Moderator: Joachim Grevel. Panel composition: Terry Shepard, Gerard Pons, Peter Milligan, Mick Looby, Leon Aarons, Nick Holford.
This discussion will recapture a recent workshop at the EMA (December 2011) and promote a future collaboration between modellers working in drug development and assessors of the regulatory agencies.
The six panel members were asked to prepare answers to the following questions in order to jumpstart a lively discussion:
- Why is the concept of the target concentration not guiding drug development during all clinical phases? And why are regulators not asking for the corresponding dosing target to guide therapy?
- How does one rationally select a dose in the absence of having characterised a dose response?
- If the likelihood of an informative p-value is small (limited evidence), which alternative approach can provide sensible inferences to guide the approval of new medications?
- Model-based reasoning is currently only accepted by regulators in cases such as paediatrics where the classic approach (p<0.05) is impractical. What can the modelling community do in order to increase the regulatory acceptance of their work in all types of submissions? Should we just wait for new guidances?
- It was suggested at the EMA/EFPIA meeting that the EMA would try to increase its capabilities to assess modelling and simulation work. What are EMA's concrete plans and how can EFPIA help?
Reference: PAGE 21 (2012) Abstr 2634 [www.page-meeting.org/?abstract=2634]
Poster: Oral: Other Topics