A Conversation with…Dr. James Doroshow

The NCI Chemical Biology Consortium was launched on August 10 at an inaugural meeting on the NIH campus. Dr. James H. Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis (DCTD), discusses the background and goals of the CBC.

What is the Chemical Biology Consortium?

The Chemical Biology Consortium (CBC) consists of 12 centers chosen for their world-class screening and chemistry qualifications to mobilize the NCI cancer drug discovery process with greater breadth and depth. With a research and development pipeline linked to the academic community, the CBC will position the institute as a world leader in innovative cancer therapeutics discovery.

For the first time, the government is building a unified drug discovery and development process. NCI will establish milestones that support either the transition of a molecule to its next step in the drug development process or the decision to eliminate the molecule from the institute’s pipeline. This will ensure that projects are on time and on budget.

The CBC drug discovery and development process is divided into five stages, from screening through clinical evaluation of candidate drugs. The consortium will provide cutting-edge chemical tools for examining complex biochemical signaling pathways related to cancer and may be instrumental in generating new targeted therapies. The research will focus on therapeutic needs in oncology that are not currently addressed by the private sector, including an emphasis on pediatric and rare cancers.

The CBC is a component of NCI’s Experimental Therapeutics (NExT) program, a partnership between DCTD and NCI’s Center for Cancer Research.

Who will benefit from the services being offered by the CBC?

Investigators from academia and the CBC awardees themselves will be the first beneficiaries of CBC services. They, and a broad range of subsequent participants, will present proposals for compounds that are at any stage of drug development. After review and acceptance by a panel of extramural scientific experts, a project will be assigned to one of the CBC centers, which will conduct the needed laboratory work to move the compound through various stages of the drug development pipeline. A unique aspect of the CBC program is that scientists whose proposals are accepted will maintain any intellectual property rights associated with the compound. This also benefits small drug companies and biotechnology firms, which are eligible to submit proposals to the CBC program.

How does the CBC fit into NExT?

The CBC is part of the new, rapidly evolving NExT program, which is opening the oncology drug discovery and development pipeline to researchers in academia, government, and industry. The CBC will be one entry point into the pipeline, and it will interface with other NCI programs that expedite new drugs from the laboratory to the bedside. Another critical component of NExT is phase 0 clinical trials, first-in-human studies that aim to cut a year or more off the drug development process.

How does the CBC work?

The NExT program, including the CBC, is not a grant or contracts mechanism. Projects can enter the CBC based on favorable review of the application’s scientific merit. To be approved, applications must include a concept associated with a compelling hypothesis that warrants clinical evaluation; a concept that will enable clinical evaluation of a new, inadequately explored therapeutic approach; or a concept that is not likely to be explored without NExT assistance. How the project fits strategically within the NExT portfolio is also evaluated.

What does NCI hope to accomplish with the CBC?

The CBC will cause a paradigm shift in the use of public-private partnerships to translate knowledge from federal and nongovernmental institutions into ground-breaking new drug candidates. When fully operational, the consortium is expected to generate two to three new investigational drug applications per year.

When are the first and subsequent proposals due?

The first proposals to enter into the NExT program are due September 15, 2009. Subsequent proposals will have quarterly deadlines: November 15, February 15, May 15, and August 15. Proposals can be submitted through the DCTD Web site.