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Life Cycle Management (LCM) Community

Monday, January 10, 2022

3:15 PM – 4:15 PM ET

Network and Community Chair(s)

Bilal AbuAsal, PhD

Team Leader
US Food and Drug Administration
David W. Boulton, PhD

Executive Director
AstraZeneca

Network and Community Speaker(s)

Brian Booth, PhD

Director
US Food and Drug Administration
Karey Kowalski, PharmD

Associate Director, Clinical Pharmacology
Pfizer

Session Description

The development of new dosing regimens, dosage forms for an approved product ideally addresses a well-defined clinical need, such as improving patient compliance or improving safety profiles, and requires the integration of pharmacodynamic (PD), pharmacokinetic (PK), and pathophysiologic considerations. Based on the PK properties or the desired PD profile, dosage forms typically aim to reduce the dosing frequency while maintaining a therapeutic concentration over a prolonged period. In this session we aim to discuss the application of clinical pharmacology principles to support the approval of new dosing regimens or route of administration. Representative speakers from FDA and industry will discuss the case examples for the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. Other examples will also be discussed by speakers from industry.

Learning Objectives

1. Discuss the application of clinical pharmacology principles to support the approval of new dosing regimens or route of administration.

2. Demonstrate case examples for the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens.

Session Schedule

3:15 PM - 3:22 PM ET
Introduction to the Life Cycle Management Community
Bilal AbuAsal, PhD

3:22 PM - 3:34 PM ET
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
Brian Booth, PhD

3:34 PM - 3:47 PM ET
Clinical Pharmacology Strategies to Support Intravenous to Subcutaneous Switches
David Boulton, PhD

3:47 PM - 4:00 PM ET
Application of Model-Informed Drug Development to Support Alternative Dosing Regimens for PD-1/PD-L1 Inhibitors: Sasanlimab and Avelumab
Karey Kowalski

4:00 PM - 4:15 PM ET
Live Q&A
All Speakers