BrIDGs Scientific Capabilities

Instead of receiving grant funds, selected researchers collaborate with NCATS intramural drug development experts. Collaborators leverage the federal government’s contract resources and assistance with establishing and implementing product development plans to generate sufficient data for an Investigational New Drug application to a regulatory agency such as the U.S. Food and Drug Administration.

Expertise

BrIDGs scientists bring decades of experience in industry and academic drug development to each project. Collaborators tap into staff expertise in process chemistry, formulations development, pharmacokinetics and toxicology. These scientific insights are combined with a thorough understanding of regulatory guidelines, which enables the program to provide assistance with establishing and implementing successful product development plans for IND applications.

Completed and active projects include small molecules, peptides, gene therapies and recombinant proteins delivered by oral, topical and injectable routes of administration.

Resources

Through the BrIDGs program, researchers partner with our 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.