By Mark Arnold and Fabio Garofolo
Growth, transformation, transition, and diversification of bioanalytical science during the last ten years has led health authorities around the globe to develop regulations that contained a core of commonality, but also a variety of not-quite-the-same, to downright different requirements. As the noise level grew around how to respond to these regulations within the bioanalytical community, it became clear to both industry and regulators that harmonized best practices were needed. Thus, the Global Bioanalysis Consortium (GBC) was born “…as an all-inclusive consortium consisting of represented scientific associations with worldwide influence to merge existing or emerging bioanalytical guidance/guidelines to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.”
During past AAPS annual meetings, preliminary GBC harmonization teams’ science-based recommendations have been presented and discussed in the context of harmonizing the Food and Drug Administration (FDA), European Medicines Agency, Brazilian Health Surveillance Agency, and Japan’s Pharmaceuticals and Medical Devices Agency. Over the past year, many of the harmonization teams have published their recommendations and are actively being discussed as counterpoints to the FDAs draft revised Bioanalytical Method Validation guidance (2013).
As part of this year’s 2014 AAPS Annual Meeting and Exposition, the GBC is planning to share its final conclusions on the regulated bioanalysis for chromatographic assays in an interactive session, Bioanalytical Science is Universal! Based on current technological evolution and insights, the recommendation permits execution of existing practices and new trends in regulated bioanalysis. They should be interpreted as the current state-of-the-art best practices in chromatographic bioanalysis. Throughout the session, we will present and engage the broader scientific community in an active debate on how to use GBC conclusions on a daily basis and how to achieve the harmonization of the multiple guidelines already issued, as well as new ones expected in the near future.
Join us on Wednesday, November 5, from 8:30 am to 11:00 am in room 6C of the San Diego Convention Center. We look forward to hearing your thoughts on the recommendations and their applicability to your job!
Mark E. Arnold, Ph.D., is executive director of the Bioanalytical Sciences & Selective Integration Department of the Bristol-Myers Squibb Co. in Princeton, NJ. In addition to nearly 30 years in the industry developing, validating, and implementing bioanalytical assays to quantify exogenous (drugs and metabolites, including biologics) and biomarkers in animal and clinical samples, Arnold has been extensively involved in industry organizations: a planning committee member for the Land O’Lakes Bioanalytical meeting, past chair of the AAPS Bioanalytical Focus Group, and member of the Global Bioanalysis Consortium and the IQ Consortium Microsampling Working Group.
Fabio Garofolo, Ph.D., has been working in the pharmaceutical and analytical fields since 1989. Since 2005, he has held the position of Vice President Bioanalytical Services at Algorithme Pharma.