California's $40 Million Alpha Clinic Round: Appeals Filed by Two Rejected Applicants

Two of the three rejected applicants in California’s $40 million-plus Alpha Stem Cell Clinic competition are seeking to overturn the decisions, but none of the cases is expected to be made public.

The appeals are being considered behind closed doors by the staff of the $3 billion state stem cell agency, which will make decisions on whether to proceed further. Directors of the agency are not expected to see the appeals at their public meeting on Thursday in Los Angeles.

Up until last year, appeals were considered in public by the board. The process was altered in the wake of often emotional outpourings involving patient advocates and the public. However, scientists and others can appear before the board on any matter, including applications. Researchers can also choose to disclose publicly their appeals.

The governing board is scheduled to ratify three awards in the Alpha round, which is designed to make the stem cell agency a one-stop, global center for stem cell treatments. The Alpha effort also will help to fund additional clinical trials aimed at afflictions ranging from cancer to heart disease.

The expected winners are the City of Hope, UC San Diego and UCLA, based on an analysis by the California Stem Cell Report. A fourth applicant is on the fence. The agency declines to reveal the names of applicants for fear of embarrassing rejected institutions and researchers. In response to a query, Don Gibbons, a spokesman for the agency, Monday said two applicants had filed appeals.

The agency’s blue-ribbon, out-of-state scientific reviewers make the de facto decisions on funding of applications during closed-door meetings. The agency’s governing  board almost never overturns the reviewers’ positive decision for funding. Occasionally, the board will approve funding for a rejected application.

Summaries of the reviews can be found here.

UC Irvine Mounts a New Stem Cell Research Blog

Randal Berg
UCI photo

California has just scored with another stem cell research blog – this one from UC Irvine and produced by Randal Berg.

Stem cell research blogs are scarce. The only other one we know of in California is written by Paul Knoepfler at UC Davis. Of course, there is the blog of the $3 billion California stem cell agency, which is more of an institutional product. 

Irvine’s Berg wrote his inaugural piece Tuesday, introducing himself and the new blogging effort at Orange County campus, which has received $97.5 million from the stem cell agency.

Berg is chief administrative officer of the UC Irvine Stem Cell Research Center.  As such, it is a fair guess that his blog will not reflect an idiosyncratic point of view. 

Berg’s item dealt with some upcoming events and developments at Irvine. One is an appearance by Randy Mills, the new president of the $3 billion California stem cell agency, on Oct. 8, which is the agency’s Stem Cell Awareness Day.

Berg also said his organization is “eagerly anticipating” the results of the agency’s closed door review of applications in its $65 million Alpha clinic program. Directors of the agency are expected to publicly approve up to five applicants later this year.

(Editor's note: An earlier version of this item did not contain a mention of the stem cell agency's blog.)

$5 Million Sliced from California's Ambitious Alpha Stem Cell Clinic Program

Directors of the California stem cell agency today cut $5 million from their $70 million plan to create a series of Alpha stem cell clinics aimed at making the Golden State the leading location in the world for stem cell therapies.

On a 6-1-1 vote, the directors trimmed the effort, much touted by former agency President Alan Trounson. Eliminated was a data/information center whose tasks would have included marketing and patient education. The center also would have worked on strategies to persuade the federal government and insurance companies to pay for what are expected to be enormously expensive treatments.

The board has 29 members. However, only eight were allowed to vote because of conflicts of interest among the others. 

The cut by the board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, came after its new president, Randy Mills, recommended scaling back the effort. He told the board the plan was not “clearly justified.”

He said in a memo,

“The proposal as written is too broad and overly complex to be successful. In a word, it lacks focus.”

Mills proposed that a refined RFA be reissued with $10 million in funding, which the board approved. It was the first time that the board had retroactively revised a concept plan and directed that an RFA be reissued.  

The Alpha clinic concept first surfaced publicly in 2011. Trounson and two other CIRM executives promoted the plan in a scientific journal financed by the stem cell agency. (See here and here for more.)

