8:00 am Welcome Coffee

8:50 am Chair’s Opening Remarks

  • David Morra Director, Devices & Digital Health, Merck

Robust Design Control to Maximize Your Injectables’ Lifecycle

9:00 am Applying Design Control & Control Strategy to Support the Development of the Combination Drug Product

  • Ajit D’Souza Director, Pharmaceutical Product Development, Kiniksa Pharmaceuticals


  • Understanding design control expectations
  • Establishing a control strategy to deliver safe and efficacious products
  • Understanding the difference between CQAs and EPRs
  • Defining your device engineering and testing parameters to ensure quality and compliance

9:30 am Understanding Break-loose & Glide Force Behavior in Prefilled Syringes Systems – Optimizing for Success in Various Patient Populations


  • Addressing challenges faced by drug companies when producing a Prefilled Syringe (PFS) system for patient specific populations with dexterity limitations
  • Gaining insight into how the interplay between the elastomer, syringe barrel, and silicone/coating impacts functional behavior and break-loose and gliding force profiles
  • Discussing interactions at the elastomer/ barrel interface and elastomeric options that can help to improve consistency with break-loose and gliding force curve

9:45 am Exploring the Impact of the Changing Regulatory Landscape on the Risk Management Process for Injectable Combination Products

  • Olivia Wong Director, Quality, Device & Combination Products, Gilead Sciences


  • Understanding how the complexity of regulatory expectations complicate risk management for combination products
  • How can we devise a harmonized strategy for implementing risk management documents to achieve clarity with global regulators?
  • How can risk management be leveraged in both premarket and postmarket phases?

10:15 am Morning Refreshments & Networking

Engaging Regulatory Bodies to Understand Best Practice in Regulatory Approval

11:00 am Overcoming Regulatory Challenges for Tapping into Global Markets

  • Kirsten Paulson Executive Director, Global CMC-Medical Device Lead, Pfizer


  • Identifying the impact of the new EU device regulations (MDR and IVDR) and preparation challenges
  • Aligning FDA’s expectations vs. EU MDR requirements
  • Understanding the Chinese market to achieve global reach with your injectable device

11:30 am Developing a Practical Application of Streamline Approach 21CFR Part 4 in The Pharmaceutical Industry

  • Leo Vanegas Director, Clinical Product Quality, Alexion


  • Reviewing the necessary regulatory considerations to scrutinize in a fast-changing environment
  • When can a platform approach help teams be more agile?
  • Applying quality 4.0 to implement best practices in regulatory submissions
  • How can you optimize the organizational culture and quality system?

12:00 pm Transforming Traditional Combination Products into Connected Injectable Devices

  • David Morra Director, Devices & Digital Health, Merck


  • How close are we to achieving a fully functional connected device?
  • Developing a connected device through integration with your drug team
  • How can connected devices accelerate speed to market through comprehensive data and validation?

12:30 pm Understanding the Evolution of Regulatory Guidance to Reflect Best Practices in the Field of Human Factors and Usability Engineering


  • Discussing human factors requirements within regulatory frameworks
  • Exploring the changing standards relating to the usability engineering process for injectables
  • Outlining future areas of opportunity for regulatory guidance based on recent combination product human factor studies

1:00 pm Networking Lunch

2:00 pm Designing a Self-Administered Injectable Device for your Patients

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals


  • Leveraging design innovation to enhance ease of drug delivery and patient comfort
  • Discussing pain free drug delivery solutions – how might we take away the physical pain, the mental barriers, the stigma & the disposal dilemma of current needle-based drug delivery?
  • Examining training and labelling best practices for self-administered injectables

2:30 pm Container Options for Injectable Devices to Meet User Needs

  • Sriman Banerjee Head of Packaging Development & Commercial Device Engineering, Takeda


  • What are the requirements for the development of combination products?
  • How can you best determine the component design and material selection of a device for self-administration?
  • How do you address complex interactions between components, containers, and processes?

3:00 pm Leveraging Digital Technologies to Design Novel Drug-Device Combination Products


  • Applying computational modelling and simulation in combination products
  • Implementing computational methodologies to model pharmacological parameters for autoinjectors
  • Recognizing the significance of digital tools in supporting the regulatory submission and lifecycle analysis of injectable devices

3:30 pm Chair’s Closing Remarks

3:45 pm End of Summit