SC3: Validation of ADA Assays and Cut Point Calculations
TUESDAY, OCTOBER 15 | 6:30 – 9:30 PM
Instructors:
Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
Angela Yang, PhD, Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.
This short course will focus on the validation of ADA Assays and Cut Point evaluations. We will provide an in-depth overview of the basic considerations around ADA assay validation, with significant focus on the process of evaluating different types of cut-points, and the translation of the cut-point established during validation to the real-world implementation during a pre-clinical or clinical study.
- Tiered Testing Strategy - Basic issues regarding screening, confirmatory and titer assays
- ADA Assay Validation Strategies – Experimental Design to execute a validation
- Stepwise process for calculating different types of cutpoints
- Practical challenges for the in-study implementation of cutpoints
- Case Studies related to the implementation of validation and study specific cutpoints
Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics
Jim McNally is Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics. He gained extensive experience in immunogenicity strategy, bioanalytical support and scientific oversight of outsourcing of large molecule programs at EMD Serono and at Shire. Previously, he was the lead of the Clinical Assay Development, Validation and Testing bioanalytical group at Pfizer based in Andover, MA. The group was responsible primarily for developing assays to support pharmacokinetic and immunogenicity analysis of the Pfizer large molecule portfolio. Prior to joining Pfizer in 2010, Jim held similar roles in the Clinical Lab Sciences group at Genzyme and Immunobiology group at Repligen. A graduate of the Microbiology and Virology Ph.D. program at LSU Medical Center in 1998, Jim has a special interest in immunomodulation and immunogenicity of biotherapeutics.
(Angela) Qi Yang, PhD, Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals
Angela Yang is a Scientist in the Bioanalytical Sciences department at Regeneron. She received a Ph.D. from the University of North Carolina at Chapel Hill, where she studied interactions between PEGylated nanoparticles and the immune system. At Regeneron, Angela has worked on the development and validation of PK, ADA, and neutralizing antibody assays in support of clinical and non-clinical studies, as well as developing tools for data analysis of immunogenicity assays.