Keynote: Challenges with New Modalities: Hitting the Stride from Day 1

Wednesday, October 23, 2024

1:30 PM – 2:30 PM MT

Location:155 F

Manufacturing and Analytical Characterization

Keynote Speaker(s)

Jennifer Chadwick, PhD

Executive Advisor & Scientific Consultant
Jennifer Chadwick
Northbrook, Illinois

Moderator(s)

Anuji Abraham, PhD

Associate Scientific Director
Bristol-Myers Squibb Company
New Brunswick, New Jersey

New therapeutic products have trended toward increased complexity to achieve more precise or targeted delivery. While novel modalities offer potential for widening therapeutic index and treating previously elusive diseases, they present unique challenges in development. With limited/no precedent for a CMC package with clinical success, sponsors must navigate unknowns in evaluating potential risk and weighing options for de-risking the path to clinic. Examples of gene therapy products, like AAV, and complex formulations will be discussed.

Learning Objectives:

understand complexities of new modalities, including gene and cell therapeutics
frame strategic thinking about development of novel modalities
identify potential risks in development that stem from unknowns