Day One

Wednesday September 9 2020

Day Two

Thursday September 10 2020

9:00 am Login & Virtual Networking

9:30 am Chair’s Opening Remarks

The Evolving Regulatory Landscape

9:40 am Keynote: Navigating the Combination Product Regulatory Framework for an Autoinjector

  • Prasad Peri Senior Director, Regulatory Affairs & CMC, Teva Pharmaceuticals

10:00 am Panel Discussion: Putting Your Users in the Designers’ Seat – Enabling Users’ to Lead the Development of Safer & More User-Friendly Injection Devices

  • Allison Y. Strochlic Research Director, Human Factors Research & Design, Emergo by UL
  • Cecilie Anker Senior Usability Engineering Lead, Novo Nordisk
  • Heydy Andolz Senior Consultant Engineer - Human Factors, Eli Lilly
  • Jonas Fransson Director Drug Product Development, Technical Operations, Swedish Orphan Biovitrum AB

10:40 am Live Q&A – Ask Our Speakers Your Burning Questions

  • Prasad Peri Senior Director, Regulatory Affairs & CMC, Teva Pharmaceuticals
  • Allison Y. Strochlic Research Director, Human Factors Research & Design, Emergo by UL
  • Cecilie Anker Senior Usability Engineering Lead, Novo Nordisk
  • Jonas Fransson Director Drug Product Development, Technical Operations, Swedish Orphan Biovitrum AB
  • Heydy Andolz Senior Consultant Engineer - Human Factors, Eli Lilly

10:55 am Virtual Speed Networking

Excellent Device Engineering

11:30 am Morning Break

11:45 am The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance

12:25 pm The Importance of Device Testing – And Should You Do it In-House?

12:45 pm Make vs Buy (vs Customize): Evidence-Led Device Decision-Making

  • Tim Quigg Programme Development Lead , Crux Product Design Ltd

1:15 pm Live Q&A – Ask Our Speakers Your Burning Questions

1:30 pm Networking Lunch

2:00 pm Digital Health – From Connected Devices to Building a Digital Ecosystem

  • Michael Song Head of Device Functionality, Safety, Digital Connectivity, AstraZeneca

Future Injectable Device Strategy

2:20 pm Balancing Drug Delivery Device Connectivity, Cost, Sustainability & Usability

  • Bill Welch Chief Technology Officer, Phillips-Medisize, a Molex company
  • Kevin Deane Executive VP Front-End Innovation, Phillips-Medisize, a Molex company

Synopsis

  • Why disposable, single use autoinjectors, introduced in the early 2000s, can no longer satisfy today’s requirements to reduce space, storage, and waste
  • The growing demand for drug delivery device connectivity to improve patient adherence, care team collaboration, and health outcomes
  • How pharmaceutical companies can create a clear path to low cost connectivity with more affordable, convenient, and sustainable injection devices
  • Examples of smart, reusable, autoinjectors that work with mobile apps to track and transmit digital data from patients to physicians
  • Key considerations when embracing a connected health platform for biologic and injectable drugs

2:40 pm Smart Device – the FDA’s Thinking of Software as a Medical Device & The Future Ecosystem

3:00 pm Live Q&A – Ask Our Speakers Your Burning Questions

3:20 pm Afternoon Break & Interactive Action Groups

Synopsis

Select the action group topic of choice where you can share your thoughts, questions and challenges with fellow participants following the morning presentations

Digital Devices – From Mechanical to Electromechanical Engineering & Ecosystem Human Factors & Usability

4:00 pm Sterility Seal Design for Prefilled Container Closure Systems & Drug Delivery Devices

  • Murat Günay Senior Consultant Engineer of Delivery, Device and Connected Solutions , Eli Lilly and Company

Synopsis

Current developments in prefilled container closure systems used in drug delivery
systems require removable sterile barriers to connect and establish a fluidic path
for drug delivery at the point-of-use. Therefore, it is essential that next-generation
reusable drug delivery devices utilizing prefilled container closure systems not only
address robust and removable sterility seal component requirements but also simplify
and improve the user experience. This talk will emphasize the advantages and
challenges of current sterility seal technologies and custom seal component design
for a new prefilled container closure system. An introduction to sterile barriers for drug
product container closure systems and specific feature design considerations for sterility
film seals will be given, as well as considerations for elastomer sterility seal design and
development for a novel drug delivery system.

4:20 pm Strategic Platforming: Leveraging Platforms for Combination Product Development

  • Tracy Hsu Associate Director, Ionis Pharmaceuticals

4:40 pm Panel Discussion: How to Leverage Human Factors at Every Stage of Combination Product Design

  • Joely Gardner, PhD Professor; Chief Researcher, California State Fullerton; Human Factors Research
  • Tim Quigg Programme Development Lead , Crux Product Design Ltd
  • Tracy Hsu Associate Director, Ionis Pharmaceuticals
  • Murat Günay Senior Consultant Engineer of Delivery, Device and Connected Solutions , Eli Lilly and Company

5:20 pm Chair’s Closing Remarks & End of Day 1

Day 2