Sunday, December 09, 2012

$40 Million High-Risk Stem Cell Research; IOM and CIRM on Engaging Biotech Biz

Directors of the California stem cell agency this Wednesday will be asked to approve initiation of a $40 million, high-risk research program aimed at filling “key gaps” in knowledge about human stem cell behavior.

The concept plan for the round – called Basic Biology V – will come up for approval at the governing board meeting in Los Angeles.  Pre-applications are expected to be due in March.

The staff proposal calls for as many as 30 awards, but did not specify a limit on the total dollars for each award. The competition is open to both business and academics and non-profit organizations.

The proposal said that the round is targeting “high-risk, exploratory pursuits.” The goal is to fill “key gaps in our understanding of fundamental human stem cell behaviors that hinder the pace of discovery, and ultimately prevent the potential of this research from being fully realized.”

Additionally up for consideration at this week's meeting is a “blueprint” for “engaging industry and supporting commercialization” of CIRM research. A blue-ribbon study by the Institute of Medicine last week also recommended that CIRM engage industry more warmly. However, there were striking differences between what the IOM recommended and what CIRM proposed. The CIRM plan was prepared prior to the release of the IOM report. 

The CIRM proposal laid out the following objectives that were prompted by an “external review” two years ago.
  •  “Attract Follow-On Financing and Co-funding of CIRM Funded Research
  •  “Support of Company Creation/Growth/Relocation
  • “Early Engagement of Top Tier Biopharmaceutical Companies in Order to Access Critical Expertise
  • “Assume a Leadership Role in Business Related Areas the are Critical for Supporting the Field”
The CIRM memo listed a number of initiatives that the agency has already started and said more are expected to come. They include the already enacted, new business-friendly award program, the recent hire of an unidentified business development officer, designation of industry “collaborators,” relocation support for high impact companies and participation with industry in developing “reimbursement pathways” that will benefit the regenerative medicine industry.

“Reimbursement” is the euphemistic term that industry prefers instead of saying “beefing up profits.”

Last week, the report by the Institute of Medicine, which cost CIRM $700,000,  noted that biotech firms have received only about 6 percent of the $1.7 billion handed out by CIRM, a figure not mentioned by the eight-year-old agency's industry engagement plan.

The IOM said that industry representation on the agency's critical, decision-making boards (the governing board and standards and grant reveiew groups) should be enhanced. Additionally, a new scientific advisory board with substantial industry presence should be created to replace existing advisory groups. All of which would be aimed at enhancing and leveraging industry “expertise and resources in product development, manufacturing, and regulatory approval in support of the ultimate goal of bringing therapies to patients,” according to the IOM.  

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