In Silico Technologies A Strategic Imperative for Accelerating Breakthroughs and Market Leadership for FDA-regulated Products

Authors: Afshari P, Canchi T, Cook J, Emili L, Fishman J, Horner M, Kleinstreuer N, Kreuzer S, Matlis D, Morales-Orcajo E, Naab A, Orcajo EM, Palmer M, Paoli G, Patil AS, Peterson A, Vadigepalli R, Watkins PB, Zhou H
Publication: Reagan-Udall Foundation for the Food and Drug Administration
Keywords: DILIsym, FDA, in silico, model-informed drug development
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

Summary

The 21st century technology revolution has the power to reshape the way organizations manage, process, and harness data, drive innovation, and unlock new possibilities for consumers and patients across the globe. These innovations enable faster data processing, complex computations, and the ability to handle enormous datasets efficiently Moreover, researchers and engineers can harness the advancements in causal (physics-based) modeling and complex systems representations to capture real-world phenomena Other supporting technologies contributing to this convergence include artificial intelligence (AI) and machine learning (ML) for data analysis and automation, cybersecurity solutions to ensure data integrity and privacy, and advancements in networking infrastructure to enhance connectivity and communication between distributed systems.

Acknowledgements
The following individuals contributed to the content of this paper.
Payman Afshari, Jeff Bischoff, Tejas Canchi, Jack Cook, Luca Emili, Jesse Fishman, Marc Horner, Nicole Kleinstreuer, Steven Kreuzer, Daniel R. Matlis, Enrique Morales-Orcajo, April Naab, Enrique Morales Orcajo, Mark Palmer, Greg Paoli, Abhijeet S. Patil, Ashley (Ash) Peterson, Rajanikanth Vadigepalli, Paul Watkins, Honghui Zhou