International School on in Silico Trials

The International School on In Silico Trials will offer a systematic, nontechnical review of the strengths and weaknesses of in silico trials technologies. The participants will be guided in the development of a better and deeper understanding of the threats and opportunities that this unprecedented technology presents, with the goal to enable more informed decisionmaking on the adoption of such innovations.
Year 2020
Main Department Industrial Engineering Department
Campus Bologna
Credits Programme without credits
Cost For profit organisation: € 2700; Not for profit € 1350; VPHi members € 1000
Starting date Sep 07, 2020
Finishing date Sep 09, 2020
Course overview
The structure of the school is organised as a SWOT analysis. After an introduction from the Chair of the International School, Prof Viceconti, four experts will evaluate strength and weaknesses of the four most popular classes of modelling methods, followed by a reflection on how high-performance computing can change. Then, six specialists will provide an overview of the opportunities that in silico trials technologies offer in some of the most important classes of disease. Last, the threats posed by the complex regulatory landscape will be analysed. In a final lecture, threats and opportunities are balanced in a vision of the possible futures of biomedical industry in the age of in silico trials.
Subject area
Sciences and technology
Learning outcomes
Until 2016 the development and validation of computer models to predict the progression of a disease, or the changes to such progression due to a specific treatment, were only of academic interest. This is because until then, for the purpose of regulatory approval, an evidence of safety or efficacy of a new medical product was acceptable only if it had been obtained experimentally, either in vitro (e.g. with tests on cell cultures), or in vivo (with animal experimentation or with clinical trials on humans). But in the last three years the two main regulatory agencies, the United States Food and Drugs Administration (FDA), and the European Medicine Agency (EMA) have, in principle, deemed admissible a third way to produce such evidence: through in silico simulations, i.e. using computer models. If we look how the use of modelling and simulation have revolutionised safety testing in industrial sectors, it is easy to predict that this will be a disruptive change. Specifically, it could affect the entire business model of the medical products industrial sector, which until now has been driven by a “high-fixed, low-marginal” cost model, dominated the huge direct and capital costs of product development and regulatory assessment. Despite this, the rate of adoption of the technology of In Silico Trials is still very low. There are a number of barriers to adoption, but one that we consider very important is cultural. A large majority of professionals and executives working in medical industries, Contract Research Organisations (CROs), research hospitals, and regulatory agencies were not trained on the use of the emerging technologies. Many of them have a medical, biological or pharmacological background, and thus find an approach heavily based on physics, mathematics and computer science completely alien. The goal of this international school is to provide to all these stakeholders an executive perspectiv
Number of participants
25
Duration
3 days
Language
English
Academic director
Prof. Marco Viceconti

Roberta De Michele

Dipartimento di Ingegneria Industriale - DIN

Viale del Risorgimento 2   Bologna (BO)

roberta.demichele2@unibo.it