Cambridge Healthtech Institute’s Ninth Annual
Immunogenicity Assessment & Clinical Relevance
Overcoming Challenges for Meaningful Evaluation
October 24-25, 2017 | The Westin Alexandria | Washington, DC
The generation of meaningful immunogenicity data with clinical relevance is beset with many challenges. Top of the list for 2017 is the challenge of cut point determination and assay validation. This conference addresses this with several case studies and a discussion with the FDA. A close second in the list of challenges is management of drug and target interference in the assay in both clinical and non-clinical studies. The third is Nab assays which continue to improve and evolve. There is uncertainty about when these should be implemented, their usefulness, how much time to devote to them and how to deal with all the variation. The fourth is the presence of pre-existing positive ADA activity in study patients as investigators have difficulty distinguishing between these and potential immune responses to the drug. The final is determining the relationship between assay data and the clinical outcome, particularly the impact on PK and efficacy.
This event will present industry case studies on how these challenges are addressed for a range of products, so that immunogenicity data can be assessed and presented to the regulatory authorities in a meaningful way.
Immunogenicity and Gaining Regulatory Approval for a Biosimilar
Susan Kirshner, Ph.D., Associate Chief, Immunology Lab, Therapeutic Proteins, Biotechnology, FDA/CDER
Case Study on Dealing with the Critical Issues in Assay Validation: The Devil is in the Detail
Don Zhong, Ph.D., Senior Scientist, PKDM Bioanalytical Sciences, Amgen, Inc.
Is There a Minimum Cut Point Value for an Immunogenicity Assay?
Robert J. Kubiak, Ph.D., Senior Manager, R&D, Translational Science, MedImmune LLC
Generating Clinically Relevant Immunogenicity Data: Setting Appropriate Assay Cut Points and Categorizing ADA Positivity
Michael Partridge, Ph.D., Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals
Cutpoints and Clinical Interpretation of Immunogenicity
Viswanath Devanarayan, Ph.D., Director, Global Exploratory Sciences, Abbvie
Discussion with the FDA on Current Recommendations on the Setting of the Cutpoint
Susan Kirshner, Ph.D., Associate Chief, Immunology Lab, Therapeutic Proteins, Biotechnology, CDER/FDA
Development of an ADCC-Based Neutralizing Antibody Assay
Shan Chung, Ph.D., Senior Scientist and Group Leader, BioAnalytical Sciences, Genentech, Inc.
Case Study on Multiple NAb Assays for Enzyme Replacement Therapies
Lakshmi Amaravadi, Director, Bioanalytical Sciences and Biomarkers, Sanofi
To NAb Assay or not to NAb Assay
Lauren Stevenson, Ph.D., Director, Translational Sciences, Biogen Inc.
Case Studies on Managing Drug Target Interference
Mauricio Maia, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc.
Experiences with Pre-Existing Antibodies with a Multi-Domain Protein
Jim McNally, Ph.D., Associate Director and Immunogenicity Expert, Global Early Development, Quantitative Pharmacology & Drug Disposition, EMD Serono
Challenges and Case Studies in Immunogenicity Assessment for Ultra-Rare Diseases
Tressa Allington, Ph.D., Development Scientist, Bioanalytical Development, Alexion
Development of Multiplex Sensitive ADA Assays for CRISPR/Cas9 Gene Therapies
Junxia Wang, Ph.D., Associate Director, Preclinical Sciences, Editas Medicine
Clinical Immunogenicity of a Checkpoint Inhibitor
Theresa Goletz, Ph.D., Director, Clinical Immunology, EMD Serono
Immunogenicity Challenges in Clinical Development of Biotherapeutics
Rong Zeng, Ph.D., Director, Bioanalytical Sciences, OncoMed Pharmaceuticals
For more details on the conference, please contact:
Nicole Lyscom Ph.D.
Senior Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Cambridge Healthtech Institute