ISoP Data Standards at ACoP7

Population pharmacokinetic (popPK) analyses are performed regularly, and stand as a commonly-included component of regulatory submissions. Datasets used in such analyses are prepared and documented inconsistently, however, with varying degrees of quality, are often difficult to review (internally and externally) and as such do not facilitate the development of precompetitive tools for process automation and data exploration. A group of around 20 enthusiastic pharmacometricians and data programmers was formed at the beginning of 2016 to address this situation. Sponsored by ISoP, the group envisions the development of common popPK data standards for interchange and analysis. Some of the benefits will include improved: * consistency in pharmacometric datasets, * quality (fewer errors), * efficiency (automation of dataset preparation, facilitation of project handover and on-boarding, enabling development of open-source tools for automatic graphical exploration), and * regulatory compliance and audit readiness (enabling development of open-source tools for packaging data for submission). The group has established close links with CDISC, who have lent their expertise to this initiative and will assist in its eventual integration with their system of standards. We intend to develop open-source companion tools to support the automation of dataset creation and checking. Once this first phase is complete, we intend to expand our focus to include PK-PD datasets. On Tuesday, October 25, 5-6:30pm, we will have an open session at ACoP 7 in Bellevue. We intend to update the community on our progress and welcome anyone with ideas that could facilitate achieving our goal and our overall vision to move the field of Pharmacometrics forward! For more information, do not hesitate to contact Andrijana Radivojevic<mailto:[email protected]> (Novartis), or any other member of the team: Justin Wilkins<mailto:[email protected]> (Occams), Brian Corrigan<mailto:[email protected]> (Pfizer), Ted Grasela<mailto:[email protected]> (Cognigen), Jill Fiedler-Kelly<mailto:[email protected]> (Cognigen), Murad Melhem<mailto:[email protected]> (Amgen), Robert Fox<mailto:[email protected]> (AstraZeneca), Huan Liu<mailto:[email protected]> (AstraZeneca), Jing Su<mailto:[email protected]> (Merck), Neelima Thanneer<mailto:[email protected]> (BMS), Maciej J Swat<mailto:[email protected]> (DDMoRE), Peter Schaefer<mailto:[email protected]> (Validated Cloud Applications), David Radtke<mailto:[email protected]> (Eli Lilly), Henning Schmidt<mailto:[email protected]> (IntiQuan), Christian Rasmussen<mailto:[email protected]> (Novo Nordisk), Warwick Benger<mailto:[email protected]> (GSK), Jeffry Florian<mailto:[email protected]> (FDA), Scott Pivirotto<mailto:[email protected]> (Metrum), Tim Bergsma<mailto:[email protected]> (Certara), Stuart Moodie<mailto:[email protected]> (Eight Pillars), Liping Zhang<mailto:[email protected]> (J&J), or simply join us this Tuesday! Andrijana Radivojevic, PhD Principal Pharmacometrics Scientist Pharmacometrics Novartis Pharmaceuticals Corporation One Health Plaza, 135/108A East Hanover, NJ 07936-1080 USA Phone +1 862 778-1152 Mobile +1 917 714-1215 [email protected]<mailto:[email protected]> http://www.novartis.com/