Integrated Pre-Formulation and Drug Product Characterization Efforts Leading to Nimble Advancement of Drug Candidates to Human Clinical Trials

18 September 2023 16:50 - 17:20

The development cost and timeline for a new drug is increasing due to high attrition rates caused by inadequate physicochemical and biopharmaceutical attributes, unacceptable safety, and sub-marginal efficacy. This development attrition rate can be reduced by strengthening non-clinical formulation screening process and establishing a drug product developability assessment plan to enable nimble selection of developable compounds to move to the clinic. It is critical to select the right formulation principles, and equally important to run developability screens by:

  • Physiochemical characterization of new chemical entities’
  • Salt form and polymorph form selection
  • Preclinical formulation development
  • Integrated non-clinical formulation testing and profiling
  • Drug delivery technologies to enable oral bioavailability of poorly water-soluble compounds 

Gaauri Naik, Director, Pharmaceutics, Relay Therapeutics