Looking for Work? Opening for Business Services/Accounting Specialist at California Stem Cell Agency

You might call this a ""show-must-go-on" stem cell item.

It has to do with hiring at the $3 billion California stem cell agency, which is running out of money. It is down to its last $27 million, a mere piffle compared to its earlier $300-million-a-year rate.

Nonetheless, the agency is looking for a business services/accounting specialist at a salary that could run as high as $110,000 a year.  The reason is that the agency needs to keep its doors open since many millions of dollars are still financing the work of California researchers and will for several more years.

However, the agency is hoping that one year from now California voters will provide another $5.5 billion a year, allowing it to continue financing new stem cell research work in the Golden State.

The agency is based in Oakland very close to BART service. Here is a link to more job information.

Job Openings at California's Stem Cell Agency

The California stem cell agency, which is set to basically expire in less than two years, is looking for a few good folks to continue to help it out.

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, has posted openings for an associate director of marketing communications and interns in the communications and human resources areas.

The associate director's responsibilities include oversight of the agency's Web site plus additional task. The person will replace Karen Ring, who is leaving to join Weber Shandwick, a major public relations firm. Here is the job information for for the marketing position.

The internships are unpaid and part-time. Here are links to the CIRM information on those openings: Communications,which also includes Web work, and human resources.

Currently the Oakland-based agency has a little more than 50 employees. It predicts it will run out of cash for new awards by the end of 2019 unless ambitious private fund-raising plans are successful.

Performance Audit of California Stem Cell Agency: Improvements Needed in $200 Million Fund-Raising Program, Staff Retention and Use of Board Members

A performance audit of California's $3 billion stem cell agency says that more needs to be done to retain the agency's staff as well as exploiting the talents of  board members as the research effort nears what could be its demise.

"There is a significant potential for staff attrition as CIRM plans for a potential wind-down," the $230,000 study by Moss Adams declared. CIRM is the abbreviation for the agency's official name,nthe California Institute for Regenerative Medicine.

The 38-page report also said that expertise of  the 29 board members "could be more effectively leveraged, especially since strong board engagement will be particularly important during organizational transition."

CIRM has estimated it will run out of cash for new awards in 2019 unless ambitious fund-raising plans are successful.  Its ultimate hope is that California voters will approve another multi-billion dollar bond measure in November 2020. To bridge the financial gap between 2019 and the end of 2020, the agency is seeking to raise more than $200 million.

Loss of employees has long been a concern of the agency as it confronts the expiration of the bond funding provided by the ballot initiative that created the program in 2004.

The performance audit said the agency should be "building on efforts to date, continue to regularly communicate transition plans to staff and consider strategies to retain employees, including implementing staff development programs, recognition and reward opportunities, work-life balance initiatives, and cross-functional initiatives."

Beyond its recommendations, the audit had praise for the agency. One example involved its "culture." The report said,

"CIRM has a collaborative, engaged, and performance-oriented culture. Managers, board members, and staff report improved morale and a more collaborative culture since CIRM 2.0 implementation. CIRM appointed a new president in 2014 and again in 2016. Turnover is often elevated during times of leadership transitions, as noted in 2014 and 2015. However, CIRM’s turnover rate dropped to 10 percent in 2016, suggesting stability in the organization’s leadership and culture."

Moss Adams, however, also said more can be done. It said the agency should "develop succession plans for the chair and vice chair, document knowledge of individuals serving in leadership roles, and continue to identify potential highly qualified prospective (board) members."

The audit recommended improvements in the agency's fund-raising efforts. It said the agency has not "formalized its ($200 million) fund development plan." The audit recommended creation of "a formal development plan that identifies roles and responsibilities and the timing of fundraising activities to meet CIRM’s programmatic and administrative funding needs."

Moss Adams additionally recommended improvements in measuring the performance of the agency's public relations program. It said,

"CIRM does not have metrics associated with the effectiveness of the agency’s communication and public education strategy. Recommendation: Develop communications and public education metrics that are integrated into CIRM’s quarterly reporting."

The study, which is required by state law, is the third conducted by Moss Adams. It will be discussed at Tuesday's meeting of the agency's board. The agenda for that meeting said the agency will have a response to the audit findings, but that document is not yet available on the CIRM web site.

The audit, which is required by state law, is the agency's third. Links and excerpts from items involving the previous two can be found here. 

Interested parties can participate in the meeting at 16 different locations throughout California. The  locations can be found on the agenda, but more specifics may be necessary for those who want to attend. They can be had by sending an email to info@cirm.ca.gov.

'Invisible Work' and the California Stem Cell Agency

At one point in its history, the $3 billion California stem cell agency had only about as many employees as a 24-hour Burger King, probably fewer.

Today it is has 46 workers, most of whom labor behind the scenes, rarely visible to the public. They do what I call "invisible work." That means you only see it when it goes away. Then the job that once was performed very well with little notice draws great and sometimes anxious attention because the work -- all of a sudden -- is not getting done.

Last week the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, to its credit moved to recognize some of those workers, which the agency calls team members.

Todd Dubnicoff, CIRM's multimedia editor, posted an item on the agency blog, The Stem Cellar, headlined,

"Meet Team CIRM: The People Behind the Mission to Save Lives."

Dubnicoff wrote,

"I don’t have the word space in this blog to introduce you to them all so, for today, say hello to a few of our 2017 CIRM Game Ball winners. At our quarterly Team meetings, we honor and celebrate members whose efforts reflect our 'All In' culture with this award."

