Monday, October 23
Morning | 10:00 AM - 1:00 PM
SC1: Mechanism of Action and Risk Based Approach for Developing Neutralizing Ab Assays - Detailed Agenda
Instructors: Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
Shan Chung, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc.
The development of neutralizing antibody assays is a daunting task that is complicated by the specific nature of each biotherapeutic. Many factors must be assessed to choose the proper assay format, to develop a robust assay, and to decide when to invest in the development and implementation of these assays. This short course will focus on these topics and provide examples of current industry practices and publications. Specific focus will be given to a mechanism of action based approach to selecting the assay format, and relevant case studies will be provided.
Afternoon | 2:30 - 5:30 PM
SC2: Overcoming Drug Target Interference in ADA Assays - Detailed Agenda
Instructors: Jim McNally, Ph.D., Associate Director,DM Immunogenicity Expert, EMD Serono
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.
TUESDAY, OCTOBER 24
dinner SHORT COURSE | 6:30 - 9:30 PM
SC3: Validation of ADA Assays and Cut Point Calculations - Detailed Agenda
Instructors: Viswanath Devanarayan, Ph.D., Executive Director, Head of Global Statistics, Charles River Laboratories
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
This short course will focus on the validation of ADA assays and cut point evaluations. We will provide an in-depth overview of the basic considerations around ADA assay validation, with significant focus on the process of evaluating different types of cut-points, and the translation of the cut-point established during validation to real world implementation during a preclinical or clinical study.
Wednesday, October 25
dinner SHORT COURSES | 6:15 - 9:15 PM
SC4: Advice on Putting Together an Integrated Summary of Immunogenicity - Detailed Agenda
Instructors: Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER-FDA
Bonnie Rup, Ph.D., Bonnie Rup Consulting LLC
The purpose of this workshop is to share experience gained in preparing and reviewing the “Integrated Summary of Immunogenicity”, and to provide case examples to illustrate the multi-disciplinary information that is most useful for the regulator assessing the scale of risk of undesirable immunogenicity for overall clinical benefit vs. risk. It will examine the sponsor team's role and provide examples of how to address potential issues (and avoid introducing any new ones!) by generating a well-thought-out and constructed integrated summary.
SC5: A Systems Pharmacology Approach for Immunogenicity Prediction - Detailed Agenda
Instructors: Xiaoying Chen, Ph.D., Senior Manager, Clinical Pharmacology, Pfizer, Inc.
Vibha Jawa, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck and Co., Inc.
Designing biologics to have minimal immunogenicity with no clinical impact is an aspirational goal for therapeutic protein development. This short course will provide a fundamental understanding of systems-based approaches, and discuss the current state of predictive technologies for immunogenicity risk assessments. The course will showcase how immunogenicity risk factors such as genetic makeup of individuals, disease, and indications can all be integrated into the systems-based approach for simulating clinical outcomes.
SC6: Strategic/Modular Bioassay Design and Analysis - Detailed Agenda
Instructor: David Lansky, Ph.D., President, Precision Bioassay, Inc.
This course will be a review of what is known about how bioassays (how they are both inherently robust and non-robust) yields good choices of targets for assay development and properties of bioassays to use for assay acceptance and monitoring. Modular design (and appropriate analyses) supports efficient and flexible procedures for development, qualification, validation (including robustness testing), transfer, and monitoring as well as supporting easy tuning of assay performance properties of reported values for various intended uses.
*Separate registration required.