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 Presentation Title & Description – TBC

9:40 am Session Reserved for Emergo by UL

10:25 am Structured Networking & Morning Refreshments

Extending Your Product Lifecycle Management

11:10 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

11:40 am 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

12:10 pm Spotlight Session Reserved for Datwyler

12:25 pm Q&A: Extending Your Product Lifecycle Management

  • Joyce Zhao Associate Director, Combination Product, Takeda
  • Ed Israelski Human Factors Consultant | CoCovener IEC/ISO Standards Groups for Usability Engineering Standards | Retired Director – Human Factors, AbbVie

Updates of Evolving Global Regulatory Landscapes

12:40 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

1:00 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

1:20 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

1:40 pm Q&A Updates in Managing Evolving Global Regulatory Landscape

  • Khaudeja Bano Executive Medical Director & Head of Combination Product Device Safety, Amgen
  • Jiaying Shen Distinguished Scientist, Merck &Co.
  • Tieming Ruan Senior Director of Device Development, Alexion Pharmaceuticals

2:05 pm Networking Lunch

How ‘Smart’ Are Your Injectable Devices?

3:00 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

3:20 pm 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

3:40 pm Q&A: Smart Devices

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals
  • Daniel Latham Head of Connected Health Product Development, Novartis

High Viscosity & High-Volume Injection Device Design & Engineering

3:55 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

4:15 pm Afternoon Networking Break & Refreshments

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

4:50 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

5:10 pm Panel Discussion: High-Viscosity & High-Volume Injection Device Design & Engineering

  • Michael Roe Senior Director, Development & Industrialization, Kaleo
  • Cindy Tritton Senior Engineer II, Device Design & Development, Biogen
  • Anthony Coston Director of Program Management, Biogen

5:40 pm Chair’s Closing Remarks

5:50 pm Chair’s Opening Remarks