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Intro to Immunogenicity: Keys to Safe and Effective Drug Development

South San Francisco, CA

10/4/2018

11:30am - 1:00pm

Biologic therapies have changed the face of how we treat patients, but a crucial consideration when developing these therapies is immunogenicity. The administration of therapeutic proteins and peptides often leads to the induction of immunogenicity – that is, the patient’s immune system reacts to the administered therapeutic by producing anti-drug antibodies (ADAs) that neutralize the drug or accelerate clearance. This can lead to a lack of efficacy or a risk of adverse reactions upon subsequent exposure to the drug, such as infusion reactions and anaphylaxis, immune-complex-mediated diseases, and on rare occasions, even more serious effects.

Evaluating ADA immune responses and their characteristics relative to clinical consequences is critical. Johnson & Johnson Innovation, JLABS (JLABS) and Janssen BioTherapeutics invite you to an introduction to immunogenicity and risk-based bioanalytical approaches.

Topics covered include:

Scientific and regulatory importance of immunogenicity
Factors that cause immunogenicity
Risk-based approach to immunogenicity evaluations
Study phase based approach to immunogenicity evaluations
Test methods and caveats

Click Here for More Information

Contact: Nikki Sarantinos
Contact Email: nsarant1@its.jnj.com

Event Address:

JLABS @ SSF
329 Oyster Point Blvd.
Floor 3
South San Francisco, CA
94080