When we provide sample concentration data for submission with new drug applications, clients have an expectation that those data will meet regulatory agency expectations for quality, accuracy, and precision. Those expectations have been evolving since the first US consensus AAPS/FDA workshop (Crystal City I) in 1990. Subsequent workshops and the resulting white papers have formed the basis for guidance documents on conducting method validations and sample analysis. These documents are published by regulatory agencies such as the US FDA and the European Medicines Agency.
Global Bioanalysis Consortium
The Global Bioanalysis Consortium (GBC) is an industry-driven global effort to propose best practices based on scientific principles for bioanalytical work. The GBC was first proposed in an open letter published in February 2010 authored by four individuals, including a Covance representative. In the two years since then, the GBC has established 20 Harmonization Teams (HT) covering all aspects of both small and large molecule regulated bioanalysis.
The role of the GBC is to propose industry-standard, globally acceptable criteria to the regulatory agencies to assist them in their promulgation of guidance documents for both GLP (nonclinical) and clinical (regulated) bioanalysis.
Covance Leads GBC Representation
In the past four years, Covance Bioanalytical personnel have been instrumental in working to shape evolving criteria that brings to bear both good scientific principles and the practical knowledge gained from running hundreds of thousands of assay samples every year. Three global leaders from Covance serve as HT leaders — a higher representation than any other pharmaceutical organization. These HT leaders are Joe Bower (Chantilly), Stuart McDougall (Alnwick), and Doug Fast (Madison). Additional Covance scientists serve as members on several other teams.
Global Harmonization of Bioanalytical Guidance
The GBC is an entirely industry-driven effort to provide a scientific perspective on current and emerging bioanalysis work to regulatory agencies in the United States, Latin America, Europe, and Asia-Pacific.
To achieve this global reach, our harmonization teams are:
- comprised of 8 to 12 individuals;
- representative of each major region in which bioanalysis is conducted;
- chartered to present recommendations at regional and global scientific and regulatory forums;
- tasked with drafting meeting presentations and white papers on their assigned topics;
- prepared to submit specific recommendations to a global consensus conference to be held in 2013; and
- building cooperative links to global regulatory authorities in bioanalysis.
Bioanalytical concentration results are the foundation of decisions about exposure, safety margins, dosing levels and intervals, and prescribing information made by regulators as they review new drug applications. We are shaping global best practices and expectations through leadership and active participation in the GBC to assure that those reported results are globally consistent, reliable, and meaningful.