Agenda Each Day

Monday March 30, 2020

07:00am-07:00pm:

  • Registration desk Open
    Come to pick up your conference program book with all the presentation slides from all the speakers

 

07:00am-05:30pm:

  • Full Day Training Sesssion M-1:

    "Advanced Biomarkers Development & Troubleshooting for LBA & Flow Cytometry: Challenges from Exploratory to Clinical/Confirmatory Biomarkers, Fit-for-Purpose, Context of Use and New Platforms" - From Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers, actual challenges in developing and implementing biomarkers assays in different phases of drug discovery/development by embedding the Fit-for-Purpose (FFP), Context of Use (COU) and new platforms in real-life situations

  • Full Day Specialized Sesssion M-2:

    "BMV Guidance Day: Interpretations & Training on ICH M10 before its Adoption; Audits Outcome using 2018 FDA; Transition from Local Guidelines to ICH M10 with Gap Analysis on Controversial Issues" - How can you be prepared for the transition from local FDA, EMA, MHLW, ANVISA Guidance/Guidelines to ICH M10? What do you need to do for the ICH M10 adoption & Global Harmonization of Bioanalytical Guidance? An in-depth gap analysis on controversial BMV issues after the public consultation of the ICH M10

Note*:
* M-1 and M-2 are in parallel from 7am to 5:30pm
* M-1 and M-2 are NOT part of the Main Workshop and requires additional Registration
* Breakfast for M-1 and M-2 starts at 7am, and lectures starts at 8am
* Breakfast, Lunch, AM and PM Break Refreshments are included for M-1 and M-2

 

05:30pm-07:00pm:

  • Evening Welcome Reception
    Join us for some drinks and networking with your peers!
    reception Sponsored by Waters

Tuesday March 31, 2020

07:00am-06:30pm:

  • Registration desk Open
    Come to pick up your conference program book with all the presentation slides from all the speakers

 

07:00am-06:30pm:

  • MAIN WORKSHOP DAY 1:

    Mass Spectrometry

    • "Innovation in Small Molecules & Novel solution"
    • "HRMS and Hybrid LCMS Assays"
    • "Regulatory Challenges"

07:00am-06:00pm:

  • Full Day Training Session T-1 for LBA scientists:

    "Large Molecules Method Development for LBA: Solving Challenges with Innovative Approaches on Critical Reagents, Learning from Vaccine Assays, Multi-Domain Biotherapeutics, Emerging Technologies" - What’s new in Critical Reagents and impact on method development? What can we learn from Vaccine Assays experience? How Multi-Domain Biotherapeutics (MDB) are changing traditional method development strategies? How can Emerging Technologies (ET) help in method development?

  • Full Day Training Session T-2 for Flow Cytometry scientists:

    "Mass Cytometry (CyTOF) - Welcome into the Future of Flow Cytometry: Learn the Major Advantages & Challenges in Using CyTOF vs Traditional Flow Cytometry in Drug Discovery/Development and Clinical Applications" - Understanding the state-of-the-art principles and practical case studies of Mass Cytometry. A new level of innovation in Flow Cytometry applications with antibodies labeled with heavy metal ion tags and readout by time-of-flight mass spectrometry. What are the method development challenges and solutions? What’s current status of this Emerging Technology (ET) vs traditional Fluorescence-based Flow Cytometry? How can your assay be improved by extending Flow Cytometry capabilities to high-throughput / high-content, single-cell assays, unmet antibody specificities in a single sample and without spillover between channels? How can you increase the number of cellular features and resolution at the same time?

Note*:
* Main Workshop Day 1 and T-1 and T-2 are all in parallel
* T-1 and T-2 are NOT part of the Main Workshop and requires additional Registration
* Breakfast for Main Workshop Day 1, T-1, and T2 all starts at 7am, and lectures starts at 8am
* Breakfast, Lunch, AM and PM Break Refreshments are included for both Workshop Day 1, T-1 and T-2

Wednesday April 1, 2020

07:00am-06:30pm:

  • Registration desk Open
    Come to pick up your conference program book with all the presentation slides from all the speakers

 

07:00am-06:30pm:

