Cambridge Healthtech Institute’s 12th Annual

Immunogenicity Assessment and Regulatory Approval of Biologics

Achieving Assay Quality and Clinical Success of Novel Biologics

April 10-11, 2019

 

Immunogenicity has always been a critical safety concern, especially when many biotherapeutics are becoming increasingly complex. Understanding and controlling immunogenicity-related risks are essential in the development of biotherapeutics to ensure meeting the regulatory requirements. The 12th Annual Immunogenicity Assessment and Regulatory Approval of Biologics conference brings industry, regulatory and scientific experts together to share best practices in assessing immunogenicity of novel biologics along with biosimilar products. The session will also discuss the challenges and solutions for addressing new regulatory guidelines in assay development and validation for cell and gene therapies.

Preliminary Agenda

MITIGATING STRATEGIES FOR ADA CUT-POINT

Mitigation of Low Cut-Point for Immunogenicity Evaluation

John Kamerud, PhD, AR Fellow, Director, Bioanalytical, Pfizer

Strategies for Setting Cut-Points for ADA Assays in Multi-Tier Vs. Single-Tier Testing in a Routine Clinical Setting

Theo Rispens, PhD, PI Antibody Structure and Function, Sanquin

Validation of ADA Assays and Cut Point Calculations

Viswanath Devanarayan, PhD, Global Head, Charles River Labs

PREDICTION OF IMMUNOGENICITY

An FDA Perspective: How to Streamline Preclinical and Clinical Assessment in Immunogenicity?

Joao A. Pedras-Vasconcelos, Biotech Quality & Immunogenicity Reviewer, CDER, FDA

Application of Mechanistic Modelling to Prediction of Immunogenicity

Timothy Hickling, PhD, Immunogenicity Sciences Lead, Biomedicine Design, Pfizer, Inc.

ASSAY FORMATS AND TITERING ASSAYS

Assay Strategies to Analyse New Antibody Therapeutics in Preclinical and Clinical Studies

Kay Stubenrauch, PhD, Expert Scientist, Pharma Research & Early Development pRED, Pharmaceutical Sciences, Large Molecule Bioanalytical R&D, Roche Innovation Center Munich

Mab Assays for Immunogenicity Assessment

Don Zhong, PhD, Associate Director, Teva Therapeutics

PANEL DISCUSSION: Current Considerations for Developing Effective Assay Formats - How Predictive is Your Assay?

Moderator: Theo Rispens, PhD, PI Antibody Structure and Function, Sanquin

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Presentation to be Announced

 

Presentation to be Announced

 

 

* The program is subject to change without notice, due to unforeseen reason.

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