PHUSE EU Connect 2020: Statistical Programming Modernization
Summary
(Abbvie, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi and more were represented in the discussions alongside vendors such as SAS and Entimo.) o Drive the requirements of a best-in-class SCE defined by top pharma companies o Define and develop a common set of SCE tools for adoption by any organization o A single framework which could be shared with regulatory agencies to facilitate and accelerate submissions They answered this through a series of review meetings with peers (Sascha Ahrweiler [Bayer], Joseph Rowley [Novartis], Olivier Leconte [J&J], Delyth Jones [GSK], Hoger Dach [Bayer], Jorinne Putter [GSK], Marie-Claude Laramee [Novartis], Mario Lozina [Boehringer Ingelheim], Paul Fioole [J&J], Oliver Richter [Boehringer Ingelheim], Jon-Paul Mewes [Roche], Des Burke [GSK]). Sam Warden and Ali Dootson of d-wise presented data compiled from the d-wise Market Monitor taxonomy tool and the PHUSE survey completed by 129 individuals from 44 organizations. The premise behind building Aspire is described by Chris Olinger, CTO d-wise, that off-the-shelf or custom-built systems both follow episodic development or deployment cycles, inevitably making them legacy. From decades of experience, we know these legacy systems are difficult and costly to maintain, restricted by SAS, typically are hosted on-premises, and do not allow for the seamless deployment of validated novel technologies.