Ann Marie Martin & Philippe Lamote,
Innovative Medicines Initiative, Brussels, Belgium

Title: The use of Open Source Software in the Pharmaceutical Industry and the Innovative Medicines Initiative Projects.

Abstract:

The definition of open source. Where is it used? What is open source development? Open source software licenses and dual licensing. Where in the pharmaceutical industry is open source software used? When does it work well and when does it not? Examples of famous open source software development projects, successful use and adoption as well as less successful examples. The concept of open is gaining popularity: we now speak about open data, open publication, open collaboration.
The Innovative Medicines Initiative Joint Undertaking is a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through its innovative funding scheme, IMI supports more efficient drug discovery and the development of safer and better medicines for patients. The total IMI budget for the period 2008-2017 is €2 billion, including €1 billion contributed by the European Commission’s Seventh Framework Programme and €1 billion provided, mainly as in-kind contributions, by the industry.
Open source software is used in several IMI projects or developed through IMI projects. The projects are partnerships between academic, small medium enterprises, non-profit organizations, patient organizations, regulatory authorities. Examples will be given and we’ll expand on the pros and cons of open source software use. Finally an IMI project is the ideal platform and provides funding to kick-start such a open source project: whether it be by developing software or whether it be for testing and adopting open-source software.

Ann Marie Martin

Ann Martin is a Chartered Statistician and holds a Masters degree in Sociology and Statistics from the London School of Economics and Political Science, UK. 

www.imi.europa.eu

Implementing OpenCDISC for Compliance Checking

Dirk Van Krunckelsven, Senior Specialist – GPSRS: Global Processes, Standards, Research and Systems for GBS, Merck N.V./S.A, Overijse, Belgium 

Verifying the compliance of your data to the CDISC models is a must! OpenCDISC is a great help in accomplishing this. A minor caveat is that the GUI (Graphical User Interface) does not allow you to select a location for the report, but this can be overcome easily through the command line. Crucial is the interpretation of the report: one still needs to understand the CDISC models and the data in order to make sense of the report and to define the actions to be taken based on it: will one correct the data or the data structure, ignore an issue and explain in for example the Reviewer’s Guide, or does one further investigate. Implementing OpenCDISC is very much worth the effort, it comes with a good basis of checks and you can even extend the checks yourself. On top of that the OpenCDISC website with full descriptions of all checks and an active forum provides a valuable source of information. The most important reason for relying on OpenCDISC for compliance checks is that both CBER and CDER use the tool when you submit data to the FDA.

presentation canceled

An Introduction to the Use of R for Clinical Research

Dimitris Rizopoulos, Assistant Professor at Department of Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands

R (http://www.r-project.org/) has become the ‘lingua franca’ of data analysis and statistical computing. Its great success is attributed to its free availability and the capability for a wide range of analyses and graphics.

In this talk we will discuss the main features of the R system and its application to clinical research. Particular attention will be given on advantages and disadvantages of the language, obtaining help and support, and reporting results.