Symposium 7: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?

Monday, September 11, 2023

1:30 PM - 5:00 PM PT

Location:Grand Ballroom E-H

CE: 3.0

Co-Chair & Faculty(s)

Khamir Mehta, PhD

Director, Clinical Pharmacology Modeling & Simulation
Amgen Inc
Piet van der Graaf, PhD, PharmD

Senior Vice President
Certara

Faculty(s)

HS

Haleh Saber, PhD (she/her/hers)

Hematology Oncology Toxicology, Office of Oncologic Diseases, Ctr for Drug Evaluation & Research
US Food & Drug Administration
Fei Hua, PhD

Vice President, Modeling & Simulation SVcs
Applied BioMath LLC
Xiling Jiang, PhD

Clinical Pharmacology Reviewer, Oncology
US Food & Drug Administration
Alexander Ratushny, PhD

Director, Quantitative Systems Pharmacology, Clinical Pharmacology, Pharmacometrics, Disposition & Bioanalysis
Bristol Myers Squibb
Vincent Lemaire, PhD

Distinguished Scientist
Genentech Inc
Julie Bullock, PharmD

Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine
Certara

This Symposium is for drug developers and clinical pharmacologists, pharmacometricians, systems modelers and data scientists, regulators, academics with focus on modeling & simulation and drug discovery and research professionals.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:

Recognize the current capabilities and challenges in using mechanistic models of multispecific antibodies to quantitatively inform drug development decisions;
Discuss about the different modeling strategies and tools to employ mechanism-based mathematical models to assist drug development questions;
Evaluate the potential strategies to overcome the current challenges in using mechanistic models for drug development.

Presentations:

Mechanistic Models for Multispecific Antibodies: An Introduction
Co-Chair & Faculty: Piet van der Graaf, PhD, PharmD – Certara
First-in-Human Dose Selection of Immune-activating Biotherapeutics in Oncology
Faculty: Haleh Saber, PhD (she/her/hers) – US Food & Drug Administration
A Next Generation Mathematical Model for the In-vitro to Clinical Translation of T Cell Engagers
Faculty: Fei Hua, PhD – Applied BioMath LLC
Harnessing the Power of Model-informed Drug Development to Support Clinical Development of T Cell Engagers
Faculty: Xiling Jiang, PhD – US Food & Drug Administration
Case Studies in Mechanism-based Models for Immune-oncology
Co-Chair & Faculty: Khamir Mehta, PhD – Amgen Inc
A Role of Multitherapy Quantitative Systems Pharmacology (QSP) Platforms in Clinical Development of Multispecific Drug Antibodies
Faculty: Alexander Ratushny, PhD – Bristol Myers Squibb
Predicting Survival in Prospective Clinical Trials Using Weakly-supervised QSP
Faculty: Vincent Lemaire, PhD – Genentech Inc
The Role of Model-informed Drug Development & QSP in Project Optimus
Faculty: Julie Bullock, PharmD – Certara
Faculty Panel Discussion: Panel Discussion: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?