抄録
The FDA’s new initiative on advancing regulatory science embraces the increased adoption of emerging technologies such as pharmacogenomics (PGx) and bioinformatics in regulatory application. These technologies are complex in nature and individual groups often do not have the resources to pursue biological qualification of biomarkers and validation of these technologies individually, thus slowing the realization in regulatory application. The FDA has developed the Voluntary eXploratory Data Submission (VXDS) program as a framework outside traditional regulatory interactions for sponsors and FDA to develop expertise, tools, and processes appropriate for regulatory interpretation of PGx data, and ultimately determine the utility, shortcomings, and needs for development and application of PGx. The program identifies considerable work in progress and controversies to be resolved before consensus is achieved on the most appropriate and valid methods at a refined and advanced level. The VXDS is thus being undertaken in parallel with ongoing research aimed at determining the best scientific practices in using exploratory data. An important parallel research effort is the MicroArray Quality Control (MAQC) project that is an FDA-led, community-wide effort aimed at developing consensus among stakeholders for optimizing the reproducibility of technologies, standardizing data analysis practices, and allowing re-analysis of the data by sharing the results across the research community. Both VXDS and MAQC programs have had to grapple with formidable difficulties in data management, analyses, and interpretation, resulting in the establishment of the new Division of Bioinformatics and Biostatistics at the FDA’s National Center for Toxicological Research (NCTR), which has developed a suite of bioinformatics tools including ArrayTrack as an efficient and adaptable bioinformatics environment to support regulatory science. Realizing that we are entering the 21st century as consumer products are increasingly globalized, regulatory science needs a strategy to develop a global path to expedite the translation of basic science innovation to regulatory application. With this goal in mind, we established the Global Summit on Regulatory Science (GSRS) which fosters the development of sustainable regulatory systems that promote global public health through scientific exchange, training and research collaborations. Importantly, we have developed a Global Coalition of Regulatory Research Scientists (GSRSR); this is an international coalition with an objective of facilitating education, scientific training and scientific exchange in the field of regulatory science. All these aforementioned efforts are designed to enhance our capability to expedite the translation of cutting edge technologies into comprehensive approaches to advance regulatory science and public health.
