Avicenna Alliance response to the ICHE11A Consultation

The Avicenna Alliance strongly supports and welcomes the ICH’s proposed goal of harmonizing methods and strategies for improved paediatric drug development, particularly through minimizing clinical trials with children.

The Avicenna Alliance is a multistakeholder non-profit organisation with the mission of accelerating medical innovation by ensuring safe, affordable and cost-effective healthcare through the large-scale adoption of in silico medicine and computer modelling and simulation (CM&S). We believe that in silico medicine is particularly crucial for paediatric extrapolation because of its potential to reduce and refine the necessary in vitro, ex vivo and in vivo processes to ensure and accelerate access to medicines for children.

We propose that the potential for computer modeling and simulation be more explicitly included in the ICH guideline E11A and that the guideline should clarify what is included when referring to CM&S approaches. Additionally, to support the success of in silico medicine, the guideline should also better define the quality, fit-for-purpose and quantity of necessary data. As an underlying tenet, the guideline must emphasize transparency of models and the data used.

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