Quest for Quality Drug – Use of First Principle Based Biophysical Assays to select Manufacturable Molecule

13:50 - 14:25

According to Trends in Clinical Success, only ~10% of drugs that enter Phase I are destined to get FDA approval. One of the potential factors that has commonly impacted the success rate is poorly behaved molecules. To save cost and to expedite development that will enable higher success rate, it is undoubtedly critical to characterize the intrinsic properties of molecules early on. This talk is designed to highlight few high throughput assays and first principle based biophysical tools to select molecules that are risk free from manufacturing challenges.

Sathya Venkataramani, Associate Director, Janssen Biotherapeutics