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. |
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 optimize the regulatory use of standardized 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. | Michael DeNieu: Working Group Lead
Michael is a member of Global Data Management Solutions at Covance, joining the team in 2019 as a data associate generating and QCing SEND data packages, moving to a supervisor in 2020. The focus of his role has been on the quality of data sets and leading initiatives to provide enhancements to processes and capabilities, as well as working with sponsors to ensure their needs and expectations are met. Michael is a volunteer with CDISC and an active member of the EX domain sub-team. Michael’s original background is in evolutionary biology and quantitative genetics, the programming and statistical skills later developed during his graduate work and postdoc are what contributed to develop an interest in the structure and use of data which led Michael to Covance. |
