Formation of a Global Contract Research Organization Council for Bioanalysis

Abstract

BioanalysisVol. 2, No. 11 General content - EditorialFree AccessFormation of a Global Contract Research Organization Council for BioanalysisNoel Premkumar, Stephen Lowes, James Jersey, Fabio Garofolo, Isabelle Dumont, Robert Masse, Betty Stamatiou, Maria C Caturla, Ray Steffen, Michele Malone, Elliot Offman, Timothy Samuels, Phillip Oldfield, Lorella Di Donato, Douglas Fast, Daniel Tang, Marc Moussallie, John Doughty, Mario Rocci, Mike Buonarati, Dominique Gouty, Darioush Dadgar, John Stamatopoulos, Alan Breau, Bernard Ntsikoussalabongui, Mohammed Bouhajib, Bob Nicholson, Richard Tacey, Peter Ketelaar, Chad Briscoe, Shane Karnik, Jaap Wieling, Jon Kirk Smith, Michael J Reid, Richard LeLacheur, John Chapdelaine, Saadya Fatmi, Farhad Sayyarpour, Xinping Fang, Jeremy Cook & David BrowneNoel PremkumarABC LaboratoriesSearch for more papers by this author, Stephen LowesAdvion BioServicesSearch for more papers by this author, James JerseyAgilux LaboratoriesSearch for more papers by this author, Fabio Garofolo† Author for correspondenceSearch for more papers by this authorEmail the corresponding author at fgarofolo@algopharm.com, Isabelle DumontAlgorithme Pharma Inc.; Algorithme Pharma Inc., 575 Armand-Frappier Blvd, Laval (Montreal) Quebec, H7V 4B3, CanadaSearch for more papers by this author, Robert MasseAnapharmSearch for more papers by this author, Betty StamatiouAnapharmSearch for more papers by this author, Maria C CaturlaAnapharm EuropeSearch for more papers by this author, Ray SteffenBASiSearch for more papers by this author, Michele MaloneWorldwide Clinical Trials Drug Development SolutionsSearch for more papers by this author, Elliot OffmanCelerionSearch for more papers by this author, Timothy SamuelsCharles RiverSearch for more papers by this author, Phillip OldfieldCharles RiverSearch for more papers by this author, Lorella Di DonatoCIRIONSearch for more papers by this author, Douglas FastCovance LaboratoriesSearch for more papers by this author, Daniel TangFrontage LaboratoriesSearch for more papers by this author, Marc MoussallieHuntingdon Life SciencesSearch for more papers by this author, John DoughtyHuntingdon Life SciencesSearch for more papers by this author, Mario RocciICON Development SolutionsSearch for more papers by this author, Mike BuonaratiIntertek Alta LCMSSearch for more papers by this author, Dominique GoutyIntertek Alta ImmunochemistrySearch for more papers by this author, Darioush DadgarKCASSearch for more papers by this author, John StamatopoulosLAB ResearchSearch for more papers by this author, Alan BreauMPI ResearchSearch for more papers by this author, Bernard NtsikoussalabonguiMPI ResearchSearch for more papers by this author, Mohammed BouhajibPharma Medica ResearchSearch for more papers by this author, Bob NicholsonPPDSearch for more papers by this author, Richard TaceyPPDSearch for more papers by this author, Peter KetelaarPRA InternationalSearch for more papers by this author, Chad BriscoePRA InternationalSearch for more papers by this author, Shane KarnikPyxant LabsSearch for more papers by this author, Jaap WielingQPS, LLCSearch for more papers by this author, Jon Kirk SmithSmithers Pharma ServicesSearch for more papers by this author, Michael J ReidSNBL USASearch for more papers by this author, Richard LeLacheurTaylor TechnologySearch for more papers by this author, John ChapdelaineWarnex Bioanalytical ServicesSearch for more papers by this author, Saadya FatmiWarnex Bioanalytical ServicesSearch for more papers by this author, Farhad SayyarpourWIL Research LaboratoriesSearch for more papers by this author, Xinping FangXenoBiotic Laboratories (XBL)Search for more papers by this author, Jeremy CookYork Bioanalytical SolutionsSearch for more papers by this author & David BrowneYork Bioanalytical SolutionsSearch for more papers by this authorPublished Online:20 Oct 2010https://doi.org/10.4155/bio.10.165AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit Keywords: bioanalysisbioanalytical CRObioanalytical guidelinesbioanalytical harmonizationbioanalytical issuescontract research organizationGCCGlobal CRO CouncilFigure 1. Global contract research organizations council dynamics.AAPS: American Association of Pharmaceutical Scientists; CRO: Contract research