The 12th WRIB will continue to feature the novel and unique 3-Day Sequential Program during the Main Workshop Days with no parallel sessions. However you have the flexibility to choose which Workshop Days based on your specific track of interest and learning needs.
In addition to the Sequential Main Workshop Days, 6 full-day Training Courses/Specialized Sessions will spread throughout the week to give you many choices to combine Main Workshop Days with Training Courses/Specialized Sessions to maximize your learning process at any level in your field of expertise.
Training Course M-1:
"Biomarkers Troubleshooting: Successes & Failures in Biomarkers Assays Development & Validation (BAV)" - Lesson learnt from practical biomarkers case studies depicting real-life situations in which problems need to be solved
Training Course M-2:
"What do you need to know to be prepared for the ICH M10 BMV adoption & Global Harmonization of Bioanalytical Guidance?" - An in-depth gap analysis on controversial BMV issues in preparation of the public consultation of the ICH M10 BMV technical document
*Please note that Course M-1 and M-2 are in parallel, each from 8am to 5:30pm.
MAIN WORKSHOP DAY 1:
"SM, Peptides & SM Biomarkers by LCMS - Novel Solutions in Method Development & Regulatory Challenges"
Specialized Session T-1 for LBA scientists:
"LBA & Flow Cytometry for Large Molecules Advanced Method Development Challenges, Solutions and New Industry Standards with NEW Case Studies" - advanced and interactive session in LBA & Flow Cytometry where original case studies and state-of the art technologies & approaches are presented from experts in the field
*Please note that Main Workshop Day 1 and Course T-1 are in parallel from 8am to 6pm.
MAIN WORKSHOP DAY 2A
"Hybrid LBA/LCMS (Immunoaffinity LCMS) for Biotherapeutics, Biomarkers and ADA - New Developments and Achievements"
MAIN WORKSHOP DAY 2B
"Regulators' Advice - Latest Regulatory Inputs from Major/Influential Regulatory Agencies on New Guidances/Regulations and Findings"
*Please note that Day 2A and Day 2B are consecutive, NOT in parallel.
MAIN WORKSHOP DAY 3:
"LBA ⁄ Cell-based Assays, LM Biomarkers Validation, and Immunogenicity - Challenges and Solutions"
Training Course Th-1 for LCMS scientists:
"Crucial importance of correct Internal Standards (IS) Response Troubleshooting & Interpretation in Effective LCMS Method Development, Validation and Sample Analysis" - Learning how to interpret “dangerous” IS behaviors & take actions through an in-depth evaluation of case studies; Putting in a place a decision-making process during method development based on IS variation to identify specific patterns which can impact method robustness and mainly data reliability during sample analysis; Be ready to answer Regulatory Agencies’ concerns on IS variation & data accuracy
*Please note that Main Workshop Day 3 and Course Th-1 are in parallel from 8am to 6pm.
Specialized Session F-1:
Cut-Points Why, When and How? Current industry standards on Cut-Points and Pre-Existing Antibodies Evaluation - Working closely with Regulatory Agencies and experts to define how to handle cut-points in complex situations such as: disease populations with high frequency of pre-Abs, new modalities, vaccines, peptides, ADC, etc. Pitfalls and challenges in the calculation of Screening (SCP) and Confirmatory (CCP) cut-points vs. false positive rates
Training Course F-2:
"Large Molecules Bioanalytical Method Development by LCMS, HRMS and Hybrid LBA/LCMS Specifically and Systematically Designed for Scientists with LBA Background" - Discover the Whole Power and Exciting Potential of LCMS in the Bioanalysis of Biotherapeutics
*Please note that Course F-1 and Course F-2 are in parallel from 8am to 5:30pm.
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