Saturday, January 24, 2015

A California Stem Cell Mystery is Solved

The California stem cell agency today cleared up one of the mysteries involving next Thursday’s meeting of its governing board and likely action on a training program.

The agency last Saturday posted the agenda for the meeting that included a cryptic description that appeared to involve the abolition of one of its several training program. The agency did not respond to a query last Monday about exactly what was meant by the agenda item, making it nearly impossible for affected parties to respond in an appropriate and timely fashion.

Following the posting yesterday on this blog of an item describing the situation -- "The California Stem Cell Agency and Its Unnecessary Mysteries" -- the agency added a memo early today from CIRM President Randy Mills to the Thursday agenda. The memo explained that what was involved was the CIRM Scholars Program.  

Look for an item on this Web site early Monday on the expected end to the program.
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Friday, January 23, 2015

The California Stem Cell Agency and Its Unnecessary Mysteries

For the second month in a row, the California stem cell agency, which sits on top of $3 billion in taxpayer cash, is playing a mystery game with the public.

Coming up next Thursday is a meeting of the 29-member board of the agency. These sessions are the most important public events involving the agency, which operates outside of normal state oversight. They deserve full transparency.

Without it, affected parties -- not to mention the people who pay the $6 billion total bill (including interest) for the stem cell research – do not have a genuine opportunity to comment and make suggestions about matters that involve their livelihoods and organizations.   

The latest problem primarily involves a cryptic agenda item for next week's board meeting that says only “consideration of the CIRM team’s determination not to present concept proposal for training program at this time.”

The agenda containing the item was posted last Saturday on the agency's Web site. The agency has not posted anything further on the matter and has not responded to a query five days ago seeking more information.

Training issues have been a subject of considerable concern and interest in the stem cell community, both at the state college level, which has received little of the agency’s cash, and universities and research institutions.

Backed by 11 top researchers, Jeanne Loring, head of the stem cell program at Scripps, has said the “Bridges” shared laboratory and training program has “provided the infrastructure upon which California’s reputation as the center of the stem cell universe was built.” (See also here.) 

Susan Baxter, executive director of the California State University’s system-wide program for biotechnology, said,
“Despite the Great Recession, Bridges graduates have succeeded in landing jobs and gaining admittance to graduate and medical schools at much higher rates than peer groups.” 
Does the training agenda item refer to the concerns of Baxter, Loring and the others? It could be a reference to the agency's high school training effort or something else entirely. It is totally unclear and unnecessarily so.

If the agency is fulfill its promise of maximum transparency, it should post ample background material on matters to be discussed when it posts the agenda 10 calendar days ahead of upcoming meetings. In the absence of that, however, it would have taken only five minutes or less to write a line specifying which training programs are up for consideration.
  
In addition to the mystery about the training programs, not to be found is information about proposed changes in the agency’s loan program. Those are scheduled to be approved next Thursday, only three business days from today. The changes likely will have a significant impact on businesses.  A board subcommittee was scheduled to consider them on Monday, but that meeting has been cancelled for unknown reasons. The agency has not responded to a query on when the session will be rescheduled, but presumably it will happen before the board meeting on Thursday.

Last month, the agency also created a similar mystery. It involved what turned out to be a $50 million program that deserved more timely attention from affected parties and the public.

In years past, the agency was infamous for failing to post material for its meetings in a timely fashion. Even board members sometimes complained about not having information. Sometimes meetings were postponed.


Since Jonathan Thomas became chairman in 2011, the situation has improved.  Randy Mills, the new president of the agency, is stressing "clarity" in what the agency does. However, the mysteries of the past two months do not auger well. The agency can and should do better. 
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Webinar Now Available on Fast-Track Plan to Hand Out $1 Billion in California Stem Cell Cash

The ins-and-outs of CIRM 2.0 – at least some of them – are explained by the CEO of the California stem cell agency, Randy Mills, in a Webinar now available on the agency’s Web site.

