2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies’ Input on Bioanalysis, Biomarkers and Immunogenicity)

Authors: Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Dasgupta A, Fischer S, Hayes R, Kamerud J, Santos GML, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H
Publication: Bioanalysis
Division: Regulatory Strategies

Abstract

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1-5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on the 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies’ input on bioanalysis, biomarkers, immunogenicity and gene therapy. Part 1 (Innovation in small molecules and oligonucleotides and mass spectrometry method development strategies for large molecules bioanalysis) and Part 3 (New insights in biomarker assay validation, current and effective strategies for critical reagent management, flow cytometry validation in drug discovery and development and CLSI H62, interpretation of the 2019 FDA immunogenicity guidance and gene therapy bioanalytical challenges) are published in volume 10 of Bioanalysis, issues 22 and 24 (2019), respectively.

By Brian Booth, Lauren Stevenson, Renuka Pillutla, Michael Buonarati, Chris Beaver, Daniela Fraier, Fabio Garofolo, Sam Haidar, Rafiq Islam, Christopher James, John Kadavil, Olga Kavetska, Fumin Li, Christina Satterwhite, Natasha Savoie, Sriram Subramaniam, Nilufer Tampal, Theingi Thway, Eric Woolf, Olivier Le Blaye, Matthew Andisik, Chad Briscoe, Stephanie Cape, Arindam Dasgupta, Sally Fischer, Sam Haidar, Roger Hayes , John Kamerud, Gustavo Mendes Lima Santos, Corey Nehls, Catherine Soo, Stephen Vinter, Emma Whale, Keyang Xu, Seongeun Julia Cho, Anna Edmison, Sean Kassim, Thais Correa Rocha, Jan Welink, Shashi Amur, Abbas Bandukwala, Elana Cherry, Shirley Hopper, Akiko Ishii-Watabe, Susan Kirshner, Kevin Maher, Joao Pedras-Vasconcelos, Yoshiro Saito, Therese Solstad Saunders, Venke Skibeli, Daniela Verthelyi, Yow-Ming Wang, & Haoheng Yan