organization; CVG: Calibration and Validation Group; EBF: European Bioanalysis Forum; GBC: Global Bioanalysis Consortium; GCC: Global CRO Council; GLP: Good Laboratory Practices.BackgroundOver the last year, the bioanalytical community strongly expressed their need for international harmonization of bioanalytical guidances through numerous international meetings and publications, and this need was acknowledged by several regulatory agencies [1–5]. Following the 4th Calibration and Validation Group (CVG) Workshop on Regulated Bioanalysis hosted in Montreal (April 2010), a unanimous consensus was reached for the global bioanalytical community to identify non-prescriptive, science-based language that could form the basis of a proposed guidance document on bioanalysis [6]. Ideally, such guidance language would describe the rationale behind each bioanalytical requirement and would be presented for consideration by agencies and industry worldwide.A recent concrete action taken towards such global harmonization of bioanalytical guidances was the creation of the Global Bioanalysis Consortium (GBC). Drawing from representatives of scientific associations with involvement in regulated bioanalysis across the globe, the objective of the GBC is to merge existing or emerging bioanalytical guidances and create a unified document that can be presented to the regulatory authorities in various countries and regions. The development of the GBC is currently in process, with the intention to present plans and updates at upcoming bioanalytical meetings and to seek input from the scientists conducting bioanalysis [7].At the 4th CVG Bioanalysis Workshop in Montreal, Canada, several Contract Research Organizations (CROs) highlighted the importance of having a strong and cohesive CRO contribution to the global harmonization process. Having CROs, academic laboratories and pharmaceutical industries appropriately represented was viewed as critical to identifying optimum language. Consequently, the proposal to build a Global CRO Council (GCC) arose, designed to be a distinct group consisting exclusively of bioanalytical CRO members conducting regulated bioanalysis business.To initiate creation of the GCC, a special closed forum was held in Montreal on 14 September 2010, where 41 executive representatives from 32 bioanalytical CROs were present to discuss scientific harmonization issues and the institution of the GCC. This first CRO closed forum was a unique occasion to discuss, review and share perspectives upon a unified CRO approach on how to support the global harmonization of bioanalytical guidances.Harmonization issuesBioanalytical CROs work under strict regulatory standards, and since they operate globally in various countries, similar to their pharmaceutical and biotechnology clients, they have to deal with different regulations and guidances. The differences in the guidance documents (or lack of) from major regulatory agencies (e.g., the FDA for USA, EMA for Europe, ANVISA for Brazil, TGA for Australia, SFDA for China and MHLW for Japan) are becoming a serious hurdle for CROs that conduct studies destined for submission to different health agencies. Many CROs performing bioequivalence studies are struggling to comply with both national and international guidelines, especially in emerging economies such as Asia-Pacific, Latin America and Eastern Europe. Therefore, global harmonization of bioanalytical guidances would have a strong, profound and positive impact on how CROs function in such a global and regulated environment, and would help to achieve a consistent bioanalytical quality standard.Several specific challenges that CROs are facing were raised and discussed during the first CRO closed forum. For instance, multiple questions regarding cross-validation of transferred methods from sponsor laboratories and associated stability assessments still need consensus. Adequate guidance and quality standards are lacking for some matrix-related issues, including the assessment of hemolysis and the use of matrices from different ethnic groups. This is also the case for many other general validation requirements concerning sample re-injection versus re-assay, investigations on incurred sample reproducibility (ISR) failures; re-assay for pharmacokinetic reasons; assays using dried blood spot analysis; and