They ranged from Lilia Leal, a finance officer, to Paul Webb, a senior science officer. Webb received his game ball for completing 40 of the important clinical advisory panel sessions in less than six months. Leal won her ball for reducing grant payment time by 30 days. 

We recommend the Dubnicoff item if you want to improve, however slightly, your understanding of CIRM and how it tries to make science happen. And congratulations to all the Game Ball winners. 

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.

California Stem Cell Agency Seeking to Fill High Level Positions

The $3 billion California stem cell agency is looking for a handful of new employees, including a top level executive who could be paid as much as $250,000 a year.

Openings for four positions are currently up on the Web site of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.  

They are a grants management specialist, systems engineer, science officer/senior science officer and associate director/director of therapeutics. They would join the 51 employees currently at the agency.

The listings with two different titles are for one job only.  The ultimate title of the successful candidate will depend on their level of prior experience, according to the agency.

The director of therapeutics position carries a maximum salary of $250,065.   The job would involve managing budgets of $600 million plus. The job listing also said candidates should know “what ‘great’ looks like and (use) that vision to set clear direction that is fully understood by the therapeutic team.”

The position would report to the vice president for therapeutics, Ramona Doyle, a former Genentech executive who joined CIRM in July.

The agency is currently based in San Francisco but will be moving its headquarters to Oakland this fall.

NDA Appoints Ellen Feigal as Partner

Ellen Feigal, formerly the No. 2 person at the $3 billion California stem cell agency, yesterday was named as a partner in NDA Partners, an international consulting firm to the medical products industry.

Feigal resigned last fall as senior vice president at the stem cell agency, about five months after Randy Mills was named as its new president.

NDA's web site says it is a "a global strategy consulting firm specializing in expert product development and regulatory advice to medical products industries" and that it deals with "emerging biopharma." The web site does not disclose the names of its clients, and it is not known whether any are involved with the California stem cell agency.

Three Top Execs Named Today at $3 Billion California Stem Cell Agency

The California stem cell agency today marked the completion of a year-long reorganization with the appointment of three top executives, including a veteran of Genentech.

Randy Mills, who became president of the $3 billion agency in May 2014, said the appointments represent a “significant inflection point.”

Mills said in a press release,

“People are everything when it comes to the potential and performance of an organization.  With the appointment of these three exceptionally talented individuals to the leadership team, CIRM is now better positioned to achieve its mission and forever change the practice of medicine.”

The trio consists of Ramona Doyle, vice president of therapeutics; Maria Millan, senior director of medical affairs and stem cell centers, and Maria Bonneville, director of administration. Millan and Bonneville both were promoted from within the organization.

Ramona Doyle, Rhodes Project photo

Doyle comes from Genentech. She was senior group medical director for respiratory product development at the South San Francisco business, where she has worked since 2009. She worked for Gilead Sciences for two years. Doyle has also taught at UC San Francisco and at the Stanford Medical School, where she worked with Millan.

Beginning Monday, Doyle will oversee projects involving neurological and ocular, cancer and blood related and cardiovascular, lung, liver and other organ system-related conditions. She is also the only person designated as vice president within the agency, formally known as the California Institute for Regenerative Medicine (CIRM).

Doyle received her M.D. from Emory University and was a Rhodes Scholar after receiving an undergraduate degree in English and literature from Sewanee: The University of the South. When she was at Sewanee, she was editor of the Mountain Goat literary magazine and wrote prize-winning poetry.

Also named today as senior director of medical affairs was Maria Millan, who formerly was a

Maria Millan

medical officer at CIRM, which she joined in 2012. Prior to that, she was vice president and chief medical officer at StemCells, Inc., and director of the pediatric liver and kidney transplant program at Stanford, where was also an associate professor. Millan, a surgeon, is overseeing the agency's $34 million Alpha stem cell clinic program. 

Prior to Bonneville's appointment today as director of administration, she was executive director of the CIRM board. She will have oversight over the agency’s board relation, human resources, communications and information technology departments. Before joining CIRM, she was a consultant with Tramultola LLC and worked for former state Treasurer Bill Lockyer as finance director for Northern California.

Other members of the agency’s “leadership team” are Chila Silva-Martin, finance director, Gil Sambrano, director of review; James Harrison, general counsel; Gabe Thompson, director of grants management, and Patricia Olson, executive director of discovery(basic research).

All have been with the agency for some time. Harrison is an outside contractor.

Not including Mills, the 8-member leadership team at CIRM now consists of five women and three men. 

California Stem Cell Audit: Praise for Mills but More Work Needed on IP, Conflicts of Interest

The California stem cell agency this week received good marks for changes made by its new president, but it is also being told that it needs to improve how it tracks potential royalties and how it prevents grant reviewer conflicts of interest.

A "performance audit" by Moss-Adams, a Seattle business consulting firm, made 12 recommendations for the $3 billion research enterprise. One of the 12 was to implement the unfulfilled recommendations made by Moss-Adams three years ago.  Seven of the 24 from that audit still need more action, the firm said.

On Thursday, the agency's governing board is scheduled to discuss the latest audit at a meeting in Berkeley.  The study is required by state law every three years. The agency's scientific performance, however,  is specifically excluded from being examined. Moss-Adams is scheduled to receive $230,000 from the agency for the audit, which was for the 2013-14 year.

On Sunday, the California Stem Cell Report covered the deficiencies involving disclosures of the financial interests of grant reviewers.

