Clinical/Regulatory Engagement

To date, InSilc has been completed interaction with regulatory bodies and clinical trial forums through attending various events that have provided networking opportunities, while also taking part in targeted one-on-one meetings with notified bodies, regulatory experts and clinicians. Several notable engagements have taken place, including several one-on-one meetings with Dr. Robert Bryne, who is a key opinion leader in the field of Cardiovascular Interventions and leader of the European Association of Percutaneous Cardiovascular Interventions Task force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention. Furthermore, there has been significant clustering activity with other projects, with InSilc involved in a recent closed-door meeting to discuss regulatory issues related to In Silico Clinical Trials organised by Prof. Viceconti. This engagement and activity is ongoing, where the ultimate aim is to develop a regulatory strategy for InSilico Medicine to fill the gap in the current regulatory landscape.

Todate, InSilc has been completed interactions with regulatory bodies and clinical trials with the following activities:

Workshop “”In-silico”” health new projects and regulatory needs, Organiser: Dr. Amalia Vlad (MD, PhD, Health and Well-being Unit, DG CONNECT, European Commission), November 2017, link with EMA.

MCR attended European Society for Cardiology Congress, 2018 Munich, Germany.

MCR attended the International Avicenna Alliance Conference on “In vivo, in vitro, in silico:  Why computer modelling is the next evolution of the healthcare sector”.

NUIG attended the Industry session at VPH 2018 on In silico clinical trials ion at VPH 2018 conference on “In vivo, in vitro,” clinical trials ion at VPH 2018 onferTina Morrison, Chair of FDA’s Modeling and Simulation Working Group participating in panel discussion.

Engagement with the ESC-EAPCI Task force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention. MCR have already Dr. Robert Bryne (leader of this Task Force) and one-on-one meeting has been conducted. As a result of this, Dr. Byrne has taken on the role of expert advisor to the InSilc project.

FEops discussed the regulatory aspects of the InSilc project with a notified body (SGS Belgium) during the yearly audit of the FEops’ Quality Management System.

MCR contacted Dr. Ingrid Klingman, President of the European Forum on Good Clinical Practice, to establish a possible connection focusing on methodological aspects of in silico clinical trials. Although there was an interest, the EFGCP board decided to not get involved due to too many ongoing initiatives and shortness of manpower.

POLIMI and NUIG attended the conference SMST where many biomedical companies producing cardiovascular devices are present (SMST also includes sessions on standards development.

FEops attended the annual Living Heart Project meeting organised by Dassault Systems (July 23-24 | Waltham, MA, USA). During the meeting, there was a workshop with the FDA (Dr Tina Morison) focused on the concept of in-silico clinical trials.

COMBINE 2019 Meeting, eustand4pm workshop, July 15-19, 2019, in Heidelberg. Engagement with key experts in the fields of standardisation (with Mrs Heike Moser: Medical Standard Committee, DIN German Institute for standardisation), data management (Prof. Carole Goble: CBE FREng FBCS CITP is Professor of Computer Science at The University of Manchester, UK. She is leading activities in European e-Infrastructure for Life Sciences including Acting Head of the UK’s ELIXIR Node and representing the UK on the ELIXIR board; she is WG leader for data/model management of ESFRI ISBE – Infrastructure Systems Biology Europe; and serves as a Council representative on the BBSRC Exploiting New Ways of Working SAP. ) and VPH approaches through Prof. Liesbet Geris who is the VPHi Executive Director.

Clustering with other projects focused on in silico trials. MCR met with Prof. Viceconti and Prof. Migliavacca from POLIMI to discuss regulatory issues related to in silico clinical trials. As an outcome a closed-door meeting on regulatory strategy involving representatives of the other similar ongoing projects was organised by Prof. Viceconti, on the occasion of the CompBioMed conference (25 September 2019). The aim is to develop a joint strategy towards regulators to fill the gap in the current regulatory asset.

CBSET has been engaged with FDA on working being carried out on InSilc to search for other opportunities such as FDA workshops and cosponsored conferences or sessions.

NUIG has been engaged with National Standards Authority of Ireland (NSAI), the Irish notified body for medical device certification.