Wednesday, October 22, 2014

California's Alpha Stem Cell Clinic Plan Hits Budget Buzz Saw

The $3 billion California stem cell agency today put the squeeze on applicants in its ambitious Alpha stem cell clinic round, which is aimed at helping to make the Golden State a global leader in stem cell treatment and research.

The action came as one rejected applicant, UC Davis, publicly appealed to the agency’s governing board to overturn tomorrow a negative decision by the agency’s out-of-state reviewers.  Cedar-Sinai in Los Angeles also filed a letter aimed at beefing up consideration of its application, which wound up on the reviewers’ funding fence.
A proposal by Randy Mills, the agency’s new president, however, contained the most surprising news – a plan to cut millions from the budgets of the expected winning applicants – City of Hope (application AC1-07659), UC San Diego (AC1-07764) and UCLA (AC1-07675).

The cuts were specified in a slide presentation  posted  yesterday or today for the board meeting in Los Angeles tomorrow. The presentation recommended approval of the three applications but with revised budgets to hit a funding cap of $8 million each. The reviewers had recommended approval of the three with budgets ranging from about $11 million to $11.7 million. 

The presentation and another document based on the closed-door review indicated that reviewers were concerned about duplicative clinical trial costs and expenses associated with a proposed $10 million information center, which was trimmed earlier this year from $15 million. The request for applications to create the center is being rewritten to sharpen its focus.­­­

The other document from the review represented the first time that such a commentary has been prepared and released publicly. It was requested by an unidentified agency board member who was present at the review session.  (When queried, the agency later identified the member as Os Steward, director of the Reeve-Irvine Research Center at UC Irvine.)

 The unusual document said, among other things,
“Some reviewers had questions regarding the wording of the RFA and the potential for duplication of costs. Specifically, there was confusion over the portion of the RFA that listed ‘Clinical Trial Costs’ as specifically being outside the scope of the RFA, while simultaneously permitting  a funded Alpha Clinic to ‘defray some costs, such as clinical operations.’”
As originally proposed, the Alpha plan would have hit $70 million with up to five clinics, although there was no requirement to fund that many. It is now down to something around $40 million if four applications are approved tomorrow at $8 million each, and the information center moves forward with $10 million.

The four-page letter from the Cedars-Sinai Medical Center in Los Angeles to the directors of the stem cell agency was signed by Timothy Henry, director of the division of cardiology.  Reviewers gave the $11 million application (AC1-07650) a scientific score of 68 and said,
“Given the large expansion into regenerative medicine that the institution has undertaken, many of the activities described as elements of the (Alpha clinic) have already been initiated or will soon be put in place. Some reviewers questioned whether the additional resources provided by (Alpha) funding would substantially supplement ongoing activities and if the (Alpha clinic) would add significant value." 
Henry’s letter did not appear to break new ground but emphasized the strengths of Cedars-Sinai, declaring that one of the clinical trials proposed is “the furthest advanced of any CIRM-funded trials.”

The score for the UC Davis’ $10.8 million application (AC1-07637) was not released by the agency.  Reviewers said,
 “While some reviewers felt that the large number of trials ongoing or planned would clearly benefit from additional resources, others questioned the added value of establishing a (an Alpha clinic) at this site and did not think the application clearly conveyed how CIRM funds would be used to leverage and enhance the already ongoing activities.”
The three-page Davis appeal letter was signed by Ted Wun,  chief of hematology oncology, Jan Nolta, director of the UC Davis stem cell program, and Frederick Meyers, vice dean of the UC Davis School of Medicine.

The letter said that since the review of its application, it has received a favorable FDA judgment on a proposed clinical trial for HIV that would begin in 2015.  In an attempt to deal with concerns about personnel, Davis said the Alpha clinic would pull over the most experienced researchers with their old positions being “backfilled.”

The letter also noted Davis’ location in Northern California. All of the top-ranked applications are situated in Southern California, presenting a scientific-geopolitical issue for the statewide stem cell agency.

(The stem cell agency does not release the names of winning applicants prior to board action. However, they were derived by the California Stem Cell Report from a variety of sources.  All of the reviews can be found on this document.) 
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  1. Judy Roberson10:26 PM

    I'm stunned to read that UC Davis in Sacramento--our state's capital--was not chosen as an Alpha Clinic site! There are approx. 18 million people living in N. Calif. Traveling to S. Calif. would be impossible for people suffering from debilitating and painful diseases such as Huntington's disease, cancer, PD, AIDS, MS, paralysis, etc. The cost of travel is one drawback then add on time taken off work for the caregiver, the hardship for the patients and the overall expenses that may make participating in trials and treatments out of reach. Sacramento is a user-friendly city; it's easy to access by 5 freeways and an international airport. Another consideration is the proximity to our law-makers in Sacramento. Please reconsider this decision, CIRM ICOC!

  2. Hopefully the CIRM decision was based on the qualifications of the institutions and their ability to design and conduct clinical trials in stem cells and regenerative medicine with qualified scientists and clinicians, rather than on the location of the institution. Although based on past decision making by CIRM, I cannot be sure of that.