• California Institute for Regenerative Medicine
  210 King Street, 3rd Floor
  San Francisco, CA 94107

• CONNECT
  8950 Villa La Jolla Drive,
  Suite A12
  La Jolla, California 92037

The California Institute for Regenerative Medicine (CIRM) will hold an interested persons’ meeting to solicit public input relating to the above-named policy.

Background:

The mission of the CIRM is to foster and promote stem cell research with the aim of improving human health. A secondary goal is to advance the biotech industry in California to benefit the state’s economy by creating projects, jobs, and therapies that will generate new tax revenue. The CIRM believes that commercial research organizations can make critical contributions towards accomplishing the Institute’s mission and realizing the vision of Proposition 71. Increased interest by the commercial sector in stem cell-related research projects would encourage the successful translation of basic research discoveries into commercial products for public use.

To enable the participation of the commercial sector in CIRM-sponsored research initiatives, the CIRM is developing a Grants Administration Policy for For-Profit Organizations. This policy will serve as the general terms and conditions governing the selection, funding, monitoring and termination of CIRM grant awards to for-profit entities. The regulations that ensue from this policy statement will carry the force and effect of law, and by accepting a CIRM grant award, grantee organizations agree to comply with the provisions to be set forth in this policy statement for the entire project period of the grant, and beyond this project period for certain documents and reports. The proposed Grants Administration Policy will be similar in form and scope to the CIRM Grants Administration Policy for Academic and Non-Profit Institutions, which may be downloaded from http://www.cirm.ca.gov/reg/default.asp. The CIRM expects that the policy statement for for-profit organizations will differ from the policy for non-profits in various aspects of administration and that certain amendments will be required. The CIRM seeks input from for-profit entities and the public regarding those operational considerations that uniquely impact the commercial sector.

Among the points to be discussed:

• What unique situations might arise in for-profit organizations as opposed to academic or non-profit settings that would impact a current or previously-funded CIRM project (e.g., partnering, bankruptcy)? How should these changes be effectively managed?
• Given that the CIRM will require annual financial and programmatic reports, as well as reports of licensing activities, patent applications, and commercialization activities, what information can reasonably be provided to the CIRM by grantees or their successors? How can the CIRM best monitor the performance and commercial development activities of grantees and licensees of CIRM-funded patented inventions?
• In the context of the CIRM’s preference for California suppliers of goods and services, what proposals or concerns should be considered by the CIRM in managing potential pass-through costs to non-Californian entities?
• Given that there are various methods of accounting for grant-related activities in for-profit organizations, how well do the Proposition 71 definitions of “direct research funding costs” and “indirect costs” reflect these activities?
• Other points for consideration

The CIRM encourages attendees to provide input on these issues and to raise additional issues for consideration. Written comments may be addressed to the CIRM at 210 King Street, San Francisco, California, 94107, to the attention of Kumar Hari, Ph.D. or Patricia Olson, Ph.D. If you have any questions about this meeting, please contact Kumar Hari at (415) 396-9123.