13th WRIB (Workshop on Recent Issues in Bioanalysis)
Where Regulators and the Industry Convene
April 1-5, 2019, New Orleans, LA, USA
Hyatt Regency New Orleans
New Method Development Challenges & Case Studies
Latest Inputs & Advice from Regulatory Agency Experts
White Paper from 13th WRIB
2019 White Paper in Bioanalysis, Biomarkers, Immunogenicity and Gene Therapy was based on the conclusions and consensus points from the 13th WRIB in April 2019. It was divided into 3 parts due to length, and was just published on Journal Bioanalysis.
- Part 1 – Chromatographic Assays - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis
- Part 2 – FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies’ Input on Bioanalysis, Biomarkers and Immunogenicity
- Part 3 – FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62
