Bioanalysis of Today and Tomorrow: Current Best Practices and Emerging Technologies Enabling Diverse Therapeutic Conjugate Evaluation

An ISSX Virtual Workshop Event | November 13 and November 20, 2024

Workshop Program-at-a-Glance

Program subject to change.

Wednesday, November 13, 2024
Day 1: Bioanalysis of Today

Overview:

Bioanalytical Basics: Including experimental design, how samples are analyzed, and what the data is used for.
Therapeutic modalities to be covered: SMOL, mAbs, mAb conjugates, nucleic acid-based.

Agenda:

11:00 am – 1:00 pm ET | Part One
Moderated by Matt Albertolle

Overview of Antibody Drug Conjugates
Stephanie Monson, Genentech, South San Francisco, CA, USA
Practical Considerations in Preclinical ADC Bioanalysis
Linlin Dong, Takeda Pharmaceuticals, Cambridge, MA, USA
Bioanalysis of Antibody-oligo (siRNA) conjugates
Yunlin Fu, Novartis, Belle Mead, NJ, USA

1:00 pm – 1:15 pm ET | Break

1:15 pm – 3:15 pm ET | Part Two
Moderated by Faye Vazvaei

Wednesday, November 20, 2024
Day 2: Bioanalysis of Tomorrow

Overview:

Three lectures focusing on modern techniques that may/may not highlight work with newer modalities.
One Lecture Vignette focused on bioanalytical stories for recently approved drugs and one lecture from the FDA focused on regulatory aspects specific to drug conjugates.

Agenda:

11:00 am – 1:00 pm ET | Part One
Moderated by Bingming Chen and Mei Han

Biotransformation of Drug-conjugate Payload and Intact Conjugate
Donglu Zhang and Rachel Shi, Genentech, South San Francisco, CA, USA
Mathematical Modeling for Antibody Drug Conjugates
Greg Thurber, University of Michigan, Ann Arbor, MI, USA
Talk Title to be Confirmed
Ankit Shah, Federal Drug Administration, Silver Spring, MD, USA

1:00 pm – 1:15 pm ET | Break

1:15 pm – 3:15 pm ET | Part Two
Moderated by Joe Cannon and Jim Shen