Safety Considerations for the Development of Antibody-Drug Conjugates
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:
Director of Consulting
BioIVT
Health & Environment Writer,
C&EN Media Group
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Start:
Wed, Apr 24, 2024 11:00 AM EDT
End:
Wed, Apr 24, 2024 12:00 PM EDT
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