Start Date: | 3/15/2023 | Start Time: | 4:00 PM |
End Date: | 3/15/2023 | End Time: | 5:30 PM |
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Event Description
BIOMED Seminar
Title:
The Value of Modeling and Simulation for the Biomedical Industry
Speaker: Daniel R. Matlis President Axendia Inc.
Details: Computational modeling and simulation (CM&S) is having a transformative effect across the biomedical product lifecycle. The use of computer-generated digital evidence can provide significant value over traditional prototyping, bench testing, design for manufacturability, manufacturing process optimization, in vivo testing, clinical studies, and post-market fault analysis.
Regulators around the world are encouraging the use of CM&S. The European Medicines Agency is actively working to enhance the use of CM&S across the product lifecycle. The FDA has identified CM&S as a CDRH and Agency-wide priority, and recognizes its value as a regulatory tool with the potential to reduce the cost and enhance the scope of device evaluation.
In addition, the use of validated digital evidence and digital twins can reduce the burden on physical testing and in vivo studies, as well as streamline manufacturing to accelerate new product introductions.
Biosketch: Daniel R. Matlis is President and Founder Axendia, Inc., an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues.
Dan has three decades of industry experience spanning the life science value chain. He is an active contributor to FDA’s Case for Quality Initiative, is a member of FDA’s Advisory Council on Modeling, Simulation and in-Silico Clinical Trial, and co-chaired the Product Quality Outcomes Analytics initiative with Agency officials. He has also provided input to the Agency on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” guidance.
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 presented Axendia’s research findings to industry executives and the FDA officials. Dan has published numerous research reports, eBooks, and articles on key issues facing the life sciences and healthcare industries.
In 2021, Dot Compliance named Dan as one of the Top 20 life science influencers to follow. He holds a BS in Electrical Engineering from Polytechnic University (now NYU School of Engineering) in NY and an MS in Management from the New Jersey Institute of Technology (NJIT). |
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Location: Papadakis Integrated Sciences Building (PISB), Room 120, located on the northeast corner of 33rd and Chestnut Streets. |
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