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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:

  • ADA assay Development, Validation, and interpretation (drug and target interference, pre-existing antibodies)

  • Advancements of predictive immunogenicity risk tools (in vitro, in silico) and lessons learned with implementation

  • Bioanalytical Strategies for New Modalities 

  • Highlights from and comments around 2022 FDA Immunogenicity Labeling Draft Guidance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 

Time (PDT)

Time (EST)

Topic

Presenter

8:30-8:45 am 

11:30-11:45am 

Welcome & Workshop Introduction

Ola Saad & Sivan Cohen

8:45-9:15 am 

11:45-11:15am 

Immunogenicity Risk Assessments to Drive the Bioanalytical Strategy for Novel Modalities

Vibha Jawa, Executive Director, BMS

9:15-9:45 am 

12:15-12:45pm 

Immunogenicity of AAV Vectors in Gene Therapy

Ronit Mazor, Principal Investigator, CBER, FDA

9:45-10:15 am 

12:45-1:15 pm 

Recent Updates to HLA-II Prediction Algorithms, and Their Application to Assess the Immunogenicity Risk of Biotherapeutics

Morten Nielsen, CEO EIR Sciences; Professor at DTU

10:15-10:30am

1:15-1:30pm

Break

 -

10:30-11:00am

1:30-2:00pm

Early In Vitro Immunogenicity Assessment Tools

Sofie Pattyn, Chief Technology Officer, ImmunXperts a Q2Solutions Company

11:00-11:30am

2:00-2:30pm

DC Internalization and Innate Activation for Immunogenicity Risk Assessment of Antibodies

Yi Wen, Advisor, Eli Lilly

11:30-12:00pm

2:30-3:00pm

Use of In Vitro Cell Based Assays to Assess Potential Immunogenicity Risk of Critical Quality Attributes 

Cathie (Dong) Xiang, Scientist, Amgen

12:00-12:30pm

3:00-3:30pm

PANEL DISCUSSION

All speakers

 

Sep. 16th 

Time (PDT)

Time (EST)

Topic

Presenter

8:30 -8:45 am 

11:30-11:45am 

Day 2 Welcome & Introduction

Ola Saad & Sivan Cohen

8:45 -9:15 am 

11:45-11:15am 

Immunogenicity of Biologic Therapeutics & Clinical Relevance

Steve Swanson, Senior Principal Scientist, Genentech

9:15 -9:45 am 

12:15-12:45pm 

Immunogenicity Information in Labeling- Highlights from the New FDA Draft Guidance

João Pedras-Vasconcelos, Product Quality and Immunogenicity Senior Staff Fellow, CDER, FDA

9:45-10:15 am 

12:45-1:15 pm 

LC/MS for ADA Analysis: Simultaneous Quantitation and Isotyping and Beyond

Lin-zhi Chen, Sr. Research Fellow/ Bioanalytical Group Leader; Boehringer Ingelheim Pharmaceuticals, Inc.

10:15-10:30am

1:15-1:30pm

Break

 

10:30-11:00am

1:30-2:00pm

Investigating the Clinical Relevance of the Immunogenicity for a Bispecific Antibody 

Wenyu Liu, Senior Scientist, Genentech

11:00-11:30am

2:00-2:30pm

Challenges in the Assessment of Biosimilar Immunogenicity Data 

Francesca Civoli, Vice President Bioanalytical Sciences, CoherusBioSciences

11:30-12:00pm

2:30-3:00pm

Immunogenicity Profile of the Port Delivery System with Ranibizumab

Mauricio Maia Senior Principal Scientist, Genentech

12:00-12:30pm

3:00-3:30pm

PANEL DISCUSSION

All Speakers


2022-10-21, [Free Online Workshop] MicroPhysiological Systems (MPS) such as "Organ-on-a-Chip" as a Tool For Drug Candidate Evaluation: Technologies, Applications and Regulatory Aspects
2022-11-02, [Free Online workshop] Bispecific Antibodies: Discovery, Engineering, Development and Regulatory Considerations
2022-11-14, [Free Online Symposium] Preclinical and Clinical Development of Cell-based Cancer Immunotherapies: Discovery, Translational PKPD, Safety, Biomarkers, Immunogenicity, CMC, Clinical Pharmacology & Clinical Trials (co-organized by AAPS)
2022-12-06, [Free Online Symposium] Gene Therapy: Discovery, Development and Regulatory Perspectives
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