title: 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).
abstract: The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.
authors.affiliation: Eli Lilly & Company, Indianapolis, IN, USA.
authors.forename: Brad
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authors.lastname: Ackermann
authors.affiliation: Pfizer, Andover, MA, USA.
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authors.affiliation: Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada.
authors.forename: Nicola
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authors.lastname: Hughes
authors.affiliation: Angelini Pharma, Piazzale della Stazione, snc, 0040 S. Palomba Pomezia (RM), Italy.
authors.forename: Fabio
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authors.lastname: Garofolo
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA.
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authors.affiliation: Seattle Genetics, Bothell, WA, USA.
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authors.lastname: Alley
authors.affiliation: Eli Lilly & Company, Indianapolis, IN, USA.
authors.forename: Patricia
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authors.affiliation: Health Canada, Ottawa, ON, Canada.
authors.forename: Mark
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authors.lastname: Bustard
authors.affiliation: Boehringer Ingelheim, Ridgefield, CT, USA.
authors.forename: Lin-Zhi
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authors.lastname: Chen
authors.affiliation: Roche Innovation Center Penzberg, pRED Pharmaceutical Sciences, Germany.
authors.forename: Julia
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authors.lastname: Heinrich
authors.affiliation: Japan MHLW-NIHS, Tokyo, Japan.
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authors.affiliation: Genentech, South San Francisco, CA, USA.
authors.forename: Surinder
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authors.affiliation: Pfizer, San Diego, CA, USA.
authors.forename: Leo
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authors.lastname: Kirkovsky
authors.affiliation: Merck & Co., Inc., Rahway, NJ, USA.
authors.forename: Omar F
authors.initials: OF
authors.lastname: Laterza
authors.affiliation: France ANSM, Saint Denis, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Le Blaye
authors.affiliation: inVentiv Health Clinical, Quebec City, QC, Canada.
authors.forename: Ann
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authors.lastname: Lévesque
authors.affiliation: Brazil ANVISA, Brasilia, Brazil.
authors.forename: Gustavo Mendes Lima
authors.initials: GM
authors.lastname: Santos
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Timothy
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authors.lastname: Olah
authors.affiliation: CFABS, Montreal, QC, Canada.
authors.forename: Natasha
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authors.lastname: Savoie
authors.affiliation: US FDA, Silver Spring, MD, USA.
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authors.lastname: Skelly
authors.affiliation: MedImmune, Gaithersburg, MD, USA.
authors.forename: Susan
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authors.lastname: Spitz
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authors.forename: Matthew
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authors.lastname: Szapacs
authors.affiliation: US FDA, Silver Spring, MD, USA.
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authors.lastname: Tampal
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Jian
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authors.affiliation: Dutch MEB, Utrecht, The Netherlands.
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authors.forename: Jaap
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authors.lastname: Wieling
authors.affiliation: US FDA, Silver Spring, MD, USA.
authors.forename: Sam
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authors.lastname: Haidar
authors.affiliation: UK MHRA, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Vinter
authors.affiliation: UK MHRA, London, UK.
authors.forename: Emma
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authors.lastname: Whale
authors.affiliation: Germany BfArM, Bonn, Germany.
authors.forename: Bärbel
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mesh_terms: D015415:Biomarkers / Q000737:chemistry*; D001702:Biopharmaceutics / Q000458:organization & administration*; D001709:Biotechnology / Q000458:organization & administration*; D049674:History, 21st Century; D006801:Humans
chemical_list: D015415:Biomarkers