  • MAIN WORKSHOP DAY 2 (Day 2A + 2B + 2C):

    Application of Multiple Technologies to solve Complex Bioanalytical Issues

    • "PK Assays & Biodistribution"
    • "Biomarkers Assays"
    • "Immunogenicity Assays"

    Regulators’ Advice - Bioanalysis, BMV Guidance/Guidelines

    • "Latest Regulatory Inputs from Major/Influential Regulatory Agencies"

    Regulators’ Advice - Immunogenicity, Biomarkers, and Gene Therapy

    • "Latest Regulatory Inputs from Major/Influential Regulatory Agencies"

Note*:
* Day 2A, 2B, 2C are sequential, NOT in parallel
* Breakfast for Main Workshop Day 2 starts at 7am, and lectures starts at 8am
* Breakfast, Lunch, AM and PM Break Refreshments are included

Thursday April 2, 2020

07:00am-06:30pm:

  • Registration desk Open
    Come to pick up your conference program book with all the presentation slides from all the speakers

 

07:00am-06:30pm:

  • MAIN WORKSHOP DAY 3:

    LBA, Flow Cytometry, qPCR and Emerging Technologies

    • "Immunogenicity Assays"
    • "Biomarkers Assays"
    • "Vaccine Assays"
    • "PK Assays & Biodistribution"

07:00am-06:00pm:

  • Full Day Training Session Th-1 for LCMS scientists:

    "Small Molecules, Oligos, Peptides Method Development for Chromatographic Assays: Solving Challenges with Innovative Approaches on Sensitivity & Selectivity, Unstable/Sticky Compounds; Column Chemistry, Orthogonal Separations, Tissue bioanalysis" - New level of Sensitivity & Selectivity (S&S); “Very” Unstable Metabolites/Pro-drugs how to catch them; Back to basic with adsorption of very “sticky” Compounds; Novel column chemistry and orthogonal separations. Novel strategies for tissue bioanalysis

Note*:
* Main Workshop Day 3 and Th-1 are in parallel
* Th-1 is NOT part of the Main Workshop and requires additional Registration
* Breakfast for both Main Workshop Day 3 and Th-1 starts at 7am, and lectures starts at 8am
* Breakfast, Lunch, AM and PM Break Refreshments are included for both Workshop Day 3 and Th-1

Friday April 3, 2020

07:00am-05:30pm:

  • Registration desk Open
    Come to pick up your conference program book with all the presentation slides from all the speakers

 

07:00am-05:30pm:

  • Full Day Specialized Session F-1:

    "Advanced Immunogenicity Day: Implementation of 2019 FDA Immunogenicity Guidance, NAb Assays, ADA Validation Reporting, Immunogenicity Risk Assessment, Regulatory Feedbacks & Controversial Issues" - Implementation of the Guidance after a year from its issuance; Current approaches on Nab (Cell-Based and Bridging) Assays; ADA Validation Reporting; Immunogenicity Risk Assessment and impact on bioanalytical strategy; Regulatory Feedbacks on submitted studies; Inspections/audits outcomes based on the new Guidance; and Case Studies on successfully implementation in compliance with the new Guidance and avoid observations and 483s

  • Full Day Specialized Course F-2:

    "Cell & Gene Therapy Bioanalysis: Recent Advancements and New Frontiers for Bioanalytical Labs on Flow Cytometry, qPCR, ELISPOT, Regulatory Requirements, CAR-T and CRISPR Assays Case Studies" - Catching up with “explosion” of recent developments Cell & Gene Therapy Bioanalysis with specific focus on Flow Cytometry, qPCR, ELISPOT and Regulatory Requirements. Ongoing research in CAR-T and CRISPR Bioanalytical, Biodistribution Biomarkers and Immunogenicity Case Studies. Strategies to be prepared to handle the increasing demand of drug discovery/development bioanalytical data in support of ongoing and future research

Note*:
* F-1 and F-2 are in parallel from 7am to 5:30pm
* F-1 and F-2 are NOT part of the Main Workshop and requires additional Registration
* Breakfast for F-1 and F-2 starts at 7am, and lectures starts at 8am
* Breakfast, Lunch, AM and PM Break Refreshments are included for F-1 and F-2