In November 2004, California voters approved Proposition 71, awarding an unprecedented $3 billion for a research program to fund stem cell research over the next ten years. Since then, the Independent Citizens Oversight Committee (ICOC) has been working to ensure that the program builds a solid foundation from the start.
Embryonic stem cell research is considered by many to hold significant potential in finding possible cures for more than 70 diseases including cancer, diabetes, Alzheimer's, multiple sclerosis and even spinal cord injuries. However, the ethical issues of using human embryonic tissue for research have prompted vigorous debate.
"California does not have a uniform policy or a consistent set of practices regarding intellectual property. The passage of Proposition 71 has made designing an effective set of intellectual property policies for the state an even more pressing issue."
-Gene Mullin, State Assembly Member
Stem cell research holds promise in advancing basic knowledge in the biological sciences, particularly with regards to transplantation and cell therapy, modeling human diseases, and pharmaceutical development. Within the next ten years, the most likely output of stem cell research is the production of medications specifically tailored to individuals.
Following the passage of the initiative, the ICOC was formed with nominations from chancellors at five University of California campuses, the Governor and other constitutional officers. One of the 29 ICOC members is a CCST Council member (Tina Nova, President and CEO of Genoptix) and two are CCST Fellows (David Baltimore, President, California Institute of Technology and Edward Penhoet, President, Gordon and Betty Moore Foundation).
The ICOC faces many challenges, including finding a location for the California Institute for Regenerative Medicine, setting up scientific working groups, and forming a search committee to hire a president. In addition, the significant commercial potential of stem cell research raises questions about intellectual property issues.
On December 6-7 2004, CCST worked with the National Research Council to put together a meeting at the Beckman Center in Irvine to discuss best practices in research management and oversight. Nearly a hundred of the country's leading researchers and medical administrators participated; ICOC Chair Robert Klein and several ICOC members were also in attendance. Following the recommendations of this meeting, on December 14 CCST formally offered to assist the ICOC on a number of science and technology policy issues surrounding stem cell research that may impact California's life-sciences research and technical workforce, economy and educational system. In particular, CCST offered to help determine "public interest" value of the research program and to assist in deciding strategies for intellectual property policy.
"California does not have a uniform policy or a consistent set of practices regarding intellectual property," said Assembly Member Gene Mullin. "The passage of Proposition 71 has made designing an effective set of intellectual property policies for the state an even more pressing issue."
CCST had in fact already taken steps to initiate a study on intellectual property policy, requested by Assembly Concurrent Resolution ACR 252 in 2004. With the passage of Proposition 71, the potential impact of this study assumed new dimensions. ACR 252 requests that CCST provide guidance to the state on streamlining intellectual property policy for state-supported contracts, grants, and agreements, and collaboration between commercial concerns and nonprofit organizations, including universities. Klein requested that the panel of experts assembled for the CCST study issue a brief list of "best practice" suggestions for the ICOC by the end of February. Assembly Member Mullin is introducing legislation to expand the scope of the study to include contracts and awards funded by Proposition 71.
"This action is timely as the California Council on Science and Technology is beginning its study of the state's intellectual property policy," Assembly Member Mullin said. "Creating a coherent policy for research contracts with state agencies will ensure the state's return on its investment."