Such a request might seem routine, but for CIRM it is novel and fraught with pitfalls. At stake is the reputation for fairness and credibility of the still young California Institute for Regenerative Medicine.
Created only in 2004 with its first grants approved in 2005, CIRM has struggled with its processes. It has been helped, but also hamstrung by the ballot initiative that created it. The measure, which bypassed the legislature and the governor, also locked in a host of restrictive procedures. One of those involves the grant review process, which is also governed by policies approved by the CIRM board of directors.
The rejected applicant, Cascade LifeSciences of San Diego, was routinely denied funding last month by the CIRM board of directors, based on the decisions of scientific reviewers. The board has almost universally ratified the $500-million-plus decisions of its scientific reviewers, who conduct their sessions in private and whose economic or professional interests are not publicly known.
Rejected applicants do not have the right of appeal except in the case of a conflict of interest. But Cascade says it does not know the identity of reviewers of its grant so it is impossible to know whether a conflict of interest exists. However, the board itself is filled with conflicts of interest -- all legal -- that even Nature magazine has warned about.
Ken Woolcott, chief business officer for Cascade, appeared before the CIRM directors last month to express concern about the grant review process. At the time, he did not seek an appeal or reconsideration of the firm's application. He had been told by CIRM that no appeal was possible. After he left the meeting, another rejected grant, albeit in a slightly higher category, won funding after a CIRM director read a letter from the applicant.
On July 3, Woolcott wrote a letter to CIRM Chairman Robert Klein and CIRM President Alan Trounson that includes a request for reconsideration of his firm's grant. Woolcott's letter does not seek an appeal.
Much of the information in it is contained in an earlier posting on the California Stem Cell Report. But Woolcott has fine-tuned the letter and added important significant details. The entire letter follows as a separate posting. Here is a sample.
"The information on the 0.3% efficiency presented to the Study Section by the Reviewer #2 is factually incorrect. Even if the reviewer was mistakenly relying on our Nov. 2007 Nature publication, that efficiency was reported as 0.66%. More importantly, on pages 5 and 8 of this grant application we provided information that the efficiency of SCNT in primates was 3.3% (1 ESC line per 30 oocytes)."We have asked CIRM if it has any comment on the situation. We will carry its response when it provides one. Here is the link to the public summary of the CIRM scientific review of the Cascade application.