AGENDA - Specialized Session F1
June 26, 2020, 11am to 4pm ET: Part 1
June 29, 2020, 11am to 4:30pm ET: Part 2

"Advanced Immunogenicity Day: Implementation of 2019 FDA Immunogenicity Guidance, NAb Assays, ADA Validation Reporting, Immunogenicity Risk Assessment, Regulatory Feedbacks & Controversial Issues"

Implementation of the Guidance after a year from its issuance; Current approaches on Nab (Cell-Based and Bridging) Assays; ADA Validation Reporting; Immunogenicity Risk Assessment and impact on bioanalytical strategy; Regulatory Feedbacks on submitted studies; Inspections/audits outcomes based on the new Guidance; and Case Studies on successfully implementation in compliance with the new Guidance and avoid observations and 483s

Advanced Immunogenicity Day Part 1: June 26, 2020 (EDT time listed)

11:00am-11:10am: Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
"Introduction of Advanced Immunogenicity Day Part 1"

Immunogenicity Guidance/Guidelines and their Application to Biosimilar and Nanobodies

Chair: Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
11:10am-11:30am: Dr. Isabelle Cludts, Scientist Biotherapeutics Department National Institute for Biological Standards and Control, UK MHRA
"Current Immunogenicity Guidance/Guideline Compatibility: US FDA and/or EU EMA Requirements"
11:30am-11:50am: Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
"FDA Regulatory Perspectives on Immunogenicity Assays for Biosimilars Programs"
11:50am-12:10pm: Dr. Johann Poetzl, Group Head Bioanalytics, Sandoz
"Current Industry Standards in Bioanalysis of Biosimilars"
12:10pm-12:30pm: Dr. Samuel Pine, Head Bioanalysis and Immunogenicity, Ablynx/Sanofi
"Immunogenicity Testing of Multi-Specific Nanobodies"
12:30pm-01:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:00pm-01:30pm: Dr. Isabelle Cludts, Scientist Biotherapeutics Department National Institute for Biological Standards and Control, UK MHRA
Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
Dr. Johann Poetzl, Group Head Bioanalytics, Sandoz
Dr. Samuel Pine, Head Bioanalysis and Immunogenicity, Ablynx/Sanofi
"Panel Discussion on Immunogenicity Guidance/Guidelines"

Reflection a Year Later on the 2019 FDA Immunogenicity Guidance

Chair: Dr. Manoj Rajadhyaksha, Director Bioanalytical Science, Regeneron
01:30pm-01:50pm: Dr. Robert Kubiak, Sr. Manager R&D, AstraZeneca
"Reflection a Year Later on the 2019 US FDA Immunogenicity Guidance: How has the FDA Guidance been applied together with the EMA Immunogenicity Guideline and Best-Industry Practices? "
01:50pm-02:10pm: Dr. Sam Song, Immunogenicity Lead, Takeda
"In-study Cut Point Assessment: Dealing with Low and Very Low Cut Point"
02:10pm-02:30pm: Dr. Michael Partridge, Assoc. Director Bioanalytical Sciences, Regeneron
"Immunogenicity Monitoring for Low Risk Molecules: How Much is Needed?"
02:30pm-03:00pm: Dr. Robert Kubiak, Sr. Manager R&D, AstraZeneca
Dr. Sam Song, Immunogenicity Lead, Takeda
Dr. Michael Partridge, Assoc. Director Bioanalytical Sciences, Regeneron
Dr. Manoj Rajadhyaksha, Director Bioanalytical Science, Regeneron
"Panel Discussion on 2019 FDA Immunogenicity Guidance"
03:00pm-03:30pm: Social Networking - Time to "Visit" Exhibitors and Posters