method parameters for biomarkers/ligand-binding assays. In addition, suitable standards outlining an appropriate Quality Management System for bioanalytical laboratories have not yet been issued by most of the major regulatory agencies. This is a small sampling of topics and not considered to be an exhaustive list.Formation of the Global CRO CouncilThe GCC is proposed to be a global independent group specifically focused on harmonization of bioanalytical guidelines that have particular relevance to scientific bioanalytical issues impacting CROs. The extended vision of the GCC is to present a formal and cohesive CRO body to global health authorities and regulatory agencies around the world to help address the specific scientific challenges CROs encounter in conducting regulated bioanalysis. The goals and objectives of the GCC include the following: ▪ Offer a forum for the CRO community to gather input and reach a consensus on concerns about regulatory developments in bioanalysis and CRO-specific challenges;▪ Communicate with other bioanalytical associations (e.g., the American Association of Pharmaceutical Scientists [AAPS], the CVG and the European Bioanalysis Forum [EBF]) and with regulatory agencies via official publications and presentations at bioanalytical meetings;▪ Generate a scientific document to be presented to the GBC that will provide input from a CRO perspective in an effort to achieve global harmonization of bioanalytical guidances;▪ Support the interests of CRO sponsors through the identification of specific solutions to bioanalytical regulatory body concerns.When building the GCC, the CROs will be considered as the members, in other words, the CRO itself will be a member, not the individual person representing the CRO. One or two representatives will represent each CRO, and these representatives must be part of the CRO’s senior management. The structure of the GCC will be established in a way that will promote collaboration, facilitate effective communication and maintain efficiency in reaching science-driven consensus.Since the GCC members are competitors often sharing the same clients, all members will have equal representation. Hence, a flat organizational structure that preserves equality and minimizes hierarchy is advocated. The GCC must not interfere with the competitive environment CROs operate in. Therefore, the operation of the GCC must officially discourage any potential anti-competitive behavior and totally avoid any operational, strategic, pricing or confidential issues. A formal articulation of the GCC’s mission in by-laws is being considered, as well as the creation of admonition statements and meeting minutes for each GCC meeting. In addition, specific GCC members will work together on the incorporation of the GCC as a nonprofit independent international organization.As previously outlined, effective communication will be crucial to the success of the GCC. This will be accomplished internally using face-to-face dialog, electronic conversations and surveys. External visibility of the GCC will be supported by official publications, presentations and involvement in cross-organization discussion groups. A GCC closed forum will be held each year, in parallel with a major scientific conference that CROs will usually plan to attend (e.g., the AAPS, CVG and EBF conferences). Other special GCC closed forums may also be organized as needed; for example, following particular events or emerging issues needing appropriate response from the CRO perspective. To ensure efficiency, the GCC will need to focus on clear goals, outcomes and action plans during GCC meetings. Figure 1 summarizes some of the dynamics surrounding the GCC.Only GCC members (i.e., CRO representatives) who are present at a particular GCC closed forum will take part in the decision-making process, utilizing the following guidelines: ▪ Inclusive: involving as many GCC member companies as possible, from various countries and regions;▪ Participatory: actively soliciting the input and the participation of all GCC members;▪ Cooperative: working to reach the most appropriate decision for the group, rather than pursuing a majority opinion potentially to the detriment of a minority;▪ Egalitarian: all GCC members having equal input;▪ Solution-oriented: GCC members aiming for common agreement