Other areas of concern included the need for better tracking of intellectual property that could mean royalties for the state, more timely review of progress reports from grantees, more timely, formal evaluation of employees and keeping up-to-date on technology related to grant management and agency efficiency.

Under the subject of "commendations," Moss-Adams said that CIRM had "many strengths."  The consultant said the agency has made "significant strides" in three areas: the grant management system, grants process improvements and "organizational culture."

The grants process comment referred to CIRM 2.0, the fast-track funding program initiated by Randy Mills since he became president a year ago. The organizational culture commendation also involved Mills' efforts, but touched indirectly and delicately on the resignation of Robert Klein as chairman and the election of Jonathan Thomas to replace him in June of 2011. 

Moss-Adams reported "enhanced seamlessness" between the president's and chairman's offices. Proposition 71, which created the agency, dictated a controversial dual executive situation that has troubled the agency since its inception.

The audit found significant deficiencies involving the treatment of CIRM employees, some of which have been addressed in a positive way already by Mills. One example cited by the audit involved performance evaluations that are tied to pay increases. It said that evaluations that were scheduled to occur in 2013-14 did not actually take place until January of this year.  

Moss-Adams said the agency also needs to do better in monitoring and protecting its intellectual property (IP), which could generate royalties. Without tight tracking of the IP and inventions funded by CIRM research, the state could lose out on revenue. Backers of Proposition 71 told voters in 2004 that the state could receive more than $1 billion in royalties from CIRM research. So far, none has resulted. 

Moss-Adams said that royalties are now more possible because the agency is backing late stage research that is more likely to make it into the market place. 

Moss-Adams said more work was needed on implementing the seven recommendations from three years ago, including those involving IP, the transition plan to deal with the possible demise of the agency and a grants outcome database. 

California's Stem Cell Agency Needs New Home by This Fall; Faces $1 Million in New Costs

The California stem cell agency isn’t quite at the stage of “Ain’t Got No Home,” the title of the immortal hit song from 1956.  But the search for a new roost for the research effort is intensifying.

And it will likely add another $1 million or so to the agency’s annual operating costs. 

The $3 billion agency now operates out of free digs in San Francisco in a gentrified neighborhood that was a tad gritty back when the agency moved in a decade ago. Today the area is much tonier. Even the Happy Donuts shop down the street (open 24 hours) has cleaned up its signage, and a chichi pizza parlor is located on the ground floor of the stem cell agency’s building.

Come next fall the agency will be moving out of its roomy offices that were built to its custom orders. No more free rent – a benefit valued at about $1 million annually by the agency’s auditor. Gone will be the free parking, a matter of great import in San Francisco.

The free office space came as the result of a $17-$18 million package put together by San Francisco to entice the agency to the city. 

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, is looking for about 12,000 to 18,000 square feet(see specifications list below). On Nov. 14, 2005, when the agency moved into its current space, it had about 20,000 square feet with 18 window offices, 17 internal offices and 19 cubicles, according to a CIRM document.  That was for about 25 to 30 employees. Those employees currently number in the mid-50s, not a large number to be handling $3 billion.

In December, the governing board’s Governance Subcommittee briefly discussed what the agency is seeking. The specifications call for a facility that could accommodate the meetings of its board of directors, which would be a major change. CIRM would like a room that could handle 50 to 75 people. Twenty-nine persons sit on the board. The space would appear to be large enough to handle normal public and staff attendance but fall short of the space needed for the few occasions when large crowds appear. 

Board meetings have generally involved rented conference rooms at hotels. The hope is that a meeting room within CIRM offices could defray meeting costs.

Office space costs have skyrocketed in San Francisco over the last several years, pushed upward by the booming tech industry. According to one office space expert, 12,000 square feet of Class A office space in the city of San Francisco could run as much $900,000 a year with additional parking costs of up to $450 a month per stall. If the agency wants 18,000 feet, the cost climbs to roughly $1.4 million.

Given that situation, CIRM has expanded its search to include cheaper locations across the bay from San Francisco, including Oakland, where California Gov. Jerry Brown has a home, and Emeryville, a city once known as Butchertown because of its slaughterhouses. Today Emeryville businesses include the Pixar Studios. CIRM was also housed in Emeryville in 2005 while it waited for its offices in San Francisco.

At the December governance meeting, Art Torres, vice chairman of the agency, said that the city of South San Francisco is also on the list of possible locations. Genentech has its headquarters there and sponsored a sign declaring the city as the “Birthplace of Biotechnology.”

During the Governance Subcommittee meeting, one board member, Al Rowlett of Sacramento, pressed for consideration of other cities. Torres, who was leading the discussion, rebuffed him, according to the transcript of the meeting. Torres said that the four locations are being considered because the staff lives in them or nearby. He continued,

“I would just hate to move to an entirely different new city and then people have to make very difficult decisions on whether they could do so or just leave CIRM. At this critical stage of our development, I would feel that would be a burden that would be very heavy for us.”

Torres also said he is working with the city of San Francisco to see if it can persuade landlords to ease rent or provide some other kind of support.

Randy Mills, CEO of CIRM, told directors in January that the office move could lead to some disruptions in its activities. The agency last week reported no major new developments in the office space search. In 2009, the agency considered the possibility of use of a nonprofit to own the office space, given the legal cap on CIRM's operational budget. However, that possibility has not surfaced publicly in recent years. 

For those who want to know more about the inimitable Clarence "Frogman" Henry, who wrote and sang "Ain't Got No Home," here is a link to his Web site.

