Specialized Workshop M1 - Monday April 13, 2026: 7am to 5:30pm
"AGENDA - Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Current Risk-based Approaches for Immunogenicity Assessment
Chair: Dr. Seema Kumar, Executive Director, Head of DMPK & Bioanalysis, Flagship Pioneering| 08:00am-08:20am: |
Dr. Weiping Shao, Senior Director, Head of Regulatory Bioanalysis, AstraZeneca "Strategic Replacement of NAbs with PD Biomarkers in Biologics Development" |
| 08:20am-08:40am: |
Dr. Johann Poetzl, Head Program Management Bioanalytics, Sandoz "Importance of Immunogenicity Assessment in Biosimilar Development" |
| 08:40am-09:00am: |
Dr. Sophie Tourdot, Immunogenicity Sciences Lead, Pfizer "Mitigation of immunogenicity during drug design" |
| 09:00am-09:20am: |
Dr. Weiping Shao, Senior Director, Head of Regulatory Bioanalysis, AstraZeneca
Dr. Johann Poetzl, Head Program Management Bioanalytics, Sandoz Dr. Sophie Tourdot, Immunogenicity Sciences Lead, Pfizer "Panel Discussions on Current Risk-based Approaches for Immunogenicity Assessment" |
| 09:20am-09:50am: | Coffee Break with Morning Snacks |
Session 2: Future Directions & Innovation to Evaluate ADC & Peptides Immunogenicity
Chair: Dr. Xiaodong Fang, Director Laboratory for Experimental Medicine, Lilly| 09:50am-10:10am: |
Dr. Andrew Asberry, Director Oncology Bioanalytical Strategy Lead, AstraZeneca "Immunogenicity Strategy for Antibody Drug Conjugates" |
| 10:10am-10:30am: |
Dr. Swati Gupta, Executive Director Clinical Immunogenicity & Translational Science, AbbVie "Advancing Immunogenicity Risk Assessment: Navigating Challenges and Innovations in Peptide Therapeutics" |
| 10:30am-10:50am: |
Dr. Mohsen Rajabi-Abhari, Director PK Sciences & Translational Medicine, Novartis "Immunogenicity of Peptide Therapeutics" |
| 10:50am-11:10am: |
Dr. Andrew Asberry, Director Oncology Bioanalytical Strategy Lead, AstraZeneca
Dr. Swati Gupta, Executive Director Clinical Immunogenicity & Translational Science, AbbVie Dr. Mohsen Rajabi-Abhari, Director PK Sciences & Translational Medicine, Novartis "Panel Discussions on Future Directions & Innovation to Evaluate ADC & Peptides Immunogenicity" |
Special Session: ASK THE REGULATORS!
| 11:10am-11:50am: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Immunogenicity Regulatory Panelists:
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| 11:50am-12:50pm: | Sit-down Hot Buffet Lunch downstairs at Marsalis B |
Session 3: When can S/N Complement/Replace Titers? New Trends & Innovations in Immunogenicity Assessment
Chair: Dr. Adrienne Clements-Egan, Vice President Bioanalytics & Developability, Larimar| 12:50pm-01:10pm: |
Dr. Boris Gorovits, Vice President Nonclinical & Clinical Bioanalysis, Regeneron "Streamlined immunogenicity assessment for biologics" |
| 01:10pm-01:30pm: |
Mr. Fred McCush, Senior Director Biologics & Immunogenicity Group Lead, Pfizer "S/N vs. Titer: Validation Assessments in Support of Clinical Study Data Correlations" |
| 01:30pm-01:50pm: |
Dr. Zhandong (Don) Zhong, Senior Director, Head of Bioanalytical Sciences, Denali "A Tale of Two Metrics: When S/N and Titer Diverge in Clinical ADA Testing" |
| 01:50pm-02:10pm: |
Dr. Boris Gorovits, Vice President Nonclinical & Clinical Bioanalysis, Regeneron
Mr. Fred McCush, Senior Director Biologics & Immunogenicity Group Lead, Pfizer Dr. Zhandong (Don) Zhong, Senior Director, Head of Bioanalytical Sciences, Denali "Panel Discussions on When can S/N Complement/Replace Titers? New Trends & Innovations in Immunogenicity Assessment" |
Session 4: Why should the Industry/Regulators Consider Moving from Traditional 3-Tier to 1-Tier Approach?
Chair: Dr. Albert Torri, Vice President Bioanalytical Sciences, Regeneron| 02:10pm-02:30pm: |
Mr. Daniel Baltrukonis, Executive Director, Head of Clinical Bioanalytics, Pfizer "Regulatory Feedback Transitioning from Titer to S/N for a Multidomain Biotherapeutic in Clinical Development" |
| 02:30pm-02:50pm: |
Dr. Daniel Kramer, Global Scientific Advisor & Coordinator Immunogenicity, Sanofi "Omitting the Confirmatory Tier for Immunogenicity Testing – a Data Driven View" |
| 02:50pm-03:20pm: | Coffee Break with Afternoon Snacks |
| 03:20pm-03:40pm: |
Dr. Robert Kubiak, Head of Bioanalytical Science , Third Arc Bio "Can we assess immunogenicity without a cut point?" |
| 03:40pm-04:00pm: |
Mr. Robert Hendricks, Senior Principal Manager , Genentech "Suitability Of ADA Assay Validation Cut Point and Approach to Determine when to use In-Study Cut Point Factors" |
| 04:00pm-04:20pm: |
Mr. Daniel Baltrukonis, Executive Director, Head of Clinical Bioanalytics, Pfizer
Dr. Daniel Kramer, Global Scientific Advisor & Coordinator Immunogenicity, Sanofi Dr. Robert Kubiak, Head of Bioanalytical Science , Third Arc Bio Mr. Robert Hendricks, Senior Principal Manager , Genentech "Panel Discussions on Why should the Industry/Regulators Consider Moving from Traditional 3-Tier to 1-Tier Approach? " |
Session 5: 2026 White Paper in Bioanalysis
| 04:20pm-05:20pm: |
Dr. Seema Kumar, Executive Director, Head of DMPK & Bioanalysis, Flagship Pioneering Dr. Xiaodong Fang, Director Laboratory for Experimental Medicine, Lilly Dr. Adrienne Clements-Egan, Vice President Bioanalytics & Developability, Larimar Dr. Albert Torri, Vice President Bioanalytical Sciences, Regeneron "Recommendations on Immunogenicity of Biotherapeutics and Panel Discussions for 2026 White Paper in Bioanalysis" |
| 05:30pm-06:30pm |
Welcome Reception at Reunion Ballroom Foyer
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