Nonclinical Topics
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. |
Resources |
Click here to search for all Nonclinical Topics deliverables, past projects are housed under the archived section. |
| For Reference |
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Susan DeHaven is a veteran of SEND standard development and implementation. She and her global team manage administration of software applications used across multiple countries for data collection, analysis, visualization and reporting, along with the associated standards governance and data management for analysis and submission. Most recently, Susan and her team have implemented data systems with tools and repositories for transforming data from sources to SEND and SDTM. Susan is a co-Lead, with FDA partners, of the PhUSE Nonclinical Topics Working Group and the CDISC/FDA SEND for CBER Initiative and is a long time member of the CDISC SEND Core Team. She has represented her opinions about pharma industry perspectives on SEND in various conference panels and has been recognized with a Collaboration Award from FDA and a PhUSE/FDA Working Group Award for Achievement. Susan is based in Bridgewater, New Jersey, USA is an avid equestrian and foxhunter, and lives on a farm in Asbury, New Jersey. |
Kevin Snyder recently served at the FDA/CDER as the Associate Director of Nonclinical Informatics, where he managed data science and informatics initiatives to support the pharmacology/toxicology review programme. These initiatives included research efforts to develop methods to optimise the regulatory use of standardised electronic CDISC-SEND-formatted toxicology study data as well as internal informatics projects to promote the development of scientifically sound, data-driven regulatory policies. Kevin has joined Certara in a new role as Director of Nonclinical Innovation and Emerging Technologies, guiding pharmaceutical sponsors in their efforts to strategically integrate nonclinical data across all phases of pharmaceutical development and enhance new drug safety. Prior to this transition, he served at the FDA: first at CDRH as a bioinformatician and in vitro diagnostic device reviewer and then as pharmacology/toxicology reviewer at CDER. He has played a leading role in precompetitive consortia, including the Pistoia Alliance, CDISC, PHUSE, VICT3R and BioCelerate, supporting efforts to enhance the implementation and use of standardised toxicology study data. Kevin is a dedicated advocate for the modernisation of regulatory toxicology via strategic adoption of data standards and data science techniques to drive innovation in areas such as predictive modelling, virtual controls and new approach methodologies (NAMs). |
Michael is a member of Global Data Management Solutions at Labcorp, 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 Labcorp. |