over differences and reaching effective decisions using mutually beneficial solutions;▪ Dissent early: maximizing chances of accommodating views.The fact that the GCC is global and not local is most certainly one of its most essential features, and this will need to be kept in mind throughout the building and growing of the GCC.Future considerationsIn the upcoming months, the GCC members will continue working together on the institution of the GCC and on the approach to adopt in communicating with regulatory agencies. The next annual GCC closed forum is planned to take place in Montreal on 15 April 2011, immediately following the 5th CVG Workshop on Bioanalysis in Montreal (11–14 April 2011). The subsequent GCC closed forum is tentatively scheduled to occur concurrently with the October 2011 AAPS conference (Washington, USA) or the December 2011 EBF conference (Barcelona, Spain). Anyone who can provide relevant insight, wisdom or knowledge in relation to the building of a group such as the GCC is invited to provide input and feedback.Financial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.Bibliography1 Lausecker B, van Amsterdam P, Brudny-Kloeppel M, Luedtke S, Timmerman P. European Bioanalysis Forum and the way forward towards harmonized regulations. Bioanalysis1(5),873–875 (2009).Link, CAS, Google Scholar2 Abbott R. European Bioanalysis Forum, 2nd Open Symposium: The broadening scope of validation: towards best practices in the world of bioanalysis. Bioanalysis2(4),703–708 (2010).Link, CAS, Google Scholar3 Timmerman P, Lowes S, Fast DM, Garofolo F. Request for global harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis. Bioanalysis2(4),683 (2010).Link, CAS, Google Scholar4 Bansal S, Arnold M, Garofolo F. International harmonization of bioanalytical guidance. Bioanalysis2(4),685–687 (2010).Link, CAS, Google Scholar5 van Amsterdam P, Lausecker B, Luedtke S, Timmerman P, Brudny-Kloeppel M. Towards harmonized regulations for bioanalysis: moving forward! 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Nicholson, Steve Lowes, Maria Cruz Caturla, Afshin Safavi, Dan Mamelak, Rafiq Islam, John Allinson, Dominique Gouty, Masood Khan, Richard LeLacheur, Ronald Shoup, Suzanne Martinez, Isabelle Dumont, Jennifer Zimmer, Ray Steffen, James Petrilla, Kayode Awaiye, Curtis Sheldon, Douglas Turk, Douglas Fast, John Kamerud, Andrew Dinan, Zhongping (John) Lin, Wei Garofolo, Daniel Tang, Laura Wright, Jenny Lin, Yasuhiro Yamashita, Yansheng Liu, Allan Xu, Roger Hayes, Mohammed Bouhajib, Ann Levesque, Sofi Gagnon-Carignan, Jake Harman, Mark Warren, Shane Karnik, Laura Cojocaru, Scott Reuschel, Pilar Gonzalez, Saadya Fatmi, Jenifer Vija, Marie Rock, Michele Malone, William Nowatzke & Xinping Fang23 October 2012 | Bioanalysis, Vol. 4, No. 192012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple GuidelinesBinodh DeSilva, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont, France Landry, Catherine Dicaire, Gabriella Szekely-Klepser, Russell Weiner, Mark Arnold, Surendra Bansal, Kevin Bateman, Ronald Bauer, Brian Booth, Scott Davis, Sherri Dudal, Dominique Gouty, John Grundy, Sam Haidar, Roger Hayes, Mohammed Jemal, Surinder Kaur, Marian Kelley, Magnus Knutsson, Olivier Le Blaye, Jean Lee, Steve Lowes, Mark Ma, Toshinari Mitsuoka, João Tavares Neto, Robert Nicholson, Eric Ormsby, Jeffrey Sailstad, Lauren Stevenson, Daniel Tang, Jan Welink, CT Viswanathan, Laixin Wang, Eric Woolf & Eric Yang9 October 2012 | Bioanalysis, Vol. 4, No. 18Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)Timothy Sangster, John Maltas, Petra Struwe, Jim Hillier, Mark Boterman, Mira Doig, Massimo Breda, Fabio Garofolo, Maria Cruz Caturla, Philippe Couerbe, Christine Schiebl, Colin Pattison, Lee Goodwin, Rudi Segers, Wei Garofolo, Lois Folguera, Dieter Zimmer, Thomas Zimmerman, Maria Pawula, Daniel Tang, Chris Cox, Chiara Bigogno, Dick Schoutsen, Theo de Boer, Rachel Green, Richard Houghton, Romuald Sable, Christoff Siethoff, Tammy Harter & Stuart Best9 August 2012 | Bioanalysis, Vol. 4, No. 14Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and CarryoverSteve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Shane Needham, Philippe Couerbe, Tim Lansing, Masood Bhatti, Curtis Sheldon, Roger Hayes, Rafiq Islam, Zhongping (John) Lin, Wei Garofolo, Marc Moussallie, Leonardo de Souza