Here is the list of specifications discussed by directors in December.

   CIRM Office Space Specifications December 2014 by DavidJensen

Update on the Search for New Execs at the California Stem Cell Agency

California’s $3 billion stem agency no longer lists on the Internet job openings for a director of medical affairs and director of administration but reports that the positions remain vacant.

The new, top level posts were created in a reorganization of the enterprise, which has less than 60 employees, by its president Randy Mills, who took over last May. He made the move as part of his CIRM 2.0 effort.

In the initial postings last month, the agency said the positions would remain open until they were filled. Three other openings for directors in the areas of blood and cancer, neuro/ocular and organ systems continue to remain up on the CIRM Web site.

No explanation was offered for removal of the medical affairs and administration openings. Kevin McCormack, a spokesman for the agency, said the positions have not been filled.

Here are job posting documents as they originally appeared.

   Director of Administration, California Stem Cell Agency

   Director Medical Affairs, California Stem Cell Agency

California Stem Cell Agency Seeks Five Executives in $3 Billion Program

California’s $3 billion stem cell agency has embarked on a wave of fresh hiring of well-paid executives to fill top slots in the new structure created by Randy Mills, who has been the chief executive of the program since last May.

Five positions are open with salary ranges that hit $244,204 annually.  All of the announcements are emblazoned with the new CIRM 2.0 logo, emphasizing the “radical” changes underway at the agency. The program is formally known as the California Institute for Regenerative Medicine or CIRM.

The postings amount to the largest number of top level positions opening at the agency in a number of years, perhaps the largest since its inception 10 years ago.  Total employment at research funding program is slightly more than 50 persons and is not expected to increase significantly.

The open positions include “directors” in the following areas:  medical affairs and stem cell centers, blood and cancer therapeutics, neuro/ocular therapeutics, organ systems therapeutics and administration, which includes everything from public relations to information technology.

The agency’s governing board in December approved Mills’ reorganization with little discussion. He said it would flatten the organization, making it speedier and more efficient.

The new structure eliminated a number of positions, including that of Ellen Feigal, who was senior vice president for research and development, then the No. 2 position at the agency. She resigned last October, giving two weeks notice. At the time, she was the fifth person to leave the agency following the hiring of Mills.

Under Mills’ organization, the agency does not have a No. 2 person or a chief scientific officer. The chief scientific officer position was eliminated years ago, although it is common in many biotech companies.

A comparison of the new and old organization can be found here.

Here is a look at some of what the new positions entail:

Director, Medical Affairs and Stem Cell Centers: Oversight of “the Alpha Stem Cell Clinics, the CIRM Stem Cell Genomics Centers of Excellence, and the CIRM hiPSC Initiative with a total budget of over $90 million.”

Director, Blood and Therapeutic Area: Oversight of more than “20 active programs and a budget of over $200 million. Projects in the therapeutic area range from translational research through human clinical trials.”

Director, Neuro/Ocular Therapeutic Area: This area “currently has over 25 active programs and a budget of over $200 million. Projects in the therapeutic area range from translational research through human clinical trials.”

Director, Organ Systems Therapeutic Area: This involves more than “25 active programs and a budget of over $200 million. Projects in the therapeutic area range from translational research through human clinical trials.” 

Director, Administration:  Oversight of Communications, Information Technology (IT), and Human Resource departments; “Importantly, the Director is also responsible for managing all Governing Board activities and communications.”

All of the positions have a salary range of $167,877 to $244,204 and report directly to Mills.

No deadline exists for filing applications. The announcements said applications will remain open until the positions are filled. Mills, however, moves with dispatch. Interested persons should submit applications quickly if they want to be considered.

California Launches $50 Million, Fast-Track Stem Cell Drive

Directors of the $3 billion California stem cell agency today approved a $50 million plan that will radically reshape its efforts to produce a widely available stem cell treatment, a goal that it has not yet reached after 10 years of trying.

Speed is what the new push is all about – shortening the agency’s funding cycle for awards from nearly two years to about four months.

The plan was devised by Randy Mills, who has been president since last May of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. He has dubbed the effort “CIRM 2.0” and says,

“We are in the business of trying to save people’s lives….We have to behave with the appropriate sense of urgency.” 

CIRM 2.0 will begin next month for awards related to clinical trials with $50 million allotted for the first six months of the year. The program will be extended to other award programs as well. The agency hands out cash at an average rate of $190 million a year and has about $1 billion left.

The program appears akin to a venture capital process but without face-to-face pitches by those seeking funds.

Researchers from both business and nonprofits will be able to apply on the last business day of each month instead of very sporadically. No caps will be stipulated on the grants, but budgets will be closely scrutinized prior to reaching reviewers.

CIRM directors from nonprofit institutions vigorously balked at a 10 percent cap on indirect costs in the awards.  The indirect funds go to the institution and not for research. Some of the indirect rates currently run as high as 20 percent of the total award and are much valued by California research institutions, most of whom have members on the CIRM board of directors.

Director Donna Weston, chief financial officer of the financially troubled Scripps Institute, led the move against the 10 percent cap. Others indicated that researchers at some nonprofits would not be allowed to apply for grants that only contained a 10 percent rate. As result, the board agreed on a 10 percent cap on indirect costs for businesses and 20 percent on nonprofits.

No opposition was heard online during what appeared to be a unanimous vote. The California Stem Cell Report queried CIRM about whether it is a legal conflict of interest for directors from nonprofit institutions to vote on the indirect cost change that would benefit their institutions.

