What are In Silico Trials?
The cost of development and regulatory certification of medical products has been growing exponentially in the last years: to bring a new drug on the market, companies spent on average 2,558 million dollars in the 2000s (Source: J Health Econ. 2016 May; 47:20-33).
This is primarily due to the fairly obsolete methods in use; other industrial sectors with similar problems were able to dramatically shorten time-to-market, product development and certification costs by adopting computer modelling & simulation.
While in the past it was possible to provide regulatory evidences almost exclusively by mean of experimentation, since 2016 regulatory agencies are becoming more interested in considering evidences obtained by modelling & simulation, the so-called In Silico Trials.
Why a Master on In Silico Trials?
So far, the adoption of in silico technologies has been quite slow: the qualification of “first in kind” methods is challenging, and neither companies nor regulatory agencies have in house the necessary skills to pursue it: the lack of specialised workforce is indicated as the main barrier to the adoption of In Silico Trials.
The Master on In Silico Trials aims specifically at filling this gap by providing new professional figures that will build expertise around in silico technologies.
Who can apply?
The master is open to a maximum of 30 students with a master’s degree in engineering, physics, mathematics, or computer science.
Led by Prof Marco Viceconti, Prof Lorenzo Chiari and Prof Luca Cristofolini from Alma Mater Studiorum University of Bologna, the course includes 210 hours of frontal teaching, 16 hours of workshops, and 600 hours of internship at a company, research hospital, or regulatory agency.
List of modules:
- Introduction to In Silico Medicine: introduction to the general concept of modelling the physical reality and to computational medicine, introducing some general concepts on regulatory affairs in general and in relation to in silico
methods, and specifically the problem of assessing the credibility of predictive models.
- Modelling the neuromusculoskeletal diseases: introduction to a series of modelling techniques to predict orthopaedic devices performance, skeletal strength, musculoarticular forces in neurodegenerative diseases, etc. We will introduce the concept of risk modelling and the design of in silico trials for paediatric orphan diseases.
- Modelling the cardiovascular and respiratory diseases: full immersion in the development of cardiovascular models, sub-cellular, cellular, and whole heart. Prediction of neurovascular hemodynamics and circulation, stenting outcome, etc.
- Modelling cancer, transmissible, and metabolic diseases: models of the sugar metabolism, of the immune system, prediction of physiology-based pharmacokinetics, molecular affinity binding, growth of solid tumours. Neurocomputational models.
- Assessing the credibility of in silico technologies: fundamentals of legislation, quality assurance, risk assessment. Certification of in silico medicine solutions. Credibility of in silico trials methods, and of molecular dynamics models. Qualification of in silico methods to assess medical devices or medicinal products.
- Industrial and regulatory perspective: in silico trials for medicinal products and for medical devices. The role of consulting firms, software developers, and of software-as-a-service portals.
Applications deadline: 5 Oct 2020
Registration deadline: 9 Nov 2020
Lecture start: 4 Jan 2021
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