Through the BrIDGs program, researchers partner with NCATS scientists to produce preclinical data as well as research and clinical material. Data and material are generated by NIH contractors under the direction of NCATS intramural researchers with expertise in the following development areas:
- Synthetic process development
- Scale-up and manufacture of active pharmaceutical ingredients
- Development of analytical methods
- Development of suitable formulations
- Pharmacokinetic/ADME (absorption, distribution, metabolism and excretion) studies, including bioanalytical method transfer and validation
- Range-finding initial toxicology studies
- Investigational New Drug (IND)-directed toxicology studies
- Manufacture of clinical trial supplies
- Product development planning and advice in IND preparation
BrIDGs collaborations are completed using the contract resources of NCATS and the National Cancer Institute.