein, a Palo Alto real estate investment banker who led the campaign that created CIRM, is talking about a $5 billion bond measure on the ballot as early as November of next year. Some political observers have predicted a less-than-warm-reception for such a proposal, given that the agency has yet to measure up to its 2004 campaign promises.

Another, rival proposal is being mentioned that would, in fact, move stem cell funding away from the agency.

One stem cell scientist, Paul Knoepfler of UC Davis, wrote last week about the agency's presidential search.

Commenting on his blog, Knoepfler said that CIRM directors should pick a "fantastic" person to replace Mills.  Knoepfler said the new president should have "strong leadership skills," a "big picture clinical vision" and "impeccable stem cell credentials," criteria that one could argue have not been met by most CIRM CEOs.

In the past, debate about presidential candidates centered on whether they should be stem cell stars or a leader who can execute an aggressive program that is already approved and in place. Given the current CIRM challenges, other criteria, such as speed and continuity, are also high.

The journal Nature this year said that the agency is in its "last stage." CIRM directors may well have that admonition on their minds as they consider fresh leadership for the program. Sphere: Related Content

Thursday, June 15, 2017

Guest Posting: "Stem Cell Options Should be on the Table"

(Editor's note: The following is a guest posting from Joseph Rodota and Bernard Munos, both of whom have been active in California policy matters for some time. More biographical information can be found at the end of the item. The California Stem Cell Report welcomes diverse, well-considered views on California stem cell issues. If you have something that you think should see the light of day, please send it to djensen@californiastemcellreport.com.)

By Joseph Rodota and Bernard Munos

The sponsors of Proposition 71, the 2004 initiative that provided $3 billion in bonds to support stem-cell research, are readying a proposal to keep the agency alive after the last of these funds have been given out. According to recent news reports, a new $5 billion bond could be on the California ballot as early as November 2018.

Researchers supported by the California Institute for Regenerative Medicine (CIRM) have published hundreds of academic articles, but placed fewer than 30 drugs in clinical trials.

Even if all of these clinical trials resulted in drug candidates, they would still come up against the so-called “Valley of Death”—the well-documented shortage of funding for early-stage translational research.

California needs to move regenerative medicine from an academic timeline to a business timeline. The skills needed to turn an academic discovery into a commercial product are very different from the skills needed to be a successful academic scientist.

We proposed an alternative to continuing the current approach -- a state bond with three distinctive features:

A Focus on Entrepreneurs: Funds would be available only to companies, not academics (who would still be able to tap into billions in NIH funding for stem cell research);

A Focus on California: Only companies with a headquarters and a majority of employees in California, the nation’s center of overall innovation, or willing to relocate here; and

A Focus on Breakthrough Medicine: Only companies working on projects that have the potential to greatly impact patient health would qualify.

The University of California is well-qualified to administer this bond and report on its operations to the Legislature and the Governor, without the need for the cumbersome and controversial governance structure put in place by Proposition 71.

In exchange for the funds they receive, companies would tender to the University of California shares of their common stock, with an estimated value as determined by the most recent outside valuation or price set by investors. These shares would become part of the UC endowment -- and the University of California be free to sell or leverage these shares, or acquire additional shares, as it sees fit.

CIRM has over-invested in academic research, and under-invested in translating that research into therapies that cure diseases and prolong heathy lives. California needs to right that balance.

(Joe Rodota served as Cabinet Secretary to former California Governor Pete Wilson and director of policy for Arnold Schwarzenegger’s 2003 recall campaign. Munos is a senior fellow with FasterCures and the founder of the Innothink Center for Research in Biomedical Innovation.).

Here is a summary of the bond proposal.

Sphere: Related Content

Tuesday, June 13, 2017

California Stem Cell Agency Reports 'Streak of Good News' on Asterias Spinal Therapy

Asterias video
California's $3 billion stem cell program today reported ongoing rosy results in a clinical trial involving a therapy for severe spinal cord injury.

