Specialized Workshop F2 - Friday May 10, 2024: 7am to 5:30pm
"AGENDA - Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy and Vaccine"
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Current Thinking on Immunogenicity Risk Assessment & Mitigation for Gene, Cell and Vaccine Therapies
Chair: Dr. LiNa Loo, Senior Director, Bioanalytical Preclinical Development, Vertex| 08:00am-08:20am: |
Dr. Swati Gupta, Executive Director, Clinical Immunogenicity, AbbVie "Immunogenicity Risk Assessment and Mitigation for Gene Therapy (GT) & mRNA-Lipid Nanoparticles (mRNA-LNP)" |
| 08:20am-08:40am: |
Dr. Yuanxin Xu, Senior Vice President, Intellia "Integrated Immunogenicity Assessment of Novel In Vivo CRISPR/Cas9 Genome Editing Therapies" |
| 08:40am-09:00am: |
Dr. Christine Grimaldi, Director, Assay Development Group, Regeneron "Immunogenicity Risk Assessments for Gene Therapies" |
| 09:00am-09:20am: |
Dr. Swati Gupta, Executive Director, Clinical Immunogenicity, AbbVie
Dr. Yuanxin Xu, Senior Vice President, Intellia Dr. Christine Grimaldi, Director, Assay Development Group, Regeneron "Panel Discussions on Current Thinking on Immunogenicity Risk Assessment & Mitigation for Gene, Cell and Vaccine Therapies" |
| 09:20am-09:50am: | Coffee Break with Morning Snacks |
Session 2: Cell Therapy & Vaccine Immunogenicity Assays: Lesson Learned and Recent Regulatory Guidelines
Chair: Dr. James Huleatt, Bioassay Development Lead, Gates Medical Research Institute| 09:50am-10:10am: |
Dr. Johanna Mora, Senior Director, Bioanalysis, Bristol Myers Squibb "Lessons Learned on Immunogenicity Assessments for Cell Therapy- Focus on Signal to Noise over Titer and Data Presentation" |
| 10:10am-10:30am: |
Dr. Christopher Beaver, Senior Director, Cell Therapies Immunogenicity and Immunoassays, Takeda "Considerations for Immunogenicity Testing in Allogeneic Cell Therapy Programs" |
| 10:30am-10:50am: |
Mr. Francis Dessy, Director and Clinical Assay Senior Advisor, GlaxoSmithKline "Vaccine Immunogenicity assays full validation: When is it full enough?" |
| 10:50am-11:10am: |
Dr. Johanna Mora, Senior Director, Bioanalysis, Bristol Myers Squibb
Dr. Christopher Beaver, Senior Director, Cell Therapies Immunogenicity and Immunoassays, Takeda Mr. Francis Dessy, Director and Clinical Assay Senior Advisor, GlaxoSmithKline "Panel Discussions on Cell Therapy & Vaccine Immunogenicity Assays: Lesson Learned and Recent Regulatory Guidelines" |
Special Session: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| 11:10am-11:50am: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Gene Therapy, Cell Therapy & Vaccines Regulatory Panelists:
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| 11:50am-12:50pm: | Sit-down Lunch on the 2nd Floor |
Session 3: NGS/Genomic Assays in a Regulated Environment: Cell Therapy, CRISPR Gene Editing and FFPE Sample Analysis
Chair: Dr. Meena Meena, Senior Vice President, Translational DMPK, Stoke| 12:50pm-01:10pm: |
Dr. Nathan Riccitelli, Associate Director, Molecular Assays, Navigate "Current Best Practices for Method Development/Validation of Next-Generation Sequencing (NGS) Assays for Use in Clinical Trial Testing" |
| 01:10pm-01:30pm: |
Dr. Jean-Claude Marshall, Vice President & Head of Clinical Assays, Supply and Logistics, Moderna "Next Generation Sequencing in the Identification of Cancer Neoantigens" |
| 01:30pm-01:50pm: |
Ms. Jessica Seitzer, Vice President Genomic Operations, Intellia "Overview of Current Genomic Analytical Tools to Enable Advancement of Investigational In Vivo Genome Editing Products into Clinical Studies" |
| 01:50pm-02:10pm: |
Dr. Mark Stern, Senior Director, Clinical Genomics & Molecular Assay Development, Bristol Myers Squibb "Navigating the Genomic Maze: Building Robust Next Generation Sequencing (NGS)Workflows for Reliable Clinical Genomic Testing replace this text with your Presentation Title" |
| 02:10pm-02:30pm: |
Dr. Nathan Riccitelli, Associate Director, Molecular Assays, Navigate
Dr. Jean-Claude Marshall, Vice President & Head of Clinical Assays, Supply and Logistics, Moderna Ms. Jessica Seitzer, Vice President Genomic Operations, Intellia Dr. Mark Stern, Senior Director, Clinical Genomics & Molecular Assay Development, Bristol Myers Squibb "Panel Discussions on NGS/Genomic Assays in a Regulated Environment: Cell Therapy, CRISPR Gene Editing and FFPE Sample Analysis" |
Session 4: PCR Sophisticated Applications for Diagnostic, Dengue Detection and mRNA Quantification
Chair: Dr. Xiaodong Fang, Senior Director, Head of Bioanalysis and Bioassay, AskBio| 02:30pm-02:50pm: |
Dr. Warren Kalina, Executive Director Diagnostic Assays, Pfizer "Sequencing-based Diagnostics used for Vaccine Phase 3 Studies" |
| 02:50pm-03:20pm: | Coffee Break with Afternoon Snacks |
| 03:20pm-03:40pm: |
Dr. Dewal Jani, Director, Clinical Assay Development, Vaccine Research and Analytics, Takeda "Quantitative Multiplex real time PCR : A case study, troubleshooting and Key Takeaways" |
| 03:40pm-04:00pm: |
Mr. Jason DelCarpini, Director, Bioanalytics, Moderna "Technical Methodologies in the Bioanalysis of mRNA-LNP Therapeutics: A Case Study " |
| 04:00pm-04:20pm: |
Dr. Warren Kalina, Executive Director Diagnostic Assays, Pfizer
Dr. Dewal Jani, Director, Clinical Assay Development, Vaccine Research and Analytics, Takeda Mr. Jason DelCarpini, Director, Bioanalytics, Moderna "Panel Discussions on PCR Sophisticated Applications for Diagnostic, Dengue Detection and mRNA Quantification " |
Session 5: 2024 White Paper in Bioanalysis
| 04:20pm-05:20pm: |
Dr. LiNa Loo, Senior Director, Bioanalytical Preclinical Development, Vertex Dr. James Huleatt, Bioassay Development Lead, Gates Medical Research Institute Dr. Meena Meena, Senior Vice President, Translational DMPK, Stoke Dr. Xiaodong Fang, Senior Director, Head of Bioanalysis and Bioassay, AskBio "Recommendations on Gene Therapy, Cell Therapy, and Vaccine and Panel Discussions for 2024 White Paper in Bioanalysis" |
