Keynote: From preclinical to clinical drug product development- a path for smooth transition

Tuesday, October 18, 2022

1:30 PM – 2:30 PM ET

Location:254 A

Keynote Speaker(s)

Sandra Suarez-Sharp, PhD

Vice President, Regulatory Affairs
Simulations Plus, Inc.
Lancaster, California

Moderator(s)

Christine Bowman, PhD

Senior Scientist
Genentech

It is challenging to establish a standard approach for moving from preclinical to clinical phases of development. Many hurdles exist during formulation selection and for extrapolation of doses from animals to humans; what may have worked well for one drug candidate may not be appropriate for others. This presentation will provide a general framework/strategy to follow when moving from preclinical to clinical studies (FIH) based on risk identification and mitigation focusing on the application of mechanistic modeling and simulation (PBPK)

Learning Objectives:

To emphasize the relevance of cross-functional multidisciplinary collaboration for successful transition from preclinical to clinical studies
To describe data collection considerations on drug product quality, biopharmaceutics, preclinical and clinical testing strategies, as well as study design on the conduct of FIH studies (small molecules)
To discuss the principles on the calculation of the starting dose to be used in humans, the subsequent dose escalations, the criteria for maximum dose and the conduct of the trial inclusive of multiple parts
To list strategies for risk assessment and mitigation
To illustrate the relevance of PBPK models on streamlining the transition from preclinical to clinical phases and its contribution in accelerating the drug product development process