Digital evidence can and must be used for regulatory approval in all parts of the world. The Research & Technology Working Group has made huge progress, which now allows to start applying modeling and simulation, as properly defined, to accelerate medical innovation access to patients.
Many organizations are willing to invest in in silico but practical implementation guidance is needed.
The new Avicenna In Silico Application Working Group aims to deploy In Silico methods downstream and design comprehensive solutions (process, access to research, software, hardware, humanware, possibly services) to allow any organization to time and cost effectively adopt and deploy in silico methods all along the development, registration and life cycle of the products.
The key goals of this group are:
Deploy in silico methods to optimize and streamline product quality and manufacturing through the product life-cycle.
- Regulatory: Identify and address the challenge to deploy Computer Modelling and Simulation & Artificial Intelligence to refine, reduce or replace animal studies and clinical trials.
- Promote and implement in silico medicine in healthcare, including clinical diagnostics (e.g., clinical decision support tool and AI-powered pathology), “proactive” vigilance.
- Engage with reimbursement entities to understand, recognize and request the integration of in silico methods for healthcare
Priorities 2023 - 2024 and beyond:
2023:
- Demonstrate added value of in silico approaches in CMC: from early stage (tech transfer) up to post-market (lifecycle);
- Evaluate the use of in silico approaches in nonclinical development;
- Assess current application of in silico approaches in clinical setting (in development and beyond).
2024:
- Position paper(s): mapping of the current added value of in silico approaches in product life-cycle and clinical use
- Promote implementation of in silico approaches (with R&T WG and Int. WG);
- Educate stakedholders via position paper(s) and/or webinars.
2025 and beyond:
- Sustain in silico advocacy for Medicinal Devices, Pharmaceuticals & other HealthTech products.
Working Group Leader
Cécile Rousseau, PhD
Senior Director
Nonclinical & Early Clinical Development, VCLS
