Seven full-day Specialized Workshops Throughout the Week

In addition to the sequential 3-DAY Main Workshop program, 7 full-day Specialized Workshops spreads throughout the week to give you many choices to combine Main Workshop DAYs with these Specialized Workshops based on your specific track of interest and learning needs.

Monday Specialized Workshops - Sep. 27, 2021: 8am to 5pm, ET

Tuesday Specialized Workshop - Sep. 28, 2021: 8am to 5pm, ET

Thursday Specialized Workshops - Sep. 30, 2021: 8am to 5pm, ET

Friday Specialized Workshops - Oct. 1, 2021: 8am to 5pm, ET

  • Full-Day Specialized Workshop F1:
    "Biomarkers Development & Translational Science: Recent Issues from Discovery to Regulatory BAV Guidance"
    Innovation in Biomarkers Assays Development in Discovery & Development. Harmonized Biomarker Assay Validation (BAV) Guidance and regulatory approval questions, advanced method development from Discovery multiplex/OMICs to Clinical primary/secondary endpoints & patients stratification, Ultra-sensitivity platforms pros/cons, best time to initiate CDx, complex assay Parallelism assessment, insights on when CLIA /ISO/GLP, challenges in Sample Collection. Focus on advancements in Exploratory Biomarkers & Target Engagement (TE) Biomarkers Assays

  • Full-Day Specialized Workshop F2:
    "Gene Therapy, Cell Therapy and Vaccine Bioanalysis: Recent Issues in Scientific Advancements and Regulations"
    US FDA & EU EMA expectations for Gene Therapy & Cell Therapy Immunogenicity Monitoring, Anti-AAV assays for patient enrollment/stratification in CAP/CLIA or/and GLP/GCP labs, need/not need to be a CDx, Assay format selection for CAR-T ADA Assay and Triplex CAR-T NAb Assay, Bioanalytical methods for CRISPR/Cas9 genome editing bioanalysis, Vaccine Bioanalysis and Harmonization on validation for Vaccine Assays, qPCR/ddPCR Bioanalytical Method Validation (BMV) and QC to monitor performance for Gene Therapy & Vaccine, Acceptance criteria for Biodistribution/Shedding Assay, Cell-based Aassays for Vaccines, current industry standards for CAR-T evaluation for Flow Cytometry & ELISpot assays

See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:

Click the Graph Above to Enlarge the Image to See Detailed Program of Each Day/Workshop

Agenda at a Glance Agenda at a Glance