MONDAY, OCTOBER 23
AFTERNOON | 2:30 – 5:30 PM

SC2: Overcoming Drug Target Interference in ADA Assays

Instructors:

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

Jad Zoghbi, Ph.D., Senior Scientist, Biomarkers and Clinical Bioanalysis, Sanofi

Soluble drug or drug target can often interfere in the detection of anti-drug antibodies. Although not always straightforward, it can be addressed and mitigated in a properly designed immunoassay. This short course will give an overview of the different types of interferences and current methodologies and approaches being utilized to resolve or reduce them.

To include:

• Types of interferences
• Immunogenicity assay designs and susceptibility to interference
• Mitigation strategies
• Case Studies

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

Until recently, Jim McNally was a QPD Program Representative, Head of Clinical Bioanalytics, and Immunogenicity Expert. In this role, he was 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.

Jad Zoghbi, MS., Principal Scientist, Biomarkers and Clinical Bioanalyses, Sanofi

Jad Zoghbi is a Principal Scientist in the Boston-Biomarker and clinical Bioanalyses group at Sanofi. In his role, he contributes to program biomarker strategy as well as manages a group responsible for the implementation of preclinical and clinical bioanalytical support. Jad holds a MS degree from California State University and more than 15 years of industry experience in Immunogenicity, PK, and Biomarkers assay development and validation.