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Can Digital Evidence Replace Clinical Evidence? - A "Straight from the Source" Webinar
Join FDA’s Tina Morrison and Axendia’s Daniel R. Matlis for a live webinar on September 18th at 11:00 AM ET.

FDA is encouraging the use of “Digital Evidence” to inform clinical trial designs, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions.

Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence.

We will discuss FDA’s perspective on:

* Shifting from traditional evidence sources to digital evidence
* How to create virtual patients with digital evidence to replace clinical evidence
* Examples of digital evidence in Pharma and Medical Device used in FDA to initiate and augment clinical studies
* Creating an in silico clinical trial Playbook
* Why data in PDF’s are not sufficient

Can't make this time? Register and you will be able to watch the On-Demand recording after the event.

Sep 18, 2019 11:00 AM in Eastern Time (US and Canada)

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Speakers

Tina Morrison, Ph.D.
Deputy Director, Division of Applied Mechanics, OSEL, CDRH @U.S. Food and Drug Administration
During her 11 years at the FDA, Tina has been working to advance the role of computer modeling and simulation in medical device design and product evaluation. She chairs the FDA Modeling and Simulation working group, and advises CDRH on simulation research and policy efforts. Additionally, Tina has led the development of pathways for enhancing modeling credibility and acceptance. For instance, she led the development a verification and validation standard for ASME, which culminated in 2018 with the first-ever set of evaluating procedures for computational modeling of medical devices, the ASME V&V 40 standard. Because of these efforts, Tina was selected as the 2019 Federal Engineer of the Year for FDA. She is the Deputy Director of the Division of Applied Mechanics in FDA’s Office of Science and Engineering Laboratories. She chairs the ASME Verification and Validation Committee, and is an Associate Editor for the Journal on Verification, Validation and Uncertainty Quantification.
Daniel R. Matlis
President @Axendia Inc.
Daniel R. Matlis is President of Axendia, an analyst firm providing trusted advice to Life-Science Executives on Business, Technology and Regulatory issues. Dan has almost three decades of industry experience spanning the Health-Science value chain. He has been an active member in FDA’s Case for Quality Initiative since 2014 and has presented Axendia’s research findings to industry executives and the FDA officials. Dan began his career at Johnson & Johnson, where he provided leadership in the areas of technology, regulatory compliance and business. Before founding Axendia, Dan was a Partner, VP and General Manager at a leading Life-Science consultancy firm. He is a frequent lecturer at Industry events and has published numerous research reports and articles on key issues facing the Life-Sciences and Healthcare industries. Dan holds a BS in Electrical Engineering from Polytechnic University (now NYU School of Engineering) in NY and a MS in Management from NJIT.