" Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
Advances in Translational Science from Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers; Latest Case Studies to Identify & Validate Relevant Biomarkers by LBA & Mass Spec and Challenge with Assay Sensitivity; Recent Developments in Vaccine Biomarkers LBA Validation; Impact of New Regulations for Biomarker Testing: US CLIA, US LDT Proposed Rule and EU IVDR; CDx Assay Development for Gene Therapy Patient Selection/Stratification and Drug Response Monitoring; Cutting-Edge Multiplex/OMICs/High-Plex Technologies in Discovery Biomarkers and Challenges in Data Integration; Implementing Clinical Biomarkers as Primary Endpoints; Novel Data on Lesson Learned from Using New Platforms and Patient Centric/Micro Sampling in Real-Life Situations; Current Best Practices on Complex/Tissue Biomarkers; And LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Biomarker Assays, BAV, IVD, CDx, LDT and Recent Controversial Issues
Session 1: Current Challenges in Biomarker Assays Development/BAV: Parallelism, Free Target Measurement, GCLP vs CLIA, New Platforms
Session 2: Vaccine Biomarkers LBA: Focus on Automation, Assay Maintenance/Performance Monitoring and Complex Matrices Development/Validation
Session 3: Mass Spec Assays vs LBA for Measuring Biomarkers and EU IVDR 2017/746 Impact on Global Biomarker Strategy
Session 4: Development & Fit for Purpose Validation (FFP BAV) of CDx/IVDs: Focus on CDx for AAV- based Gene Therapies (GT)
Session 5: 2024 White Paper in Bioanalysis
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2024 White Paper on Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders
Consensus & Conclusions on Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders for 2024 White Paper
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
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Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Biomarkers & CDx/BAV
Regulatory Panelists:
- Mr. Abbas Bandukwala (US FDA CDER)
- Ms. Leslie Wagner (US FDA CBER)
- Dr. Joshua Xu (US FDA NCTR)
- Dr. Shirley Hopper (UK MHRA)
- Dr. Alessandra Buoninfante (EU EMA)
- Dr. Hilke Zander (Germany PEI / EU EMA)
- Dr. Joerg Engelbergs (German PEI / EU EMA)
- Dr. Chad Irwin (Health Canada)
- Dr. Julie Joseph (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
- Ms. Dulcyane Neiva Mendes (Brazil ANVISA)