ASK THE REGULATORS!
Interactive Panel Discussion with All the Regulators

03:30pm-04:10pm: Address any questions you have on Immunogenicity directly to the Regulator Experts
 Regulatory Panelists:
  • Dr. Joao Pedras-Vasconcelos (US FDA)
  • Dr. Haoheng Yan (US FDA)
  • Dr. Susan Kirshner (US FDA)
  • Dr. Daniela Verthelyi (US FDA)
  • Dr. Mohsen Rajabiabhari (US FDA)
  • Dr. Isabelle Cludts (UK MHRA)
  • Dr. Therese Solstad Saunders (Norway NoMA)
  • Dr. Elana Cherry (Health Canada)
  • Dr. Lucia Zhang (Health Canada)
  • Dr. Akiko Ishii (Japan MHLW)


Advanced Immunogenicity Day - Part 2: June 29, 2020 (EDT time listed)

11:00am-11:10am: Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
"Introduction of Advanced Immunogenicity Day Part 2"

Current approaches on NAb (Cell-Based and Bridging) Assays

Chair: Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
11:10am-11:30am: Dr. Madeleine Dahlbäck, Department Manager Immunogenicity Assay Development, Novo Nordisk
"Cell-based NAb Assays - Sensitivity and Drug Tolerance and The Relevance for Clinical Outcome"
11:30am-11:50am: Dr. George Gunn, Head Immunogenicity and Sr. Scientific Director, GlaxoSmithKline
"Consideration for Functional Cell-based Neutralizing Antibody Assay: Experience and decision-making process, when to use them and when they were deemed unsupportable or not-ideal"
11:50am-12:10pm: Dr. Bonnie Wu, Assoc. Scientific Director Biologics Development Sciences, Janssen
"Novel NAb Assay Design: Lesson Learnt and Advanced Approaches for the Assessment of NAbs to Bispecific Antibody"
12:10pm-12:30pm: Dr. Yuling Wu, Assoc. Director Clinical Immunology and Bioanalysis Group, AstraZeneca
"Recent Trends and Expectations for NAb Assays;Integrated Assessment of ADA/NAb on PK/PD, Safety and Efficacy"
12:30pm-01:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:00pm-01:30pm: Dr. Madeleine Dahlbäck, Department Manager Immunogenicity Assay Development, Novo Nordisk
Dr. George Gunn, Head Immunogenicity and Sr. Scientific Director, GlaxoSmithKline
Dr. Bonnie Wu, Assoc. Scientific Director Biologics Development Sciences, Janssen
Dr. Yuling Wu, Assoc. Director Clinical Immunology and Bioanalysis Group, AstraZeneca
Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Reviewer, US FDA
"Panel Discussion on NAb (Cell-Based and Bridging) Assays"

Advanced Immunogenicity Day: What’s new?

Chair: Dr. Manoj Rajadhyaksha, Director Bioanalytical Science, Regeneron
01:30pm-01:50pm: Dr. Manoj Rajadhyaksha, Director Bioanalytical Science, Regeneron
"Definition of Persistent ADA Responses and its Clinical Relevance in Assessment of Immunogenicity"
01:50pm-02:10pm: Dr. Marco Petrillo, Senior Scientist Biomarker Group, Biogen
"Immunogenicity for Antisense Oligonucleotides (ASOs): A Risk-based Assessment"
02:10pm-02:30pm: Dr. Vibha Jawa, Director Risk Assessment and Clinical Immunogenicity, Merck
Immunogenicity Risk Assessment Tools and Outputs to Drive Bioanalytical Strategy in Clinic
02:30pm-03:00pm: Dr. Manoj Rajadhyaksha, Director Bioanalytical Science, Regeneron
Dr. Marco Petrillo, Senior Scientist Biomarker Group, Biogen
Dr. Vibha Jawa, Director Risk Assessment and Clinical Immunogenicity, Merck
"Panel Discussion on What’s new in immunogenicity?"
03:00pm-03:30pm: Social Networking - Time to "Visit" Exhibitors and Posters

2020 White Paper on Immunogenicity

03:30pm-03:50pm: Dr. Manoj Rajadhyaksha, Director Bioanalytical Science, Regeneron
"Consensus & Recommendations on Immunogenicity"
03:50pm-04:20pm: Immunogenicity White Paper Working Experts Group
"Panel Discussion on Immunogenicity"




Final Agenda Agenda at a Glance