Agenda at a Glance

The 13th WRIB will continue to feature the novel and unique 3-Day Sequential Program during the Main Workshop Days (Day 1, Day 2 and Day 3) with NO parallel sessions. However you have the flexibility to choose which Workshop Days - either Day 1 and Day 2 (LCMS Track) OR Day 2 and Day 3 (LBA Track) based on your specific interest and learning needs.

In addition to the Sequential Main Workshop Days (Day 1, Day 2 and Day 3), 6 full-day Training Sessions will spread throughout the week to give you many choices to combine Main Workshop Days with Training Sessions to maximize your learning process at any level in your field of expertise.

You can Click the Below to See Enlarged Agenda

Agenda of the Whole Week

Monday April 1, 2019

  • Full Day Training Sessions (7am - 5:30pm):

    • Training Session M-1:

      "New Insights in Biomarkers Assays Validation (BAV): From US FDA BMV (2018) Guidance, Revised C-Path (2018) White Paper and CLSI Draft Document H62 to Fit-for Purpose Validation - Case Studies from LBA and Flow Cytometry"Evolution of BAV strategy based on New US FDA BMV Guidance, Revised C-Path White Paper and CLSI Draft Document H62 versus traditional Lee (2006) Fit-for-Purpose White Paper

    • Training Session M-2:

      "IMPLEMENTATION of 2018 FDA BMV Final Guidance LCMS & LBA: Regulatory Inputs, Inspections Outcomes/Observations and Industry Experiences" - Lessons Learned from Case Studies in Small Molecules & Biotherapeutics

  • *Please note that M-1 and M-2 are in parallel from 7am to 5:30pm.

Tuesday April 2, 2019

  • MAIN WORKSHOP DAY 1 (7am to 6pm):

    • Main Workshop Day 1A:

      "LCMS, HRMS and Immunoaffinity LCMS: Innovation in Method Development and Novel Solutions in Drug Discovery/Development"

    • Main Workshop Day 1B:

      "ICH M10 BMV Draft Guideline - Chromatography: Industry/Regulators’ Perspectives - Working together to provide official Recommendations to ICH for the Chromatography portion of the document"

  • Full Day Training Session (7am to 5:30pm):

    • Training Session T-1 for LBA scientists:

      "Current & Effective Strategies for Critical Reagent Characterization, Storage, LT Stability, Re-testing and Life Cycle Management for LBA & Flow Cytometry PK, ADA and Biomarkers Assays & Bioanalytical Troubleshooting of Critical Reagents Issues" - Recent Advancements and New Frontiers for the Bioanalytical Lab

  • *Please note that Main Workshop Day 1 and Training Session T-1 are in parallel from 7am to 6pm.

Wednesday April 3, 2019

  • MAIN WORKSHOP DAY 2 (7am to 6pm):

    • Main Workshop Day 2A

      "LCMS & LBA: Orthogonality/Complementarity - PK, Biomarkers and Immunogenicity Assays"

    • Main Workshop Day 2B

      "ICH M10 Common Topics Chromatography & LBA: Industry/Regulators’ Perspective – Working together to provide official Recommendations to ICH for Common Topics portion of the document"

    • Main Workshop Day 2C

      "Regulators’ Advice - Immunogenicity Final Guidance and Biomarker Guidance/Papers: Latest Regulators’ Inputs & Asking your Questions and Interacting Directly with Regulators"

    • Main Workshop Day 2D

      "Regulators’ Advice - Bioanalysis, BMV Guidance/Guidelines: Latest Regulators’ Inputs & Asking your Questions and Interacting Directly with Regulators"

  • *Please note that Day 2A, 2B, 2C and 2D are consecutive, NOT in parallel.

Thursday April 4, 2019

  • MAIN WORKSHOP DAY 3 (7am to 6pm):

    • Main Workshop Day 3A

      "LBA, Cell-based Assays/Flow Cytometry, and Emerging Technologies: Innovation in Method Development and Novel Solutions in Drug Discovery/Development"

    • Main Workshop Day 3B

      "ICH M10 BMV Draft Guideline - LBA: Industry/Regulators’ Perspective – Working together to provide official Recommendations to ICH for the LBA portion of the document"

  • Full Day Training Session (7am to 5:30pm):

    • Training Session Th-1 for LCMS scientists:

      "Mass Spectrometric Novel & Advanced Method Development Strategies for Large Molecules Bioanalysis: Therapeutic Proteins, ADC, Biomarkers, Oligonucleotides, Peptides & New Modalities"Expand your Experience in PK Assays, Biotransformation and Biomarkers Assays, and Learn LCMS Technology Most Recent Updates and Refinements

  • *Please note that Main Workshop Day 3 and Training Session Th-1 are in parallel from 7am to 6pm.

Friday April 5, 2019

  • Full Day Training Sessions (7am - 5:30pm):

    • Training Session F-1:

      "Cut Points – 'The Evolution': Issues in statistical evaluation & current Regulatory Perspectives of Cut Points and impact on Immunogenicity Assay development" - Building on Industry/Regulators’ recommendations & Working together for harmonization

    • Training Session F-2:

      "The Gene Therapy Bioanalytical Challenges: PK/Biodistribution, Immunogenicity and Shedding Assays, qPCR, ELISPOT, Flow Cytometry in Bioanalytical labs, and Regulatory Perspectives"What you need to know to develop bioanalytical assays for Gene Therapy and how Gene Therapy is impacting Bioanalysis in both Pharma and CRO - Multiple platforms & multiple approaches to deal with unsolved bioanalytical issues

  • *Please note that Training Session F-1 and F-2 are in parallel from 7am to 5:30pm.

Agenda in Charts according to your Focus

 

 

Full Immersion Agenda Chart

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LCMS Focus Agenda Chart

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LBA Focus Agenda Chart

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