8:00 am Morning Networking Coffee

8:50 am Chair’s Opening Remarks

Sustainability & Reusability of Injectable Devices

9:00 am Fit for Circularity as Measure of Medical Device Concepts Sustainability

  • Jesper Bogelung Program Manager of Device Design for Circularity, Novo Nordisk

Synopsis

  • Four levers for incorporating sustainability into medical device development
  • Three main dimensions of the circular economy
  • Two tools for directing and communicating
  • One overall KPI to compare concepts and gauge progress

9:30 am Panel Discussion: How Do Pharma & Biotech Adapt Their Injectables Program to Achieve Sustainability Targets

  • Jesper Bogelung Program Manager of Device Design for Circularity, Novo Nordisk
  • Nick Song Director, Commercial Device Engineering, Takeda

10:10 am Beyond the Datasheet – Maximizing Your Drug Delivery Device Materials & Designs for Precision Friction Performance & Sustainability

  • Don DeMello Field Development Engineer – Medical Engineered Material, Celanese

Synopsis

  • Mechanical drug delivery devices for respiratory or injectable pharma can feature many sliding parts in high force, high pressure contact with one another where stick-slip or unexpected friction is a concern. Since friction is a system property between two material pairs and other conditions, this is difficult to capture on a datasheet
  • This presentation will highlight types of lab tribology testing and friction data available that can be used by mechanical engineers to mitigate risk in their designs. By plugging precision friction data into their models, engineers can optimize designs before mold steel is cut and increase opportunity for success
  • As devices slim down for human factors, cost reasons or require precise glide forces to push viscous biologics, this puts more performance needs on the materials used. System friction data is requisite for engineers designing precision dosing or other types of applicator devices
  • The good news is that low friction polymers are now available in grades to assist with medical device sustainability design goals

10:40 am Morning Networking Break & Refreshments

Device Engineering & Control Strategies

11:10 am Applied Digital Twins: The Use of In-Silico Tools to Inform Device Design Decision-Making

Synopsis

  • Historic device design initiatives – evidence-led, analytical approaches
  • An ever-evolving state-of-art – how tools and techniques have matured over the last decade
  • Applied example – using physics-based computer simulations to evaluate device reliability and drug-device interactions
  • Key learnings – the successes and limitations of a data-driven approach
  • Project significance – preventative failure detection and adoption of digital techniques to support GSK’s device portfolio

11:40 am Supplier Engagement During a Drug Injectable Product Development

  • Emily Ho Associate Director, Merck & Co.

Synopsis

  • Understanding the quality management system requirements for an injectable device/combination product supplier
  • Determining the suppliers’ responsibilities and expectations for each design control phase/milestone
  • What are the benefits and challenges when developing a vaccine prefilled syringe combination product with a supplier?

12:00 pm Building a Virtual Test Lab Delivering Results in 1 Hour

  • Martin Ebro Team Lead – Engineering Analysis, Device Research & Development, Novo Nordisk

Synopsis

  • Reducing design iteration lead times from months to hours
  • Predicting the failure rate of 1.000.000 samples of a device – when variation is present
  • Expanding modelling capabilities to skin/tissue penetration, packaging, storage, and more

12:20 pm Q&A: Device Engineering & Control Strategies

  • Steve Chamberlain Director Device Engineering, GSK
  • Tim Quigg Development Director, Crux Product Design Ltd
  • Emily Ho Associate Director, Merck & Co.
  • Martin Ebro Team Lead – Engineering Analysis, Device Research & Development, Novo Nordisk

12:35 pm Panel Discussion: Next Generation Injectables Devices, Technologies & IoT Data Collection

  • Alasdair Young Director – Device Engineering, Coherus Biosciences
  • Anthony Coston Director of Program Management, Biogen
  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals
  • Nick Song Director, Commercial Device Engineering, Takeda

1:10 pm Networking Lunch

2:00 pm Device Engineering & Design Control Strategies; The Important Aspects of Life Cycle Management

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals

Synopsis

  • How to manage component, manufacturing, assembly and/or analytical vendors through proper controls and common sense responsibilities
  • Design for manufacture benefits and criticality in today’s demanding economy
  • Lifecycle management: Thinking ahead and utilizing risk based manufacturing and device iterative design

2:20 pm Taking a Delivery System from Feasibility Through Development – Challenges & Opportunities with Progressing a Device Portfolio

Synopsis

  • Design control and how to take a device from feasibility into development
  • Challenges and opportunities and product development for pharmaceuticals
  • Understanding best practice around device injectable device development; aligning responsibilities and roles for injectable devices correctly
  • Making the best selection for each program; how difference diseases and the complications it gives patients and how they interact with the device
  • Creating devices with consideration to the medication going to be used

2:40 pm CMC Considerations Transitioning from Vial to Prefilled Syringe

  • Jamie Tsung Associate Director, Alnylam Pharmaceuticals

Synopsis

  • Identifying the key activities for developing prefilled syringe
  • Meeting and understanding the challenges for the vial-prefilled syringe transition.
  • Identifying the key factors to consider in primary packaging materials

3:00 pm Q&A: Device Engineering & Control Strategies

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals
  • Casey Dean Device Development Manager, Tolmar
  • Jamie Tsung Associate Director, Alnylam Pharmaceuticals

3:15 pm Chair’s Closing Remarks

3:25 pm End of Conference