Speaker Spotlight: A Slice of the Immunerdy Pecan Pie- Regulatory Stakeholders in CDER’s Integrative Immunogenicity Review of Therapeutic Proteins and Peptides

Tuesday, October 22, 2024

2:30 PM – 3:30 PM MT

Location:Spotlight Stage A, Aisle 1100, Exhibit Hall

Spotlight Speaker(s)

Joao Pedras-Vasconcelos, PhD (he/him/his)

Senior Staff Fellow- Product Quality & Immunogenicity
U.S. Food and Drug Administration, Maryland

Moderator(s)

Troy Voelker, PhD (he/him/his)

Senior Director Laboratory Operations
Aliri Bioanalysis
Salt Lake City, Utah

This presentation would provide an overview of the various CDER regulatory stakeholders currently involved in reviewing immunogenicity of therapeutic proteins and peptides and discuss their various roles in CDER’s Integrative immunogenicity processes.

Learning Objectives:

To have a general understanding of CDER regulatory stakeholders involved in immunogenicity review process for therapeutic proteins and peptides.
To have an understanding of specific roles that each regulatory stakeholder group plays in CDER's integrative immunogenicity review process
To have an understanding of how product quality CMC interacts with other subdisciplines