Intro to Immunogenicity: Keys to Safe and Effective Drug Development

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

Presenter's Biography:
Gopi Shankar | Sr. Director, Janssen BioTherapeutics
Dr. Shankar is a Senior Director at Janssen BioTherapeutics (a division of Johnson & Johnson), where he heads the Bioanalytical Sciences & Immunogenicity department. A world-renowned expert in the field of immunogenicity, Dr. Shankar has published in the areas of basic immunological research and technical, strategic and regulatory best practices. He is a prominent member of the American Association of Pharmaceutical Scientists (AAPS) and has led or contributed to several highly impactful scientific advances in immunogenicity, including 6 industry whitepapers and a chapter in the United States Pharmacopeia. His research, consensus-building efforts and best-practice publications, both independently and via AAPS, have transformed the thinking and tactical processes related to immunogenicity around the globe.
Connect with Gopi:


Agenda:
11:30 AM | Registration Opens, Networking Lunch
12:00 PM | Presentation
12:45 PM | Q&A
1:00 PM | Program Close


Who Should Attend:
This workshop is ideal for inventors in academic centers and hospitals, and early stage healthcare start-ups


Fees:
$20 | Students/Academic
$25 | General Public
$35 | At the door