The Webinar includes presentation slides and a Q&A. About 200 persons logged in for the session earlier this week on the new, fast-track effort to unload the agency’s next $1 billion. Kevin McCormack, senior director for communications, said after the Webinar,
"Of the 234 people who registered and, at some point tuned in today (Jan. 21), 108 were industry. Over the course of the 50 minute webinar some tuned in and dropped out so there was a rolling audience with 200 being the most tuned in at any one time."
If you are one of those who would like some cash from CIRM, this is must viewing. The 51-minute session can also be downloaded for later consumption.
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Wednesday, January 21, 2015

Faster Cash but Tougher Competition for California Stem Cell Researchers

A slide from today's Webinar on CIRM 2.0
Randy Mills, who has led California’s $3 billion stem cell agency just since last May, today told a cyberspace audience that his agency will finance only the “absolute best” proposals under his new “2.0” version of the research effort.

Mills addressed about 200 persons who logged into a Webinar to learn more about the radical changes that began this month at the California Institute of Regenerative Medicine (CIRM), as the agency is formally known. Mills has dubbed the new direction CIRM 2.0.  And he said,
CIRM 2.0 is going to be highly, highly competitive.”
It was a theme that the CIRM CEO came back to several times. He advised listeners that the competition will be tougher than in the past and that the agency will be more discerning.

CIRM 2.0 is aimed at both improving the quality of applications and at speeding money into the hands of researchers, cutting the time from application to funding from an average of 22 months to four months.   Mills intends to extend the new process to basic research and translational research later this year. 

Mills, the former CEO of Osiris Therapeutics in Maryland, said,
“We’re in the time business at CIRM.”
Mills said he expects the quality of applications to improve as the agency becomes more engaged in working with researchers to build proposals that will meet the agency’s needs.  CIRM will additionally become a partner with successful applicants and provide outside, expert help to overcome such things as logjams involving possibly the FDA or manufacturing problems, Mills said.

One of the major changes in CIRM 2.0 involves timing of grant rounds. Instead of rounds a year or more apart, Mills said,
“The application window is always open.”
The agency kicked off the new program this month with clinical stage programs. The deadline for filing applications is a week from this Friday(Jan. 30). No applications have been filed as of today.  No worries, Mills basically said. Applications will be accepted again next month with a deadline of Feb. 28 and every month thereafter with the deadline falling on the last business day of each month.

The agency has strict legal requirements to limit its spending to California operations. But in a Q&A session during the Webinar, Mills made it clear that a foreign-based company was eligible to seek funding for research activities that were being conducted with the Golden State.

In a brief telephone interview later, Mills said today's session was part of a "massive" effort on the part of the agency to spread the word about research funding opportunities involving CIRM.  He said he has been surprised about the lack of awareness -- outside of a relatively small circle in California -- of the availability of CIRM cash for biotech enterprises that traditionally have been struggling for funding.  

During the Webinar, Mills also acknowledged that CIRM 2.0 is new and is likely to encounter “some bumps” that he said the agency will work to solve. Nonetheless he told the researchers,
“This is going to be one wild ride.”
Mills’ Webinar on CIRM 2.0 is expected to be posted on the CIRM Web site either later today or tomorrow. Sphere: Related Content

Tuesday, January 20, 2015

A Show-and-Tell Tomorrow on Handing Out California's Next $1 Billion for Stem Cell Research

Want to know more – from the horse’s mouth, so to speak -- about how California’s stem cell agency plans to give away its next $1 billion?

The public and researchers have a chance to hear directly tomorrow, via the Internet, from the agency concerning its plans for CIRM 2.0, the name of its new fast-track plan for handing out cash.

Registration is required, however, for the Webinar, which is scheduled for 12 p.m. PST.  CIRM says,
“Questions may be submitted in advance of the Webinar via email to cschaffer@cirm.ca.gov or via Webex registration.  During the webinar questions may be submitted via the Webex Q&A functionality.”
CIRM 2.0 was initiated by CIRM President Randy Mills as part of his efforts after he was appointed last spring. Mills will be personally presenting the proposal for the Webinar.

