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Center for Cancer Research National Cancer Institute
NCI Drug Development Collaborative

Additional Proposal Elements

In addition to the requirements of a good compound, knowledge of any of the following data will strengthen your proposal. These items will have to be assessed prior to NeXT approval. The DDC can assist achieving these answers.

• Demonstrate the activity of the compound in vivo-Xenografts, orthotopic models, genetically engineered mice, tumor explants, syngeneic mouse hosts for immunological studies, veterinary animals, etc
-Must confirm target engagement following an intervention
-Administration of compound that works best in animals - routes, schedule and dosing
•Are there analogs to the compound? Have they been tested in vitro and/or in vivo?
•Has the compound been submitted to the DTP 60 cell-screening program?  What is the IC50 and/or GI50?
•What was the efficacy?
•Indicate formulation issues
•Is there a pharmacodynamic (PD) assay for the target? If so, what is the assay variability?
•Is there an analytical assay to measure the drug in biological fluids?
•Is the drug metabolized? If so, what enzyme system?
•What are the pharmacogenetics for the agent (PK or target)?
•Have toxicology experiments been performed? If so, what species?
•Has teratogenicity testing been performed? If so, what species?
•Will this compound ultimately be used singularly or in combination? If in combination, how will this be tested clinically? What model system will be used?
•Is this a Phase 0 candidate?
-Is it 1 to 1.5 years from the clinic? Are there a group of agents? Is there a PD assay to show target engagement?

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Added by Boersma, Brenda (NIH/NCI) [E] , last edited by Boersma, Brenda (NIH/NCI) [E] on Mar 25, 2013 10:28