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CHI's Immunogenicity Assessment & Clinical Relevance Conference - Immunogenicity and Bioassay Summit 2016


 
Cambridge Healthtech Institute’s Eighth Annual
Immunogenicity Assessment & Clinical Relevance
Overcoming Challenges for Reliable Immunogenicity Evaluation

   October 26-27, 2016 | Hyatt Regency Baltimore | Baltimore, Maryland 
Part of CHI's Immunogenicity and Bioassay Summit 2016

The goal of developing a biotherapeutic that is safe and efficacious and receives regulatory approval with few hurdles is beset with challenges. Management of interfering drug in the ADA assay is clearly a common difficulty, together with the timing and protocol for neutralizing antibody assays, and the clinical significance of all immunogenicity assays, particularly in the presence of pre-existing drug. CHI's Eighth Annual Immunogenicity Assessment & Clinical Relevance conference presents approaches from leading Pharma and Biotech and from the clinic for a wide range of products: enzyme replacement therapies, multi-domain antibody products, ADCs, Pegylated biotherapeutics, Botulinum neurotoxins and anti-TNF monoclonal antibodies. The FDA and NDA Advisory Board will present the regulatory perspectives for innovators and biosimilars.

Preliminary Agenda


REGULATORY AND INDUSTRY PERSPECTIVES ON IMMUNOGENICITY
ASSESSMENT FOR INNOVATORS AND BIOSIMILARS

Current FDA Perspectives on Immunogenicity Risk Assessment and Regulatory Strategy

Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER/FDA

Challenges in Assessing Relative Immunogenicity for Biosimilars and for Manufacturing Change

Paul Chamberlain, NDA Advisory Board


PRE-EXISTING ANTIBODY

Determination of the Clinical Significance of Pre-Existing Antibodies

Li Xue, Ph.D., Principal Scientist, Pharmacokinetics Dynamics & Metabolism –NBE, Pfizer, Inc.


APPLICATION AND SIGNIFICANCE OF NEUTRALIZING ANTIBODY ASSAYS

Neutralizing Antibody Titers Measured with a Cell-Based Flow Cytometry Assay Show No Association with Reduced Efficacy or Pharmacodynamic Effect in Elosulfase Alfa Treated Subjects

Andrew C. Melton, Ph.D., Scientist II, Bioanalytical R&D, BioMarin Pharmaceutical, Inc.

Application of a Cell-Based Neutralizing Antibody Assay for Botulinum Neurotoxins

Samuel Pine, Ph.D., Principal Scientist, Immunology, Nonclinical and Translational Sciences, Allergan


MANAGING DRUG TOLERANCE DRUG INTERFERENCE

Method to Improve the Recovery of pH Labile Anti-drug Antibodies during Acid Dissociation and Extraction

Weifeng Xu, Ph.D., Senior Research Investigator, Bioanalytical Science-Biologics, BMS

Benefits of Waiting until Drug Levels Reach Trough before Immunogenicity Assessment

Joe Balsanek, Development Technologist, Mayo Clinic


CASE STUDIES FOR SPECIFIC PRODUCTS

Relationship between Immunogenicity, Drug Concentration, Efficacy, Safety and How this Correlates with Tests and Methods for TNF Inhibitors

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

Immunogenicity Strategy for a Multidomain Protein Containing Endogenous Counterparts

Jim McNally, Ph.D., Associate Director and Immunogenicity Expert, Global Early Development, Quantitative Pharmacology & Drug Disposition, EMD Serono

Challenges in Developing Neutralizing Antibody Assays for Antibody Drug Conjugates

Shan Chung, Ph.D., Senior Scientist, BioAnalytical Sciences, Genentech, Inc.

The Implementation of Therapeutic Drug Monitoring in Clinical Practice as a Reactive or Proactive Tool to Optimize Treatment Outcomes of Biologics

Niels Vande Casteele, Pharm.D., Ph.D., Postdoctoral Fellow, Gastroenterology, University of California, San Diego


FOCUS ON ADAs TO FACTOR VIIa

rFVIIa Analog Clinical Trial Including 3 Year Follow-Up Study in Patients with Anti-Drug Antibodies

Karin Nana Weldingh, Ph.D., Principal Scientist, Immunogenicity Assessment, Novo Nordisk A/S

Retrospective Immunogenicity Risk Prediction of Bioengineered Factor VIIa

Kasper Lamberth, Ph.D., Manager, Immunogenicity Prediction & Tolerance, Novo Nordisk A/S




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

For exhibit and sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 1 781-972-5412
Email: cbenton@healthtech.com

For media and association partnerships, please contact:
James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute
Tel: 781-972-5472
Email: jprudhomme@healthtech.com



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