in silico meets clinical trials: A new type of combined trials

As the medical devices industry moves towards a digital ecosystem, in silico trials and their combination with traditional trials are becoming a reality. Yet, to cross the chasm between people’s needs for digital solutions and their abilities to master the complexities of the required tools means to become more comfortable with technologies like mechanistic, multiphysics simulation, or AI/ML.

In this presentation, we will discuss our vision, the path forward, and some practical use cases for the adoption of in silico trials for the medical devices industry, including the requirements on how to integrate the full process along the way to regulatory submission.  But in silico is not here to replace clinical trials (quite yet): we need to combine the best of both worlds to reduce cost and time to market. We will touch on this topic, but the main content of this presentation focuses on in silico trials and will speak to the established leaders in the industry, SMEs but also the radical innovators at start-ups. The in silico approach can boost productivity and regulatory compliance for major manufacturers and agile startups alike.

Kristian Debus:

After more than 7 years with Siemens Industries Software as director of Medical Devices, I joined Thornton Tomasetti to lead their Life Sciences team. I have worked at both startups and major software companies, partnered with regulatory agencies, and served on the ASME V&V 40 committee for the standardization of computational modeling of medical devices. At TT we support our clients in the use of simulation to design better medical devices faster and more cost-effective, as we grow our offering to serve our clients from Ideation/Design and in silico trials to regulatory reporting.

Kristian has a PhD in mechanical engineering, CFD from the Technical University of Munich. He has experience from ICEM CFD, Agilent, Bechtel and PAX Scientific. As the Industry Expert Medical Devices, Appliances and Tools for CCM products at Siemens, he focused on business development in the Biomedical Device and Home Appliances Industries. In 2005, he also founded Computational BioDynamics, a company dealing with Medical CFD Software for diagnostic and treatment planning.

Reza Salari:

Dr. Reza Salari has two decades of experience in computational solid mechanics, with a special focus on the development and use of finite element analysis-based methods to solve challenging problems in a variety of industries, ranging from medical devices to high tech and structural engineering. His work typically involves the development of new software tools and modules, development of new methodologies by advancing state of the art methods and bringing together ideas and techniques from a variety of different industries to solve clients’ problems. For the past 15 years at Thornton Tomasetti’s Applied Science Practice Reza has been using a combination of modeling and simulation, machine learning and optimization techniques to solve problems involving various domains such as biomechanics, structural dynamics, shock and impact, structural acoustics, etc.

 

Event Information

Event Topic:
in silico meets clinical trials: A new type of combined trials

Event Description:

Date/Time:
Date(s) - 12/01/20
8:30 am - 10:30 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/85043660945:

Speaker Information

Event Speaker:
Kristian Debus & Reza Salari

Event Speaker Title:
VP Life Sciences & Senior Associate

Event Speaker Company:
Thornton Tomasetti

Event Speaker Bio:

Event Details

Cost:
$0

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