In silico tools at the centre of new FDA regulatory strategy to accelerate innovation

Scott Gottlieb commissioner of the USA Food & Drug Administration has recently written an article (see post dated 7 July 2017) for the FDA blog “FDA Voice” on the impact of the 21st Century Cures Act, which authorised $6.3 billion in additional funding, part of which is dedicated to research and drug development. In the article, Dr Gottlieb writes: “Today we announced our detailed work plan for the steps we’re taking to implement different aspects of cures. I want to highlight one example of these steps, which we’re investing in, and will be expanding on, as part of our broader Innovation Initiative. It’s the use of in silico tools in clinical trials for improving drug development and making regulation more efficient”.

He continues: “In silico clinical trials use computer models and simulations to develop and evaluate devices and drugs. Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials. FDA’s efforts in modeling and simulation are enabled through multiple collaborations with external parties that provide additional expertise and infrastructure to advance the development of these state-of-the-art technologies”.

This declaration could have been extracted, almost verbatim, from the Avicenna action roadmap published in 2015.

“I am delighted to see the regulators finally recognising that in silico medicine technologies can transform biomedical industry”, commented Prof Marco Viceconti, Director of the Insigneo Institute for in silico Medicine, and coordinator of the Avicenna Action. “this is what I have been preaching since 2002; it is great to see the Avicenna visions becoming reality”.

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