Main Workshop DAY 1 - Tuesday April 14, 2026: 7am - 5:30pm
"AGENDA - Ligand-Binding, Cell-Based, and Molecular Assays - Must-Know Breakthroughs, Developments, and Best Practices"
| 07:00am-08:00am: | Start your day at WRIB with Networking Continental Breakfast in the Exhibit |
Session 1: Immunogenicity (ADA) Assays and Regulatory Expectations
Chair: Dr. Huaping Tang, Executive Director Bioanalysis & Soluble Biomarkers, GlaxoSmithKline| 08:00am-08:20am: |
Ms. Kelly Coble, Global Head of Bioanalysis, Boehringer Ingelheim "Novel and innovative approaches used for PK and ADA bioanalytical methods supporting a masked cytokine project" |
| 08:20am-08:40am: |
Dr. Theingi Thway, Director of Pharmacokinetic & Bioanalysis, Eisai "Challenges in immunogenicity methods: Novel case studies, lesson learned, recent advancements to update the WRIB recommendations on this topic" |
| 08:40am-09:00am: |
Dr. Roland Staack, Head of Bioanalytics & Biomarkers, Roche "How a more quantitative ADA detection might change the ADA testing paradigm" |
| 09:00am-09:20am: |
Ms. Kelly Coble, Global Head of Bioanalysis, Boehringer Ingelheim
Dr. Theingi Thway, Director of Pharmacokinetic & Bioanalysis, Eisai Dr. Roland Staack, Head of Bioanalytics & Biomarkers, Roche "Panel Discussions on Immunogenicity (ADA) Assays and Regulatory Expectations" |
| 09:20am-10:10am: | Networking Coffee Break with Morning Snacks in the Exhibit |
Session 2: Biomarker Assays Development, CDx, IVD, and BAV
Chair: Ms. Sarah Hersey, Vice President, Head of Precision Medicine, Bioanalytical & Translational Sciences, Bristol Myers Squibb| 10:10am-10:30am: |
Mr. Brian Baker, Executive Director Regulatory Affairs, Regeneron "IVD Regulatory Implications for Gene Therapies" |
| 10:30am-10:50am: |
Dr. Sarah Bond, Senior Director Bioanalytical Sciences, Alnylam "Considerations for the use of diagnostic assays to support PD biomarker endpoints" |
| 10:50am-11:10am: |
Dr. Maciej Cabanski , Vice President Biomarkers & CDx, Monte Rosa "Biomarker Modalities in Early Development of Molecular Glue Degraders for Immune-mediated Diseases and Oncology" |
| 11:10am-11:30am: |
Mr. Lingyi Zheng, Senior Director Clinical Biomarker , Moderna "Choice of Bioanalytical Assay(s) in Establishing Correlates of Protection (CoP) for Infectious Diseases: Case studies, Lesson learned and Recent advancements" |
| 11:30am-11:50am: |
Mr. Brian Baker, Executive Director Regulatory Affairs, Regeneron
Dr. Sarah Bond, Senior Director Bioanalytical Sciences, Alnylam Dr. Maciej Cabanski , Vice President Biomarkers & CDx, Monte Rosa Mr. Lingyi Zheng, Senior Director Clinical Biomarker , Moderna "Panel Discussions on Biomarker Assays Development, CDx, IVD, and BAV" |
Session 3: Cell & Vaccine Therapies: CAR-T Predose Positivity, CBA, and NGS
Chair: Dr. David Cooper, Vice President Clinical Immunology & Diagnostics, Pfizer| 11:50am-12:10pm: |
Dr. Dilki Wickramarachchi, Associate Director Integrated Bioanalysis, AstraZeneca "Investigation and Mitigation of Pre‑existing Positivity in Immunogenicity Assays for Engineered Therapeutics: CAR‑T/ScFv and ADC" |
| 12:10pm-01:10pm: |
Sit-down Hot Buffet Networking Lunch downstairs at Marsalis B Note: Lunch Desserts and Coffee/Tea are served in the Exhibit Room |
| 01:10pm-01:30pm: |
Dr. Ingrid Scully, Executive Director, Head of Clinical Immunology, Pfizer "A Tale of Two Assays: Impact of Reference Standards and Diluents on Cell Based/Biofunctional Assays" |
| 01:30pm-01:50pm: |
Dr. Anupreet Kour, Head of Molecular Platforms, Sanofi "Bench to Digital: Assay Development and Regulatory Framework for RSV/HMPV Vaccine Efficacy Assessment via Next-Generation Sequencing" |
| 01:50pm-02:10pm: |
Dr. Dilki Wickramarachchi, Associate Director Integrated Bioanalysis, AstraZeneca
Dr. Ingrid Scully, Executive Director, Head of Clinical Immunology, Pfizer Dr. Anupreet Kour, Head of Molecular Platforms, Sanofi "Panel Discussions on Cell & Vaccine Therapies: CAR-T Predose Positivity, CBA, and NGS " |
Session 4: Gene Therapy: CRISPR/Cas9 Gene Editing and Molecular/Genomic Assays
Chair: Dr. Rocio Murphy, Senior Director, Head of Global Clinical Immunology, Sanofi| 02:10pm-02:30pm: |
Dr. Yuanxin Xu, Senior Vice President Translational Medicine, Intellia "Clinical Pharmacodynamic Assessment for Novel CRISPR/Cas9 Gene Editing Therapies" |
| 02:30pm-02:50pm: |
Dr. Kay-Gunnar Stubenrauch, Lead Gene Therapy Bioanalytics & Biomarkers, Roche "Lost in the Bioanalytical Triangle of AAV-based Gene Therapy" |
| 02:50pm-03:10pm: |
Dr. Mark Stern, Senior Director, Head of Clinical Genomics & Molecular Assay, Bristol Myers Squibb "Hacking the Workflow: Smarter Genomics by Design" |
| 03:10pm-04:10pm: |
Networking Break with Afternoon Snacks, and Wine and Beer Reception in the Exhibit |
| 04:10pm-04:30pm: |
Dr. Yuanxin Xu, Senior Vice President Translational Medicine, Intellia
Dr. Kay-Gunnar Stubenrauch, Lead Gene Therapy Bioanalytics & Biomarkers, Roche Dr. Mark Stern, Senior Director, Head of Clinical Genomics & Molecular Assay, Bristol Myers Squibb "Panel Discussions on Gene Therapy: CRISPR/Cas9 Gene Editing and Molecular/Genomic Assays" |
Session 5: 2026 White Paper in Bioanalysis
| 04:30pm-05:30pm: |
Dr. Huaping Tang, Executive Director Bioanalysis & Soluble Biomarkers, GlaxoSmithKline Ms. Sarah Hersey, Vice President, Head of Precision Medicine, Bioanalytical & Translational Sciences, Bristol Myers Squibb Dr. David Cooper, Vice President Clinical Immunology & Diagnostics, Pfizer Dr. Rocio Murphy, Senior Director, Head of Global Clinical Immunology, Sanofi "Recommendations on Immunogenicity Assays, Biomarker IVD/CDx Assays, Gene/Cell Therapy and Vaccine Assays and Panel Discussions for 2026 White Paper in Bioanalysis" |
