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NIH: National Institute of Diabetes and Digestive and Kidney Diseases NIH: National Institute of Diabetes and Digestive and Kidney Diseases 75 years: 1950-2025 75 years: 1950-2025
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  5. Pre-Clinical Development

Translational Research: Pre-Clinical Development

The pre-clinical development of a potential therapeutic agent involves the manufacturing and formal testing of ADMET properties in preparation for submission to a regulatory agency for human trials. Rigorous efficacy studies of a pre-clinical lead candidate may also be conducted. These processes require regulatory expertise in their design, good manufacturing practices (GMP) manufacturing, and good laboratory practice (GLP) toxicology studies as well as consideration of future clinical trial design.

Starting Points
  1. Disease
    Biology
  2. Unvalidated
    Target
    Target ID
    Putative
    Targets
  3. Nominated
    Target
    Assay Development
    Screenable
    Assays
  4. Target Assay
    Screening
    Hits and
    Starting Points
  5. Hit
    Hit to Lead
    Lead Series
  6. Pre‑clinical
    Candidate
    Pre‑clinical
    Development
    Clinical
    Therapeutic
    Candidate
  7. Licensing and
    Commercializa-
    tion Partners
    Market-ready
    Therapeutics
Outcomes and Resources

NIH Funding Opportunities

  • PAR-22-111, Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01 Clinical Trial Not Allowed) has expired. The NIDDK is still interested in supporting this type of translational science and another potential option is to apply to the Parent R01 NOFO (PA-20-185) and consider requesting review assignment to any of CSR’s Drug Synthesis, Discovery, Disposition, and Xenobiotics study sections, or another relevant review panel. Applicants should consult the NIH/CSR study section descriptions before requesting a specific review panel. 
  • RFA-NS-24-019, HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

Related Resources

Staff Contacts

Division of Kidney, Urologic, and Hematologic Diseases
Dr. Anna Sadusky

Division of Digestive Diseases and Nutrition
Dr. Bonnie Burgess-Beusse

Division of Diabetes, Endocrinology, and Metabolic Diseases
Dr. Yan Li

Last Reviewed October 2023