In the week of 15-18 May 2017 the Avicenna Alliance was in Washington DC, following an invitation by the FDA and by the staff of Senator T. Cochran to discuss the role of in silico medicine.
The Delegation consisted of Avicenna Alliance and VPHi members, an EMA representative, FDA representatives, US-Avicenna contacts, US Senate staff and the RPP Group.
The Avicenna Alliance is pleased to announce that all goals of the trip have been achieved and all expectations exceeded during this very successful trip. Whereas the main purpose of the trip for the Alliance was to sign an agreement with the FDA, to source new members for the Alliance and to establish relations with the US Senate staff, the summary below will highlight how far the Avicenna Alliance delegation succeeded in going beyond these points.
Visit to the FDA
On the first day of the trip, the Avicenna Alliance delegation had the opportunity to hear about the vision of the FDA in terms of Computation Modeling and Simulation and, in turn, to present Avicenna Members’ visions from a medical device (Medtronic- Markus Reiterer), pharmaceuticals (Johnson and Johnson- Céline Bourguignon), software (ANSYS) and Academic (VPHi Executive Director- Prof. Liesbet Geris) perspectives to the FDA staff. Another very insightful part of the day was a tour of the FDA Facilities, Labs and Explanation of the work of different sections.
The undisputed main achievement of the day was the signature of the Memorandum of Understanding by the FDA Chief Scientist Luciana Borio and Avicenna Alliance Secretary General Adriano Henney, making the FDA an Observer Member of the Alliance. The MoU is meant to ensure that the successful collaboration will continue in the next months and years and to guide and help each other. Another great achievement is that the FDA agreed to put the Avicenna Alliance in touch with other regulators in the Asia-Pacific regions, thereby further extending the global cooperation on in silico that the Alliance is striving to achieve.
BMES conference- Frontiers in Medical Devices
The Biomedical Engineering Society (BMES) and the FDA formed a partnership to co-sponsor the 3rd annual BMES/FDA Frontiers in Medical Devices Conference, a meeting for researchers, engineers, clinicians and other professionals in the fields of designing, building and using medical devices.
The Conference theme for the 2017 meeting was Innovations in Modeling and Simulation: Advancing Translational Science which was meant to highlight exemplary applications of computational modeling and simulation from initial disease diagnosis through long-term follow-up and rehabilitation. The Avicenna Alliance had the opportunity to present and advertise its activities at the conference on why policy matters for business. The Avicenna Alliance also made good use of its booth at the conference which allowed to further promote the Alliance and VPiH as not just 50% of the Alliance board but as a stand-alone institute for interested academic and research groups.
The main outcome of this day was the fact that the globally active medical devices manufacturer Boston Scientific joined the Avicenna Alliance as a Member.
Meetings at US Senate Buildings
On the agenda of the third day was the visit to the US Congress and a meeting with Senator Thad Cochran, the current senior United States Senator from Mississippi (the third most-senior Senator and the second most-senior Republican member). The Avicenna delegation met with him in order to discuss closer EU-US cooperation in the field of in silico medicine.
Senator Cochran has been a leading figure in promoting the need to modernize existing policy frameworks to take into account the advent of in silico medicine and to ensure its potential for healthcare is realized. A core goal of the Alliance’s International Affairs Working Group is to encourage cross-border Regulatory cooperation on in silico medicine. With a great deal of regulatory work in the pipeline at EU level on modelling and simulation and significant progress already made in the US, the time is now to ensure harmonization and exchange of best practices.
The Avicenna Alliance was thus welcomed by the Senator and his staff and had the opportunity to explain the potential brought by in silico medicine and its opportunity to make medicine both more affordable and more impactful. The Avicenna Alliance delegation was pleasantly surprised by the attention and the interest of the Senator and his staff and their desire to help scientists and industrial actors in this crucial journey and to see the need for a transatlantic and global cooperation to better protect and benefit patients.
The key outcomes from this meeting was the promoted need to fund FDA Modeling and Simulation, the agreement with Senate Staff to exchange information on health activities between Avicenna and Senate offices as well as the possibility for Senate Staff to form part of the US Delegation to the EU/Asia in future years.