A research team at UCLA – Stanley F.
Nelson and M. Carrie Miceli – also apparently won its appeal on its application but
only on a substantially revised basis, according to a CIRM document.
The agency indicated it would fund the grant but at reduced scope and
cost – $6 million instead of $20 million.
However, StemCells, Inc., which was
publicly supported by the former chairman of the stem cell agency,
Robert Klein, lost its appeal for $20 million. The CIRM document said
research cited by Klein as contradicting what reviewers identified as a key weakness did not contain “compelling data.”
A fifth applicant who appealed, Tim
Hoey of OncoMed Pharmaceutical of Redwod City, Ca., was also rejected during the re-review
process on a $20 million application.
The CIRM governing board, in July, sent
all five applications back for reconsideration as a result of appeals of negative decisions by reviewers. The move followed a record-breaking level of appeals by researchers during an emotional meeting filled with
testimony from patient advocates. The appeals came in a round that was budgeted originally for $243 million
and that represents one of the agency's key efforts to commercialize stem
cell research.
It was also the first time the agency's
governing board has engaged in such an extensive re-review process on
applications.
The revised recommendations for funding
are scheduled to be acted on tonight at a meeting of the CIRM board in Burlingame, Ca. The panel has
almost never rejected positive decisions by its review group and is
likely to accept the latest recommendations. The board is deeply
concerned about maintaining the integrity of the review process and
not rejecting reviewer decisions without ample consideration.
The recommendations for funding on
Capricor's application by Linda Marban, CEO of the firm, and the one from UC Irvine by Henry Klassen both contain conditions, but those
probably will not stand in the way of acceptance by the applicants. (The executive chairman of Capricor is
Frank Litvack, who last year was a candidate for chairman of the
California stem cell agency.)
StemCells, Inc., of Newark, Ca., which
is a publicly traded firm, had two applications in the disease team
round. One dealing with spinal injuries was approved. However, the
agency in its re-review of the second, dealing with Alzheimer's,
said,
“The reviewers did not feel there was compelling data for neuron migration in the submitted manuscript. This is the manuscript specifically referenced at the ICOC (CIRM governing board) meeting (in July) that prompted the call for additional analysis. The manuscript is not yet accepted, it is 'potentially acceptable' but requires 'major revisions' according to the journal editor note. In addition, however, the studies in this manuscript used mouse NSCs, not the human NSCs proposed for the disease team award....”
In his pitch to the CIRM board, Klein
said, “....(W)e have brand-new data that demonstrates and totally
contradicts the key weakness on which it was downgraded.”
In the document prepared for the CIRM
board, Ellen Feigal, senior vice president for research and
development, discussed the re-review process and gave more details on
the decisions. She said,
“In consultation with the Chair of the ICOC and CIRM scientific staff, the President and the Co-Vice Chair determined that the additional analysis should be conducted by the Review Chair of the GWG(grant review group), another scientific member of the review panel, and a patient advocate member of the GWG. The additional scientist reviewer was selected based on the expertise necessary to assess the new information. Each of the 3 individuals (chair, scientist, and patient advocate) voted on whether the information changed the funding recommendation by the GWG. A new score was not assigned."
Feigal continued,
“For each application, the information provided or referenced at the board meeting, and associated specific additional material were requested from the applicant. The new information was evaluated in all cases by the GWG Review Chair as well as one of the originally assigned reviewers and a patient advocate.”
Feigal's report does not identify the
applicants by name – only by application number. Here is the number
and name for those who do not want to wade through the CIRM web site
to determine who is who: 5735 Capricor, 5739 Klassen, 5426 UCLA,
5352 Oncomed, 5416 StemCells, Inc.
The California Stem Cell Report will provide gavel-to-gavel coverage of tonight's and tomorrow's meeting of the CIRM board. The session will be audiocast live on the Internet. Interested parties can participate in the meeting at teleconference locations in Pleasanton, Los Angeles and La Jolla. The agency has added another way of listening to the proceedings -- a dial-in method using an 800 number. Details are on the agenda.
No comments:
Post a Comment