3 CIRM challenges: search for new prez, funding, & clinical POW!

The idea of CIRM as a dedicated state stem cell agency was one of the things that got me excited about starting my time as a professor doing research on stem cells in California way back in 2005-2006 on the job hunt. Fast forwarding to today now 11 years later, CIRM is still on the cutting edge, but some major things have changed for California’s stem cell agency and as it looks to its future, the questions and challenges are different too.CIRM 2.0

By analogy, the original CIRM was at first like a stem cell itself navigating its differentiation branches as it went. The new CIRM of 2017, what some call CIRM 2.0, is in contrast more like a developing tissue. It has matured and has a history to build upon as it continues. Today CIRM and its staff aren’t newbies. They were newbies by necessity when I came to California in 2006 because they were literally inventing themselves with no past example to use as a model. Now they are stem cell veterans and CIRM is trying to sort out its fresh path ahead relative to its current path rather than strike a path from scratch.

Three key areas need tackling to navigate the new path for maximum positive impact.

Funding. Does CIRM 2.0 and its backers go for a “Prop 71 2.0” to get another round of California state funding? If so, how much and how to approach the voters? If not (or if “yes”, but the effort isn’t successful), where does CIRM get its funding to continue? Of course, in theory a third option is that CIRM simply ends when its current funding runs out, but to me that’s not a real option. CIRM cannot end because it has so much more to do and it is in some ways just getting to the most exciting part: the bedside part of the bench-to-bedside path. Update: over at California Stem Cell Report, David Jensen has the scoop on an industry-centric stem cell bond proposal idea.

New Prez. CIRM 2.0 President and CEO Randy Mills announced the surprising news recently that he’s moving on from CIRM after a relatively short, but impactful tenure. Who will be the new CIRM President? It’s anybody’s guess at this point, but I’d say that CIRM needs to achieve two things at once here: move very quickly to get a new leader and make that leader be a fantastic choice for CIRM. What exactly do I mean by the latter? The new CIRM President ideally should have impeccable stem cell credentials and also big picture clinical vision as well as strong leadership skills. I asked CIRM where things stand on the President search today and CIRM Sr. Director Public Communications & Patient Advocate Outreach, Kevin McCormack, provided this quote:

“the Presidential Search subcommittee is going to be meeting on July 17th to evaluate the options regarding appointing a permanent President and CEO to replace Randy. They’ll then make their recommendations to the full Board.”

I’m planning a future post to throw some names out on the table for discussion of people who might be considered for the position by CIRM.

Clinical POW! CIRM’s mission is focused on having transformative clinical impact so the agency needs some snap, crackle, and POW! on that front moving forward. It already has provided key support for a number of ongoing clinical trials and the goal moving forward is final approved products that are proven safe and effective. I would call that some stem cell POW! Not everything is going to be a success, but I predict that some will.

I believe that CIRM has the potential to achieve all this. That doesn’t mean it’ll be easy, but what great things have ever been easy?

President Mills Leaving, CIRM Needs New Leader to Navigate Future Challenges

Randy MillsCIRM announced today that its President and CEO, Randy Mills, is soon leaving for a new job as President of the National Marrow Donor Program/Be The Match in Minnesota. Update: Dr. Maria Millan, the CIRM Vice President of Therapeutics, will be its leader starting July 1 until a new leader is chosen.

For this kind of position three years is a relatively short tenure so CIRM will need to scramble a bit to keep continuity and momentum as it searches for and ultimately puts in place a new leader. It’s a critical time for CIRM as it and its allies consider big picture strategy for the future, approaches to future funding such as a possible new proposition for state funding (Prop 71 2.0), and how to continue all those exciting clinical trials and research beyond the current period of its funding.

In general, Mills had a big positive impact on CIRM and helped it go to the next level. About the only thing I wasn’t a fan of in terms of his leadership was my perception of his negativity toward the FDA and toward FDA oversight of stem cells, and how that manifested at CIRM during his time there. But good people can strongly disagree on policy. We’ll have to wait and see how the regulatory experiment of stem cell provisions in the 21st Century Cures Act, which Mills may have helped to make possible, will impact regenerative medicine in terms of changes in FDA oversight. It could also impact CIRM too.