The treatment is being developed Asterias Biotherapeutics, Inc., of Fremont, Ca., with $14.3 million from the state research program, which is now in its 12th year.

The latest news was reported on The Stem Cellar, the agency's blog, and was based on a news release from Asterias, which is publicly traded. 

Todd Dubnicoff, the agency's multimedia editor, wrote the item which discussed nine-month results for the trial involving six patients paralyzed from the neck down. He said,
"In a nut shell, their improvements in arm, hand and finger movement seen at the earlier time points have persisted and even gotten better at 9 months."
Dubnicoff said that the level of improvement "can mean the difference between needing 24-hour a day home care versus dressing, feeding and bathing themselves."

He said,
"The impact of this level of improvement cannot be overstated. As mentioned in the press release, regaining these abilities, 'can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.'"
In the Asterias press release, Edward Wirth, chief medical officer for the company, said,
“The new efficacy results show that previously reported meaningful improvements in arm, hand and finger function in the 10 million cell cohort treated with AST-OPC1 cells have been maintained and in some patients have been further enhanced even 9 months following dosing. We are increasingly encouraged by these continued positive results, which are remarkable compared with spontaneous recovery rates observed in a closely matched untreated patient population.”
The company also reported that no "serious adverse events" have surfaced that could be attributed to the therapy, which was initially developed  by Geron, Inc., which received $6.4 million from the stem cell agency. Geron abandoned the trial for financial reasons, and Asterias acquired the technology.

Aserias' stock price jumped nearly 13 percent today, hitting $3.55. Its 52 week high is $5.80 and its 52-week low is $2.30. Sphere: Related Content

Saturday, May 27, 2017

California Stem Cell Report Going Dark for a Few Days

The California Stem Cell Report expects to be offline for perhaps the next five to seven days.

The moving home of this web site, the sailing vessel Hopalong, will be making a passage north from Mazatlan into the Sea of Cortez, formally known as the Gulf of California. We will not have access to cellular or Internet coverage during that time. Sphere: Related Content

A Longer Look at the Golden State's Stem Cell Research Efforts

Here is the overview of the California stem cell agency, published May 23, 2017, on Capitol Weekly and written by yours truly.
Sphere: Related Content

Full Text: The California Stem Cell Agency's Response on its Accomplishments

Sphere: Related Content

Friday, May 26, 2017

California's 'Great Ideas,' Stem Cell Awards Target Universal Blood Supply, Alzheimer's and Much More

The California stem cell agency this week awarded a total of $1.4 million to six scientists to jump start their work in what it calls its "great ideas" program.

The awards went for research ranging from creation of a universal blood supply with human stem cells to mitigating Alzheimer's disease, which has seen an increase of 55 percent in its death rate from 1999 to 2014, according to results of a new study released yesterday

The agency said in a press release that the "Inception" program  "provides seed funding for great ideas that have the potential to impact human stem cell research, but need some initial support. It’s hoped this will enable the researchers to test their ideas, and give them the data they need to compete for more substantial funding."

Jonathan Thomas, chairman of the agency's governing board, said,
"This is a high risk, high reward program. We feel that a small investment now could produce enormous benefits later.”
The funding is small indeed. The California Institute for Regenerative Medicine(CIRM), as the agency is formally known, finances some clinical trials at $20 million a crack. The largest award in the "great ideas" program was $265,500.

The blood supply award was a reminder of another program that the agency used to entice star researchers to California. The blood grant went to Tannishtha Reya of UC San Diego. She came to California with her spouse, Robert Wechsler-Reya. He was lured by CIRM in 2010 with $5 million in funding to work at the Sanford-Burnham Medical Research Institute in La Jolla.. He has not received any further funding from the agency. This is the first CIRM award for Reya.

Another round of the Inception program is scheduled to open up in January 2018. Here is a link to the most recent request for applications. 

