Bioanalytics – Biomolecular
Lauren Stevenson, PhD (she/her/hers)
Chief Scientific Officer
Immunologix Laboratories
Tampa, Florida
Jenny Valentine, PhD (she/her/hers)
Principal Scientist
Regeneron Pharmaceuticals
Tarrytown, New York
Laura Salazar-Fontana, PhD (she/her/hers)
Principal
LAIZ Regulatory Science Consulting
Lausanne, Vaud, Switzerland
Michael Partridge, PhD
Director
Regeneron
Tarrytown, New York
Kyra Cowan, PhD
Senior Director, Global Head of NBE DMPK
Merck KGaA
Frankfurt am Main, Hessen, Germany
The emergence of new biotherapeutic product modalities has resulted in the need to evaluate immunogenicity in contexts that were not imagined when the current three-tiered immunogenicity testing paradigm for therapeutic proteins was developed two decades ago. With the benefit of collected experience and data sets from implementation of that paradigm for the last 20 years, the timing is perfect to revisit our original assumptions, evaluate what we have learned, and develop a thought risk-based framework that can meet the ever-expanding needs of 21st century drug development.
As defined by BEST (The Biomarkers, EndPointS and other Tools, BEST glossary) a biomarker is a characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. This session will introduce the concept that immunogenicity assays are in fact biomarker assays given that they are measuring responses to an exposure or intervention, and as such, an understanding of the specific context of use for the data should be understood to ensure the developed assays meet the needs of the question being asked. Presenters will provide context from traditional modalities as well as brief case studies/vignettes from new modalities that highlight this concept. As examples, for virus-mediated gene therapy products, pre-existing anti-virus antibodies are presently being considered for some developers as a susceptibility/risk factor for patient enrollment criteria and for immune-modulatory drugs, such as check-point inhibitors, ADA responses can be leveraged as part of the pharmacodynamic effect of the drug. A specific case study for a drug modality that incorporates a virus-like particle where ADA can be considered a biomarker and has the potential to be linked with efficacy and/or used as a surrogate for PK will be described in more detail.
The presentation portion of the session will conclude with discussion on how to take a context-of-use approach, leveraging lessons learned from the biomarker realm to craft a risk-based framework by which scientists and regulators can also evaluate immunogenicity of new product modalities. Presentations will be followed by a 30-minute panel discussion/roundtable to discuss the associated technical, scientific, regulatory and organizational cultural challenges posed by a shifting paradigm.
Please note that there will be 3 named speakers (listed in this submission) but there are two additional experts intended to be included in the panel/roundtable discussion, Dr. Michael Partridge and Dr. Kyra J. Cowan.