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.

NIDDK-Specific Funding Opportunities

  • PA-17-131, Lead Optimization and Pre-Clinical Development of Therapeutic Candidates for Diseases of Interest to the NIDDK (R41/R42, Small Business Technology Transfer Research Grant)
  • PA-17-130, Lead Optimization and Pre-Clinical Development of Therapeutic Candidates for Diseases of Interest to the NIDDK (R43/R44, Small Business Innovation Research Grant)

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