A two-days workshop was organised in Leuven on 25-26 April 2019 to discuss how to tackle the validation challenge of in silico models for drug development.
In silico technologies are penetrating healthcare at breakneck speed. Drug design and development has a long-standing tradition in the use of in silico technologies. Yet the in silico toolbox is rapidly expanding beyond the classical QSAR, PK/PD and PBPK. When these tools are used in the design and development of drugs, they might eventually end up in a regulatory application. In order for the regulatory bodies to accurately and expertly handle this digitally created evidence, this digital evidence needs to follow certain reporting standards, demonstrating appropriate verification and validation (V&V) of the results. Recently, ASME and FDA collaborated to establish the V&V40 guidelines on verification and validation of medical devices (https://www.asme.org/products/codes-standards/v-v-40-2018-assessing-credibility-computational).
On April 25-26, Belgian regulators, Belgian VPHi researchers and Avicenna Alliance industrial partners met in Leuven to start the process of defining a set of practical guidelines to tackle the validation challenge of in silico models for drug development. The two days were filled with presentations from the different stakeholders, brainstorms and discussions. The results of this initial meeting will be published as a perspective paper before summer. In the coming months, the working group will be extended to include members of the European Medicines Agency (EMA) and VPHi members from the whole of Europe with expertise in in silico drug development. This working group will produce a comprehensive white paper on the validation of in silico models for drug development early in 2020.