Antibody drug conjugates (ADCs) are revolutionizing the pharmaceutical industry. This emerging modality comes with the promise of targeted therapy with increased precision and selectivity therefore enhancing the overall therapeutic index. ADCs, by nature, have characteristics of both antibody therapeutics and small molecules, posing a unique challenge for the field of PK/PD and clinical pharmacology.

In this webinar, we bring top scientists of the field to introduce how the concepts of PK/PD and clinical pharmacology are being applied to support discovery and development of ADCs. Specific focus will be given to model-informed drug discovery and development.

The first part of the webinar will cover how the different pieces of PK/PD data can be brought together with quantitative systems pharmacology (QSP) modeling to aid the preclinical to clinical translation of ADCs. It will showcase how the complexity of the ADC modality can be characterized for its PK/PD and how the different data can be integrated with the approach of QSP modeling and simulations.

The second part of the webinar will focus on clinical development of ADCs. Industry examples will be presented on dose selection and justification during clinical development that were supported by population pharmacokinetic modeling and exposure-response analysis. It will demonstrate how the complex challenges associated with unique characteristics of ADCs were tackled using the concepts of clinical pharmacology.

Learning Objectives:

• How the PK/PD principles are applied to the ADC modality
• Clinical pharmacology considerations of ADCs
• Application of MIDD concepts for ADCs
  

Eshita Khera, Ph.D.

Dr. Khera earned her PhD in Chemical Engineering from the University of Michigan. Dr. Khera’s research is focused primarily on using in silico, in vitro, and in vivo tools to understand the intratumoral distribution of antibody-drug conjugates (ADCs), from both the perspective of the antibody and released payload, and reverse translate the learnings to develop guidelines for designing optimal ADCs. The highlighted work is a serendipitous product from the innovative integration of niche academic knowledge and industry practices – finding its humble beginnings as Dr. Khera’s graduate summer internship project at Novartis and eventually growing to become a part of her doctoral dissertation at the University of Michigan.

Currently, Dr. Khera is a Principal Scientist in Pharmacokinetic Sciences (PKS) Modeling & Simulation at Novartis Institutes for BioMedical Research, where she provides translational modeling support for ADCs and immuno-oncology therapies. In the discovery space, she uses Quantitative Systems Pharmacology (QSP) modeling to help guide the design and optimization of preclinical drug candidates, while in the development space, she uses QSP and population PK/PD to translate preclinical data to a recommended First-in-Human trial dose range.

Claire Li, Ph.D.

Claire is currently Director of Quantitative Clinical Pharmacology at Daiichi Sankyo, and she supports clinical development of oncology drugs including Enhertu (Trastuzumab deruxtecan). Prior to her position at Daiichi, she has worked at Janssen Pharmaceuticals in clinical pharmacology department to support CAR-T and bi-specific mAbs in Oncology. She has also worked previously at Merck for Pembrolizumab and other early Oncology pipelines in Quantitative Pharmacology and Pharmacometrics.

She obtained her B.S. in Biochemistry and Molecular Biology from University of Georgia, GA and Ph.D. in Medical and Molecular Genetics from Indiana University, IN.