Now CIRM’s Board has an exciting, difficult task ahead. Who do they want as their new leader to tackle CIRM’s challenge? What kind of background and future vision? The priorities, leadership skills, and vision of the new leader are likely to together be a major factor in CIRM’s future success. Who are the top possible candidates out there right now? I’m going to do a follow-up, future post on these questions and CIRM’s future.

Welcome CIRM 2.0 and President Mills

The future is now.

Or so goes the expression.

For CIRM, it rings true today.

CIRM 2.0

Last year I blogged about what we might expect from the new CIRM that would evolve and take form in the future.

I was particularly thinking about this coming incarnation of CIRM, which I called CIRM 2.0, as it related to post-2017 when existing Prop. 71 state funding will run out and I was making the case for additional state funding for beyond 2017 for CIRM.

However, the stem cell field often changes rapidly, even overnight.

In that spirit, from my view for all intents and purposes CIRM 2.0 started yesterday. A big change came years early.

CIRM announced yesterday that C. Randal “Randy” Mills will be its new President taking the place of departing President Alan Trounson.

C. Randal Mills

Biotech leader Mills (formerly of Osiris) serving as the new CIRM President ushers in a fundamentally new era for CIRM and so it immediately kicks off CIRM 2.0.

A warm welcome to President Mills.

What does this all mean for CIRM from a broad perspective?

At and even before its inception, CIRM was all about human pluripotent stem cells, especially embryonic stem cells. The same was true for the first few years.

The production of iPS cells in mouse and human forms in 2006 and 2007 set in motion an ensuing shift for CIRM to include a great deal of iPS cell research in its portfolio.

The election of US President Obama in 2008 eventually released pressure on human ES cell research along with the resolution of the Sherley v. Sebelius Case. Sure, there were some painful moments such as during that time when all NIH hESC research was halted, but they were resolved. And CIRM’s focus continued to shift just a bit further.

Even with these changes, CIRM was still primarily focused on pluripotent stem cells. The notion of a leader with a primarily for-profit mesenchymal stem cell-centered focus at the helm of CIRM would have seemed impossible even just a few years ago. However, a tidal shift just happened. Okay, so it didn’t happen all at once overnight and observers of CIRM could see this trend begin a few years ago, but the appointment of Mills as the new CIRM Prez crystallizes this change.

It bears repeating. The future is now at CIRM.

What’s the bottom line?

The CIRM of today and the future is primarily going to be about focused stem cell clinical product development (the main goal of Prop. 71) and raising capital to support that development beyond 2017.

Let’s see what develops.

More on CIRM’s Search for a New President

EvanSnyder410CIRM, the California Stem Cell Agency, is looking for a new President since current President Alan Trounson announced that he will be moving on at some point in the near future.

CIRM itself is undergoing changes as it anticipates a key turning point in 2017 when it will not have state funding from Prop 71 any longer barring some new development.

I posted before about the results of a very informal survey of stem cell bigwigs about who they were thinking about as possible candidates for the new CIRM President. That post was clearly just a tip of an iceberg of the potential range of candidates.

Since that time, not surprisingly, more names have come up for potential candidates to be the new CIRM President.


An name that has popped up several times recently is that of Dr. Evan Snyder. Evan is an M.D., Ph.D. who is the Director of the Stem Cells & Regenerative Biology Program at Sanford/Burnham. He is a true pioneer in the stem cell field with strong translational interests.


In addition, Dr. Peter Donovan has been mentioned to me by several people recently as a candidate for the new CIRM President. Peter started the UC Irvine Stem Cell Center and has outstanding stem cell research experience.

Current CIRM Vice President, Ellen Feigal, who certainly knows the agency like no other candidate could and has great leadership experience, has also been mentioned by several people as a logical candidate to be the new President.

An important question is whether Evan or Peter would be willing, as some have suggested would be necessary for stem cell scientists who might be the new CIRM President, to give up their research programs and labs. Or, perhaps, one of them could convince CIRM to let him keep it part time?

It seems like Evan, Peter, and Ellen are all candidates that CIRM should take a close look at as they search for a new President.

