National Cancer Institute Next Program

Purpose: The NCI Experimental Therapeutics (NExT) program is designed to assist investigators in "bench to bedside" translation of novel anticancer therapeutic interventions, synthetic, natural product, or biologic, arising from academic, industrial, or government entities. The program provides the resources for selected discovery tasks, comprehensive pre-clinical IND-enabling tasks, and biomarker development for Phase 0 clinical studies. The tasks are completed by NCI staff and contractors, rather than through direct investigator grants. The program goal is to provide NCI with an integrated pre-clinical pipeline of novel anticancer agents.

Website: http://next.cancer.gov/

Eligibility: Academic investigators, non-profit organizations, SBIR-eligible small businesses

Intellectual Property: A review of intellectual property, relevant to the project, is requested as part of the application. The guidelines for ownership of intellectual property generated will vary with each project and generally depend on the stage of the project.

Background: The NCI has traditionally had a strong pre-clinical drug development program, dating back over 50 years. These programs include Drug Development Network, Rapid Access to NCI Discovery Services (RAND), RAID, and Drug Development Group (DDG). The NexT program is a consolidation of these programs into a single integrated pipeline. The purpose of an integrated pipeline is to ensure that the available NCI resources are allocated to the most meritorious programs. The pipeline is managed by multiple collaborative governance committees using a milestone and stage-gate approach.

Logistics: Applications to the NExT program are submitted electronically (https://proposalcentral.altum.com/default.asp?GMID=76) and reviewed by a panel of experts. Application deadlines are on a quarterly cycle.

Program Capabilities: The NExT program has the capability of performing both discovery and development tasks including target identification, lead small-molecule optimization, and early toxicology and pharmacoki-netic analysis. The NexT program will also support all the necessary development tasks for the submission of an INDA for both small molecules and biological products. A summary of the services is given below.

Discovery: Projects classified as discovery would include, but are not limited to, the following tasks:

  • Identification of targets (genes, pathways, molecules, biologics, etc.)
  • Biological function of targets (pathway dissection, miRNA/siRNA/ shRNA studies, model building in vitro and in vivo)
  • Exploratory screen development and high-throughput screening (HTS) optimization
  • Novel leads for medicinal chemistry optimization
  • Exploratory toxicology studies and pharmacokinetic evaluation

Development: Projects classified as development would include, but are not limited to, the following activities to support INDA submission:

  • In vivo efficacy studies
  • Bulk API synthesis (GMP or non-GMP) including analytical methods development
  • Formulation development, production, and stability testing of clinical dosage form
  • Development of pharmacology assays
  • Pharmacokinetic (PK) and pharmacodynamic (PD) studies
  • Range-finding and IND-enabling toxicity studies
  • Planning of clinical trials
  • INDA submission consultation
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