Last Updated: 04/06/07
Joint Early Therapeutics Development Program
The Division of Cancer Treatment and Diagnosis (DCTD) is reexamining its discovery and development paradigm. Pharmacokinetic and pharmacodynamically (PK/PD)–guided clinical trials are being emphasized in conjunction with assays of specific molecular targets. Such studies are already used to examine the biological effects of drugs in animals and humans. By studying PK/PD responses, researchers will be better able to administer the appropriate dose to achieve the desired therapeutic response with a minimum risk of toxic effects.
A new collaborative effort between the DTP drug developers in DCTD and the programs and clinicians at the Center for Cancer Research (CCR), called the joint early therapeutics development program, uses PK/PD principles to streamline the development of novel cancer therapeutics. This initiative builds on CCR’s strengths in integrated research and its clinical program, as well as DCTD’s expertise in drug development and its relationships with pharmaceutical companies. The goal is to shorten the drug development timeline for new molecular entities and cytotoxic agents by rapidly screening new drugs in humans before making a commitment in time and resources to a full therapeutic development plan.
In 2005, this new initiative began to take shape. DTP’s Toxicology and Pharmacology Branch identified laboratory resources required to support the program and is working to expand capacities to perform PD assays, in vitro toxicity analysis, and virus toxicity testing. DTP also is augmenting its animal model efficacy program. A National Clinical Target Validation Laboratory was established within the Toxicology and Pharmacology Branch to assess the pharmacodynamic effects of therapeutics on cellular targets, perform target validation assays, and evaluate the consequences of anticancer drugs on patients in early clinical trials.
