Sue Forda is Vice-President GRA International at Eli Lilly and chair of the Scientific, Regulatory and Manufacturing Policy Committee at EFPIA. Sue will give an overview of EFPIA's and Eli Lilly's viewpoint and guidelines regarding clinical trial data transparency, the progress made against the 2013 commitments and provide an outlook regarding transparency for the life sciences companies in a broader sense.
Andrew Freeman is Director of R&D policy at GSK and responsible for many of GSK's initiatives and executing on policies around publishing of clinical trial registry, protocol information to external researchers including the well-published initiative to make annonymized patient-level data available on https://clinicalstudydatarequest.com/ together with such companies as Roche, Boehringer Ingelheim, Novartis, Sanofi and ViiV Healthcare. Andrew will shed light on the progress of this initiative and list up aspects that organizations should consider when sharing patient data from clinical trials.
Ulla Outrup is Vice-President of Clinical Development at NovoNordisk. Ulla will share the status of the data transparency project at NovoNordisk and will give us an overview of objectives and outlook to the future.
Sarah Nolan is a Medical Statistician in the Department of Biostatistics, University of Liverpool, United Kingdom. Sarah is an author and statistician for the Cochrane Epilepsy Group and is responsible for eight ongoing individual participant data reviews. Sarah is two years into a part-time PhD in the research area of evidence synthesis including current issues around data sharing and data transparency in academic research. In her presentation, Sarah will cover the activities of the academic researcher in the context of clinical trial data analysis, the reasons why academia desires access and the exact requirements, the meaning of transparency and the obligations of external researchers.
Gregrory Steffens is Associate Director Programming at Novartis. Greg will discuss how to de-identify patient data in practice, from the process of de-identification to bringing it in practice with re-usable programming procedures.
Matt Gross is Business Director at the SAS Health and Life Sciences Global Practice. During his presentation, Matt will summarize the themes from the day's presentation, panels and break-out sessions.