Avicenna Alliance at Capitol Hill for meetings at the US Congress

 

The Avicenna Alliance returns from a contact programme to the US Senate and House of Representatives with resounding success and clear next steps for furthering in silico medicine through policy. The delegation, consisting of Avicenna Alliance members, 4 representatives of the US Food and Drug Administration (FDA) and 2 Observer Representatives of the European Commission met with the Office of Senator Ben Cardin and of Representative Dutch Ruppersberger.

The wider uptake of computer modeling and simulation (CM&S) is dependent on the creation of a policy framework that allows for the submission of CM&S data as part of the regulatory process for treatments. Whether for clinical trials, marketing autorisation, health technology assessment decisions or reimbursement, clear rules on the use of CM&S is crucial to expand the in silico sector.

Avicenna members’ main request was that a joint letter be sent by Members of Congress and the European Parliament calling on the FDA and the Commission to jointly develop “Good Simulation Practices” which would provide much needed guidance to the in silico community. This is being followed up on by the Avicenna Alliance Secretariat to ensure this translates to action on the ground.