Early Development & Drug Safety (EDDS) Community

Session Description

The Early Development & Drug Safety Community Session is designed to engage the audience with the most interesting topics and cutting-edge sciences of two relatively new therapeutic approaches, gene therapy for diverse clinical indications and T-cell redirection for cancer immunotherapy. The feature of the scientific presentations in this session is on the undertaking in early drug development with an emphasis on drug safety considerations from clinical pharmacology perspectives. The learnings from this session would be directly applicable in the therapeutic areas; the scientific approach and the strategy can also benefit other new therapeutic areas during early development phase.

Learning Objectives

1. Upon completion, participants will understand the key considerations for developing AAV-based gene therapy and have insight on new opportunities with future vision in gene therapy.

2. Upon completion, participants will be able to learn about the pharmacokinetic/pharmacodynamic (PK/PD) and dosing strategy to minimize cytokine release syndrome risk and molecular attributes and target properties contributing to the safety and efficacy of T-cell redirectors.

Session Schedule

1:45 PM - 1:50 PM ET
Goals and Objectives of the Early Development & Drug Safety Community
Chao Han, PhD & Michael Liao, PhD

1:50 PM - 2:05 PM ET
Challenges and Opportunities of In Vivo Gene Therapies
Michael Liao, PhD

2:05 PM - 2:24 PM ET
Translational PK/PD and Dosing Considerations for Developing Safe and Effective T-Cell Redirecting Therapeutics
Siddharth Sukumaran, PhD

2:24 PM - 2:45 PM ET
Live Q&A
All Speakers