SC2: Overcoming Drug Target Interference in ADA Assays
MONDAY, OCTOBER 22 | 2:30 - 5:30 PM
Instructors: Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
Lilia Macovei, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
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.
Topics covered include:
- Types of interferences
- Immunogenicity assay designs and susceptibility to interference
- Mitigation strategies
- Case studies
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.
Lilia Macovei, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
Lilia earned Ph.D. in Molecular Biology from the University of Agricultural Sciences and Veterinary Medicine, Cluj-Napoca, Romania and later completed postdoctoral research studies in Microbiology, Infectious Diseases and Immunology at The Forsyth Institute/Harvard Medical School.
Lilia’s expertise includes non-regulated and regulated bioanalytical support for the Pfizer WRD Large Molecules biotherapeutic portfolio. She worked in in the development and validation of PK and Immunogenicity Assessment Assays (ADA and cell-based neutralizing antibody) for non-clinical GLP IND enabling and clinical studies. She is experienced with a broad range of biotherapeutic modalities and diseases, including monoclonal antibodies, fusion proteins, bi-specifics, antibody drug conjugates, enzyme replacement therapeutics (ERT) using diverse viral vector platforms and chimeric antigen receptor T-cell (CART) therapies.