Working Group Scope A collaboration working to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner through limited term projects. Our focus is on using informatics approaches and standards for delivering ideas and solutions to nonclinical data challenges. Annually, at the Computational Sciences Symposium (CSS), we present our progress and achievements and develop new projects that further the value of nonclinical data. |
Current Projects Harmonization of SEND Implementation to Enable Historical Control Data Analysis Nonclinical Study Data Reviewers Guide |
Kevin Snyder: Working Group Lead
Dr. Kevin Snyder manages data science and informatics initiatives to support the pharmacology/toxicology review staff in the Office of New Drugs in the Center for Drug Evaluation and Research at the US FDA. These initiatives include research efforts to develop methods to optimise the regulatory use of standardised electronic CDISC-SEND-formatted toxicology study data as well as the development of software solutions to improve the efficiency of research and review activities conducted by the pharmacology/toxicology review staff. Dr. Snyder also leads an agency-wide Data Science and Software Development working group that is focused on building out the internal infrastructure necessary to support the work of data scientists across the agency and is an active collaborator with several consortia efforts, e.g. CDISC, PHUSE, and BioCelerate, to improve the implementation and use of the SEND data standard. Dr. Snyder received his Bachelors in biochemistry from the University of Maryland in 2008 and his PhD in neuroscience from the University of Pennsylvania School of Medicine in 2013. |
