Beyond the Analysis: Immunogenicity and Beyond: Panel Discussion

Tuesday, July 15, 2025

11:05 AM - 11:55 AM ET

Location: Vienna Ballroom: South, East + West

Moderator(s)

Mark Wissel, PhD

Director Research and Development
Eurofins Viracor BioPharma Services
Lenexa, Kansas

Speaker(s)

HISANORI HARA, MSc

Immunogenicity Advisor and EU/Asia Business
B2S Life Sciences
Franklin, Indiana
Karen Liao, MD

Principal Scientist
Merck
Collegeville, Pennsylvania
Ronald R. Bowsher, PhD, FAAPS

Partner & CSO
B2S Life Sciences
Indianapolis, Indiana

Handouts
Mohsen Rajabi, PhD

Director. Pharmacokinetics Sciences Governance
Novartis
Cambridge , Massachusetts
Lynn Kamen, PhD

Scientific Officer, Executive Director
BioAgilytix
Durham, North Carolina

Today the complexity of biotherapeutics is increasing while the range of novel treatment modalities continues to evolve. These factors are making immunogenicity testing more complicated. Accordingly, in this session speakers will present their cutting-edge experiences and bioanalytical strategies for detecting anti-drug antibody responses in patients after administration of contemporary biotherapeutics. Attendees will gain valuable insights into the various successful analytical solutions and potential pitfalls presented during this session.

Learning Objectives:

Current approval pathways for peptide theraputics
Strategies for evaluating immunogenicity risk
Current industry and regulatory paradigm in immuogenecity testing
align immunogenicity strategy with the results of risk assesment in the context of current HA regularoty guidelines