2011 White Paper on Recent Issues in Bioanalysis & Regulatory Findings from Audits and Inspections

The 5th Workshop on Recent Issues in Bioanalysis was organized by the Calibration and Validation Group (CVG) as a two-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon consistent approaches on recent issues in the bioanalysis of both small and large molecules. The foundation of the workshop was based on high quality, better compliance and scientific excellence. As in the previous editions of this significant event, recommendations were suggested and a consensus was achieved among panelists and attendees on topics of interest in the bioanalytical field. This workshop led to the creation of the present 2011 White Paper in Bioanalysis, which aims to provide an authoritative guide that addresses major recent bioanalytical issues and ‘hot’ topics and how to solve them

2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies & Biomarkers (Part 1 – Small Molecule by LCMS)

The 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) was held in Miami, Florida on April 13-17, 2015 with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The workshop included three sequential core workshop days and six specialized training sessions that together spanned an entire week in order to allow exhaustive and thorough coverage of major issues in bioanalysis, biomarkers and immunogenicity. Like the previous workshops, the 9th WRIB was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in both small and large molecule bioanalysis using LCMS, hybrid LBA/LCMS, and LBA approaches. An in depth focus was on biomarkers, immunogenicity and emerging technologies. The actively contributing chairs in the 2015 edition of the WRIB were Dr. Eric Fluhler (Pfizer), Dr. Jan Welink (EMA / Dutch MEB), Dr. Brad Ackermann (Eli Lilly), Dr. Fabio Garofolo (Angelini Pharma), Dr. An Song (Genentech), Dr. Theingi Thway (Amgen), Dr. Lakshmi Amaravadi (Biogen Idec) and Dr. Heather Myler (Bristol-Myers Squibb). The numerous regulatory agency representatives who contributed to the 9th WRIB included Dr. Sam Haidar (US FDA), Dr. Susan Kirshner (US FDA), Dr. Brian Booth (US FDA), Dr. Michael Skelly (US FDA), Dr. Nilufer Tampal (US FDA), Dr. Jan Welink (EMA/Dutch MEB), Dr. Olivier Le Blaye (France ANSM), Ms. Emma Whale (UK MHRA), Mr. Stephen Vinter (UK MHRA), Dr. Bärbel Witte (German BfArM), Dr. Mark Bustard (Health Canada), Mr. Gustavo Mendes Lima Santos (Brazil ANVISA) and Dr. Noriko Katori (Japan MHLW-NIHS). Each of the three Sequential Core Workshop days was designed to cover a wide-range of bioanalytical topics suggested by members of the community, and included presentations from industry leaders and regulatory representatives, culminating in an open panel discussion between the presenters, regulators and attendees in order to determine the consensus items presented in this white paper

2017 White Paper on recent issues in bioanalysis: Aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: Small molecules, peptides and small molecule biomarkers)

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. 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 analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches. This 2017 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 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for Small Molecules, Peptides and Small Molecule Biomarkers using LCMS. Part 2 (Biotherapeutics, Biomarkers and Immunogenicity Assays using Hybrid LBA/LCMS and Regulatory Agencies' Inputs) and Part 3 (LBA: Immunogenicity, Biomarkers and PK Assays) are published in volume 9 of Bioanalysis, issues 23 and 24 (2017), respectively