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. 

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

​​

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

​ 

​​

  • The second webinar in the series, Beyond Usability/Human Factors for Digital Healthcare was held on Tuesday, September 21, 2021.   

​Moderators:

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

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

 

Click here for a recording of the webinar. PDFs of the presentations are available below.  

Introduction

Designing Digital Healthcare:  HFE and UX in Partnership

  • Julian Dixon, HF Consulting Director, Team Consulting

 

Beyond Usability/Human Factors for Digital Healthcare  (pdf not available)​

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

​

  • The third webinar Digital Devices: Manufacturing and Design Considerations was held on Wednesday, September 29, 2021. 

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

 

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

Introduction

Design of Connected Devices with High Functionality, Good Usability and Low Environment Impact

  • Andreas Meliniotis, Director, Device Development, Vectura

  • Phil Swanbury, Director, Device Development, Vectura

​

Practical Considerations for Developing Software in Connected Health Solutions and the Assessment of Sustainability in Respiratory Devices

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

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

​

  • The fourth webinar Business Case for Digital Devices was held on Monday, October 4, 2021. 

Moderators:

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

  • Robyn Parker, MS, Associate Director, Global Regulatory Affairs, Sunovion

 

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

Introduction

Business Case for Digital Inhaler Devices: A platform provider’s perspective on creating a compelling user experience and driving adoption

  • David Pettigrew, DPhil, Vice President Global Accounts, BrightInsight

​Business Case for Digital Inhaler Devices:  A pharma company perspective

  • Ulf Ericsson, MS, Vice President Drug Development, Nanologica

​

​

​

REGISTRATION IS OPEN:   

​​​

  • November 22, 2021 10:00 AM - 12:00 PM ET - Digital Devices:  Regulatory Challenges and Considerations.

    • Click here for details.​

​

​