AGENDA - Specialized Workshop M1 - Monday September 27, 2021: 8am - 5pm

"ADA/NAb Guidance Day: Recent Advancements in the Harmonization of Immunogenicity Testing & Reporting"

Industry/Regulators focused and interactive discussions on Immunogenicity Issues/Audits/Submissions outcome, controversial Issues on US FDA/EU EMA Immunogenicity Guidance/Guideline, finalization of NAb Assays Harmonization recommendations with multiple Agencies, ADA Validation Reporting, Immunogenicity Risk Assessment and impact on bioanalytical strategy, regulatory observations and 483s on ADA Assay Validation, Immunogenicity Assays for Multi-Domain Biotherapeutics (MDBs) & Bispecific drugs, Comparability of ADA assay performance/results

Session 1: Harmonization of Immunogenicity Assessment, Reporting and Monitoring

Chair: Dr. Yuling Wu, Head of Discovery Bioanalysis US, AstraZeneca
08:00am–08:20am: Dr. Robert Kubiak, Senior Manager R&D, AstraZeneca
"False Positive Rates at 1-5% are too High for Drugs with Low Immunogenicity: Why is Placebo More Immunogenic than my Drug?"
08:20am–08:40am: Mr. Gregor Jordan, Lab Head, Roche
"Immunogenicity: Testing Strategies and their Harmonization – Overcoming Soluble Target Interference in Drug Tolerant ADA Assays"
08:40am–09:00am: Dr. Johann Poetzl, Head Program Management Bioanalytics, Sandoz
"Biosimilar ADA Assay Validation & Harmonization - How to Demonstrate Appropriateness of one Assay Approach "
09:00am–09:20am: Dr. Robert Kubiak, Senior Manager R&D, AstraZeneca
Mr. Gregor Jordan, Lab Head, Roche
Dr. Johann Poetzl, Head Program Management Bioanalytics, Sandoz
"Panel Discussions on Harmonization of Immunogenicity Assessment, Reporting and Monitoring "
09:20am-09:40am: Short Break

Session 2: Multi Domain Biotherapeutics & Bispecific Biotherapeutics: Harmonization of Immunogenicity Testing & Reporting

Chair: Dr. Manoj Rajadhyaksha, Executive Director and Global Head of Immunogenicity, Alexion
09:40am–10:00am: Dr. Kate Peng, Director Department BioAnalytical Sciences, Genentech
"Effective Evaluation of Immunogenic Responses Towards Bispecific Antibodies"
10:00am–10:20am: Dr. Kay-Gunnar Stubenrauch, Head Large Molecule Bioanalytical Sciences 1, Roche
"ADA Characterization for Biotherapeutics: New Methods for ADA-Specificity and ADA- Isotype Analysis "
10:20am–10:40am: Dr. Gregor Lotz, Group Leader Bioanalytics, Roche
"Development of an Appropriately Designed PK assay to Neutralizing ADA Impact on Exposure of Bispecific Drugs"
10:40am–11:00am: Dr. Kate Peng, Director Department BioAnalytical Sciences, Genentech
Dr. Kay-Gunnar Stubenrauch, Head Large Molecule Bioanalytical Sciences, Roche
Dr. Gregor Lotz, Group Leader Bioanalytics, Roche
"Panel Discussions on Multi Domain Biotherapeutics & Bispecific Biotherapeutics: Harmonization of Immunogenicity Testing & Reporting"
11:00am-11:20am: Short Break

ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

Chair: Dr. Yuling Wu, Head of Discovery Bioanalysis US, AstraZeneca
Chair: Dr. Manoj Rajadhyaksha, Executive Director and Global Head of Immunogenicity, Alexion
11:20am–12:20pm: Regulatory Feedbacks on Submitted studies and Inspections/audits Outcomes on Immunogenicity
 Regulatory Panelists:
  • Dr. Susan Kirshner (US FDA)
  • Dr. Daniela Verthelyi (US FDA)
  • Dr. Joao Pedras-Vasconcelos (US FDA)
  • Dr. Haoheng Yan (US FDA)
  • Dr. Kimberly Maxfield, (US FDA)
  • Dr. Mohsen RajabiAbhari, (US FDA)
  • Dr. Meenu Wadhwa (UK MHRA)
  • Dr. Isabelle Cludts (UK MHRA)
  • Dr. Günter Waxenecker (Austrian AGES)
  • Dr. Therese Solstad (Norway NoMA)
  • Dr. Elana Cherry (Health Canada)
  • Dr. Lucia Zhang (Health Canada)
  • Dr. Akiko Ishii (Japan MHLW)
12:20pm-12:40pm: Short Break

