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IPAC-RS ROUNDTABLES - 2024

IPAC-RS ROUNDTABLES - 2024

IPAC-RS is continuing its Roundtable series in 2024, 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. 

IPAC-RS ROUNDTABLES - 2023

The first webinar of 2024, Regulatory and Technical Considerations in Sustainable Lifecyle Approaches for OINDP Device and Container Closure Systems (Part III) was held on Thursday, March 14, 2024 at 10:00 - 11:30 AM US ET.   

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This virtual roundtable brought together pharmaceutical industry and supply chain representatives, was open to the public and aimed to increase understanding of the current and emerging scientific and regulatory context for sustainability in the drug device combination product lifecycle as supply chains and product manufacturers seek to decrease their carbon footprints, produce less waste, and create circularity in resource use where possible.  Communication and coordination among all stakeholders will be needed to implement and navigate these changes.    

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Moderator:

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Presenters:

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Panelists:

 

Webinar Program:

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I.     Welcome and Overview of Webinar (5 minutes)

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II.    Presentations (15 minutes each) 

 

  • Harriet Lewis (Chiesi) and Timothy Buxton (Grundon Waste Management, Ltd.)

  • Nolwenn Stephan (Nemera)

  • Hasmukh Patel (FDA/CDER)

  • Steven Hoare (MHRA)

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​​III.     Moderated Q&A Session with the Presenters and Panelists (25 minutes)

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PDFs of the presentations are linked above. Recording of the Roundtable available here.

Click here to view the Moderator, Presenter, and Panelist bios.

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IPAC-RS is continuing its Roundtable series in 2023, 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. 

 

Upcoming IPAC-RS Roundtable topics include:

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  • Advancing Sustainability of Device and Container Closure Systems (Part III) 

  • Sustainability - Alternate Propellants​

  • Advanced Data Analytics​

  • Regulatory Evolution

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  • The first webinar of 2023, Advancing Sustainability of Device and Container Closure Systems (Part II) was held on February 7, 2023. 

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Moderator:

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Presenters:

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Panelists:

  • Edward Jackson, Device Development Team Leader, Kindeva Drug Delivery

  • Marc Severin, Program Manager Sustainability and Innovation, Presspart

  • Beate Treffler, Regional Sales Manager Europe, Healthcare Polymer Solutions, Avient Colorants Germany GmbH

 

Click here to view a recording of this webinar.  PDFs of the presentations are linked above.​

Click here to view the Moderator, Presenter, and Panelist bios.

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IPAC-RS ROUNDTABLES - 2022

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  • The second webinar in the 2022 series, Advancing Sustainability of Device and Container Closure Systems (Part I) was held on Wednesday, November 30, 2022.    

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​​Moderator:  Lee Nagao, Ph.D., Senior Director - Science, Regulatory & Policy, Faegre Drinker Biddle & Reath, LLP, IPAC-RS SecretariatI

 

Presentations:

 

Click here to view a recording of this webinar.  PDFs of the presentations are linked above.

Click here to view the Moderator and Presenter bios.

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  • The first webinar in the 2022 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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Publications

Presentations 

Comments on Guidances

Reference Links

IPAC-RS REGULATORY ROUNDTABLE 2020

In 2020, IPAC-RS hosted a Roundtable:  A Conversation with the FDA:  Perspectives in the Time of COVID-19 on November 2, 2020.  Click here to review the summary of the webinar.

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