Last week AIFA – The Italian Medicines Agency, organized in collaboration with the VPH Institute a workshop aimed to present the state of the art of Digital Twin technologies for the development and assessment of new treatments for diabetes. The event saw the participation of many experts from different fields including academia, industry, and international regulatory bodies.
Diabetes is a complex, multi-organ disease, for which a good quantitative mechanistic understanding of the pathology and physiology is available, an essential requirement for the development of Digital Twins in healthcare. Diabetes is a major clinical and social problem also in Italy, with costs for the national healthcare service estimated in excess of €8 billion per year.
Between other guests and experts, Professor Marco Viceconti, Coordinator of the EU-funded project In Silico World, reported on the adoption pathways of in silico medicine in Italy: “In silico medicine in general and Digital Twins in healthcare in particular are developing rapidly; an early and continuous dialogue between regulatory authorities, academia, and industry is pivotal to analyse the potential applications of this approach and define an appropriate regulatory framework, which will ultimately benefit the patient.”
The workshop foster such dialogue between regulatory authorities, academia, and industry and takes a step forward after the publication of the report “Adoption Pathways for In Silico Medicine in Italy” by the Italian National Health Council (Consiglio Superiore di Sanità), the Italian Health Minister’s technical and scientific consulting body, to which Prof Viceconti, Prof Claudio Cobelli (Emeritus Professor of Bioengineering at the University of Padova) and many others contributed.
The report analyses both the current barriers to in silico medicine adoption and the necessary recommendation to speed up the adoption process.
“We are interested in discussing emerging technologies with the aim of promptly defining the problems or gaps in the regulatory framework. We also focus on understanding all the skills that need to be acquired to be able to assess new technologies from a regulatory point of view. The regulatory authorities – concluded Paolo Foggi, Director of the Innovation and Drug Strategy Sector at AIFA – must never block innovation because they don’t know how to evaluate it”.
Watch the full workshop here