Starting in 2020, IPAC-RS has organized a number of roundtables with thought leaders to discuss key regulatory and scientific topics in respiratory products.  Continuing that practice, in 2021, IPAC-RS launched a new series focusing on drug-device combination products with digital components, and digital-health opportunities and challenges more broadly.  Presented by subject matter experts in the pharmaceutical sciences, this is a unique opportunity to learn about the latest research and regulatory trends focused on digital devices. 

Publications

Presentations 

Comments on Guidances

Reference Links

• The first webinar in the series, What is a Digital Biomarker and Why Is It Important? was held on September 10, 2021. 

Moderators:

• Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group

• Lee Nagao, Ph.D., Senior Director Science, Regulation & Policy, Faegre Drinker Biddle & Reath LLP, IPAC-RS Secretariat

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Click here to view a recording of this webinar.  PDFs of the presentations are available below. 

Introduction

The Progression of Digital Biomarkers in Clinical Trials and Beyond

• James Blakemore, Ph.D., Senior Consultant, Strategy Group, Medical Technology Division, Cambridge Consultants

• Joe Corrigan, CEng MIMechE, Head of Intelligent Healthcare, Global Medical Technology, Cambridge Consultants

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Realizing the Vision of Digitally Enabled, Patient-Centric Clinical Trials

• Marissa Dockendorf, Ph.D., Director, Global Digital Analytics & Technologies, Merck Research Laboratories

• Bryan J. Hansen, Ph.D., Associate Principal Scientist, Global Digital Analytics and Technologies, Merck Research Laboratories

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• The second webinar in the series, Beyond Usability/Human Factors for Digital Healthcare is scheduled for Tuesday, September 21, 2021 from 10:00 AM – 12:00 PM US ET.  

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 Moderators:

• Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group

• Fredrik Mannerstråle, Director Regulatory CMC, Medical Devices and Combination Products, AstraZeneca 

Speakers:

• Haydyn Phillips, User Experience (UX) lead, AstraZeneca

• Ian Culverhouse, Ph.D., Co-Founder, Rebus Medical Ltd.

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Click here for abstracts and more information on this webinar. 

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• The third webinar Digital Devices: Manufacturing and Design Considerations will be held on Wednesday, September 29, 2021 from 8:30 - 10:00 AM US ET.

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Moderators:

• S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.

• Daniela Gramaglia, Ph.D., Design Control and Documentation Specialist, Chiesi Group

Speakers:

• Andreas Meliniotis, Director, Device Development, Vectura

• Phil Swanbury, Director, Device Development, Vectura

• Stathis Louridas, Ph.D., Head of Electronics and Software, Team Consulting

• Brennan Miles, Managing Consultant – Drug Delivery, Team Consulting

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Click here for abstracts and more information on this webinar.

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SAVE THE DATES:   Additional Webinars are scheduled below.  Registration information will be available shortly.

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• The fourth webinar Business Case for Digital Devices will be held on Monday, October 4, 2021 from 10:00 AM - 12:00 PM US ET.

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