James Harrison, general counsel to the board, replied,

"No, it is a standard, so it is exempt."

Mills’ plan calls for researchers to receive their money within about four months of submitting an application. Board approval is scheduled for 90 days after submission. Work must begin within 45 days after board action. Unsuccessful researchers with applications that have potential will be coached by the agency so that they can turn in a successful proposal. Successful applicants will see greater involvement in their work by CIRM staffers and will face go-no go milestones. Failing to meet a milestone will mean loss of funding.

Moving the cash quickly to biotech businesses is critical, says Mills, who was a CEO of a stem cell firm for 10 years. Most operate on a thin financial edge and are perpetually raising money. Business applicants, however, will have to show six months of cash-on-hand to win approval. Matching funds will be required in some of the first rounds, and in some cases also from non-profits.

   

Mills predicts that CIRM 2.0 will result in higher quality applications because of the coaching and because proposals are less likely to be submitted prematurely in order to conform to CIRM’s previous funding cycles.

CIRM directors also approved Mills’ reorganization plan that is likely to break up silos at CIRM that may have formed over the past eight years. Mills said his structure will be more efficient and encourage innovation. The new plan calls for the staff – Mills prefers the word “team” – to be organized on much different lines than previously. Units will be organized on therapeutic lines such as “blood and cancer” and “organ systems.” Currently the CIRM team has been organized into such things as “research and development” and “scientific activities.”

For more on CIRM 2.0, see here, here and here. Here is a link to the CIRM press release.

New President and Organizational Tea Leaves from the California Stem Cell Agency

The new organization chart at the $3 billion California stem cell agency looks much different than the way it has looked has over the last 10 years.

Gone is the office of research and development, once headed by Ellen Feigal, who resigned last month. Gone is the office of scientific activities. Instead CIRM will have a “blood and cancer” unit and an “organ systems” unit, among other things.

CIRM President Randy Mills, who devised the plan, says it will be flatter, speedier and more efficient than the structure that has been in place more or less for the last 10 years. Mills joined he agency last May. CIRM directors are expected to ratify his plan later today.

Another interesting note popped up in examining the current organizational chart. James Harrison, who formerly was described as outside counsel to the CIRM board, is now listed as general counsel to the entire agency, albeit an independent contractor.

The change recognizes a reality that has been in place for 10 years. Indeed, Harrison, who is a partner in Remcho Johansen & Purcell of San Leandro, Ca., wrote portions of Prop. 71, the ballot initiative that created the agency in 2004.

Remcho is under a $500,000-a-year contract to provide services to CIRM, which it has been doing for the last decade.

The charts available this week for the new structure did not contain a list of employees in each unit nor did they list how many persons worked in the chairman’s office. In 2011, 12 of the 53 persons at the agency worked partly or entirely within the chairman’s office. That number had dropped to eight as of this week but prior to approval of the new structure.

The relationship between the chairman and the president of the agency has been rocky at times in the past because Prop. 71 gives them legally overlapping responsibilities. The situation has stirred public flaps, hampered executive recruitment and been criticized as harming accountability.

It is worth noting that for several early years in CIRM history, the number of its employees was less than the 29 persons who served on the agency’s governing board.

Here are two charts on the CIRM organization. The first contains the structure as of yesterday. The second is one that being presented to CIRM directors today. 

Old CIRM Structure Above

Former California Stem Cell Board Member Shestack Comments on the Agency's Record

Jonathan Shestack, a former member of the board of the California stem cell agency, was interviewed by telephone during the reporting for the 10th anniversary article today on the California stem cell agency.

Jonathan Shestack (left) and CIRM Chairman J.T. Thomas
at 2012 board meeting. CSCR photo

Shestack served on the board from 2004 until 2013. A Hollywood producer, he has been a longtime patient advocate for autism. He and his wife co-founded Cure Autism Now in 1995. Here is a link to Shestack's resignation letter from the board.

The 10th anniversary article was written by David Jensen, the publisher of this blog, and appeared in The Sacramento Bee.

Here is a summary of Shestack’s comments, which were trimmed from print article for space reasons.

He said, “CIRM has funded an amazing amount of great projects. It does an amazing amount of good.” He said, however, it should be “more bold going forward.”

Shestack was critical of the senior staff at the agency. He said they did “not like to do what the board wants.” He said, “The staff made a monkey out of the (10) patient advocates (on the board) for eight years.” There was no mechanism by which the board could pressure the staff on “programmatic” issues, he said.

Shestack said he was disappointed in the funding for research funding for autism. He said the agency wants to take credit for more funding on autism than is justified. He suggested that alternative grant-making proposals would been useful, such as creating a round for research on specific diseases.

Shestack was critical of the way in which grant rounds were handled. He said it led to “bloated proposals that people felt they had to approve.” He said the agency could have “more ruthless” on the “big disease” rounds and more willing to spend on basic research. “Ossified” is the way he described the grant-making process. During the review of grant applications, he said the staff “exerted a lot of pressure but in a passive-aggressive way.”

On conflict of interest issues, he said, “Trying to legislate away all conflict is a way to install permanent idiocy.”  Knowledgeable people in a small field such as stem cell research are nearly always going to have conflicts. He said the key is to manage them properly.

Shestack remarked on the impact of the state laws concerning open meetings. Compared to the private sector, they were “incredibly onerous” and made it difficult to do things, although he recognized they were necessary.

