Wednesday, January 28, 2015

California Stem Cell Appeal: $1.8 Million Needed for Removing Bone Replacement Bottleneck

A UC Davis researcher is making a strong pitch to the California stem cell agency to finance a $1.8 million effort to “resolve bottlenecks in engineering replacement bone and cartilage.”

J. Kent Leach, UC Davis photo

J. Kent Leach, an associate professor in the departments of biomedical engineering and orthopedic surgery, said his proposal addresses “a major hurdle in regenerative medicine of the musculoskeletal system (that) impairs the inherent personalized medicine component of stem cell-based methods.”

In a letter to the agency’s board for its meeting tomorrow, Leach said the research team involved is “arguably the most qualified team in the nation to conduct these studies.” 

Other scientists participating are Laura Marcu and Kyriacos Athanasiou.

Kyriacos Athanasiou
UC Davis photo
Reviewers for the $3 billion agency, who make the de facto decisions on awards, scored the application at 72 and did not approve it for funding. The agency’s staff also nixed the proposal, declaring,
“There is another application recommended for funding in Tier 1 that proposes to optimize and apply the same imaging technology platform to a different test system. In addition, the scientific leadership of the two applications is the same.”
Leach said,
“The co-PI (Dr. Marcu) of this proposal is also PI (principal investigator) on RT3-07879, which is focused on assessing stem cell repopulation and remodeling of engineered vascular tissue constructs. 
Laura Marcu, UC Davis photo
"However, the use of this technology for monitoring the maturation of engineered bone and cartilage, tissues composed of dense matrix reflective of the differentiation of contributing stem cell populations, is substantially different from cardiovascular applications. Of course, both applications involve instrumentation based on optical spectroscopy and ultrasound principles, but the implementation and subsequent commercial hurdles for this technology is very different.”
 (For the summary of reviewer and staff comments, see application RT3-07981 in this document.)

Leach noted that another competing application in the round received an identical 72 score and was approved by the agency’s staff.

The grant round was budgeted for as much as $35 million. Reviewers and CIRM staff recommended approval of awards totaling $29.2 million.

Scientists making appeals directly to the board have not been successful in the last 12 months or so. The board has been more reticent about overturning reviewer and staff recommendations since it changed review and appeal procedures in 2013.
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Follow Complete Coverage of Tomorrow's California Stem Cell Meeting

Keep track of all the “thrills and chills” at tomorrow’s meeting of the governing board of the $3 billion California stem cell agency with gavel-to-gavel coverage from the California Stem Cell Report.

This blog will monitor the session via the Internet from our perch in Banderas Bay in Mexico and file stories as warranted. On tap is as much as $35 million in awards. Reviewers and agency staff have approved only $29 million. But three UC Davis researchers are seeking another $1.8 million.  

Also up for action are major changes in the administration of grants – all part of the CIRM 2.0 effort designed to fast-track cash and beef up the quality of applications.

The session, scheduled for eight hours, can also be heard via a listen-only audiocast and Webcast for the slides being used.  Teleconference locations where the public can attend and comment are also available in Sacramento, Irvine and two in La Jolla.  Specific locations and directions for the Internet access are available on the agenda.  

The meeting begins at 9 a.m. PST in Burlingame.
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Tuesday, January 27, 2015

Bump on CIRM 2.0 Speedway: California's Missing Stem Cell Loan Rules

When the applications come in this Friday for the California stem cell agency’s new, $50 million stem cell research round, business applicants will not be seeing a substantial portion of key financial rules for the awards.  

Missing will be the terms of loans that the agency expects to offer to for-profit enterprises. Loans -- rather than grants -- have been the favored method of businesses for receiving awards. The reason is that the agency’s loans have been forgivable if the research does not generate an appropriate amount of cash for the company. Grants, on the other hand, carry requirements for royalty payments. (None have been generated.)

Under the terms of the fast-track, CIRM 2.0 applications, businesses will have the choice of grants or loans. New grant terms are expected to be approved at Thursday’s meeting of the governing board of the $3 billion agency, one day before the deadline for applications for the first round of CIRM 2.0.

Action on new loan rules was originally scheduled for this week but postponed a few days ago after the agenda was posted Jan. 17. The specific reasons are not entirely clear.  The California Stem Cell Report yesterday asked about the delay and for a copy of the latest loan proposal. Kevin McCormack, senior director for communications, replied, 
“We are in the process of revising the (loan policy) and nAeeded additional time to ensure alignment with CIRM 2.0 and the other policy changes so we postponed the meeting.  It will be rescheduled before the March board meeting.
 “And as we are still working on the loan policy it would be premature to share that with you right now, it's still a work in progress.”  
Given that businesses have amounted to a tiny percentage of awards in the past, the delay in the loan rules question may not be significant. But this round is aimed at clinical stage projects, which are more likely to involve businesses and could generate more applications from the private sector.

