TUESDAY, OCTOBER 24
DINNER | 6:30 – 9:30 PM

SC3: Validation of ADA Assays and Cut Point Calculations

Instructors:

Viswanath Devanarayan, Ph.D., Executive Director, Global Statistics, Charles River Labs

Jim McNally, Ph.D., Principal, McNally Bioanalytical Consulting LLC

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

Viswanath Devanarayan, Ph.D., Executive Director, Global Statistics, Charles River Labs

Dr. Devanarayan has 21 years of combined pharmaceutical research experience from Eli Lilly, Merck, and AbbVie. He is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS). His statistical & data-analytic contributions span a wide range of applications across drug discovery and development, such as target identification, high-throughput-screening, genomics, proteomics, bioanalytical methods, biomarker discovery, precision medicine, companion diagnostics, and development of composite clinical endpoints. He has filed 10 patent applications, given over 100 invited talks at scientific meetings, and co-authored over 55 publications. He has published several white-papers with regulatory, academic and industry scientists on immunogenicity, bioanalytical methods, genomics, and biomarker qualification. He has recently been appointed Executive Director of Global Statistics at Charles River Labs.

Jim McNally, Ph.D., Principal, McNally Bioanalytical Consulting LLC

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.