Symposium: Translational Biomarkers: From Bench to Bedside (BM)

Wednesday, October 19, 2022

9:00 AM – 11:00 AM ET

Location:152

Government Speaker(s)

Yow-Ming Wang, PhD

Associate Director for Biosimilars and Therapeutic Biologics
US Food and Drug Administration
Silver Spring, Maryland

Handouts

This moderator's presentation will provide a brief introduction of the symposium including the learning objectives, the speakers, and presentation title.

Learning Objectives:

Upon completion, participants will understand the history, the current state, and the regulatory pathways for the development and qualification of biomarkers in cancer immunotherapy drug development.
Upon completion, participants will learn strategies in identifying biomarkers, application of biomarker-based modeling for dose optimization in clinical development of immune-oncology products.
Upon completion, participants will understand the challenges in discovery and validation of biomarkers in cancer immunotherapy

Presentations:

9:00 AM – 9:30 AM ET

Predictive and Therapeutic Biomarkers in CAR T-Cell Therapy
Speaker: Aman P. Singh, M.S., PhD – Takeda Pharmaceuticals, USA
9:30 AM – 10:00 AM ET

Pharmacodynamic Systems Analysis for Identifying Biomarkers of Allogeneic CAR-T-Cell Therapy
Speaker: Donald E. Mager, PharmD, PhD – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC
10:00 AM – 10:30 AM ET

Biomarkers for Oncolytic Viruses and Intratumoral Immunotherapy
Speaker: Howard Kaufman, MD – Massachusetts General Hospital/Harvard Medical School/Ankyra Therapeutics
10:30 AM – 11:00 AM ET

It Takes Two to Tango: FDA-Approved Immune Checkpoint Inhibitors and Companion Diagnostics
Government Speaker: Baolin Zhang, PhD – Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)