Shestack said the board is one of the best he has ever served on.  He said all the members were “pulling incredibly hard for the success of the agency. None of them had a hidden agenda.”

Text of Letter by Ellen Feigal on Her Resignation

Here is a copy of the letter that Ellen Feigal sent to her co-workers at the California stem cell agency earlier this week, announcing her departure.

"To my colleagues at CIRM:

"With some regret and after careful consideration, I have submitted my resignation as Senior Vice President of Research and Development at CIRM, effective November 10, 2014, in order to pursue other opportunities.

"It’s been an amazing four years.  I am proud of what’s been accomplished under my leadership for the research and development programs, none of which would have been possible without all of the contributions you each made, and was built on the foundation of science, education, training, basic biology and early translational programs of the previous 5 years. 

"The list of our accomplishments is indeed long, but let me highlight just a few.  When I began there were no operational development programs, and to date we have awarded over 27 disease and strategic partnership teams, 18 to move into the clinic, 8 already actively enrolling or ready to enroll patients, with a total of 10 expected to reach the clinic by the end of this year.

"In addition, there are more than 60 preclinical projects in the pipeline. I’m especially proud that our efforts have led to clinical trials reaching a broad range of patients with serious medical conditions including diabetes, spinal cord injury, blinding eye diseases, heart failure, cancer, sickle cell disease, beta-thalassemia, and HIV/AIDS.  With funding just approved Thursday for the first alpha stem cell clinics, CIRM and our investigators are well-positioned to reach the next level of progress – it will be an exciting time.

"I want to particularly thank the development team for the tremendous work of the hands-on management of the development projects – disease teams and strategic partnerships; the grants management team for handling the financial and business aspects of the projects; and our business development team for forging the substantive industry partnerships that will facilitate moving these projects towards commercialization.  Special thanks to our grants review officers for their expert handling of concepts and RFA solicitations and external peer review, in close collaboration with our science officers, and administrative support.

"I am proud to have created CIRM’s first external Clinical Development Advisory Panels.  These panels of multidisciplinary advisors served as a resource to our funded disease and strategic partnership team investigators in areas of preclinical, manufacturing, disease, stem cell biology, regulatory, clinical, and commercialization, to better position the disease and strategic partnership teams for success.

"I want to particularly thank the contracting officers and the legal office for their contributions to vetting the external advisors and ensuring all was done with due regard for COI and CIRM regulations; to science officers on the development team for the extensive discussions they held with the CIRM funded investigators to prepare the questions and issues to address --  your in depth knowledge of the projects and working relationships with the investigators greatly benefited the projects’ ability to progress. I forged a strong working relationship between CIRM and the FDA.  This included twice yearly webinars and yearly roundtables involving FDA, industry and academia to tackle regulatory issues on the product development pathway, and included CIRM scientific team input and participation in elucidating the topics selected for discussion; in addition, it included organizing in 2013, the first meeting of international regulatory authorities from the US, Japan, Europe, United Kingdom and Canada, and investigators from industry and academia, to discuss the regulatory pathways for stem cell treatments. Once again, the contracting office and administrative program support was instrumental in ensuring the webinars, roundtables and workshops proceeded smoothly, and the communications team facilitated the rapid dissemination of these sessions and white papers through CIRM’s public website.

"Over this time period, our repertoire of communications has steadily strengthened due to the direct efforts of our communications team – I have enjoyed working with the group in this critical component of CIRM’s mission.

"Our basic biology and early preclinical translational teams harnessed the engine of discovery to help increase our scientific understanding of diseases, stem cell biology, and how stem cells could function as tools for elucidating disease pathogenesis, target identification and drug discovery and as cellular candidates to fill the pipeline for the development projects – I want to extend my sincere thanks to the teams in their expert management of the CIRM funded investigator projects in these endeavors.

"We have invested in the future creating the next generation of researchers with our training programs – thanks again to the hard work of the teams managing these CIRM funded programs.

"Together – and by this I mean every single one of you – administrative and HR support teams, communications team, grants review officers, basic biology team, early translation team, development team, grants management, contracting officers, legal team, business development officers, financial officers, information technology team, and the leadership team of CIRM - I think we have accomplished a great deal. While there is much yet to be done, this is a good time for me to pursue other opportunities.  I am confident you will all continue to build on what has been accomplished.  I look forward to learning about CIRM’s successes in the future.' 

A Top Exec Departs from California Stem Cell Agency

The No. 2 person at the $3 billion California stem cell agency resigned this week, becoming the fifth person to leave the research enterprise since Randy Mills became president last spring.

Ellen Feigal
CIRM photo

Ellen Feigal gave two weeks notice on Monday that she would be departing as senior vice president for research and development.  The No. 3 person at the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, left last July and has not been replaced.

The agency staff now numbers 54.

Asked today whether Michelle Williams, the former chief scientific officer of Mills’ previous firm, Osiris Therapeutics of Maryland, would replace Feigal, a spokesman for the agency, Kevin McCormack, said,

 “I can say categorically that Ellen will not be replaced, by Michelle Williams or anyone else.”

Williams was at Osiris Therapeutics in Maryland while Mills was president of the publicly traded business. Williams left Osiris in March. She is now listed on Linked In as a consultant. Williams is also on the panel of scientists who review CIRM grant applications.

Elona Baum, who was general counsel and vice president for business development, left her position in July to join Coherus BioSciences of Redwood City, Ca., as vice president and associate general counsel.  McCormack said discussions are “ongoing” about whether her position will be filled.

