Welink, Jan, Fluhler, Eric , Hughes, Nicola , Arnold, Mark , Garofolo, Fabio , Booth, Brian , Bustard, Mark , Coppola, Laura , Dhodda, Raj , Evans, Christopher , Gleason, Carol , Haidar, Sam , Hayes, Roger , Heinig, Katja , Katori, Noriko , Le Blaye, Olivier , Li, Wenkui, Liu, Guowen , Santos, Gustavo Mendes Lima , Meng, Min , Nicholson, Bob , Savoie, Natasha , Skelly, Michael , Sojo, Luis , Tampa, Nilufer , van de Merbel, Nico , Verhaeghe, Tom , Vinter, Stephen , Wickremsinhe, Enaksha , Whale, Emma , Wilson, Amanda , Witte, Bärbel and Woolf, Eric (2015) 2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies & Biomarkers (Part 1 – Small Molecule by LCMS). Bioanalysis.

Abstract

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.

Item Type:	Article
Date Deposited:	27 Apr 2016 23:45
Last Modified:	27 Apr 2016 23:45
URI:	https://oak.novartis.com/id/eprint/26990