2025 FDA Updates

* More Confirmed Talks Coming Soon

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

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