2016 saw the establishment of the Avicenna Alliance, a partnership with industries that focuses on challenges to the in silico medicine market. With 50% industry membership (from medical devices, pharmaceutical and software companies) and 50% membership of the VPH institute, the Alliance will work toward addressing barriers to the uptake of VPH solutions.
The activities of the Alliance for 2017 are divided into 3 different working groups:
- Policy WG, chaired by Celine Bourguignon (Johnson&Johnson)
- Research WG, chaired by Prof Stig William Omholt (Norwegian University of Science and Technology - VPHi BoD)
- International Affairs WG, chaired by Markus Reiterer (Medtronic)
2017 Activity plan:
- Advocate for the inclusion of a framework for the validation of in silico clinical trials in the reopened EMA Regulation
- Advocate for maintaining the current Council text on the Medical Devices Regulation (MDR) with regard to the inclusion of modelling and simulation data in applications to a notified body
- Coordinate and contribute to the Policy Recommendations on in silico medicine to be submitted to the European Commission
- Implementation of the MDR provisions relating to in silico:
Meeting with the European Medicines Agency with a view to explore how to implement the amended EMA Regulation
- Explore ways in which these could be introduced
- Provide recommendations to EC on how these could be carried through
- Communicate with the FDA on developments in this field
International Affairs WG
- Develop detailed call texts for the Healthcare related sections of H2020 programme
- Key areas of focus with industry and regulators:
- New instrumentation development for measuring tissue level phenotypes
- Model reduction approaches
- Methods to combine data analytics and mechanistic modelling
- Molecular & gene regulatory networks as constraints on tissue level models
- Validation, verification & uncertainty quantification
- Modelling populations: “virtual patient” development for chronic and rare diseases etc.
- Formalise FDA engagement and establish routine working protocol
- Outreach to regulators in Japan & China, possibly also India, Brazil
- Establish connections with International Committee on Harmonisation
- Explore joint workshop with FDA/MDIC
Working group participation:
The working groups meet by teleconference every trimester. A calendar of the meetings for the whole year will be defined in the next few weeks. In addition to teleconferences, WG members are requested to offer their expert views on specific topic and contribute to the drafting of documents. For what concerns the policy WG and, in general all initiatives related to policy, specialised policy consultants will drive the activities, while members of the WG will only have to bring in their scientific expertise (no specific policy knowledge is requested).
In case you are interested to collaborate in any of these WGs, please contact us, sending an email to firstname.lastname@example.org and indicating the name of the WG you would like to join. Your contribute can make the difference!