Main Workshop DAY 2 - Wednesday April 15, 2026: 7am to 5:45pm
"AGENDA - Regulators' Inputs and 'Ask the Regulators' Panel Discussions"
| 07:00am-08:00am: | Start your day at WRIB with Networking Continental Breakfast in the Exhibit |
DAY 2B: Regulators' Inputs on Immunogenicity of Biotherapeutics and Gene Therapy, Cell Therapy, and Vaccines
Chair: Dr. Fabio Garofolo, CSO, BRI - A Frontage CompanyImmunogenicity of Biotherapeutics
| 08:00am-08:10am: |
Dr. Zuben Sauna, Division Director, US FDA "Immunogenicity Risk-Assessment of Novel Modalities Using In Silico, In Vitro and Ex Vivo Tools" |
| 08:10am-08:20am: |
Dr. Adrian Wong, Senior Clinical Evaluator, Health Canada "The impact of assay performance on the labeling of immunogenicity data in the Canadian Product Monograph" |
| 08:20am-08:30am: |
Dr. Seth Thacker, Biologist, US FDA "Immunogenicity Risk Assessment for Oligonucleotide Products" |
| 08:30am-08:40am: |
Mr. Christian Mayer, Quality Assessor, Austria AGES/ EU EMA "EMA's Reflection paper on a tailored clinical approach in biosimilar development" |
| 08:40am-08:50am: |
Dr. Yow-Ming Wang, Associate Director for Biosimilars & Therapeutic Biologics, US FDA "Evaluating Immunogenicity Impact: Recent Topics in Clinical Pharmacology" |
| 08:50am-09:00am: |
Dr. Mohanraj Manangeeswaran, Senior Research Scientist, US FDA "Immunogenicity Risk Assessment and Mitigation Strategies for Therapeutic Peptides" |
| 09:00am-09:10am: |
Dr. Omar Tounekti, Manger Cell and Gene Therapies, Health Canada "Health Canada Major Regulatory Modernization Initiatives" |
| 09:10am-09:20am: |
Dr. Kristina Howard, Research Veterinary Medical Officer, US FDA "Can immune-humanized mice help evaluate immunogenicity risk?" |
| 09:20am-10:05am: | Networking Coffee Break with Morning Snacks in the Exhibit |
Gene Therapy, Cell Therapy, and Vaccines
| 10:05am-10:15am: |
Dr. Shirley Hopper, Medical Assessor, UK MHRA "Individualised mRNA cancer immunotherapies" |
| 10:15am-10:25am: |
Dr. Vijaya Simhadri, Biologist, US FDA "Immunogenicity risk assessment of SaCas9, AsCas12a and CasΦ proteins" |
| 10:25am-10:35am: |
Dr. Ingrid Schellens, Senior Clinical Assessor, Dutch MEB / EU EMA "Regulatory challenges around the use of immunogenicity data for vaccines – an EU perspective" |
| 10:35am-10:55am: |
Dr. Surender Khurana, Scientist, US FDA "Immune response to Ebola virus and Marburg virus" |
| 10:55am-11:05am: |
Dr. Sarah Cummings, Scientific Evaluator Cell and Gene Therapies, Health Canada "Secondary Malignancies Related to Chimeric Antigen Receptor (CAR) T Cell Therapy" |
| 11:05am-11:15am: |
Dr. Anna Nowocin, Principal Scientist, UK MHRA "Development of T cell suppression assays for Cell Therapy Products" |
| 11:15am-11:25am: |
Dr. Joshua Xu, SBRBPAS Expert and Branch Chief, US FDA "AdVentSeq: A Comprehensive Bioinformatics Pipeline for Adventitious Viral Agents Detection with RNA-seq" |
| 11:25am-11:35am: |
Dr. Huixin Lu, Research Scientist, Health Canada "An overview of NGS applications in the development of biotherapeutics and advanced therapies" |
| 11:35am-11:45am: |
Dr. Chad Irwin , Senior Scientific Evaluator, Health Canada "Considerations for immunogenicity assays used in the clinical development and licensure of vaccines" |
