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7:30 am Registration & Welcome Coffee

8:30 am Chair’s Opening Remarks

Fortifying User-Centric Design Thinking in Your Injectable Device

8:40 am Understanding Injection Device Needs in Rare Disease Patients: A Holistic Approach for Early Stage Research

  • Sindhuja Kuchibhatla Device Development Engineer, New Technologies Management, Regeneron Pharmaceuticals
  • Emily Dubuc Senior Engineer – Device Development, Regeneron Pharmaceuticals

Synopsis

  • Meeting and understanding the specific challenges for rare disease patients to design usable devices
  • Approaches to prioritize patient experience over the solution; why usability and patient experience matters
  • Case study: early findings from qualitative user research
  • Value of patient needs research at the early stage of device development

9:10 am Making a Difference: Utilizing Human-Centered Design to Improve Health Outcomes

Synopsis

  • Many factors influence adherence and persistence to injectable therapies
    Only a small subset of these broader factors can be influenced by the injection device
  • Lilly’s design team developed a concise framework of device-related factors that can impact adherence.
  • Organized across the two dimensions “patient factors & outcomes” and “ease-of-use”, the framework consists of nine distinct elements
  • Employing simple human-centered design processes around the framework can help to conceive of device designs, geared to improve adherence and persistence
  • The framework-based application of design processes offers guidance to product design teams as they discover and capture novel opportunities available in the dawning age of digital health

9:40 am Appllied 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

10:10 am Structured Networking & Morning Refreshments

Extending Your Product Lifecycle Management

11:00 am Leveraging Connected Health & Smart Devices

  • Daniel Latham Head of Connected Health Product Development, Novartis

Synopsis

  • Opportunities to enhance current treatment offerings with connected health and the role of data in benefiting patients, HCP’s and healthcare systems
  • Development of the right solutions in connected health and impacting the user experience
  • Overcoming challenges to bringing connected injectables to the market

11:30 am Leveraging Cutting Edge Technologies into Combination Product Lifecycle Management

  • Joyce Zhao Associate Director, Combination Product, Takeda

Synopsis

  • Identifying the needs to improve the launched injection system based on postmarket investigations
  • Challenges from device design and manufacturing during design improvement
  • Leveraging cutting edge technologies such as FEA, CFD and Moldflow simulation into the device improvement to mitigate risk, shorten lead time and reduce cost

12:00 pm Usability Engineering Methods to Address Use Related Risk for Medical Devices

  • Ed Israelski Human Factors Consultant | CoCovener IEC/ISO Standards Groups for Usability Engineering Standards | Retired Director – Human Factors, AbbVie

Synopsis

  • Common methods to analyze use related risk including Use FMEA, URRA, Fault Tree Analysis; pitfalls and additional considerations in applying these risk management tools
  • FDA regulatory expectations in using risk management methods and human factors for injectables
  • Ensuring human factors are a part of design to fulfil product requirements and user needs; how new products are being developed and manufactured based on the user needs and clinical requirements
  • Increasing patient medication adherence and improving onboarding for new patients, ensuring patients take their medication on time, stored properly and following correct application methods

Updates of Evolving Global Regulatory Landscapes

12:30 pm Networking Lunch

1:10 pm Evolution of the Safety Organization to Support Post-Market Safety Reporting (PMSR) for Combination Products

  • Khaudeja Bano Executive Medical Director & Head of Combination Product Device Safety, Amgen

Synopsis

  • One year after implementation of FDA’s PMSR requirements for combination products how has it changed the world of safety and what does industry need to be aware of?
  • How does FDA review and regulate combination product reporting?
  • How can industry adapt to the global divergence of PMSR requirements?
  • Challenges that still exist for PMSR compliance for injectable products

1:40 pm “Plug & Play”? Leveraging Established Device Platform for Combination Product Development

Synopsis

  • Understand the regulatory agency’s expectation about devices for pivotal clinical trials
  • When leveraging an existing device platform, how to decide what existing data can be leveraged and what extra steps to complete to satisfy the regulatory requirements
  • How to communicate your development strategy to the regulatory agencies
  • How to determine the development timeline

2:10 pm Case Study: Combination Products Bridging Study Landscape

  • Tieming Ruan Senior Director of Device Development, Alexion Pharmaceuticals

Synopsis

  • Industry strategies to ensure correct bridging of clinical trials
  • Regulatory guidance of combination products bridging study; interpreting regulatory guidance to ensure successful submission
  • Lessons learned from successful and unsuccessful submissions for injectables to regulatory agencies

2:40 pm Afternoon Break

How ‘Smart’ Are Your Injectable Devices?

3:10 pm The Multiple Benefits of User Centered Smart Devices

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals

Synopsis

  • What are wearable technologies and how does the device developer maximize their benefits
  • What patients want is comfort and convenience: How do device developers address these needs using biosensors and embedded sensor technology
  • The evolution of human factors engineering and how the regulators are aligning

3:40 pm Session Reserved – Sponsored by Koru Medical Systems

  • Dr. Bob Geng Assistant Clinical Professor, UC San Diego School of Medicine

High Viscosity & High-Volume Injection Device Design & Engineering

4:00 pm Technical & Human Factors Considerations for High Viscosity/High Volume Injection

  • Michael Roe Senior Director, Development & Industrialization, Kaleo

Synopsis

  • Future trends: market direction driving the move to high viscosity/high volume injection
  • Addressing engineering and technical considerations in delivering these formulation and drugs through injectable format
  • Understanding and fulfilling human factors challenges in these scenarios
  • Decision making for high volume/high viscosity injectors; balancing pain and usability for patients

4:30 pm Combination Product Development for Large Volume Delivery Device

  • Cindy Tritton Senior Engineer II, Device Design & Development, Biogen

Synopsis

  • Patience tolerance to high volume injectables; Understanding the boundaries with high volume injectables
  • Addressing the technical challenges for path injectors, wearables with higher volumes.
  • Satisfying technical requirements for on-body high volume injectors
  • Future trends: industry direction for large volume injections

5:00 pm Optimization & Patient Tolerance of a High Viscosity, High Volume Platform Technology Approach Towards Subcutaneous (SC) Injections

Synopsis

  • Perceptions and facts associated with the current practice for SC injections
  • New data that addresses user acceptability of multiple volume and viscosity permutations
  • Strategies to optimize SC delivery systems
  • Future trends: expanding the design and performance space for SC delivery devices

5:30 pm Chair’s Closing Remarks & End of Day 1