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Developmental Therapeutics Program (DTP)
Last Updated: 09/27/18

About the Stepping Stones Program

NCI Stepping Stones Initiative: Advancing innovative drug leads toward clinical development by providing resources and data 'stepping stones.' An arrow from Discovery to Clinical Development, connected by stepping stones: PK/PD, Toxicity, Synthesis, Formulation, Efficacy, CMC

The Stepping Stones Program provides critical resources to advance innovative anti-cancer therapeutics toward clinical development. This initiative is intended to augment grant-supported programs with access to NCI/DCTD/DTP drug development capabilities to fill knowledge and data gaps, thus enabling these programs to advance and procure additional resources for development toward clinical testing. The goals are:

  • Support peer-reviewed anti-cancer product development
  • Facilitate access to federal resources for preclinical product development
  • Fill the NCI/NExT pipeline with innovative therapeutic candidates

Project selection criteria

  • Therapeutic candidate development programs supported by NCI/DCTD grant funding
  • Well-characterized and validated intervention target/mode of action
  • Addresses unmet clinical needs (orphan cancers, glioblastoma, small cell lung cancer, pancreatic cancer, pediatric cancers, etc.)
  • Lead candidates with demonstrated preclinical in vitro/in vivo efficacy

Access to Stepping Stones

NCI grantees may submit a Drug Development Consultation Request. A consultation meeting will be arranged for grantees to discuss the most promising grant-supported therapeutic candidate with a panel of NCI staff with therapeutic development expertise. Grantees with qualified research projects may be invited for further discussion with NCI/DCTD/DTP staff to identify research gaps and opportunities for NCI to perform a discrete set of studies to address the most critical product development gap. The scope of studies is preclinical; IND-enabling support (GLP, GMP) is not provided.