2025 FDA Updates

FDA’s Experience: Integrated Summary of Immunogenicity (ISI) for Therapeutic Peptides
Sophie Shubow, PhD, Senior Biologist, CDER, FDA

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Keynote Presentation: Clinical Pharmacology Evaluations of Immunogenicity Impact: Ongoing Efforts to Facilitate Harmonization
Yow-Ming Wang, PhD, Associate Director for Biosimilars and Therapeutic Biologics, CDER, FDA

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The Sex Gap in Gene Therapy: How Biological Sex Shapes AAV Immunogenicity from Preexisting Immunity to Innate Activation
Ronit Mazor, PhD, Principal Investigator, CBER, FDA

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TBA
Anurag Sharma, PhD, Gene Therapy Reviewer, CBER, FDA