Monday, December 10, 2012

California Stem Cell Agency: Two Researchers Seek to Overturn Grant Review Rejection

Two University of California scientists whose applications for millions of dollars were turned down by reviewers at the California stem cell agency are asking its governing board this Wednesday to overturn the rejections.

They are Jonathan Lin of UC San Diego and Sophie Deng of UCLA, who are seeking $3.1 million and $3 million respectively.

They have filed appeals using a process known as extraordinary petitions, which a blue-ribbon report by the Institute of Medicine last week said should be abandoned. The study on the performance of the $3 billion agency said the petitions “undermine the credibility and independent work” of grant reviewers.  However, under state law stem cell researchers and the public have the right to address the CIRM board on any issue whatsoever.

In recommending abolition of the petitions, the IOM cited the flap in Texas concerning its $3 billion cancer research program. Reviewers there resigned en masse to protest what they considered abuse of the grant review process.

Lin and Deng's petitions were written prior to the release of the IOM report.  But they come as the agency is already examining ways to tighten up its free-wheeling appeal process, which this year has seen a record number of appeals, backed by emotional presentations from patients and lobbying by the former chairman of the agency, Bob Klein.

In the grant round to be considered Wednesday, reviewers have approved 12 applications out of 27 generated by the “New Faculty Physician Scientist Translational Research” RFA. The approved grants have scientific scores ranging from 87 to 65. Positive decisions by reviewers are almost never overturned by the CIRM board. The approved applications total $36.2 million, according to California Stem Cell Report calculations. The agency budgeted $80 million for the round. One application, the proposal that scored 65, was approved for what CIRM calls “programmatic” reasons, which have been defined as “issues beyond scientific merit, such as disease representation and societal impact.”

In her petition, Deng challenged the reviewers' remarks that her proposal was not worthy of funding because it is “not exceptionally novel.”

Sophie Deng
UCLA photo
She wrote,
“This comment reflects a misunderstanding of translational research. There is a huge gap between a novel discovery and delivering a new therapy to the clinic; translational research is about bridging this gap, not the novelty of the discovery. If the discovery is not translatable, it is meaningless for patient care....Our approach might not be the most novel, but it has the highest potential to bring a new therapy to the clinic.”
Deng also said that “multiple criticisms” in her review “reflected flawed understanding” of its clinical aspects.

Lin's petiton was briefer. He said an attempt to approve the application for programmatic reasons during the review failed because “CIRM was already funding AMD (age-related macular degeneration), and that significant progress was being made elsewhere in the world.”

Lin said,
Jonathan Lin
UCSD photo
“I contest these claims because CIRM has not funded AMD-related research in prior New Faculty Physician Scientist Translational Research RFAs. Furthermore, stem cell research to treat AMD remains in basic science, preclinical research, and clinical safety phases in California. Significant research and clinical studies are still ahead before stem cells can be approved for therapeutic use in patients with AMD.”
CIRM did not disclose the scores of either Lin or Deng. Only the scores of approved applications were listed for this meeting. In some cases in the past, scores of some rejected grants have been listed on the CIRM web site. The agency did not disclose the names of the other applicants or their institutions. 

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