Panel discussion: immunogenicity assessment of therapeutic proteins

What will you learn?

• The platforms and techniques used to assess immunogenicity and how the choice of platform may change over time 
• The factors to consider when developing immunogenicity assays 
• The challenges associated with immunogenicity testing, including the setting of cut points 
• How to overcome regulatory guidance hurdles 

Who this may interest?

• Bioanalytical Scientists interested in preclinical and clinical immunogenicity analysis
• Scientific Group Leaders managing bioanalytical technologies for immunogenicity programs

Robert Kernstock, PhD, MBA
Director, Bioanalytical Science
ICON Bioanalytical Laboratories (NY, USA)

Robert has been in the bioanalytical field since 2008, focusing on pharmacokinetic, immunogenicity and biomarker assays. His current role focuses on the science of bioanalysis, considering the increase in novel therapeutic modalities and instrumentation used to support bioanalytical activities. He spent 8 years in the pharmaceutical industry and the remaining years at contract research organizations supporting clinical and non-clinical development. Robert is extremely passionate about helping new medicines reach the market to aid patients’ unmet medical needs. He is an active member of the American Association of Pharmaceutical Scientists (AAPS), the Global CRO Consortium (GCC) and was named a We Work for Health Champion (PhRMA) in 2014. Robert received his MBA from Xavier University and his PhD from the University of Toledo (both OH, USA).

Rita Martello
Scientific Director, NBE DMPK
Merck KGaA (Darmstadt, Germany)

Rita earned her PhD at the University of Konstanz (Germany) and gained experience in bioanalysis at Bayer (Leverkusen, Germany) and Sanofi (Paris, France), pushing LC–MS technology for the analysis of biotherapeutics. At Merck KGaA, Rita works as DMPK Lead and is responsible for nonclinical PK and immunogenicity strategy from discovery to clinic. Besides her role, she is also the Head of External DMPK Leads, overseeing many externalized NBE DMPK deliverables in the clinical stages. She is also an active member of several AAPS working groups.

Jenny Valentine
Senior Principal Scientist, Bioanalytical Sciences
Regeneron Pharmaceuticals, Inc (NY, USA)

Jenny Valentine currently works in the Bioanalytical Strategy Group at Regeneron, where she leads bioanalytical strategy for multiple clinical programs in oncology that utilize both traditional and emerging drug modalities. She has 9 years of experience in large molecule bioanalysis, with previous roles in immunogenicity assay development, validation and sample testing. Jenny earned her PhD in Chemistry from Yale University (CT, USA) and is an active participant in several AAPS working groups.

Stephen Bradley 
Biomarker and Bioanalytical Lead, Genomic Medicines
Alexion (MA, USA), part of AstraZeneca (Cambridge, UK)

Stephen has more than 20 years of experience across pharma, biotech, contract research and diagnostics and has a diverse background in managing all bioanalytical aspects of drug development. As an SME in the fields of bioanalysis and immunogenicity, he has broad expertise from discovery to market approval with successful regulatory submissions. Additionally, Stephen has worked in fields spanning oncology, immunology and ophthalmology and more recently in rare diseases. He is also a Consultant in the immunogenicity field and has effectively built immunogenicity platforms for standardized analysis and reporting, as well as translational risk assessment strategies utilizing cytokine release and T-cell activation assays.

Madhukar Aryal
Associate Director, Bioanalytics & Immunogenicity Assessment
Vir Biotechnology, Inc (CA, USA)

Mr. Madhukar is currently affiliated with VIR Biotechnology as Associate Director of Bioanalytics and Immunogenicity Assessment and has over 15 years of experience in the biotechnology industry. Previously, he worked at Amunix (now Sanofi; Paris, France) and BioMarin (CA, USA), where he drove bioanalytical strategies, assay development and assay implementation for various therapeutic modalities including monoclonal antibodies, bispecific antibodies, pegylated proteins and AAV gene therapies.