IDENTIFICATION AND DELIVERY OF CLINICAL DRUG CANDIDATES

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

The mission of the NCI Division of Cancer Treatment and Diagnosis (DCTD) is to advance new therapies into patients requires that promising compounds navigate numerous technical activities in order to qualify for IND directed studies. This process often includes the development of a high throughput screening assay, running the high throughput screen (often with >200,000 compounds), validation of hit compounds, development and use of secondary assays assessing the specificity and selectivity of the hit compounds against the target, medicinal and synthetic chemistry, in vitro and in vivo (e.g. animal) dose and schedule, efficacy, pharmacokinetic (PK) and pharmacodynamics (PD) studies in order to consider a compound sufficiently validated to have the intended biological outcome. The experience of DCTD?s drug discovery efforts over the past decade has proven that more than 3 years is required for a single compound to become a clinical candidate that is ready for IND-directed preclinical development, and that many projects fail prior to reaching that goal. The NCI established the Chemical Biology Consortium (CBC) as the discovery engine of the NCI Experimental Therapeutics (NExT) Program seven years ago to move projects through the following steps in the drug discovery process: Exploratory Screen Development; Screening/Hit-to-Lead; Lead Optimization; and Candidate Selection. The present DCTD contract through Leidos Biomedical Research, Inc. consists of a consortium of subcontracts (centers) drawn from academic, government and private institutions. These Centers provide the essential scientific knowledge, skills and technical capabilities required to discover hit compounds and advance them into chemical leads and clinical candidates. One CBC center at NCATS-NCGC is a government entity and is managed by DCTD.