DTP has traditionally worked with large pharmaceutical companies in all phases of drug discovery and development. Large companies have access to our repository (with reimbursement of costs in some cases) and screening services in a manner similar to researchers from academic institutions and small businesses, as well as to the Rapid Access to Intervention Development (RAID) initiative in collaboration with an academic partner. Most large corporations have the scientific and financial resources necessary to take a compound from discovery to the late preclinical stages of development, but they may wish to enter into a relationship with NCI at the level of IND-directed toxicology testing or at the level of conducting clinical trials, especially for "Orphan" drugs or compounds with higher-risk targets. Entry of a drug at this stage of the development process is possible through a presentation to the Drug Development Group (DDG) and by completing a Clinical Trials Agreement (CTA) whereby the originating organization agrees to submit a sufficient amount of material for NCI to formulate and study in toxicologic evaluations, with the understanding that NCI will have the ability to use this material for Phase I and Phase II clinical trials. In this event, cost sharing of formulation and toxicologic evaluation may be negotiated. Factors entering into these considerations include the demands presented by a particular compound, offset by its availability and scientific novelty.
