title: Regulatory bioinformatics for food and drug safety.
abstract: "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements necessary to ensure the safe introduction and effective use of these applications.
authors.affiliation: Food Standards Australia New Zealand, Barton, Australian Capital Territory, 2905, Australia. Electronic address: marion.healy@foodstandards.gov.au.
authors.forename: Marion J
authors.initials: MJ
authors.lastname: Healy
authors.affiliation: National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079-9502, USA. Electronic address: weida.tong@fda.hhs.gov.
authors.forename: Weida
authors.initials: W
authors.lastname: Tong
authors.affiliation: US Food and Drug Administration, Silver Spring, MD, 20993-0002, USA. Electronic address: stephen.ostroff@fda.hhs.gov.
authors.forename: Stephen
authors.initials: S
authors.lastname: Ostroff
authors.affiliation: European Medicines Agency, London, E14 5EU, United Kingdom. Electronic address: hans-georg.eichler@ema.europa.eu.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Eichler
authors.affiliation: European Commission, Joint Research Centre, Ispra, Varese, 21027, Italy. Electronic address: alex.patak@ec.europa.eu.
authors.forename: Alex
authors.initials: A
authors.lastname: Patak
authors.affiliation: Canadian Food Inspection Agency, Ottawa, Ontario, Canada. Electronic address: margaret.neuspiel@inspection.gc.ca.
authors.forename: Margaret
authors.initials: M
authors.lastname: Neuspiel
authors.affiliation: European Food Safety Authority, Parma, 43126, Italy. Electronic address: Hubert.deluyker@efsa.europa.eu.
authors.forename: Hubert
authors.initials: H
authors.lastname: Deluyker
authors.affiliation: National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079-9502, USA. Electronic address: william.slikker@fda.hhs.gov.
authors.forename: William
authors.initials: W
authors.lastname: Slikker
mesh_terms: D000818:Animals; D001688:Biological Products / Q000009:adverse effects*; D019295:Computational Biology / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005516:Food Microbiology / Q000331:legislation & jurisprudence; D059022:Food Safety / Q000379:methods*; D033161:Government Regulation; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D007881:Legislation, Food; D011050:Policy Making; D057285:Precision Medicine; D021281:Quantitative Structure-Activity Relationship; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D001688:Biological Products
keywords: Bioinformatics; Drug safety; Food safety; GCRSR; GSRS; Genomics; Microbiome; Next-generation sequencing; Regulatory bioinformatics; Regulatory science