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Immunogenicity Studies for Biotherapeutics

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Agenda Day Two

Agenda Day Two

For complete information, including full descriptions of the following sessions, please download the conference brochure.

Technology

8:00Morning Coffee
8:15Chairpersons' Recap of Day One
8:30

Immunogenicity of Protein Therapeutics in a Global Context

Philippe Stas, PhD, Chief Operating Officer, ALGONOMICS

9:00

Bridge or Not Bridge: Lessons Learned From Selection of ELISA Formats For Measuring Immunogenicity of a Therapeutic Protein in Preclinical And Clinical Trials

Xing Li, PhD, Senior Scientist, VIRON THERAPEUTICS

9:30

Immunogenicity Validation for a Protein Therapeutic, Case Study of Sandwich ELISA and Sample Analysis: Lessons Learned

Lynne LeSauteur, PhD, Scientific Director, Immunology, Laboratory Sciences, CHARLES RIVER LABORATORIES PRECLINICAL SERVICES

10:00

30-Minute Morning Break

10:30

Comparison of Enzyme-linked and Electrochemiluminescent Immunoassays

Deborah Finco-Kent, Immunoassay Coordinator, Immunotoxicology Lab, Safety Sciences, PFIZER

11:00

Novel Approaches to Overcoming Immunogenicity Challenges

Pankaj Oberoi, PhD, Director, Scientific Service, MESOSCALE DISCOVERY

11:30

Assay Comparison Panel Discussion
Comparison of Enzyme-linked, Electrochemiluminescent Immunoassays and Surface Plasmon Resonance Tools in Immunogenicity Studies

Panelists:
Joleen White ,Scientist II BioAnalytical Sciences BIOMARIN

An Song, PhD, Scientist, GENENTECH

Michael Moxness, PhD, DABCC, Principal Scientist, AMGEN

Pankaj Oberoi, PhD, Director, Scientific Services, MESOSCALE DISCOVERY

12:15Networking Luncheon
1:15

Panel Discussion
Outsourcing Immunogenicity Studies, Can It Be Done?

Panelists represent:

CHARLES RIVER LABORATORIES
ALGONOMICS

1:45

 

 

2:15

 

Strategies for the Rational Development of a Pre-Clinical Immunogenicity-Testing Platform

Maria Barbosa, Ph.D. President and CEO. CA CONSULTANTS

Pre-Clinical Assessment and "De-Risking" of Immunogenicity

Harald Kropshofer, PhD, Global Coordinator Immunosafety, F. HOFFMANN LA ROCHE



3:00

Conference Concludes



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