"Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
LBA & Mass Spec (MSA) challenges in complex biomarker development; Latest applications of Fit-for-Purpose Validation (BAV) in support of the 2026 US FDA Guidance BMV for Biomarkers; Identification/quantification of Novel Translational Biomarkers with Multiplex/OMICs/High-Plex by Emerging Technologies and Integrating AI/ML; Strategies in the Development/Validation of IVD/CDx Assays for Patient Selection/Stratification and Drug Response Monitoring; Updated Biomarkers Development Strategies to meet EU IVDR; Updated strategies for Biomarker assays in CAP/CLIA/ISO labs used in drug development; Strategies for development of Target Engagement (TE) PD biomarkers; Current best practices in Translational Science from Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers for novel therapies; Overcoming challenges with Assay Sensitivity; Recent developments in Vaccine Biomarkers LBA; 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; Considerations on Next Generation Biomarkers to optimize dosing & predict safety. Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Biomarkers Discovery, Development, Validation & Regulatory Approval and recent Controversial Issues.
Session 1: Overcoming Sample Collection/Stability Issues during BAV & Clinical Biomarker Analysis
Session 2: Sophisticated IVD & CDx Assay Strategies to meet Regulatory Requirements
Session 3: COU Limitations & Enhanced Solutions for Overcoming Issues in Complex Biomarkers Development
Session 4: Novel/Alternative Approaches in FFP BAV: Linearity, Automation, Cross-validation, Singlicate
Session 5: 2027 White Paper in Bioanalysis
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2027 White Paper on Biomarkers Discovery, Development, Validation & Regulatory Approval
Consensus & Conclusions on Biomarkers Discovery, Development, Validation & Regulatory Approval for 2027 White Paper
Finale: ASK THE REGULATORS!
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Panel Discussion with All the Regulators:
Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Belgium FAGG / EU EMA, Health Canada
Ask the Regulators any Questions You Have on Biomarkers & Companion Diagnostics and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