Teixeira, Thais Rocha, Paula Jardieu, James Truog, Jenny Lin, Richard Lundberg, Alan Breau, Carmen Dilger, Mohammed Bouhajib, Ann Levesque, Sofi Gagnon-Carignan, Rand Jenkins, Robert Nicholson, Ming Hung Lin, Shane Karnik, William DeMaio, Kirk Smith, Laura Cojocaru, Mike Allen, Saadya Fatmi, Farhad Sayyarpour, Michele Malone & Xinping Fang18 April 2012 | Bioanalysis, Vol. 4, No. 7Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)Mark Boterman, Mira Doig, Massimo Breda, Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Isabelle Dumont, Suzanne Martinez, Shane Needham, Maria Cruz Caturla, Philippe Couerbe, Joelle Guittard, John Maltas, Tim Lansing, Masood Bhatti, Christine Schiebl, Petra Struwe, Curtis Sheldon, Roger Hayes, Timothy Sangster, Colin Pattison, Johanne Bouchard, Lee Goodwin, Rafiq Islam, Rudi Segers, Zhongping (John) Lin, Jim Hillier, Wei Garofolo, Dieter Zimmer, Lois Folguera, Thomas Zimmermann, Maria Pawula, Marc Moussallie, Leonardo de Souza Teixeira, Thais Rocha, Daniel Tang, Paula Jardieu, James Truog, Jenny Lin, Richard Lundberg, Chris Cox, Alan Breau, Chiara Bigogno, Dick Schoutsen, Carmen Dilger, Mohammed Bouhajib, Ann Levesque, Sofi Gagnon-Carignan, Robert Nicholson, Rand Jenkins, Ming Hung Lin, Shane Karnik, Theo De Boer, Richard Houghton, Rachel Green, William DeMaio, Romuald Sable, Kirk Smith, Christoph Siethoff, Laura Cojocaru, Mike Allen, Tammy Harter, Saadya Fatmi, Farhad Sayyarpour, Michele Malone, Stuart Best & Xinping Fang28 March 2012 | Bioanalysis, Vol. 4, No. 6Conference Report: The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical ForumMassimo Breda, Fabio Garofolo, Maria Cruz Caturla, Philippe Couerbe, John Maltas, Peter White, Petra Struwe, Timothy Sangster, Suzanne Riches, Jim Hillier, Wei Garofolo, Thomas Zimmerman, Maria Pawula, Eileen Collins, Dick Schoutsen, Jaap Wieling, Rachel Green, Richard Houghton, Bernard Jeanbaptiste, Quinton Claassen, Tammy Harter & Mark Seymour, 20 December 2011 | Bioanalysis, Vol. 3, No. 24Conference Report: Discussion on harmonization and globalization of bioanalytical guidances at the 19th International Reid Bioanalytical ForumFabio Garofolo, John Smeraglia, Ray Briggs, Mark Seymour & Howard Hill20 December 2011 | Bioanalysis, Vol. 3, No. 242011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and InspectionsFabio Garofolo, Mario L Rocci, Isabelle Dumont, Suzanne Martinez, Steve Lowes, Eric Woolf, Peter van Amsterdam, Surendra Bansal, Ariadna Cristina Gomes Barra, Ronald Bauer, Brian P Booth, Montserrat Carrasco-Triguero, Binodh DeSilva, John Dunn, Keith Gallicano, Dominique Gouty, Stacy Ho, Richard Hucker, Mohammed Jemal, Noriko Katori, Olivier Le Blaye, Jean Lee, Wenkui Li, Steve Michael, Corey Nehls, Robert Nicholson, Eric Ormsby, Daniel Tang, CT Viswanathan, Russell Weiner & Graeme Young26 September 2011 | Bioanalysis, Vol. 3, No. 18Conference Report: Bioanalysis: Challenges and Solutions SeminarAndrew Roberts8 September 2011 | Bioanalysis, Vol. 3, No. 17Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for BioanalysisSteve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Natasha Savoie, Ejvind Mortz, Shane Needham, Maria Cruz Caturla, Ray Steffen, Curtis Sheldon, Roger Hayes, Tim Samuels, Lorella Di Donato, John Kamerud, Steve Michael, Zhongping (John) Lin, Jim Hillier, Marc Moussallie, Leonardo de Souza Teixeira, Mario Rocci, Mike Buonarati, James Truog, Saleh Hussain, Richard Lundberg, Alan Breau, Tianyi Zhang, Jianine Jonker, Neil Berger, Sofi Gagnon-Carignan, Corey Nehls, Robert Nicholson, Martijn Hilhorst, Shane Karnik, Theo de Boer, Richard Houghton, Kirk Smith, Laura Cojocaru, Mike Allen, Tammy Harter, Saadya Fatmi, Farhad Sayyarpour, Jenifer Vija, Michele Malone & Dennis Heller16 June 2011 | Bioanalysis, Vol. 3, No. 12Conference Report: The 1st Conference in Asia-Pacific on Recent Issues in BioanalysisIsabelle Dumont & Fabio Garofolo31 March 2011 | Bioanalysis, Vol. 3, No. 7 Vol. 2, No. 11 Follow us on social media for the latest updates Metrics History Published online 20 October 2010 Published in print November 2010 Information© Future Science LtdKeywordsbioanalysisbioanalytical CRObioanalytical guidelinesbioanalytical harmonizationbioanalytical issuescontract research organizationGCCGlobal CRO CouncilFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.PDF download