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 and Valerie Kramlinger

  • Overview of Antibody Drug Conjugates
    Matt Albertolle, Avidity Biosciences, San Diego, CA, USA

  • Practical Considerations in Preclinical ADC Bioanalysis
    Linlin Dong, Takeda Pharmaceuticals, Cambridge, MA, USA

  • Bioanalysis of Antibody-Oligonucleotide Conjugates
    Long Yuan, Biogen, Cambridge, Massachusetts, USA

1:00 pm – 1:15 pm ET | Break

1:15 pm – 3:15 pm ET | Part Two
Moderated by Bingming Chen and Thomas Kraft

  • Antibody Drug Conjugate-based Bioanalysis
    Jian Chen, BMS, Summit, NJ, USA

  • Physiologically-Based Pharmacokinetics Meets Quantitative Protein Mass Spectrometry for Mechanistic Modeling of Target-Mediated Drug Disposition (TMDD)
    Armin Sepp, Certara, Cambridge, United Kingdom

  • Expert Panel with Q&A

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 Faye Vazvaei 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

  • Antibody-Drug Conjugates: A Clinical Pharmacology Perspective on Bioanalytical Needs
    Ankit Shah, Federal Drug Administration, Silver Spring, MD, USA

1:00 pm – 1:15 pm ET | Break

1:15 pm – 2:55 pm ET | Part Two
Moderated by Joe Cannon and Jim Shen

  • Case Study on ACDs in Development
    Cynthia Chavez-Eng, Merck & Co., West Point, PA, USA

  • Discovery Bioanalysis for ADC Therapeutics

  • Yifan Shi, Johnson and Johnson, Spring House, PA, USA

  • Expert Panel Q&A