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ANSYS on Capitol Hill: Simulation is An Important Component to Solve the Global Healthcare Issue

Over the last six months, significant progress has been made to foster Transatlantic collaboration in the area of in silico medicine. I say significant because the collaboration is now being fostered beyond the technical level. It is happening at the regulatory and policy levels. On October 11th, 2016, the U.S. FDA spoke at the European Parliament as part of an inauguration event for the Avicenna Alliance, the association of predictive medicine, of which ANSYS is a founding member. Last week, the collaboration was reciprocated. The Avicenna Alliance was invited by the FDA and by the staff of Senator T. Cochran to discuss the role of in silico medicine in both a technical context at the 2017 BMES conference and also at the policy level on Capitol Hill.

Most importantly, these exchanges are not just talk. During the series of meetings, the Chief Scientist of the FDA, Luciana Borio, and Adriano Henney, Secretary General of the Avicenna Alliance signed a Memorandum of Understanding, making of the FDA an Observer Member of the Alliance. The goal of this agreement is to ensure that we continue and formalize our collaboration for the future; we intend to guide and help each other so that we could assist our industrial partners in the best and fastest possible way for a rapid adoption of in silico medicine.

In what was an incredibly hectic schedule, the series of meetings covered policy, regulation and technical collaboration and exchange.

Briefing the Policy Makers on Capitol Hill

It is crucial to educate and keep legislators aware of the rate of technological progress so that they can carefully review the necessary legal framework required to support the practical exploitation of in silico medicine. In this effort we were strongly supported by Senator T. Cochran and his staff who clearly understand the potential brought by in silico medicine and its opportunity to make medicine both more affordable and more impactful. We appreciate their strong desire to help scientists and the industry as a whole during this crucial journey — not only at the national level but also favoring Transatlantic and more global collaboration to better protect and benefit patients.

Dialogue with the Regulator

Under the guidance of Tina Morrison, Deputy Director at the FDA, we heard the Computational Modeling and Simulation vision of the FDA and confirmed the close alignment with both industry and the Avicenna Alliance strategy. We visited numerous state of the art research labs that demonstrated the fundamental role computer modeling and simulation plays in their activities. By sharing medical device, pharmaceutical, software and Academic perspectives on in silico medicine to the FDA staff we validated the transatlantic convergence on strategy and this was rounded off by a talk from the European Medicine Agency (EMA) delegate, Ine Skottheim-Rusten, Chair of the EMA Modelling and Simulation Working Group. It is clear that the vision, strategy and commitment is there to accelerate the progress and deliver the benefits in in silico medicine.

Proving the Technology Base

Guiding policy and establishing regulatory practices is built on a foundation of proven and validated technology. During this visit I attended the 2017 BMES/FDA conference hosted close to the FDA headquarters.

This conference is a unique forum that brings together the academic, industrial and regulatory world that is focused on the application of computational modeling and simulation in healthcare. While there is still a lot of work to do to accelerate adoption of computational methods broadly in the industry, it was exciting to witness the energy in this conference with over 300 top scientists and practitioners helping drive the vision forward and focused on collaboration, verification and validation.

Next Steps

Across all these interactions it is clear that from the policy, regulatory and technology perspectives, there is a consensus on the benefits of in silico medicine:

  • Getting medicines and treatments in the hands of those who need them faster and at lower cost
  • Predicting the individual outcome of a treatment before embarking upon it
  • Exploring a wider range of options earlier in the development process to eliminate redundant effort and accelerate successful options

There is a strong desire to collaborate and move forward together for the benefit of all.

So I encourage you to join us on this journey as we begin to harmonize not just across the Atlantic, but globally.

Further reading:

Harmonizing US and EU Policy on In-Silico Medicine: Taking the First Steps