Here is a list of the winners with their application numbers. The summaries of reviewer comments on each application and their scores can be found here.  All of the institutions have ties to CIRM board members, who are not permitted to vote on applications involving their institutions. However, they can vote on creation of the research grant programs, establishment of their scope and rules.
DISC1-10074 Reprogramming human stem cells for blood cell generation T. Reya – U.C. San Diego $232,200

DISC1-10036 Prodrug innovation to target muscle stem cells and enhance muscle regeneration H. Blau – Stanford University $235,834

DISC1-10079 An exosome-based translational strategy to mitigate Alzheimer’s disease neuropathology J. Baulch – U.C. Irvine $179,911

DISC1-09912 A novel tissue engineering technique to repair degenerated retina B. Thomas – University of Southern California $215,133

DISC1-09999 Generation of expandable, self-renewing muscle stem cells for Duchenne Muscular Dystrophy A. Sacco – Sanford-Burnham Medical Research Institute
Letter to board
$265,500

DISC1-09984 Hypo-immunogenic cardiac patches for myocardial regeneration S. Schrepfer – U.C. San Francisco
Letter to board
$238,500


Sphere: Related Content

Tuesday, May 23, 2017

A Look at the California Stem Cell Agency: Its Origins, Its Accomplishments and Its Future

The Capitol Weekly online news and information service this afternoon posted a major overview of the $3 billion California stem cell agency.

The piece covered the agency's origins, recent high water marks and discussed its future. Here is the beginning of the freelance article by yours truly.
"C. Randal Mills, the 45-year-old CEO of California’s $3 billion stem cell research program, is a man who loves his milestones. 
"A private pilot, he charts his course in the air from one specific point to the next. Three years ago, Mills brought that same sort of navigation to the state stem cell agency. Miss one of the agency’s milestones, and — if you’re a stem cell scientist — you may not crash and burn, but you could lose millions of dollars in research funding from the state. 
"Mills has left an indelible stamp on the agency with his emphasis on concrete, measurable results. But he is resigning from the research program at the end of June in the midst of what some say is its “last stage.” His surprise departure to head the world’s largest bone marrow donor organization shocked many in California’s stem cell community. And it added to the unease about its future along with the future of possible stem cell therapies."  
(For those of you who read a brief item this morning about how this blog was going to go dark for a few days while it was on an ocean passage in the Sea of Cortez, we had a minor setback. Our floating home, the sailing vessel Hopalong, suffered a mechanical problem that we could not fix at sea, so we returned to port for repairs. The voyage begins anew tomorrow morning.) Sphere: Related Content

Major Overview of California Stem Cell Upcoming This Afternoon

Look for a major overview of the $3 billion California stem cell agency later today on Capitol Weekly, a well-respected online news and information service that focuses on state government and politics.

The piece was written by yours truly on a freelance basis for Capitol Weekly and includes the latest developments at the agency, including what departing president Randy Mills leaves behind.

Given the vagaries of the Internet and news, publication of the article cannot be totally guaranteed this afternoon. So if it doesn't pop up today, try again later this week.

Meanwhile, the California Stem Cell Report is going dark for a number of days while it makes an ocean voyage in its maritime home, the sailing vessel Hopalong, in the Sea of Cortez.  Coverage of the agency is expected to resume perhaps by this weekend when an Internet connection can be found in Baja California. Sphere: Related Content

Monday, May 22, 2017

California Stem Cell Agency Has Opportunity for 'All-in" Executive Assistant

Looking for a great job with a $3 billion operation headquartered in downtown Oakland? You will be able to share in the progress of one of the hottest biomedical fields in the country and perhaps help save some lives.

The job is executive assistant to the president of the California stem cell agency. The current president, Randy Mills, is leaving at the end of June. Maria Millan, now vice president for therapeutics, is taking over as the interim CEO. She is line to succeed Mills, but there is no guarantee on that.

The job is no walk-in-the-park. The agency is small -- only 46 employees -- despite its reach. Long hours could be the order of the day.

The job posting on the agency's web site says the position requires an "all-in" commitment to the goals of the agency. Salary can range up to $10,433 a month.

Sphere: Related Content