Unfortunately, details of proposals were revealed too late publicly for meaningful comments from the scientists and businesses that would be most likely affected. The CIRM directors' Science Subcommittee will consider the proposals on Monday. The agency's plans were not laid out fully on its web site until Friday, in the case of the grant review changes, and yesterday for the new fund.
The grant review proposal involves major disease team and clinical trial research rounds. The plan would depart radically from the current peer review process and bring CIRM and potential investigators together early to work out issues and smooth the way for better applications and better results from the research.
The CIRM proposal said,
"These are complex grants requiring multidisciplinary expertise for execution, and a multidisciplinary group of external experts to review the applications."Under the plan, the agency would hold a Q & A session with investigators prior to the application deadline. Investigator questions would be addressed and key categories of needed information discussed.
Peer reviewers would provide their assessments of the applications 14 days prior to the meeting of the grant review group along with a list of key questions and issues. Applicants would receive the questions 10 days in advance of the review session and would be asked to provide written responses.
Applicants would have a chance to address "pivotal questions" by telephone on the actual day of the review, but apparently only at the discretion of the review group. Some applications could be deferred until additional information is gathered.
CIRM said it believes the changes – aimed principally at dealing with "pivotal questions" – will improve the research and also facilitate timely review.
Creation of an opportunity fund was recommended by a blue-ribbon external review panel last fall. CIRM said its proposal would "attract industry participation through a funding mechanism that is more aligned with industry’s financing practices."
Under the the first phase of the fund, CIRM President Alan Trounson would have $25 million to help out select grant recipients: disease team and targeted clinical development projects and early translational projects that target a development candidate.
Called a bridge funding program, it would "enable uninterrupted funding of development activities (but not new patient enrollment) to occur until the next relevant RFA/review is offered," CIRM said.
The grants would limited to $5 million and one year. Recipients would be required to submit an application in the next applicable round.
The next phases of the opportunity fund would involve the following:
"...timely short-term one year funding to new projects where an external high impact research opportunity has been identified through an inventory of the research landscape, collaboratively partnered with a California researcher and the team is assembled and research is available for immediate implementation."And
"...preclinical, first-in-man studies and Phase II studies for projects satisfying the accelerated review eligibility requirements and receiving GWG (grant review group) recommendation."The public and interested parties can take part in tomorrow's discussions telephonically at locations in San Francisco, Healdsburg, Irvine(2), La Jolla and Stanford. Specific addresses can be found on the agenda.
Monday's meeting calls for discussion of the grant review changes and the opportunity fund, which presumably means that they will be acted on at a later date by the committee. But if researchers or businesses want to help shape the proposals, they should listen in on Monday, make comments at the time or/and file written suggestions via email to CIRM following the meeting. Both written and oral comments are needed to have a maximum impact.
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