innovation through healthcare simulation

Innovation Through Simulation in Healthcare

October 11, 2019

10:00 AM - 3:00 PM (EDT)

Venue:
College Park Marriott Hotel & Conference Center
3501 University Blvd E
Hyattsville, MD 20783
USA

Contact:
Krista Loeffler

Transforming Computational Modeling from A Valuable Scientific Tool to A Valuable Regulatory Tool: Myth or Reality?

Healthcare companies have been investing in computer modeling and simulation (i.e., in silico) methods for decades to accelerate the innovation of safer and more robust products. Over the past few years, FDA has established various regulatory frameworks that accommodate the incorporation of in silico (digital) evidence in device submissions. Their efforts include the publication of guidance documents, collaboration with medical device industry stakeholders to develop the ASME V&V 40 standard, and collaboration with international organizations.

ANSYS, US FDA, and the Avicenna Alliance are organizing a roundtable discussion focusing on modeling and simulation in the medical device and pharmaceutical industries.  The goal of the meeting is to discuss opportunities and challenges when utilizing in silico approaches during development and regulatory review.  The event will be organized around 2 panel discussions, where senior leaders from the largest medical device and pharmaceutical companies will be sharing their experience and expectations.

Please register to reserve your spot!


Agenda

Time Topic
9:30 AM REGISTRATION & BREAKFAST
10:00 AM - 12:00 PM How Can Simulation Play A More Pervasive Role in The Medical Device Industry?
Opportunities, challenges, and best practices for in silico approaches during development and regulatory review
12:00 PM - 1:00 PM LUNCH
Pras Pathmanathan, Scientist, Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health, Food and Drug Administration
1:00 PM - 3:00 PM How Can Simulation Play A More Pervasive Role in The Pharma/Biopharma Industries?
Opportunities, challenges, and best practices for in silico approaches during development and regulatory review

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Medical Device Panel

Marc Horner

Marc Horner, Ph.D.

Vice Chair V&V 40
Principal Engineer
Healthcare, ANSYS

Payman Afshari

Payman Afshari, Ph.D.

Sr. Principal Engineer
DePuy Synthes Spine Johnson and Johnson

Mark Palmer

Mark Palmer, MD, Ph.D.

Distinguished Scientist,
Strategic Scientific Operations
Medtronic

Dr. Anton E. Dmitriev

Dr. Anton E. Dmitriev

Deputy Director for Innovation and Regulatory Engagement
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)

 

Ken Merdan

Ken Merdan

Sr. R&D Fellow
Global Technology & Services
Boston Scientific Corporation

Luca Emili

Luca Emili

Founder and CEO
InSilicoTrials Technologies

Finn Donaldson

Finn Donaldson

Team Lead, Peripheral Interventional Devices Team
Office of Cardiovascular Devices in CDRH/FDA

Dr. Mohammad Usman

Dr. Mohammad Usman

Sr. Manager R&D, Simulations and PLM
Global Research and Engineering Services
Stryker

 

Pharma/Biopharma Panel

Liang Zhao

Dr. Liang Zhao

Director, Division of Quantitative Methods and Modeling (DQMM),
Office of Research and Standards
Office of Generic Drugs Center for Drug Evaluation and Research
Food and Drug Administration

Yaning Wang

Yaning Wang, Ph.D.

Director, Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration

Francios-Henri Boissel

Francois-Henri Boissel

CEO
Novadiscovery

Flora Musuamba

Flora Musuamba

Vice Chair
EMA Modelling and Simulation Working Party

 

Marc Horner

Marc Horner, Ph.D.

Vice Chair V&V 40
Principal Engineer
Healthcare, ANSYS

Pablo Rolandi

Pablo Rolandi

Director
Process Development - Digital Integration & Predictive Technologies
Amgen

Suresh Nulu

Suresh Nulu

Director
Merck

 

Moderator

Thierry Marchal

Thierry Marchal

Secretary General, Avicenna Alliance
Global Industry Director
Healthcare, ANSYS

 

Guest Speaker

Dr. Pathmanathan

Dr. Pathmanathan

Scientist
Office of Science and Engineering Laboratories (OSEL),
Center for Devices and Radiological Health, Food and Drug Administration