"We are very proud to share that the STriTuVaD project has successfully achieved all the intermediate objectives foreseen in the initial proposal, and now, we are looking forward to reaching the final goal: the validation of the in silico trial framework with the phase IIb clinical trials running in India.
The opportunities gained during the project development are far beyond our initial expectations: a plethora of scientific publications demonstrate the groundbreaking work that this consortium is active in delivering; the exploitation of high-quality results enabled our consortium to engage with other EU funded projects, establishing new alliances in the fields of tuberculosis and in silico trials, pioneering new regulatory paths, advancing scientific knowledge, with the ultimate goal to accelerate the time to market of new drugs; the computational model developed in STriTuVaD has reached the maturity level to initiate the bureaucratic process to obtain recognition by the Regulatory Authorities.
At the current stage, UISS-TB, the heart of STriTuVaD project, is an open access platform, ready to use, and powerful tool, enabling any scientist interested to evaluate hypotheses in the tuberculosis field, to generate in silico individuals and to observe the outcome of a treatment in the digital patients in a defined timeframe." - Dr Epifanio Fichera (ETNA Biotech srl) STriTuVaD coordinator
On 13 September 2022, Prof Pappalardo and Dr Giulia Russo held a seminar at the Griffith University (Queensland, Australia) – School of Medicine and Dentistry, Centre for Applied Health Economics (CAHE) on “Universal Immune System Simulator applied to respiratory infectious disease”.
The presentation provided an overview of the modelling dynamics of infectious diseases, the involvement of immune system modelling and an agnostic view of the main types of mathematical methodologies to be modelled, with different perspectives, goals, and applications that help in understanding and manage infectious diseases.
Some important regulatory issues have also been introduced along with a critical overview of the main milestones that major regulatory agencies (EMA and FDA) have reached on the topic of in silico trials.
Dr Curreli from University of Bologna presented the most recent work on "Assessing credibility of an in silico trial model for the development of new vaccines against tuberculosis" during the poster session of VPH2022 Conference, one of the most important conferences on in silico medicine. The work is co-authored by C. Curreli, V. Di Salvatore, G. Russo, F. Pappalardo and M. Viceconti, and was later accepted for publication in the Annals of Biomedical Engineering.
FROM THE LITERATURE
The agent-based Universal Immune System Simulator was used to develop an In Silico Trials environment that can predict the dose–response of new therapeutic vaccines against pulmonary tuberculosis, supporting the optimal design of clinical trials. But before such in silico methodology can be used in the evaluation of new treatments, it is mandatory to assess the credibility of this predictive model. This study presents a risk-informed credibility assessment plan inspired by the ASME V&V 40-2018 technical standard. Based on the selected context of use and regulatory impact of the technology, a detailed risk analysis is described together with the definition of all the verification and validation activities and related acceptability criteria. The work provides an example of the first steps required for the regulatory evaluation of an agent-based model used in the context of drug development. Read more.
In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. This position paper investigates the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. The authors suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing. Read full paper.
Prof. Marco Viceconti gave a lecture to the European Medicine Agency staff and European National Competent Authorities officers to present the challenges that digital health poses to the regulatory process for the qualification of in silico trials models.
The event has been held online on 29th September 2022, organised by the Working Group On New TB Vaccines as an opportunity for early career researchers to discuss about some key issues regarding tuberculosis and the development of new vaccines.
The updated document has been published by World Health Organization’s End TB strategy in August and it's available for download here
PAPER SUBMISSION DEADLINE 30th OCTOBER 2022! It provides junior engineers, early researchers and medical doctors with an integrative view of state-of-the-art research for in silico medicine, following a complete pipeline from basic science and clinical needs, to model application. More info