Last Updated: 04/06/07

James H. Doroshow, M.D., FACP
Director of the Division of Cancer Treatment and Diagnosis

Pharmacodynamic Assays and Imaging Techniques

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.