McCormack said that Feigal “decided that this is a good time to leave and pursue other opportunities.” McCormack reported,

“In an email to staff she wrote: ‘It’s been an amazing four years.  I am proud of what’s been accomplished under my leadership for the research and development programs, none of which would have been possible without all of the contributions you each made.’"

No public mention of Feigal’s imminent departure was made at the agency’s governing board meeting last Thursday.

In addition to Feigal and Baum, those who have left include Natalie DeWitt, former special projects officer for former CIRM President Alan Trounson. She joined Stanford University. Others are Celeste Heidler,  a financial services officer who retired, and Ian Sweedler, an attorney who joined the Moore Foundation.  

No job openings are currently listed on the CIRM Web site. 

Tightening the Revolving Door at the California Stem Cell Agency

Directors of the California stem cell agency next week will consider a proposal aimed at partially addressing revolving-door and conflict-of-interest problems at the $3 billion research enterprise.

The proposal comes in the wake of a wave of unfavorable publicity this summer that embarrassed the agency when its former president, Alan Trounson, was named to the board of a stem cell company only seven days after he left the state research effort.

The Newark, Ca., firm, StemCells, Inc.,  is the recipient of $18.4 million in awards from the California Institute of Regenerative Medicine (CIRM), as the agency is formally known.  The news surprised the agency and prompted its new president, Randy Mills, to sign an agreement that he would not accept employment from a CIRM grant or loan recipient for at least a year after he left the agency.

Michael Friedman
CIRM photo

In a memo to CIRM board members yesterday, Mills said he was offering a new proposal on revolving door matters after CIRM Director Michael Friedman, president of the City of Hope, made such a suggestion in July.

Mills wrote,

“Under the proposed policy, CIRM team members (employees) would remain free to pursue other employment opportunities, including with CIRM-funded institutions. To prevent inadvertent violations of California’s conflict of interest laws and to ensure the integrity of CIRM’s decision-making process, however, the policy would request that CIRM employees notify CIRM legal counsel when the employee begins employment discussions with a CIRM grantee or current applicant. CIRM’s legal counsel will maintain the confidentiality of this information and advise the employee of the steps he or she needs to take to remain in compliance with the law. Thus, the policy balances the privacy interests of CIRM employees with the need to protect the integrity of  CIRM’s decisions.”

Mills said,

“As Dr. Friedman recognized, CIRM has a highly talented team. It is therefore understandable that California institutions, including those that receive CIRM funds, would be interested in recruiting them. Currently, there is no prohibition on CIRM team members accepting employment from CIRM funded institutions, however I believe additional clarity regarding this topic would help avoid potential conflict of interest occurrences.”

The board will act on the proposal at its meeting in Berkeley next Wednesday.

 Our comment: The proposal will not eliminate revolving door problems at the nearly 10-year-old agency as it winds down its funding and employees may want to seek other employment.  The proposal contains ambiguities that make it difficult to adhere to, such as the question of when employment discussions begin. It also does not contain any indication of the consequences for violation of the policy. However, coupled with the Mills’ personal declaration on future employment and the deplorable situation involving Trounson, the new policy helps make it clear that actions such as Trounson’s do not measure up to what is now expected at CIRM.  Mills has also produced a fresh perspective on CIRM’s future finances that would stretch them out to 2020 instead of 2017, another action that removes an incentive for employees to consider seeking employment elsewhere.  

Stem Cells and Revolving Doors: The California Experience

The phrase “revolving door” is not one that rolls off the tongues of most Americans. But it is shorthand for an issue that concerns both Elon Musk of Tesla and SpaceX fame as well as taxi drivers in New York City.

It is also a matter of importance to the $3 billion California Institute for Regenerative Medicine (CIRM) and other state agencies.

Natalie DeWitt
CIRM photo

The issue surfaced this week with the departure of a high level staffer at the San Francisco-based agency -- Natalie DeWitt, special projects officer for its former president, Alan Trounson. DeWitt's final day at the agency was last Friday. She began her new job on Monday at Baxter Laboratory at Stanford University.

Garry Nolan, Helen Blau, Peter Jackson
Baxter Laboratory photo

Baxter is run by Stanford scientists Helen Blau, Garry Nolan and Peter Jackson. Blau has received $2.8 million from the stem cell agency. Nolan has received $1.3 million. He is also a leader (co-PI) on a $20 million award in the agency's signature disease team effort.

No one is alleging that DeWitt or others have done anything wrong. She has a fulsome resume and a record of accomplishment.

Her departure from CIRM and employment at Baxter, nonetheless, does bring to the fore revolving door employment issues that now are a matter of greater concern for the agency than they were five years ago. The agency is scheduled to run out of funds for new awards in less than three years. Some of its employees are undoubtedly going to be looking for future employment in California's small, stem cell research community. It would be natural for agency employees to want to capitalize on their unique experience at CIRM. That is what gaining professional experience is all about.

But there are legal and ethical constraints. To prevent improper influence on governmental actions, the state of California has laws dealing with revolving door employment. Briefly summarized, state law says that certain former state employees and consultants can be banned from attempting to influence their former agency, either for one year or permanently. Current state officials also can be barred from taking part in decisions that directly relate to a prospective employer.

