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Assessment of immunogenicity is a real challenge for the biotherapeutics industry. Every year at Immunogenicity at PEGS we present NEW findings and NEW case studies. Furthermore, we encourage NEW speakers to participate; from industry and from academia, including regulatory experts. In this track on Immunogenicity Assessment and Clinical Relevance, we present real examples of immunogenicity assessment in preclinical studies and in the clinic for a range of products, and examine the many challenges encountered and overcome. We also present recommendations for presenting immunogenicity data to the regulatory authorities.


MEETING REGULATORY EXPECTATIONS REGARDING IMMUNOGENICITY ASSESSMENT: WHAT IS THE ESSENTIAL STRATEGY 

KEYNOTE PRESENTATION: AAPS Sub-Committee Recommendations on Presentation of Immunogenicity Data in the BLA

Meena Subramanyam, Ph.D., Vice President, Translational Sciences & Technology, Biogen Idec, Inc.


CHALLENGES IN DEVELOPING NEUTRALIZING ANTIBODY (NAb) ASSAYS  

Driving Factors for Choice of Immunogenicity/NAb Strategy

Shalini Gupta, Ph.D., Director, Clinical Immunology, Amgen, Inc.


STRATEGIES FOR OVERCOMING DRUG AND TARGET INTERFERENCE 

Advances in Evaluation of Drug Tolerance of NAb Assays

Christian Vettermann, Scientist, Clinical Immunology, Amgen, Inc.

Strategy for Overcoming Target Interference throughout Development

Olivier Petricoul, Senior Investigator II, DMPK, Clinical PK/PD, Novartis Institutes for Biomedical Research

Case Studies on Troubleshooting Immunogenicity Assays in the Clinical Space

Qiang Qi, Pfizer, Inc.


EXPERIENCES WITH IMMUNOGENICITY ASSESSMENT CHALLENGES IN THE CLINIC 

Evaluation of Pre-Existing Antibodies: How Meaningful is the Investigation?

Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine, Biogen Idec, Inc.


IMMUNOGENICITY STRATEGY AND ASSAY METHODOLOGY FOR VARIOUS PRODUCTS 

Development of Neutralizing Antibody Assays for Antibody Therapeutics with Cell Depletion MOA

Shan Chung, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech – A Member of the Roche Group

Immunogenicity of Elosulfase Alfa, an Enzyme Replacement Therapy in Patients with Morquio A Syndrome: Results from MOR-004, a Phase 3 Trial

Becky Schweighardt, Ph.D., Director, Immunogenicity Assessment, BioMarin Pharmaceutical, Inc.

Case Study on Characterization of Immunogenicity to Multiple Domain Biotherapeutics

Boris Gorovits, Ph.D., Director, PDM, Pfizer, Inc.


NEW AND INTERESTING STUDIES 

Evaluation of Antibodies of IgE Isotype to Xolair and Correlation to Anaphylaxis

Sally Fischer, Ph.D., Senior Scientist and Group Leader, Assay Development and Technology, Genentech, Inc.


For more details on the conference, please contact:
Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute
T: +44 7791 866489
E: nlyscom@healthtech.com 

For partnering and sponsorship information, please contact:
Jason Gerardi (Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452
E: jgerardi@healthtech.com 

Carol Dinerstein (Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com