Specialized Workshop M1 - Monday May 06, 2024: 7am to 5:30pm
"AGENDA - Advanced Strategies for Immunogenicity of Biotherapeutics "
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Evolution of Immunogenicity Assessment Beyond ADA and NAb: Focus on Clinical Relevance
Chair: Dr. Cecil Chen, Group Director, Head of CPQP Clinical Immunogenicity, AstraZeneca| 08:00am-08:20am: |
Dr. Yuan Song, Executive Director, BioAnalytical Sciences, Genentech "Leveraging Novel Graphical Approaches to Understand the Influence of Sampling Frequency and Testing Method on ADA Incidence Rates" |
| 08:20am-08:40am: |
Dr. Roland Staack, Head of Bioanalytics and Biomarkers, Roche "Model informed ADA assay development improves clarity of ADA assay results and might path the way to better understand clinically relevant ADAs" |
| 08:40am-09:00am: |
Mr. Daniel Baltrukonis, Clinical Bioanalytics Head, Biologics & Immunogenicity, Pfizer "Evolving the ADA Testing Strategy: Towards Data Driven Application of Additional Tiers" |
| 09:00am-09:15am: |
Dr. Yuan Song, Executive Director, BioAnalytical Sciences, Genentech
Dr. Roland Staack, Head of Bioanalytics and Biomarkers, Roche Mr. Daniel Baltrukonis, Clinical Bioanalytics Head, Biologics & Immunogenicity, Pfizer "Panel Discussions on Evolution of Immunogenicity Assessment Beyond ADA and NAb: Focus on Clinical Relevance" |
| 09:15am-09:45am: | Coffee Break with Morning Snacks |
Session 2: Complex Immunogenicity Characterization for Bispecific Therapeutic Proteins and mAb Therapy for Alzheimer Disease
Chair: Dr. Giane Sumner, Executive Director, Assay Development, Regeneron| 09:45am-10:05am: |
Dr. Weiping Shao, Senior Director and Head of Regulatory Bioanalysis, Astra Zeneca "Characterization of Immunogenicity for Bispecific Antibodies" |
| 10:05am-10:25am: |
Dr. Bonnie Wu, Associate Scientific Director, Bioanalytical Sciences, J&J Innovative Medicine "Implementing Synthetic Multi-transmembrane Receptor Protein in a Duplex Immunoassay for Assessment of Neutralizing Antibody to a Bispecific Biotherapeutic" |
| 10:25am-10:45am: |
Dr. Garrett Mullins, Executive Director, Clinical Immunogenicity, Eli Lilly and Co. "Donanemab: Characterization of immunogenicity from the TRAILBLAZER-ALZ & TRAILBLAZER-ALZ 2 trials" |
| 10:45am-11:00am: |
Dr. Weiping Shao, Senior Director and Head of Regulatory Bioanalysis, Astra Zeneca
Dr. Bonnie Wu, Associate Scientific Director, Bioanalytical Sciences, J&J Innovative Medicine Dr. Garrett Mullins, Executive Director, Clinical Immunogenicity, Eli Lilly and Co. "Panel Discussions on Complex Immunogenicity Characterization for Bispecific Therapeutic Proteins and mAb Therapy for Alzheimer Disease" |
Session 3: Final Proposal on Cross-validation for ADA/NAb Assays and Re-evaluation of Minimum Noise Reduction & False Positive Range
Chair: Dr. Boris Gorovits, Vice President, Bioanalysis, Regeneron| 11:00am-11:20am: |
Dr. Luying Pan, Senior Director, Clinical Biomarker Innovation and Development, Takeda "Overcome the Challenge of Cross Validation to Meet Study Needs" |
| 11:20am-11:40am: |
Dr. Daniel Kramer, Global Scientific Advisor Immunogenicity, Sanofi "Cross-Validation of Immunogenicity Assays" |
| 11:40am-12:00pm: |
Dr. Sam Song, Associate Director, Immunogenicity, Takeda "Noise in ADA Assay: Friend or Foe?" |
| 12:00pm-01:00pm: | Sit-down Lunch on the 2nd Floor |
| 01:00pm-01:20pm: |
Dr. Robert Kubiak, Associate Director, Clinical Immunogenicity, Astra Zeneca "2-11% False Positive Range for Immunogenicity Testing Law of the Land or a Rule of Thumb?" |
| 01:20pm-01:40pm: |
Dr. Luying Pan, Senior Director, Clinical Biomarker Innovation and Development, Takeda
Dr. Daniel Kramer, Global Scientific Advisor Immunogenicity, Sanofi Dr. Sam Song, Associate Director, Immunogenicity, Takeda Dr. Robert Kubiak, Associate Director, Clinical Immunogenicity, Astra Zeneca "Panel Discussions on Final Proposal on Cross-validation for ADA/NAb Assays and Re-evaluation of Minimum Noise Reduction & False Positive Range " |
Session 4: Further Developments in Risk-Based Approaches for Immunogenicity Prediction & Mitigation
Chair: Dr. Adrienne Clements-Egan, Vice President, Bioanalytics & Developability, Larimar Therapeutics| 01:40pm-02:00pm: |
Dr. Michele Rasamoelisolo, Senior Director & Head of Specialty Bioanalytics, Teva "In vitro cell-based methods to assess innate immune responses" |
| 02:00pm-02:20pm: |
Dr. Federico Riccardi Sirtori, Director, Head of NBE-DMPK Innovative BioAnalytics, EMD Serono "Preclinical immunogenicity strategy to support the development of novel NBEs and ADCs" |
| 02:20pm-02:40pm: |
Dr. Ola Saad, Distinguished Scientist, BioAnalytical Sciences, Genentech "Advantages, Opportunities and Challenges of MHC-Associated Peptide Proteomics (MAPPs) Assays in Immunogenicity Risk Assessment: Where are we and where are we going?" |
| 02:40pm-02:55pm: |
Dr. Michele Rasamoelisolo, Senior Director & Head of Specialty Bioanalytics, Teva
Dr. Federico Riccardi Sirtori, Director, Head of NBE-DMPK Innovative BioAnalytics, EMD Serono Dr. Ola Saad, Distinguished Scientist, BioAnalytical Sciences, Genentech "Panel Discussions on Further Developments in Risk-Based Approaches for Immunogenicity Prediction & Mitigation" |
| 02:55pm-03:25pm: | Coffee Break with Afternoon Snacks |
Session 5: 2024 White Paper in Bioanalysis
| 03:25pm-04:25pm: |
Dr. Cecil Chen, Group Director, Head of CPQP Clinical Immunogenicity, AstraZeneca Dr. Giane Sumner, Executive Director, Assay Development, Regeneron Dr. Boris Gorovits, Vice President, Bioanalysis, Regeneron Dr. Adrienne Clements-Egan, Vice President, Bioanalytics & Developability, Larimar Therapeutics "Recommendations on Immunogenicity of Biotherapeutics and Panel Discussions for 2024 White Paper in Bioanalysis" |
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| 04:25pm-05:30pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Immunogenicity Regulatory Panelists:
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| 05:30pm-07:00pm |
Welcome Reception at Marriott Riverwalk Hotel River Terrace / Oak Tree Terrace
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