IPAC-RS DIGITAL-DEVICE ROUNDTABLES

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. 

  • 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

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

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.  

 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.

Click here for abstracts and more information on this webinar. 

  • 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.

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

Click here for abstracts and more information on this webinar.

 

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.