Dear all,
Thanks to
@Susan Richards and
@Joleen White 's willingness to share their expertise and experience, the AAPS Immunogenicity Risk Assessment and Integrated Summary of Immunogenicity webinar is approved, and it's scheduled for 12:30 pm – 2 pm EST on Dec 6, 2022. Please follow this link (
https://www.pathlms.com/aaps/webinars/31540) to register and view the details of this webinar. Please help spread the word through your network.
Thank you.
Yi
DESCRIPTION
Biotherapeutics have the potential to elicit undesired immune responses, i.e., immunogenicity. For more traditional biological modalities, including antibodies, proteins, and peptides, immunogenicity is often referred to anti-drug antibodies (ADA). ADA can negatively impact the PK, efficacy, and safety of biotherapeutics. Therefore, an immunogenicity assessment is performed during stages of the drug development process, utilized for IND/CTA submission and as part of the Integrated Summary of Immunogenicity (ISI) for regulatory submissions (BLA/MAA).
The special issue in the AAPS Journal, Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work, consists of 5 manuscripts from industrial experts. Each manuscript discusses risk assessment and bioanalytical strategy using a hypothetical molecule as case study. These case studies cover diverse molecule structures and risk levels, including a monoclonal antibody, a fusion protein, a bispecific antibody, a human cytokine analogue, a PEGylated enzyme, and a PEGylated growth factor. This webinar is a continuation of such efforts. The expert speakers will discuss the challenges and strategies regarding immunogenicity risk assessment, bioanalysis, and Integrated Summary of Immunogenicity and potential/proposed solutions based on their real word experience.
Learning Objectives:
- Understand the significance and potential impact of immunogenicity
- Describe the aspects of immunogenicity risk assessment
- Define the bioanalytical strategy for immunogenicity assessment during clinical development
- Identify the preparation and components of Integrated Summary of Immunogenicity
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Yi Wen Ph.D.
Research Scientist
Eli Lilly and Company
Indianapolis IN
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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