title: 9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
abstract: The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.
authors.affiliation: MPI Research, Mattawan, MI, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Hayes
authors.affiliation: Agilux Laboratories, Worcester, MA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: LeLacheur
authors.affiliation: Algorithme Pharma, Laval, QC, Canada.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Dumont
authors.affiliation: Atlanbio, Saint-Nazaire, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Couerbe
authors.affiliation: BioAgilytix, Durham, NC, USA.
authors.forename: Afshin
authors.initials: A
authors.lastname: Safavi
authors.affiliation: Celerion, Lincoln, NB, USA.
authors.forename: Rafiq
authors.initials: R
authors.lastname: Islam
authors.affiliation: Charles River, Edinburgh, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Pattison
authors.affiliation: Covance, Madison, WI, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Cape
authors.affiliation: ICON, Whitesboro, NY, USA.
authors.forename: Mario
authors.initials: M
authors.lastname: Rocci
authors.affiliation: PRA Health Sciences, Lenexa, KS, USA.
authors.forename: Chad
authors.initials: C
authors.lastname: Briscoe
authors.affiliation: Tandem Labs, West Trenton, NJ, USA, currently at Covance, WestTrenton, NJ, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Cojocaru
authors.affiliation: WIL Research, Ashland, OH, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Groeber
authors.affiliation: 3S-Pharmacological Cons. & Res. GmbH, Harpstedt, Germany.
authors.forename: Luigi
authors.initials: L
authors.lastname: Silvestro
authors.affiliation: Agilux Laboratories, Worcester, MA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Bravo
authors.affiliation: AIT Bioscience Indianapolis, IN, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Shoup
authors.affiliation: Algorithme Pharma, Laval, QC, Canada.
authors.forename: Manon
authors.initials: M
authors.lastname: Verville
authors.affiliation: Alturas Analytics, Moscow, ID, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Zimmer
authors.affiliation: Anapharm Europe, Barcelona, Spain.
authors.forename: Maria Cruz
authors.initials: MC
authors.lastname: Caturla
authors.affiliation: Axis Clinicals, Dilworth, MN, USA.
authors.forename: Ardeshir
authors.initials: A
authors.lastname: Khadang
authors.affiliation: BASi, West Lafayette, IN, USA.
authors.forename: James
authors.initials: J
authors.lastname: Bourdage
authors.affiliation: Bioanalytical Laboratory Services, Toronto, ON, Canada.
authors.forename: Nicola
authors.initials: N
authors.lastname: Hughes
authors.affiliation: Biotrial Bioanalytical Services Inc., Laval, QC, Canada.
authors.forename: Saadya
authors.initials: S
authors.lastname: Fatmi
authors.affiliation: CAPRION, Montreal, QC, Canada.
authors.forename: Lorella
authors.initials: L
authors.lastname: Di Donato
authors.affiliation: Celerion, Lincoln, NB, USA.
authors.forename: Curtis
authors.initials: C
authors.lastname: Sheldon
authors.affiliation: Charles River, Senneville, QC, CAN, currently at Algorithme Pharma, Laval, QC, Canada.
authors.forename: Anahita
authors.initials: A
authors.lastname: Keyhani
authors.affiliation: Charles River, Reno, NV, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Satterwhite
authors.affiliation: CIRION BioPharma Research, Laval, QC, Canada.
authors.forename: Mathilde
authors.initials: M
authors.lastname: Yu
authors.affiliation: Covance, Chantilly, VA, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Fiscella
authors.affiliation: Eurofins Pharma Bioanalytics Services, St Charles, MO, USA.
authors.forename: James
authors.initials: J
authors.lastname: Hulse
authors.affiliation: Frontage Laboratories, Inc., Exton, PA, USA.
authors.forename: Zhongping John
authors.initials: ZJ
authors.lastname: Lin
authors.affiliation: Global CRO Council for Bioanalysis (GCC).
authors.forename: Wei
authors.initials: W
authors.lastname: Garofolo
authors.affiliation: Global CRO Council for Bioanalysis (GCC).
authors.forename: Natasha
authors.initials: N
authors.lastname: Savoie
authors.affiliation: Global CRO Council for Bioanalysis, Envigo, East Millstone, NJ, USA.
