A commentary paper has recently been published in "CPT: Pharmacometrics & Systems Pharmacology" reporting the outcome of a multistakeholder workshop on the validation challenges for in silico models in drug development. The event was organized on 25 - 26 April 2019 in (Leuven) Belgium in collaboration with the VPH Institute.
The added value of in silico models for drug development is now unanimously recognized by the scientific community. Irrespective of the model used and the concerned part of the drug development pipeline, the evidence generated from these models might be included in regulatory submissions. In that case, the incorporation of digital evidence needs to follow standards of data/evidence generation, analysis, and reporting to enable the regulatory bodies to efficiently perform an adequate assessment of the submitted material.
Specific guidance documents on the reporting, verification, and validation of in silico models for drug development/approval are currently missing. In order to fill up this gap, a White Paper is planned to be delivered in 2020, identifying in detail all the gaps and challenges for in silico models verification and validation as well as the proposed approaches for moving forward illustrated by examples.
The VPHi is leading the working group that will deliver the White Paper, in collaboration with representatives of EMA and other key stakeholder groups.
We will keep you posted on further developments!
Read the full article here