Trounson wrote that the scientific community owes it to persons suffering from diseases “to rapidly implement the best and safest practices for cell therapy clinical trials and move toward fast-tracking in therapies where safety and efficacy has been proven.” Nature Medicine said it would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

Eight institutions have applied for the main portion of the award, which is designed to make California a one-stop shopping center for stem cell therapies. The hope is that patients will be attracted from throughout the world. Up to five awards are scheduled to be made for those clinics.

A separate RFA deals with the data center. Five institutions have applied in that RFA, including some also involved in the main portion.  The agency has already received all of the applications in both categories. Based on testimony today, it appears that UC San Diego, the City of Hope and Stanford have all submitted applications in the data center round. 

Although the applicants have not been identified by the agency, virtually all are likely to be represented by persons sitting on the CIRM governing board because of the nature of the concept plan and the RFA.

Review of the applications is scheduled for this September but was originally scheduled for June. In one of his first public actions, Mills delayed the review. The agency said it needed more time to secure knowledgeable reviewers, who must come from out-of-state.

Reduction of the size of the proposal will free cash for other research efforts. Directors are feeling increasingly pressed by financial issues. The agency is scheduled to run out of cash for new awards in less than three years. It is looking into some sort of public/private combination of financing that will allow it to continue in the same fashion beyond 2017.

The CIRM board approved the original Alpha concept in July 2013. At the time, the plan was hailed by the directors, who spent little time discussing the data center that was revised today.

Earlier items on the California Stem Cell Report incorrectly indicated that the effective reduction proposed totaled $15 million instead $5 million.

California's $70 Million Alpha Stem Cell Clinic Project Runs Into Roadblock

The California stem cell agency's $70 million Alpha Clinic plan has hit a stumbling block in the drive to make the Golden State the“go-to” location worldwide for stem cell treatments.

The agency reported today that it has encountered difficulties in lining up the necessary expertise to make the decisions on the complex applications, which are now awaiting judgment. The closed-door review session was originally scheduled for this month.

The delay surfaced when the California Stem Cell Report asked the agency about the reviews of the applications. In a brief response, Kevin McCormack, senior director for communications for the California Institute for Regenerative Medicine (CIRM), said,

“It's being rescheduled because it is just taking a little longer than anticipated to get the caliber of experts needed to review something as complex as this.”

McCormack said the new review session would probably be held in the fall. The agency expects to have 15 experts from outside of the state to examine the applications in addition to eight members of the agency board. 

The Alpha clinic proposal attracted applications from eight, unidentified, major California institutions earlier this year. The intention is to create one-stop locations for stem cell treatments that would lure patients and scientists from around the world.

The plan is a much-touted initiative by former CIRM President Alan Trounson, who resigned to rejoin his family in Australia. Randy Mills, the former CEO of Osiris Therapeutics, replaced Trounson six days ago. Trounson has been pushing Alpha Clinics since 2011. Just last month, he extolled the proposal before hundreds of regenerative medicine specialists at a Berkeley conference sponsored by the Regenerative Medicine Foundation.

Trounson said that the clinics would serve as a “proving ground” to develop business models, to build and share data and to create a strategy that would help convince insurance companies and Medicare to pay for the treatments.

He said that existing clinical research centers are not able to provide all the resources necessary for development and application of stem cell treatments. He said developing clinical expertise in a “random, spontaneous way doesn't work in the best interests of the patient.”

Trounson, who is renown for his IVF work, said the existing structure of the IVF industry in the United States is evidence of the weakness of an unstructured approach.

Agency spokesman McCormack did not answer a question about whether applicants would be given a chance to modify their proposals in the wake of the delay. One of the aspects of the RFA involves applicants providing some sort of matching funds or equivalent support to leverage the funds provided by the state of California. More time could mean that applicants could round up more matching cash.

The delay also could possibly endanger existing commitments of support and affect employment arrangements as well as building schedules.