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Session 3 Track 2A: The Trouble with IgG: Immunogenicity in the Clinical Deveopment of Biologics
Session Chair(s)
Darryl L'Heureux, PhD, MPharm, MSc
Director, Clinical Science, Medical Writing, and Publications
Ambrx, Inc, United States
The use of protein therapeutics has increased dramatically over the past decades, since the introduction of the first recombinant protein therapeutic, human insulin, as replacement therapy more than 30 years ago. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders. While proteins have a dynamic role in the body (catalyzing biochemical reactions, forming receptors and channels in membranes, providing intracellular/extracellular scaffolding, and transporting molecules), protein-based therapeutics have a tendency to trigger unwanted immune responses against themselves. This session will discuss immunogenicity, the safety and efficacy implications in clinical development, and the communication of risk to stakeholders.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify the use of therapeutic proteins in treatment, immunogenicity response, and regulatory requirements
- Understand and assess risk-based approach for clinical development and communication to Health Authorities
- Communicate clinical relevance and significance of immunogenicity to both patients and clinicians
Speaker(s)
Speaker
Darryl L'Heureux, PhD, MPharm, MSc
Ambrx, Inc, United States
Director, Clinical Science, Medical Writing, and Publications
Speaker
Lisa Iacono Sheehan, PharmD
Bristol-Myers Squibb, United States
Director Global Regulatory Strategy