Vision
To provide a forum for academic, industry, and regulatory colleagues to engage, align and communicate more effectively on immunogenicity topics related to drug development. The scope is modality agnostic and pertains to immunogenicity risk identification and mitigation through proactively understanding relevance and immunogenicity data interpretation in the context of non clinical and clinical studies, data reporting and harmonization outputs and terminology.
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Leadership
Chair: Laurent Malherbe | Vice Chair: TBD | Past Chair: Yi Wen | Secretary: Robin Walsh | Learning Opportunities Managers: Michele Gunsior, Martin Ullmann | Member Engagement Managers: Kirk Hofman | Scientific Advisory Committee Regulatory Response Subcommittee Members: Devangi Mehta, John Pirro
2024 Therapeutic Product Immunogenicity Goals (PDF)
Community email address: aaps-therapeuticproductimmunogenicitycommunity@connectedcommunity.org