SC3: Validation of ADA Assays and Cut Point Calculations
MONDAY, OCTOBER 22 | 6:15 - 9:15 PM
Instructors: Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
Michael Partridge, PhD, Senior Staff 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 preclinical or clinical study.
Topics covered include:
- 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 cut points
- Practical challenges for the in-study implementation of cut points
- Case studies related to the implementation of validation and study specific cut points
Speaker Biographies
Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
Jim McNally is a QPD Program Representative, Head of Clinical Bioanalytics, and Immunogenicity Expert. In this role, he responsible for the immunogenicity strategy, bioanalytical support and scientific oversight of outsourcing of large molecule programs for EMD Serono. 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.
Michael Partridge, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.
Born and raised in Australia, Michael received his Ph.D. from Sydney University (CSIRO) developing immunoassays to screen for genetic variants in plants. He moved to the US for a post doc at Columbia University where he investigated integrin-mediated cell signaling and motility. He went on to study tumorigenesis and eventually develop immunoassays to detect biomarkers of radiation exposure. Michael left academia to work in industry, and for the last 9 years at Regeneron he has lead a group of scientists developing and validating PK, ADA, Nab and biomarker immunoassays for nonclinical and clinical studies with biologics.