The agency says the plan is intended to put money in the hands of researchers with greater alacrity and improve the quality of grant applications. The agency describes the changes in the award process as radical.  Read more about it here, here and here
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Sunday, January 18, 2015

California to Pump $35 Million into Removing Stem Cell Therapy Roadblocks

California is set to give away as much as $35 million later this month to create tools and technology to help researchers develop the stem cell therapies that were promised to voters 11 years ago.

The idea behind the awards is to eliminate bottlenecks that block commercialization of research. California’s $3 billion stem cell program was created by voters late in 2004 with the expectation that it would quickly lead to stem cell cures.  It has spent about $1.9 billion so far but no therapies have reached the marketplace.

The latest, $35 million round is budgeted for as many as 20 awards of up to $1.2 million each to be distributed over a period as long as three years.  The $1.2 million is for "direct" research costs. CIRM would also pay for "indirect" costs that raise the total substantially.

Applications were sought last year from both academics and businesses with possible collaboration involving out-of-state partners, including China, Australia, Germany and Brazil.  Non-California enterprises would not receive funding from the state agency.

Action on the applications is part of the agenda for the Jan. 29 meeting of the 29-member governing board of the California Institute for Regenerative Medicine (CIRM), the formal name of the stem cell agency.  

The round is not part of the new fast-track program, CIRM 2.0, initiated by CIRM President Randy Mills. The “tools” effort contains different timetables, among other things. The work must begin within six months of approval of the awards, considerably longer than the 45 days specified under CIRM 2.0, which began just this month.  The old process also contained a pre-application review that has been eliminated.

The board is additionally expected to approve new rules for CIRM 2.0 awards, including loans to businesses.  Given that the deadline for applying for the first round of CIRM 2.0 is Jan. 31, potential applicants would be well-served to scrutinize the proposed new regulations. Interested parties can make comments or suggestions in advance of the board meeting and the related sessions of the board’s Science Subcommittee on Tuesday and the Intellectual Property (IP) Subcommittee on Jan. 26.  

The grant rules can be found on the Science panel agenda. The new loan rules have not yet been posted on the IP agenda. Comments can be sent by email to mbonneville@cirm.ca.gov or made at one of the public meeting sites. 

Public teleconference sites for the Science Subcommittee session Tuesday include San Francisco, Oakland, Irvine, Duarte, La Jolla and Sacramento. Addresses are on the agenda.  The only public site listed currently for the IP subcommittee is San Francisco.

The Jan. 29 full board meeting will be held in Burlingame but remote teleconference locations are also available where the public can participate. They currently include locations in Irvine and La Jolla, but that could change prior to the meeting.  Addresses are available on the agenda. 
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Wednesday, January 14, 2015

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.


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.
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Monday, January 12, 2015

Fast Cash in California for Stem Cell Research; $50 Million Up for Grabs

The stem cell agency's new logo to promote CIRM 2.0
California’s $3 billion stem cell agency this month is kicking off the first round of radical changes in how it finances research, including funding of the clinical trials that it hopes will push nascent therapies into widespread use.

The money is scheduled to start flowing to scientists in the Golden State as soon as June in a new, fast-track program that is called CIRM 2.0. But only if the researchers file their applications within the next 19 days. Slow-moving researchers, however, will have a chance to file again at the end of next month and each following month.

The effort has all the earmarks of a venture capital program with heavy involvement by the financing party (CIRM), involving both the budget and the science.  The agency, known as CIRM after its formal name of the California Institute for Regenerative Medicine, last Friday repeated its pledge to be an “active investor,” which may or may not be welcomed by some researchers.

