Dassault Systèmes Life Sciences Business Consultant, Sara Dutta is scheduled to speak at the 22nd Mass Medic Annual
Conference taking place at the Boston Exhibition & Convention Center, April 18. Her talk “Virtual Clinical Trials – Sci Fi or Reality?“ will be part of terrific line up of speakers that include Dr. Jeffrey Shuren, Director, CDRH – FDA, among other notable industry speakers.
Did you know that it takes over 100 million dollars and 8 years to bring a new high-risk medical device to market? These numbers are growing every year, but what if instead we could cut those numbers in half? During her talk at Mass Medic, Dutta will look at how computational modeling and simulation (CM&S) – used in other key industries – is now becoming possible for life sciences companies. Thanks to huge collaborative initiatives often driven by leading experts in academia (such as the Virtual Physiological Human and The Virtual Brain projects), computational models of complex biological processes and the human body are becoming very accurate. In fact, the U.S. FDA believes as much as 50% of future evidence will come from CM&S and is taking initiatives to incorporate these models into the approval process for medical devices and drugs, such as the guidelines published in 2016 and the Medical Device Development Tool (MDDT) program.
According to Dutta, “Computational modeling and simulation can significantly reduce the time and cost to design, develop and gain regulatory approval of a new medical device by leveraging a holistic model-based design environment that combines multi-physics behavior modeling, big data, social collaboration, and intuitive decision support. In addition – with the 3DEXPERIENCE platform, medical device companies can deploy an end-to-end virtual environment for exploration, discovery, development, testing, and commercialization – with full visibility across internal and external ecosystems. This is a method that all medical device companies should incorporate now.”
Sara Dutta is a Business Consultant for the Life Sciences Industry at Dassault Systèmes. She is based at the US headquarters in Waltham, MA. Her aim is to leverage her expertise and the strength of the Dassault Systèmes platform to help pharmaceutical and medical device companies innovate and transform their businesses.