The California Stem Cell Report this week queried CIRM about its revolving door policies. Kevin McCormack, senior director of public communications, replied,

“These are issues that we are encouraged to be mindful of from the day we are hired to the day we leave. Once we accept the job we are given an 'employee handbook' (see below) which includes information about the state policy on what is appropriate behavior. As state employees, we have to periodically go through ethics training, and this covers what is and is not acceptable behavior in these instances. We are also encouraged to consult our in-house lawyers for guidance or to get advice from the state ethics agency on how the rules might apply to a particular situation.”

Revolving door problems are not new to either state or national government. They have long dogged such agencies as the Department of Defense. That's what Musk complained about via Twitter in a matter involving his space exploration firm, SpaceX. According to Bloomberg News, Musk tweeted last month about how competitors of his space company hired an Air Force official allegedly as part of a move to secure a chunk of a $68 billion Pentagon satellite project. And in New York City, questions also rose last month concerning the employment of a former top city taxi regulator by the noted ride-sharing company Uber, a competitor in the city's big taxi business.

DeWitt, who was paid $199,000 in 2013, worked for the stem cell agency from September 2011 until this month.  She played a key role in the $70 million Alpha Clinic proposal championed by Trounson. She was also deeply involved in the $40 million stem cell genomics award that went to a Stanford consortium last January following a controversial review process. She and Trounson co-authored an article in Nature Biotechnology promoting the genomics plan.

DeWitt, who has a Ph.D. in cell and molecular biology from the University of Wisconsin, was a senior editor at Nature from 2001 to 2010. Seven months after joining CIRM, she co-founded a firm called AccendoEditing. According to her Linked In profile, the firm works with clients to “to present scientific manuscripts and grants in a clear and engaging fashion.” It also “provides insights into the review process.”

DeWitt was one of the organizers of a conference last September at the University of Oxford dealing with cancer and stem cells. Her new bosses, Blau and Nolan, were scheduled speakers along with Stanford's noted stem cell scientist Irv Weissman.

At the Baxter Laboratory, DeWitt is its director of research development. Asked last Friday about leaving CIRM, she replied via email,

“The reason I'm moving on is simply that what I consider a fantastic opportunity presented itself to me.”

She has not responded to a query Monday about her views on the subject of revolving door issues.

  California Stem Cell Agency on Revolving Door Issues

New California Stem Cell CEO Begins Work May 15

C. Randal Mills, a man who has spent his entire professional life in the private sector, will take over on May 15 as the new president of the state of California's $3 billion stem cell agency.

Mills, 42, was named last week to succeed Alan Trounson, a longtime academic researcher who is leaving to return to his family in Australia. Mills, former CEO of Osiris Therapeutics of Maryland, is scheduled to begin half-time work in 10 days at the stem cell headquarters in San Francisco. At that point, Trounson will be designated as a senior scientific advisor to the agency. Mills' work will initially be half-time while he works out his move from Maryland.

The news from the agency, which is formally known as the California Institute for Regenerative Medicine (CIRM), came along with more details about Mills' employment agreement, including provisions that deal with outside activities that he might pursue.

Randy Mills (left) and Jonathan Thomas
CIRM photo

The information was contained in an “offer letter” from CIRM Chairman Jonathan Thomas to Mills, dated and signed by both men on April 28, two days before the agency governing board ratified its terms(see here and here). The letter was provided by the agency at the request of the California Stem Cell Report. The full text can be found at the end of this item.

As reported previously, Mills' annual salary will total $550,000, compared to the $490,008 earned by Trounson. Mills' total compensation at Osiris was $554,750 in 2013, according to company filings with the federal government. He left Osiris in December 2013 for “personal reasons.”

The

offer letter provided for $95,000 in relocation and travel costs for house-hunting and moving. Mills is also entitled to reimbursement for meals and temporary housing for 60 days, contingent on approval by the state Personnel Administration Department. That would amount to $40 a day for meals and $178 a day for lodging. That could run up to $13,080 if the full 60 days are used.

Mills' agreement with CIRM allows him to use his “personal time and resources” to engage in outside activities that are compatible with his CIRM duties. Those outside activities include service on boards of for-profit companies, which can be lucrative, as well as service on non-profit boards. The agreement stipulates that such service be disclosed to the chairman of the board and that he confirm that the service is compatible with Mills' role as president.

Mills, who goes by the nickname Randy, is subject to the agency's conflict of interest policy which requires him to divest himself of any investments in companies that devote more than 5 percent of their research budget to stem cell research. In addition to the policy, Mills is required by state law to disclose his economic interests generally and is subject to the agency's “incompatible activities statement”(see below) and the “employee conflict of interest code.”

Mills will serve at the pleasure of the board. However, if the board fires him “without cause” within 36 months, he will be entitled to six months salary.. The agency's offer letter also said,

“You shall not be entitled to any payment if the (governing) board terminates you for cause, including knowing violation of state conflict of interest law and/or CIRM policy, willful or corrupt misconduct or a criminal conviction.”

The offer letter said the effective date of the appointment is June 2. However, Kevin McCormack, senior director of public communications, said last week that stipulation has been modified to reflect the May 15 start. McCormack said Trounson will serve as a scientific advisor to CIRM to June 30 “to help shepherd through a number of projects and commitments he has made.” Presumably that would include the closed-door review of applications in the $80 million Alpha stem cell clinic plan, which is scheduled to be acted on by the CIRM board later this year.

Here is the text of the April 28 offer letter and the agency's incompatible activities statement. 

Offer letter from California stem cell agency to Randy Mills

Incompatible Activities Statement California Stem Cell Agency