Small Populations SIG

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The challenge of generating evidence in small populations is one of the main factors hampering the market authorization of orphan drugs. To enhance the clinical phase of orphan drug development, the European Union funded three consortia IDeAl (Integrated Design and AnaLysis of small population group trials), InSPiRe (Innovative methodology for small population research) and Asterix (Advances in Small Trials dEsign for Regulatory Innovation and eXcellence). EFSPI/PSI is one of the consortium partners in the Asterix project and this generated the idea to set up a Special Interest Group (SIG) for Small Populations.

The SIG Small Populations is the most recent Special Interest Group and started in January 2016. The purpose of this SIG is to provide a forum for statisticians working in the Pharmaceutical Industry engaged in the topic of rare diseases cq. small populations.

The main aims of this SIG are the following:

  • To exchange information, share case studies and discuss strategies and methodology being applied in this area of research,
  • To form a working expert group to interact with the external community, like the FP7 programs (IDEAL, INSPIRE and ASTERIX), and in particular to be in reach for the ASTERIX project in which EFSPI is a partner
  • Organise and/or participate in workshops and create visibility on biostatistics activities for small populations

 

The SIG Steering Committee consists currently of the following 4 members:

Name Company
Francois Aubin Venn Life Sciences
Karola Beckmann Bayer
Egbert Biesheuvel Danone
Olivier Imbert Servier

 

Currently, the SIG Small Populations is working through monthly teleconferences on the last Friday of the month.

For further information, or to join our Small Populations SIG, please contact Egbert Biesheuvel (egbert.biesheuvel@danone.com)