DCTD and the Center for Cancer Research (CCR) are working in close collaboration to reinvigorate cancer drug development at NCI. Through a new, joint early therapeutics development program, extramural and intramural teams have prioritized a pipeline of NCI-driven targeted therapeutics for development. This program, called the NCI Experimental Therapeutics Program (NExT), combines the strengths of DCTD’s extensive expertise in anticancer drug development with CCR’s dynamic in-house research and its location within new state-of-the-art facilities at the NIH Clinical Research Center. This collaboration will also utilize a recent guidance from the U.S. Food and Drug Administration concerning exploratory studies of investigational new drugs.
Clinical trials performed using an exploratory investigational new drug (IND) will facilitate targeted therapies entering early phase evaluation where the target can be carefully monitored. The goal of this new guidance is to safely shorten the timeline for drug development. As part of the DCTD-CCR collaboration, novel agents for high-priority targets originating from academic and other extramural researchers will be eligible to take advantage of intramural resources.
Exploratory IND studies are ideal, as well, for imaging and other advanced technology applications aimed at developing clinically relevant assays of bio-markers that could help predict whether later-stage trials are likely to be successful. Biomarker assays can also assess the efficacy, mechanism of action, and toxicity of promising treatments. DCTD is also improving its capabilities to develop and validate pharmacodynamic markers. The division is developing standardized operating procedures for handling human tissue specimens and for pharmacodynamic assays. One major goal of this program is to incorporate molecular imaging techniques routinely into early therapeutics development; in particular, there will be a special emphasis on the development of novel imaging probes for monitoring new drug targeting to tumors and for determining the therapeutic benefit of the targeted therapy.
The goal is to produce a diverse portfolio of pharmacodynamic assays and imaging tools that are in the public domain. These complex tasks are time-consuming and expensive, and NCI is well suited to take on this enterprise. It is anticipated that this investment will reap many benefits by making a library of new molecular tools available to all researchers in the cancer research community to assess new targeted drugs and diagnostics.
These efforts also support an NCI-wide priority to better integrate preclinical and clinical research. In addition to partnering with intramural researchers in CCR, DCTD is working to link preclinical and clinical resources seamlessly within the division. This will support extramural trials of targeted therapies and foster better assimilation of molecular imaging and radiation techniques into therapeutics development. Teams of experts across NCI will unite to form integrated drug development teams. A joint CCR-DCTD drug development committee will oversee these teams, determine resource priorities, assess agent progress, identify gaps in the portfolio particularly suited to NCI drug development efforts, and evaluate new compounds for inclusion in the pipeline.
The following improvements in the use of DCTD resources were made to accelerate drug development: