Safety Considerations for the Development of Antibody-Drug Conjugates

DATE

April 24, 2024

TIME

8:00 a.m. PDT, 11:00 a.m. EDT, 16:00 BST, 17:00 CEST

Duration: 60 Minutes

Overview

Antibody-drug conjugates (ADCs) are a novel modality leveraging monoclonal antibody (mAb)-mediated delivery of a cytotoxic payload molecule to its target. Since the drug conjugated to mAb, typically a highly cytotoxic small molecule, can be released unconjugated in plasma and contribute to drug-drug interaction (DDI) potential, both the antibody and small molecule drug component are considered from the perspective of ADC safety.

Numerous chemotherapies utilizing ADCs are being developed for treatment of advanced cancers, however, the regulatory guidance for evaluation of ADC DDI potential is not well established.

Key Learning Objectives:

Introduce the novel therapeutic modality of antibody-drug conjugates
Summarize the mechanism of action and safety considerations for FDA-approved ADCs
Describe drug interaction potential of ADC payloads currently in the clinic
Outline experimental strategies for identification of drug interaction potential for novel small molecule ADC payloads

Who Should Attend:

Research scientists and drug development leadership aiming for successful IND / NDA submission, needing to meet regulatory requests and expectations, desiring to formulate a development plan that mitigates risks of late-stage failure, or simply wanting to better understand the ADME properties and potential DDI risks of their ADC.

Brought to you by:

Speakers

Maciej Czerwinski, PhD
Director of Consulting
BioIVT

Melissa O'Meara
Forensic Science Consultant,
C&EN Media Group

Registration

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