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
-
Disease
Biology -
Unvalidated
TargetTarget IDPutative
Targets -
Nominated
TargetAssay DevelopmentScreenable
Assays -
Target AssayScreeningHits and
Starting Points -
HitHit to LeadLead Series
-
Lead
CompoundLead
OptimizationPotential
Therapeutic
Leads -
Pre‑clinical
CandidatePre‑clinical
DevelopmentClinical
Therapeutic
Candidate -
Clinical
CandidateClinical
DevelopmentClinical Proof
of Concept -
Licensing and
Commercializa-
tion PartnersMarket-ready
Therapeutics
Outcomes and Resources
NIDDK-Specific Funding Opportunities
- RFA-NS-22-034, HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain
Related Resources
- Bridging Interventional Development Gaps (BrIDGs)
- Therapeutics for Rare and Neglected Diseases (TRND)
- Academic Drug Discovery Consortium
- NIDDK Small Business Programs
- IND/FDA
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