Tuesday, May 2: with Dinner, 6:00 – 8:30
Overcoming the Challenges of Immunogenicity Assays, Risk Assessment and Regulatory Requirements
Jim McNally, Ph.D., Associate Director and Immunogenicity Expert, Global Early Development - Quantitative Pharmacology & Drug Disposition, EMD Serono
Bonnie Rup, Ph.D., Independent Consultant
This interactive session will enable attendees to work out a basic immunogenicity pre-clinical and clinical testing strategy for various molecules including ADCs, bi-specifics and other novel scaffolds. Areas of difficulty will be discussed with examples. Attendees are encouraged to contribute with their own experiences and to bring questions for discussion or submit to the meeting organizers in advance. The second part session will examine regulatory concerns including data requirements, and common pitfalls.
The following topics will be covered:
- Immunogenicity Assays
- Assay methodologies and various technologies
- Current approaches to data analysis
- Pre-clinical and clinical considerations
- Challenges and approaches to resolve commonly encountered issues
- Multi-domain binding proteins
- Pre-existing ADAs
- Immunogenicity Risk Assessment and Regulatory Concerns
- Benefits of timely discussion with the regulators
- Neutralizing antibody assays (NAbs): when are they necessary?
- The case for binding assays versus cell-based assays for NAbs
Jim McNally, Ph.D., Associate Director and Immunogenicity Expert, Global Early Development, Quantitative Pharmacology & Drug Disposition, EMD Serono
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.
Bonnie Rup, Ph.D., Independent Consultant
Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow at Pfizer, and lead the Immunogenicity Discipline, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. Bonnie is a member of AAPS, and has been a member of EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.