I’m thinking the names of yet additional qualified candidates are going to be discussed in the interim until we hear more from CIRM itself about its list of candidates, which I imagine will happen sometime in the first half of next year. Time is of the essence and the new leader will play a crucial role not only for CIRM, but for all of stem cell research in California for many years to come.


Dozen Top Candidates To Be New CIRM President

CIRM 2.0Who might make a fantastic new CIRM President?

The California stem cell community is abuzz with this question.

This new President will not only lead CIRM today, but also in all likelihood will steer CIRM in its new incarnation after 2017, what I’ve called CIRM 2.0. At least that would be ideal.

CIRM has posted a position/candidate specification document here including a summary of the position that includes this statement:

The President of CIRM must be a nationally recognized leader with a vision, scientific credibility, and exceptional leadership skills, unassailable integrity, a keen appreciation of the financial and business aspects of scientific research, a sense of urgency and ability to deliver results, and a profound respect for the ethical issues involved in this project. He or she also must be comfortable operating in a very public capacity, adept at working with a board or other oversight body, have a good rapport with regulators, and sufficiently self-possessed to not be perturbed by criticism or controversy.

To summarize, this means the successful candidate must have great scientific stem cell chops, must be a proven leader (i.e. already held a high level leadership position elsewhere), ideally would have some business experience, being ethically unassailable (as much as possible at least), must already ideally have worked with the FDA, and not be easily spooked by public criticism or media storms. Almost everyone that I talked to thought that the person should be existing California stem cell scientist too for practical reasons.

The CIRM Presidential Search Committee tasked with finding people meeting these criteria, just met on Friday.

I’ve been talking behind the scenes with some folks in the know who are particularly interested in this question. They’ve thrown some names out onto the table, but of course not all of these people will necessarily be up for being considered and it’s not an all inclusive list. Update: To be clear, these names are NOT from me, but were suggested to me by others.

Candidates mentioned by stem cell community to me in alphabetical order by last name.

  • Jim Battey is Director of NIDCD at NIH, Former Chair of NIH Stem Cell Task Force, grew up in the Bay Area, went to Caltech.
  • Fred “Rusty” Gage is a Professor of Laboratory Genetics at the Salk, Past President of ISSCR, and a true pioneer in the stem cell field.
  • Larry Goldstein, Professor of Cellular and Molecular Medicine and Director of the UCSD Stem Cell Program, Scientific Director, Sanford Consortium for Regenerative Medicine, and another top international leader in the stem cell field.
  • Arnold Kriegstein is the Director of the UCSF Stem Cell Center and Professor of Neurology at UCSF.
  • Story Landis is Director of NINDS at NIH. She is a Neurobiologist, Former Chair of NIH Stem Cell Task Force in 2007, Graduate of Wellesley and PhD from Harvard.
  • Jeanne Loring is a pioneering stem cell researcher who is the Director of the Scripps Center for Regenerative Medicine.
  • Thomas Okarma is CEO of Asterias Biotherapeutics, and former President & CEO of Geron. Received his MD and PhD from Stanford plus on the faculty at Stanford from 1980-1985.
  • Mahendra Rao is Director at NIH of The Center For Regenerative Medicine and a long-time stem cell researcher. He received his Ph.D. from Caltech.
  • Brock Reeve, Director of the Harvard Stem Cell Institute. Strong commercial sector experience and graduate of Harvard Business School.
  • Clive Svendsen is Professor in Residence of Medicine and Director of the Cedars-Sinai Regenerative Medicine Institute. Former Director of University of Wisconsin Stem Cell and Regenerative Medicine Center.
  • Michael West, CEO of California-based stem cell biotech BioTime and long time leader in the stem cell field. Former leader of ACT and founder of Geron.
  • Keith Yamamoto is a Professor of Cellular and Molecular Pharmacology at UCSF. In addition, he is Vice Chancellor for Research, Executive Vice Dean of the School of Medicine, and Professor of Cellular and Molecular Pharmacology at the University of California, San Francisco, UCSF.

I’m sure there are more worthy candidates than just these, but this list seems like a good place to start.

Who’s your pick?