Science Researcher Update: Spotlight on Meetings, Conferences, and Events

 

Workshop - Munich, Germany

 

This is the 3rd immunogenicity-related workshop of EUCRAF. The first dealt with the scientific basis of immunogenicity, its immunological fundamental, the methods used in determining immunogenicity and the approaches available to engineer novel molecules towards low immunogenicity potential. The second workshop provided insights into how to present immunogenicity data in the regulatory dossier, how to prepare an integrated discussion of immunogenicity data and how regulatory agencies evaluate the immunogenicity data package as part of the benefit-risk assessment.

The 3rd event of this series focuses on the clinical parameters that need to be considered in designing clinical studies to receive a database for the interpretation of immunogenicity data. Discussion into product-specific such as biosimilars will be addressed on how clinically significant signals can be complemented by post-approval monitoring. Upon completion of this session, attendees should be able to:

Explain how anti-drug antibodies can affect PK/PD properties of biologics
Describe which clinical parameters need to be built into clinical studies to discuss and interpret immunogenicity
Analyse the anti-drug antibody response and its impact on clinical parameters

Organization: EUCRAF

 

 

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