The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,
"One way for CIRM to accelerate research is by creating more of a library system for stem cells – except we don’t want the cells back."The agency expects to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by the CIRM board no later than Feburary of next year.
To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use. The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,
"This permits CIRM to have complete control of this valuable resource and is consistent with the practice of NIH’s Center for Regenerative Medicine which is also creating a repository for iPSC lines and derived materials."
Baum also said,
"The (current) IP regulations were drafted to address conventional drug discovery activities and did not contemplate creation of a comprehensive repository of cell lines intended for broad distribution. As a result, the IP regulations contain a number of provisions which are either not applicable or worse could impede the success of the hiPSC bank. For instance, IP regulations permit the exclusive licensing of CIRM funded inventions and technology. This would be counterproductive to the goals of the hiPSC repository which are predicated on wide spread access."
Baum provided the
following summary of the $30 million banking initiative:
"These lines will serve as valuable tools in drug discovery and will be available to researchers worldwide. The Tissue Collection RFA No. 12-02 will fund clinicians and other scientists to identify, recruit and consent sufficient numbers of affected individuals within a disease population so as to effectively represent the disease’s manifestations. Tissues will be collected and appropriate clinical, medical or diagnostic information, will be obtained to enable informed discovery of disease-related phenotypes and drug development activities using hiPSC-based models. These tissue samples will be provided (without charge) to the recipient of the CIRM hiPSC Derivation Award (RFA No. 12-03) for the production of the hiPSC lines. Once derived, characterized and released, the lines will be deposited in the CIRM hiPSC bank funded under RFA No. 12-04."
Specific addresses
for the public meeting locations can be found on the agenda.