Cambridge Healthtech Institute’s 12th Annual
Immunogenicity Assessment and Regulatory Approval of Biologics
( 生物制剂的免疫原性评估和监管机构核准 )
Achieving Assay Quality and Clinical Success of Novel Biologics
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.
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
Presentation to be Announced