A 2-part event covering developments in assay technologies, risk assessment, regulatory guidance and means of predicting and avoiding immunogenicity
PART ONE: Immunogenicity Assessment and Clinical Relevance
November 16-17
PART TWO: Immunogenicity Prediction and Mitigation
November 17-18
Update on US Regulatory Guidance
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA
European Update on Unwanted Immunogenicity of Biologicals and Biosimilars
Robin Thorpe, Ph.D., FRCPath, Head, Biotherapeutics Group, National Institute for Biological Standards and Control, UK
Clinical Immunogenicity Testing Road Map: What We’ve Learned from Clinical Studies
Sue Richards, Ph.D., Group Vice President, Clinical Laboratory Sciences, Genzyme Corp.
Innate Immune Response Modulating Impurities
Daniela Verthelyi, M.D., Ph.D., Chief, Laboratory of Immunology, Therapeutic Proteins, CDER, FDA
November 15
1: Technical Advise on Assay Development, Validation and Sample Analysis
2: Development of Neutralizing Antibody Assays
Course Instructors:
Deborah Finco, Ph.D., Immunogenicity Lead, Immunotoxicology COE, Drug Safety R&D, Pfizer, Inc.
Jaya Goyal, Ph.D., Senior Scientist, Clinical Science & Technology, Biogen Idec, Inc.
Click here for full details on both short courses.
*Separate registration is required to attend a pre-conference short course.
Quotes from previous years’ events:
“It was a stimulating meeting and a pleasure to attend.”
- Principal Investigator, FDA
“It was a great conference and I enjoyed all the talks; Good content and good networking opportunities. Nice mix of US and EU speakers."
- Principal Scientist and Director, Genentech
“A nice meeting that combined sessions with interactive discussion."
- Senior Scientist, Charles River
“Congratulations on a very well put together conference.”
- Assistant Vice President, Pfizer
“A premier event to understand and correlate immunogenicity and clinical sequelae.”
- SVP, R&D, Biometric Therapeutics Inc.
“Both conferences were extremely useful. The gamut of important topics were covered, the quality and diversity of presentations was outstanding.”
- Senior Scientist, Pfizer
“High level science, timely topics, cutting edge technology. Superb substance as to immunogenicity.”
- Director, Anon
“Program and participants, first class.”
- Immunologist, Novo Nordisk
“Great conference learned a lot.”
- Associate Director, Axion Pharmaceuticals Inc.
“The entire concept of having this summit was an excellent idea. Thank you for organizing this. I think future summits will be even more useful going forward.”
- Senior Project Manager, Protherics Inc.
“Good feel of the field, many different varied talks.”
- Immunologist, Novo Nordisk
“The best immunogenicity conference I have attended. Good / relevant program, good speakers, good delivery.”
- Business Development, Phadia AB
“Break-out interaction with FDA experts was very valuable.”
- Associate Director, Alexion Pharmaceuticals Inc.
“I learnt how other companies are dealing with the same problems as us."
- Senior Scientist, Shire
“This will better enable me to establish an appropriate assay.”
- Senior Scientist, Cephalon, Inc.