Resignation of FDA Commissioner Gottlieb – a note of Marco Viceconti


We have read this morning that Scott Gottlieb, US Food and Drug Administration Commissioner, will leave the job at the end of the month, for personal reasons. We cannot comment in general on his tenure, but with respect to the specific focus on eHealth and in silico methods we will miss him. Dr Gottlieb has been, since his appointment, a clear supporter of the modernisation of the regulatory process by means of innovative technologies in general, and in silico methods in particular.

We can only hope that the recent drive within FDA toward a more extensive adoption of in silico methods and other innovative technologies such as wearable sensors into the regulatory process for both drugs and medical devices is irreversible, and that, regardless of who will succeed Dr Gottlieb, such drive will continue unaltered. There is the need to ensure the highest possible level of safety for more and more complex products, while drastically reducing the costs and the time to market involved with the regulatory process, if we want to ensure that modern healthcare remains affordable and as universally accessible as possible. We also need to reduce, refine, and where possible replace in vivo experimentation. We believe all these challenges can be met only by means of radically innovative technologies such as those in silico trials can offer.

There are extraordinary ongoing efforts in this direction. Just to name a couple I am personally involved with: the STriTuVaD project funded by the European Commission H2020 framework, where a revolutionary in silico trials technology is being tested as a means to drastically reduce the cost and duration of clinical trials for new therapies for tuberculosis; and the MOBILISE-D project, due to start on April 1st, 2019 through the support of the Innovative Medicine Initiative, where data collected from wearable sensors and processed by advanced analytics software will make it possible to evaluate during clinical trials of new drugs their impact on mobility, physical activity, and other long-term indicators of quality of life.

We invite the new FDA Commissioner to set a long-term goal: same safety with 50% less animals and 50% less costs within 10 years, a conservative objective if In Silico Trials approaches are adopted. There is a vibrant Community of Practice on In Silico Trials, a community of academics, industries, regulatory science specialists, coordinated by international not-for-profit institutions such as the VPH Institute and the Avicenna Alliance. A community that is ready to accept the challenge that such long-term goal represents.

Professor Marco Viceconti
President, VPH Institute
Board Member, Avicenna Alliance