Medical Device Link.

Final Thoughts

The Joint Committee on Traceability in Laboratory Medicine (JCTLM) has listed more than 200 higher-order certified reference materials (CRMs) and more than 120 reference-measurement procedures used in laboratory medicine. CRMs and reference-measurement procedures for disease signatures and pharmacogenomic markers must be developed, and the JCTLM and its member organizations have begun to act. An “Ask the Industry” meeting in July 2008 included IVD representatives involved in new immuno- and molecular diagnostic technology development. This meeting was just the beginning for the promotion of calibration traceability in laboratory medicine methods.

National metrology institutes (the U.S. National Institute of Standards and Technology and its counterparts in other countries) and the EC’s Institute for Reference Materials and Measurements develop and provide reference methods, materials, and data based on expert review and consensus within professional organizations, regulatory agencies, academic institutions, and industry. Reference materials for pharmaceuticals and specifications for their measurement are most commonly the province of national pharmacopeias. FDA’s requirement for companion diagnostics to support therapeutics of biological origin and calibration traceability interests of IVD and pharmaceutical companies is clearly complementary.

In October 2008, NIST conducted a meeting, “Accelerating Innovation in 21st Century Biosciences: Identifying the Measurement Standards and Technological Challenges,” to identify measurements, standards, and technology gaps that are barriers to innovation. This meeting included directors of national metrology institutes, international science policy experts and individuals from government, and academic and industry stakeholders. Laboratory medicine was a major topic of discussion. A plenary lecture described the need for better measurement tools, integrated multidisciplinary approaches, and advanced computational tools so that personalized medicine can be predictive, preventative, and participatory. Meeting participants identified measurement needs common to laboratory medicine and other areas of the biosciences. These included better methodologies and practices for sample handling, more-robust protein measurements, high-throughput multiplexed measurements, improved tools and standards for bioinformatics, and improved tools and methods to ensure confidence in data and enable comparability across multiple platforms.

A meeting sponsored by the International Bureau of Weights and Measures, the Consultative Committee for Amount of Substance-Metrology in Chemistry, and United States Pharmacopeia—with participation of the European Directorate for the Quality of Medicines & Healthcare and the National Institute for Biological Standards and Control—was held in December 2008 to initiate discussions between the biopharmaceutical industry and the organizations responsible for developing traceable measurement systems. The goal of the workshop was to define the challenges and required developments for analytical and bioanalytical measurements to ensure the comparability and consistency of pharmaceutical and biopharmaceutical products. More than 30 experts from industry, standards-developing organizations, and national metrology institutes attended. Topics included strategies for the value assignment of the properties of materials, the development of reference materials and methods, regulatory requirements for the characterization of pharmaceutical and biopharmaceutical products, and others. Additional topics were the challenge of defining the measured property in bioassay measurements and the unit in which it is expressed, and requirements for and possibilities of establishing traceability to the International System of Units.

While several conclusions emerged from these discussions, pharmacopeias have not yet embraced modern metrological traceability principles. As a result, prospects for harmonization may be hindered. However, given the clear advantages afforded the IVD field by taking a systematic approach to measurement traceability and comparability, it is expected that the therapeutic arena will embrace a voluntary consensus-based approach to harmonization.

Craig M. Jackson, PhD, is the quality system team leader of Working Group 1 of the JCTLM, (San Diego, CA). He can be reached at cjackso2@san.rr.com.

Robert I. Wielgosz, PhD, directs the secretariat of the JCTLM, which resides at the BIPM (Paris). He can be reached at rwielgosz@bipm.org.

Michael D. Amos, PhD, is the biosciences advisor in the director’s office of the chemical science and technology laboratory at NIST (Gaithersburg, MD). He can be reached at michael.amos@nist.gov.

William F. Koch, MS, PhD, is chief metrology officer at USP (Rockville, MD). He can be reached at WFK@usp.org.