ECETOC Workshop Session at 56th Annual SOT Meeting and ToxExpo, Baltimore, Maryland, USA, 15 March 2017.
Chairperson(s): Weida Tong, US FDA/NCTR, Jefferson, AR; and Timothy W. Gant, Centre for Radiation, Chemical and Environmental Effects, Oxfordshire, United Kingdom.
Endorser(s): Molecular and Systems Biology Specialty Section Regulatory and Safety Evaluation Specialty Section Risk Assessment Specialty Section
Molecular events associated with the effects of chemical, biological, and physical agents on biological systems can be globally determined using ’omic high-throughput technologies. These technologies are playing a major role in the generation of new knowledge and understanding in mechanisms of toxicity. However, use and application of these technologies has been slower in hazard identification and regulatory risk assessment. This slow uptake has been associated with technical issues of data quality and reproducibility. Although such challenges still exist, the main challenge now is achieving consistency in data processing and biological interpretation. Consistent methods and agreed frameworks and processes for collection/curating, processing, analyzing, and interpreting data are paramount to support regulatory assessments. Consensus amongst stakeholders including industry, academia, and regulatory agencies on this issue will provide guidance and confidence on how ’omic technologies can be applied in regulatory decision-making.
To that end, this workshop aimed to propose transparent frameworks and suitable processes to provide a baseline and confidence on the application of ’omics in regulatory decision making, with a specific emphasis on data analysis and interpretation in risk assessment. Challenges and issues in the regulatory application of ’omic data were addressed in the context of status and future direction for developing objective protocols for the analysis, interpretation, and reporting of ’omic results. The presenters gave their views on a path forward with time for the audience to respond and discuss. The session will have been of interest to bioinformaticians, research toxicologists, and regulators alike, and welcomed input from all of these sectors.
#3084 2:00 Data Standardization Across ’Omic Platforms
in Regulatory Toxicology.
2:00 Introduction. W. Tong. US FDA/NCTR, Jefferson,
#3085 2:05 Towards Developing a Framework for Using
New Technologies in Next Generation Risk
Assessment and Decision Making. A. Poole.
ECETOC, Brussels, Belgium. Sponsor: W. Tong
#3086 2:30 Quality Assurance of ’Omics Technologies
Considering GLP-Like Requirements. B.v.
Ravenzwaay. BASF SE, Ludwigshafen, Germany.
#3087 2:55 Transcriptomics Data Analysis: Lessons
Learned from the US FDA-Led Community-
Wide Consortium Effort. W. Tong. US FDA/NCTR,
#3088 3:20 Analyzing Data: Towards Developing a
Framework for Transcriptomics and Other “Big
Data” Analysis for Regulatory Application. T.W.
Gant. Chemical and Environmental Effects, Public
Health England, Oxfordshire, United Kingdom.
#3089 3:45 Standardization in Metabolomics—The
Current Effort and Future Directions. H.C. Keun.
Imperial College London, London, United Kingdom.
Sponsor: W. Tong
4:10 Panel Discussion/Q&A.