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Workshop
[Free Online workshop] Immunogenicity of Biologic Drugs – Clinical Relevance case studies, Predictive Tools & Challenges with New modalities
Speakers:
Steve Swanson, Genentech; Yi Wen , Eli Lilly; Francesca Civoli , Coherus BioSciences; Vibha Jawa , BMS; Wenyu Liu , Genentech; Lin-zhi Chen ,Boehringer Ingelheim Pharmaceuticals, Inc.; Mauricio Maia, Genentech; Sofie Pattyn, ImmunXperts; Cathie (Dong) Xiang, Amgen; Ronit Mazor, FDA; João Pedras-Vasconcelos, FDA; Morten Nielsen, EIR Sciences, DTU
Organizers:
Ola Saad, Sivan Cohen and Surinder Kaur (Genentech, Inc.)
Date:
2022-09-15- 09/16/2022
Time:
8:30-12:30 Pacific Time
Registration fee:
Free
Location:
Online via zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2022-09-14
(it will close sooner if the seating cap is reached)
About the Topic
The Immunogenicity of Biologic Drugs workshop is a 2 half-day program aimed to promote the discussion and exchange of scientific ideas from the FDA and leading industry and academic experts on the application and clinical relevance of immunogenicity mitigation and assessment assays. Tentative topics covered in this workshop include, but are not limited to:
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ADA assay Development, Validation, and interpretation (drug and target interference, pre-existing antibodies)
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Advancements of predictive immunogenicity risk tools (in vitro, in silico) and lessons learned with implementation
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Bioanalytical Strategies for New Modalities
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Highlights from and comments around 2022 FDA Immunogenicity Labeling Draft Guidance
Note: This is an online meeting, The Zoom link will be sent to the registrants 1+ days before the event. About the Speakers
- Steve Swanson (Senior Principal Scientist, Genentech)
- Yi Wen (Advisor, Eli Lilly)
- Francesca Civoli (Vice President Bioanalytical Sciences, Coherus BioSciences)
- Vibha Jawa (Executive Director, BMS)
- Wenyu Liu (Senior Scientist, Genentech)
- Lin-zhi Chen (Sr. Research Fellow/ Bioanalytical Group Leader, Boehringer Ingelheim Pharmaceuticals, Inc.)
- Mauricio Maia (Senior Principal Scientist, Genentech)
- Sofie Pattyn (Chief Technology Officer, ImmunXperts a Q2 Solutions Company)
- Cathie (Dong) Xiang (Amgen)
- Morten Nielsen (CEO EIR Sciences; Professor at DTU - Technical University of Denmark)
- Ronit Mazor (Principal Investigator, CBER, FDA)
- João Pedras-Vasconcelos (Product Quality and Immunogenicity Senior Staff Fellow, CDER, FDA)
Agenda:
Sep. 15th
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Time (PDT)
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Time (EST)
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Topic
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Presenter
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8:30-8:45 am
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11:30-11:45am
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Welcome & Workshop Introduction
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Ola Saad & Sivan Cohen
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8:45-9:15 am
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11:45-11:15am
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Immunogenicity Risk Assessments to Drive the Bioanalytical Strategy for Novel Modalities
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Vibha Jawa, Executive Director, BMS
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9:15-9:45 am
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12:15-12:45pm
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Immunogenicity of AAV Vectors in Gene Therapy
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Ronit Mazor, Principal Investigator, CBER, FDA
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9:45-10:15 am
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12:45-1:15 pm
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Recent Updates to HLA-II Prediction Algorithms, and Their Application to Assess the Immunogenicity Risk of Biotherapeutics
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Morten Nielsen, CEO EIR Sciences; Professor at DTU
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10:15-10:30am
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1:15-1:30pm
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Break
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10:30-11:00am
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1:30-2:00pm
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Early In Vitro Immunogenicity Assessment Tools
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Sofie Pattyn, Chief Technology Officer, ImmunXperts a Q2Solutions Company
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11:00-11:30am
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2:00-2:30pm
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DC Internalization and Innate Activation for Immunogenicity Risk Assessment of Antibodies
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Yi Wen, Advisor, Eli Lilly
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11:30-12:00pm
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2:30-3:00pm
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Use of In Vitro Cell Based Assays to Assess Potential Immunogenicity Risk of Critical Quality Attributes
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Cathie (Dong) Xiang, Scientist, Amgen
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12:00-12:30pm
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3:00-3:30pm
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PANEL DISCUSSION
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All speakers
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Sep. 16th
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Time (PDT)
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Time (EST)
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Topic
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Presenter
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8:30 -8:45 am
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11:30-11:45am
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Day 2 Welcome & Introduction
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Ola Saad & Sivan Cohen
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8:45 -9:15 am
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11:45-11:15am
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Immunogenicity of Biologic Therapeutics & Clinical Relevance
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Steve Swanson, Senior Principal Scientist, Genentech
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9:15 -9:45 am
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12:15-12:45pm
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Immunogenicity Information in Labeling- Highlights from the New FDA Draft Guidance
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João Pedras-Vasconcelos, Product Quality and Immunogenicity Senior Staff Fellow, CDER, FDA
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9:45-10:15 am
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12:45-1:15 pm
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LC/MS for ADA Analysis: Simultaneous Quantitation and Isotyping and Beyond
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Lin-zhi Chen, Sr. Research Fellow/ Bioanalytical Group Leader; Boehringer Ingelheim Pharmaceuticals, Inc.
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10:15-10:30am
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1:15-1:30pm
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Break
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10:30-11:00am
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1:30-2:00pm
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Investigating the Clinical Relevance of the Immunogenicity for a Bispecific Antibody
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Wenyu Liu, Senior Scientist, Genentech
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11:00-11:30am
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2:00-2:30pm
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Challenges in the Assessment of Biosimilar Immunogenicity Data
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Francesca Civoli, Vice President Bioanalytical Sciences, CoherusBioSciences
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11:30-12:00pm
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2:30-3:00pm
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Immunogenicity Profile of the Port Delivery System with Ranibizumab
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Mauricio Maia Senior Principal Scientist, Genentech
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12:00-12:30pm
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3:00-3:30pm
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PANEL DISCUSSION
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All Speakers
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