IPAC-RS is hosting a new Roundtable series in 2022, supplementing the podium presentations held at the IPAC-RS/RDD Joint session that addressed Regulatory, Science and Technology Innovations Enabling Novel and Improved OINDP Design, Development and Manufacturing. 

The upcoming IPAC-RS Roundtable topics include:

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• Sustainability

• • Alternate Propellants​

  • Supply Chain Considerations

• Advanced Data Analytics​

• Regulatory Evolution

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• The first webinar in the series, Patient Centric Product Design was held on September 22, 2022.

Moderator:  Jeremy Clarke, Ph.D., Senior Fellow, Manufacturing Science & Technology, Global Supply Chain, GSK​

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Panelists:

• Gregor Anderson, MSc, Managing Director, Pharmacentric Solutions

• Juan Cheng, Ph.D., RAC, Device Development, Merck Research Labs (MRL) Merck

• Sven Stegemann, Ph.D., Professor of Patient Centric Drug Design and Manufacturing, Graz University of Technology

• Paul Upham, Head, Smart Devices, Roche/Genentech

• Róisín Wallace, B.Sc., MRSC, Head of Global Device Development, Viatris

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Click here to view a recording of this webinar.  A PDF of the presentation is available here.​

Click here to view the Moderator and Panelists bios.

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IPAC-RS DIGITAL-DEVICE ROUNDTABLES - 2021

• 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 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.

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• 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

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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

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• 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

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• The fifth webinar Digital Devices:  Regulatory Challenges and Considerations was held on Monday, November 22, 2021. ​

Click here to view a partial recording of this webinar. 

Moderators:

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

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

Speaker:

• Robert Berlin, JD, M.P.H., Head of US Regulatory Policy, GlaxoSmithKline

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