Some time is available to adopt new rules before CIRM board action on the awards, possibly during an April 23 telephonic meeting. But one of the main points of CIRM 2.0 is to put cash in the hands of recipients significantly faster than in the past. This is especially important for stem cell companies, which are always pretty much cash starved.

Delays in any portion of the aggressive timetable for CIRM 2.0 could mean delays in handing out money.

It is not surprising that some difficulties have arisen in the new award procedures. Randy Mills, CEO of the stem cell agency, last week told an Internet audience of about 200 there would be “some bumps.” He said,
“This is going to be one wild ride.”  
To help smooth it out for both the agency and applicants, it would behoove the agency to post the proposed loan terms in a timely fashion. That means that they should be available to the public when a meeting agenda involving the rules – be it for a subcommittee or full board meeting -- is posted on the CIRM Web site. That is normally 10 calendar days ahead of the session.  The agency, which is costing taxpayers $6 billion including interest, doesn’t need any more mysteries.
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Monday, January 26, 2015

$131 Million and 887 Papers: Demise of California's First Stem Cell Grant Program

The $3 billion California stem cell agency on Thursday is expected to put to rest its oldest grant program – an effort that was begun with bravado in 2005 but minus the cash to back it.

It was a matter -- at the time -- of showing the Golden State’s stem cell flag despite legal challenges that had stalled the progress of the agency.  The grants were the agency’s first and came on a late summer day in Sacramento during a governing board meeting marked by confusion and frustration.

David Baltimore
PasadenaNow photo
Board members complained they did not have enough information to make good judgments on the awards. 

Nobel Prize winner David Baltimore, a board member and president of Caltech, objected to what he considered loose standards in evaluating the applications for millions of dollars.

At one point, a crusty reporter from The Associated Press, Paul Elias, jumped up and demanded to know exactly what was going on.

The headline on the story the next day in the California Stem Cell Report said, 
“CIRM Hands Out $39 Million (sort of)….”
The awards created a training program for stem cell scientists. It was aimed at attracting more researchers into a field that was atrophying because of the Bush administration’s restrictions on stem cell research funding. 

Without adequate financial resources, the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, appealed to the recipient institutions to advance the funds with the expectation they would be reimbursed later.

Zach Hall, who was appointed president of the agency the same day, called the awards “historic.” Robert Klein, the chairman of the CIRM board, said he was thrilled by the program.

One of the major goals of the board action was to show that the agency and that its tiny staff (something less than 20) was still kicking despite the legal dispute that blocked issuance of the bonds that provide funding for the agency. 

In that regard, CIRM was more than successful.  The meeting was well-covered by major newspapers in the state, a far cry from the situation today. The message in the stories was largely favorable. The California Stem Cell Report wrote on Sept.11, 2005,
“Subordinated was the reality that the agency does not yet have the money. Even more deeply subordinated were complaints about the grant process from critics.”
The initial awards ultimately grew into a nine-year, $131 million effort. In a Jan. 20 memo to the CIRM board, the agency’s current president, Randy Mills, said,
“The programs have trained 859 CIRM Scholars. These trainees have worked in 436 different laboratories on a broad range of research projects, with the majority focused on basic research. CIRM Scholars have been authors on 887 scientific publications.”
The average cost for each “scholar” was about $152,000, Mills reported. The California Stem Cell Report calculated an average expense of about $148,000 for each scientific article, although such articles usually have more than one author. Mills said 34 percent of the recipients were graduate students, 48 percent post-doctoral and 18 percent clinical fellows.

Not noted by Mills was the fact that nearly all the awards went to institutions linked to members of the agency’s governing board. Virtually no other institutions existed, however, in California that could provide the training.

In December 2013, the board asked the agency staff to prepare a new version of the training program, a task that was not completed before the board hired Mills last spring.

In his memo last week, Mills said that “the CIRM team determined that a new training grant program is no longer an optimal method of supporting the education and training of stem cell scientists.” He continued,
“CIRM believes that supporting the training of new stem cell scientists is best accomplished by bolstering funding for our research grants programs, particularly the earlier discovery and translational phases where each program can be individually evaluated for its merit and contribution to CIRM’s mission.”
Mills said he will present concept plans for new discovery and translation rounds, including training within them, during the next six months. And he asked the board to approve his recommendation to drop the plans continue the old, once-hailed training program.
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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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