Nonetheless, Los Angeles Times columnist Michael Hiltzik recently wrote that scientists would find a “lot to like” in the new direction at the agency. Here is how CIRM put it in a news release Dec. 31 that contained links to the detailed program announcements, 
“CIRM 2.0 is a radical overhaul of the way the agency does business, implementing efficient new systems and programs that place added emphasis on speed, partnerships, and patients.
“CIRM 2.0 makes it easier for both companies and academic researchers with promising projects to partner with CIRM to get the support they need when they need it, reducing the time from application to funding from around two years to just 120 days.”
The release laid out some of the aspects of the new grant review and funding process, which the agency expects to extend to all its remaining $1 billion in award programs, 
“Speed:  In addition in to reducing the time to funding to 120 days, new clinical stage projects may be submitted to CIRM year round instead of only once or twice a year as in the past. Applications simply have to be filed by 5pm PT on the last business day of the month to be eligible for consideration in that round of review. If you miss the deadline one month, you only have to wait 30 days for the next one.
“Partnerships:  Under CIRM 2.0, the agency will not act as a passive funding source, but instead will be an active investor, devoting significant internal resources and leveraging its vast external team of world-class subject matter experts to advance the projects it selects. This will result in a true partnership that both accelerates programs and gives them the greatest opportunity for success.
“Patients: Each project will be partnered with a project-specific Clinical Advisory Panel  (CAP) to help advise and guide it forward.  Importantly, every panel will include at least one patient advisor with first-hand experience of the specific condition, who will provide input, recommendations and the appropriate sense of urgency that can only come from the unique perspective of someone living with the disease.” 
The agency has allotted $50 million to be handed out between now and July for programs involving clinical trials or preparation for clinical trials.  Applicants can ask for as much cash as they desire. But their proposed budgets will be scrutinized by an outside panel and subject to possibly substantial revision. If CIRM does not fancy the researcher’s figures, the application will not be presented to reviewers.  

The budget review is a significant change from past procedures.  It is just one of many changes, small and large, that scientists need to understand about the new process. Others involve restrictions on appeals, solvency requirements for businesses and, in some cases, hefty co-funding requirements that must be documented in advance. In-kind support, for example, will no longer be acceptable as  matching cash or for co-funding.

If scientists want to be competitive, they would be wise to carefully review the program announcements posted at the first of the month. In some cases in years past, applicants have lost out simply because they failed to understand in a timely fashion all the nuances of the process.

Other changes include the following:
  • Businesses are limited to 10 percent indirect costs compared to 20 percent nonprofits, a requirement backed by CIRM board members representing nonprofits.  The agency said no legal conflict of interest existed for board members from nonprofits who voted for the bigger indirect allotment for their enterprises.
  • Budgets must contain contingency plans for financing should expenses exceed initial estimates.
  • Applicants must be ready to work within 45 days of CIRM board approval of their applications.
  • The agency – not grant reviewers -- will determine whether applications meet eligibility requirements. If they do not, they will not be reviewed. An appeal by an applicant may be made behind closed doors to the grant review group.
  • No public appeals are formally allowed. However, state law permits all members of the public, including researchers, to speak directly to the board on any issue. That avenue for seeking funding, however, has not been very successful in recent months. 
The grant review group is likely to continue to make -- behind closed doors -- virtually all the de facto decisions on application approvals. Their actions will come in three "recommendations" to the board: fund the application, do not fund but allow re-submission or do not fund and do not allow resubmission.  The CIRM board will then ratify in public the group’s decision, as it has almost invariably in the past. The board has the legal authority to do anything it wants with applications, but it has rarely overturned positive decisions by the board. Infrequently, it would approve some lower ranked applications. The new procedures would seem to make any public appeals to the board by researchers even less likely to be successful.

Randy Mills, CIRM photo
CIRM 2.0 is the brainchild of Randy Mills, who took over the presidency of the agency last May. He has launched a major effort to spread the word about the move. It includes a Jan. 21 “webinar” conducted by Mills to discuss CIRM 2.0. Advance registration is required.

On Jan. 20, the CIRM directors Science Subcommittee is scheduled to vote on new grant administration rules involving CIRM 2.0. That is another matter that researchers who wish to be successful in securing funds should be following and making recommendations on.  Sites where they can participate are in San Francisco, Oakland, Irvine, Duarte, La Jolla and Sacramento. See the agenda for specific addresses.

Gil Sambrano continues to head the review process, albeit with a new title: director of portfolio development and review. His phone number and email can be found on the program announcements posted at the first of the month (see here, here and here). 

For additional news stories on CIRM 2.0, see here and here.
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