Why the FDA Will Bet More on in Silico Simulations To Trigger Better Success Rates for NDAs

1:45 PM - 2:45 PM (PDT), Tuesday, June 14, 2022 ・ Upper Level, Session Room 3

Given a less than 8% likelihood for a New Drug Approval from first in man clinical trials, drug developers and pharma companies are faced with questions around how to accelerate the discovery and development of new therapeutics. New strategies around use of diagnostics, regulatory engagement, and industry alliances are often insufficient. But the path to NDA is now supported in many cases by in-silico work on top of the traditional endeavors. 
Driven by rich clinico-genomic data, such as whole exome sequencing, RNAseq, and patient treatment history, AI technologies and bio simulations are creating a paradigm shift that will is radically transforming drug discovery, clinical trial development, and the acceleration of drug commercialization. This panel will showcase recent examples in digital, AI, and in-silico models that highlight this new reality and the real potential to decrease the timelines around clinical trials, speed up drug development, and ultimately improve patient care.


Chief Executive Officer
GNS Healthcare
VP - Global Head, Data Sciences and Engineering
Eli Lilly and Company
Vice President and Head of Translational Oncology, Global Product Development
Pfizer, Inc.
Professor, Computational Biology and Chair, Department of Biostatistics
Harvard T.H. Chan School of Public Health
Program Strategy Leader
Gilead Sciences