authors.forename: Yi Qun
authors.initials: YQ
authors.lastname: Xiao
authors.affiliation: Global CRO Council for Bioanalysis, Envigo, East Millstone, NJ, USA.
authors.forename: Kai
authors.initials: K
authors.lastname: Kurylak
authors.affiliation: Intertek USA, San Diego, CA, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Harris
authors.affiliation: Intertek USA, San Diego, CA, USA.
authors.forename: Manju
authors.initials: M
authors.lastname: Saxena
authors.affiliation: Intertek USA, San Diego, CA, USA.
authors.forename: Mike
authors.initials: M
authors.lastname: Buonarati
authors.affiliation: Previously at InVentiv Health Clinical, Quebec City, QC, CAN.
authors.forename: Ann
authors.initials: A
authors.lastname: Lévesque
authors.affiliation: Previously at InVentiv Health Clinical, Quebec City, QC, CAN.
authors.forename: Nadine
authors.initials: N
authors.lastname: Boudreau
authors.affiliation: CMIC, Inc., Hoffman Estates, IL, USA.
authors.forename: Jenny
authors.initials: J
authors.lastname: Lin
authors.affiliation: KCAS Bioanalytical Services, Shawnee, KS, USA, currently at Alliance Pharma, Malvern, PA, USA.
authors.forename: Masood U
authors.initials: MU
authors.lastname: Khan
authors.affiliation: KCAS Bioanalytical Services, Shawnee, KS, USA.
authors.forename: Gene
authors.initials: G
authors.lastname: Ray
authors.affiliation: KCAS Bioanalytical Services, Shawnee, KS, USA.
authors.forename: Yansheng
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Keystone Bioanalytical, Inc., North Wales, PA, USA.
authors.forename: Allan
authors.initials: A
authors.lastname: Xu
authors.affiliation: Lambda Therapeutic Research, Ahmedabad, India.
authors.forename: Gunjan
authors.initials: G
authors.lastname: Soni
authors.affiliation: LGC, Fordham, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ward
authors.affiliation: LGC, Fordham, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Kingsley
authors.affiliation: Mercodia AB, Uppsala, Sweden.
authors.forename: Hanna
authors.initials: H
authors.lastname: Ritzén
authors.affiliation: PPD, Richmond, VA, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Tabler
authors.affiliation: PPD, Richmond, VA, USA.
authors.forename: Bob
authors.initials: B
authors.lastname: Nicholson
authors.affiliation: PPD, Richmond, VA, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Bennett
authors.affiliation: PRA Health Sciences, Assen, The Netherlands.
authors.forename: Nico
authors.initials: N
authors.lastname: van de Merbel
authors.affiliation: Pyxant Labs, Colorado Springs, CO, USA.
authors.forename: Shane
authors.initials: S
authors.lastname: Karnik
authors.affiliation: Pharma Medica, Toronto, ON, Canada.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Bouhajib
authors.affiliation: QPS, Groningen, The Netherlands, currently at Antaeus Biopharma, Groningen, Netherlands.
authors.forename: Jaap
authors.initials: J
authors.lastname: Wieling
authors.affiliation: Quintiles, Ithaca, NY, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Mulvana
authors.affiliation: Quintiles, Oss, The Netherlands.
authors.forename: Benno
authors.initials: B
authors.lastname: Ingelse
authors.affiliation: Tandem Labs, Durham, NC, USA, currently at Covance, Durham, NC, USA.
authors.forename: Mike
authors.initials: M
authors.lastname: Allen
authors.affiliation: Worldwide Clinical Trials, Austin, TX, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Malone
authors.affiliation: WuXi/XBL, 107 Morgan Lane, Plainsboro, NJ, USA.
authors.forename: Xinping
authors.initials: X
authors.lastname: Fang
mesh_terms: D015415:Biomarkers / Q000032:analysis* / Q000097:blood; D059451:Biosimilar Pharmaceuticals / Q000032:analysis*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D057286:Electronic Health Records; D007753:Laboratories; D012955:Societies, Medical; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers; D059451:Biosimilar Pharmaceuticals
keywords: biomarker; biosimilar; blood partitioning