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. (March 2016)

• Record Type: Journal Article
• Authors: Hayes, Roger; LeLacheur, Richard; Dumont, Isabelle; Couerbe, Philippe; Safavi, Afshin; Islam, Rafiq; Pattison, Colin; Cape, Stephanie; Rocci, Mario; Briscoe, Chad; Cojocaru, Laura; Groeber, Elizabeth; Silvestro, Luigi; Bravo, Jennifer; Shoup, Ron; Verville, Manon; Zimmer, Jennifer; Caturla, Maria Cruz; Khadang, Ardeshir; Bourdage, James; Hughes, Nicola; Fatmi, Saadya; Di Donato, Lorella; Sheldon, Curtis; Keyhani, Anahita; Satterwhite, Christina; Yu, Mathilde; Fiscella, Michele; Hulse, James; Lin, Zhongping (John); Garofolo, Wei; Savoie, Natasha; Xiao, Yi Qun; Kurylak, Kai; Harris, Sarah; Saxena, Manju; Buonarati, Mike; Lévesque, Ann; Boudreau, Nadine; Lin, Jenny; Khan, Masood U; Ray, Gene; Liu, Yansheng; Xu, Allan; Soni, Gunjan; Ward, Ian; Kingsley, Clare; Ritzén, Hanna; Tabler, Edward; Nicholson, Bob; Bennett, Patrick; van de Merbel, Nico; Karnik, Shane; Bouhajib, Mohammed; Wieling, Jaap; Mulvana, Daniel; Ingelse, Benno; Allen, Mike; Malone, Michele; Fang, Xinping;
• Is Part Of: Bioanalysis. Volume 8:Number 6(2016)
• Page Start: 487
• Page End: 495
• Publication Date: 2016-03
• Subjects: biomarker -- biosimilar -- blood partitioning; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.16.16
• Languages: English
• ISSNs: 1757-6180

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.