Patients all over the world should benefit from the achievements of predictive medicine and the introduction of in silico trials, which promise the accelerated and safe introduction of new products such as medical devices or pharmaceuticals to the market place. These concepts cannot be developed by academics or in industry alone, and ultimately they need to be accepted by regulatory agencies around the world. When regulators accept simulation augmented submissions and agree upon a common model credibility assessment philosophy will patients benefit from the utilization of in silico medicine.
The objective of the Avicenna Alliance International Working Group is the promotion of the benefits of predictive medicine and in silico trials through the global connections of experts from academia, industry, and regulatory agencies. Together we will work on developing objective standards, increasing confidence in in silico methods and their acceptance in support of regulatory approval process
The key goals of this group are:
• Facilitating dialogue on in silico with regulators and actors around the world:
• active engagement with priority countries (China, Japan, South Korea)
• follow-up with additional countries (India, Israel, Canada, Singapore, Australia, Brazil, Russia and Switzerland).
• Seek opportunities to expand the Alliance geographically
Priorities 2022 - 2023 and beyond:
For current year:
- Identify of strategic contacts and implement an outreach plan;
- Co-organize intl.
- GSP web-event;
- Engage with international contacts in APAC;
- Engage with UK authorities;
- Map of who’s who in the regulatory community.
For 2023:
- IMDRF engagement;
- Organize local event with APAC regulators;
- Participate in international events to represent the Avicenna Alliance;
- Plan and organize of local events.
For 2024 and beyond:
- Organize local event with APAC regulators;
- Evangelise the US market in collaboration with FDA;
- Provide global evidence.
Working Group Leader
Mark Palmer, MD, PhD
Research Director & Technical Fellow, Core Technologies
Lead, Enterprise Modeling & Simulation Working Group, Medtronic