Session 3: Integrated Summary of Immunogenicity Harmonization: US FDA, EU EMA, China NMPA Immunogenicity Guidance/Guideline

Chair: Dr. Yuling Wu, Head of Discovery Bioanalysis US, AstraZeneca
12:40pm–01:00pm: Dr. Sue Richards, Presidential Scientific Fellow Translational Medicine and Early Development, Sanofi
"Challenges and Approaches in Developing a “living” Integrated Summary of Immunogenicity for Global Submissions: Experience and Perspectives "
01:00pm–01:20pm: Dr. Anders Holm Millner, Principal Scientist Immunogenicity Assessment, Novo Nordisk
"Recent Developments in the PK, PD, ADA Integrated Approach versus NAb Assay"
01:20pm–01:40pm: Dr. Tong-Yuan Yang, Senior Scientific Director Biotherapeutics, Janssen
"NMPA Immunogenicity Guidance and Related Topics"
01:40pm–02:00pm: Dr. Sue Richards, Presidential Scientific Fellow Translational Medicine and Early Development Sanofi
Dr. Anders Holm Millner, Principal Scientist Immunogenicity Assessment, Novo Nordisk
Dr. Tong-Yuan Yang, Senior Scientific Director Biotherapeutics, Janssen
"Panel Discussions on Integrated Summary of Immunogenicity Harmonization: US FDA, EU EMA, China NMPA Immunogenicity Guidance/Guideline"
02:00pm-02:20pm: Short Break

Session 4: ADA Assay Comparability

Chair: Dr. Manoj Rajadhyaksha, Executive Director and Global Head of Immunogenicity, Alexion
02:20pm–02:40pm: Dr. Joao Pedras-Vasconcelos, Sr. Staff Fellow Office of Biotechnology Products, US FDA
"Immunogenicity Assay Comparability for Biologics- current perspectives from CDER Office of Biotechnology Products"
02:40pm–03:00pm: Dr. Rachel Palmer, Head Biomarkers and Clinical Bioanalysis, Sanofi
"ADA Assay Comparability"
03:00pm–03:20pm: Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences 2, Roche
"ADA Assay Comparability: Sharing the Latest Data on the Evolution of the CP-ARC Concept, Roche’s Experience"
03:20pm–04:00pm: Dr. Joao Pedras-Vasconcelos, Sr. Staff Fellow Office of Biotechnology Products, US FDA
Dr. Rachel Palmer, Head Biomarkers and Clinical Bioanalysis, Sanofi
Dr. Roland Staack, Head Large Molecule Bioanalytical Sciences 2, Roche
"Panel Discussions on ADA Assay Comparability"
04:00pm-04:10pm: Short Break

Session 5: 2021 White Paper in Bioanalysis

04:10pm–04:40pm: Dr. Yuling Wu, Head of Discovery Bioanalysis US, AstraZeneca
Dr. Manoj Rajadhyaksha, Executive Director and Global Head of Immunogenicity, Alexion
"Recommendations on Recent Advancements in the Harmonization of Immunogenicity Testing & Reporting"
04:40pm–05:10pm: Dr. Yuling Wu, Head of Discovery Bioanalysis US, AstraZeneca
Dr. Manoj Rajadhyaksha, Executive Director and Global Head of Immunogenicity, Alexion
And ALL Participating Panelists...
"Panel Discussions on 2021 White Paper in Bioanalysis draft Recommendations"
05:10pm-05:30pm: Short Break
05:30pm-06:30pm: Poster Spotlight Sessions with open access to all attendees




Agenda at a Glance Agenda at a Glance