STriTuVaD consortium plan its regulatory strategy
The team of Prof. Francesco Pappalardo organised in Catania (Sicily) a two-day meeting to develop a strategy for the regulatory qualification of the In Silico Trials technology being developed in the STriTuVaD project.
The team of Prof. Francesco Pappalardo organised in Catania a two-day meeting to develop a strategy for the regulatory qualification of the In Silico Trials technology being developed in the STriTuVaD project.
The meeting saw the participation of Prof. Marco Viceconti (University of Bologna), Prof. Santo Motta (University of Catania), Dr. Epifanio Fichera (Etna Biotech), as well as Dr. Giulia Russo and Dr. Marzio Pennisi, from Prof. Pappalardo team. Last but not least Dr. Flora Musuamba-Tshinanu, Vice-Chair of the Modelling and Simulation Working Party at the European Medicine Agency (EMA), the European Union Agency for the evaluation of medicinal products.
Following the positive feedback of the EMA Innovation Task Force, which agreed earlier this year to evaluate the Universal Immune System Simulation (UISS), the consortium is now exploring the best approach to pursue the Qualification Advice, the first step to have full regulatory qualification.
“I am delighted for the outcome of this meeting” said Prof. Pappalardo; “I think we now have a clear plan on how to approach the qualification advice”.
Prof. Viceconti is clear on the innovative value “We are breaking new ground here. UISS is one order of magnitude more complex that any predictive model submitted for qualification so far; it represents a new generation of In Silico Trials technologies, for which the regulatory pathways are in the making”.
“At EMA modelling and Simulation Working Party we all see the huge potential of the new class of technologies that those being developed in the STriTuVaD project represent” - said Dr. Flora Musuamba-Tshinanu - “But we also fully aware of the complexity that qualifying such technologies for regulatory purposes involves; the interactions with the STriTuVaD consortium will hopefully produce new best practices in this area”.
Dr Fichera, Project Manager at Etna Biotech, the coordinator of the STriTuVaD project, is very clear: “In Silico Trials will change the pharmaceutical industry’s approach to product development. The best way to conjugate the need for shortening the time to reach the market with that of protecting public health is to radically innovate how to test safety and efficacy. This will ensure that more affordable, safe, and effective medicinal products are accessible to a much wider population ”.
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