8:00 am Registration & Welcome Coffee

9:00 am Chair’s Opening Remarks

State-of-Play: The Fast Evolving Injectables Market

9:10 am Opening Address: Understanding the FDA’s Expectation for Postmarketing Safety Reporting (PMSR) for Combination Products

Synopsis

  • What does the regulatory agency expect under the PMSR final rule?
  • Overview of combination product PMSR types
  • Example/scenarios of case reports to illustrate how to comply with specific requirements of PMSR final rule

9:40 am Why Risk Management is Key to Support Your Next Generation Injectable Development

  • Thomas Altobelli Senior Manager, Device Quality & Risk Management, Janssen Pharmaceuticals

Synopsis

  • Relationship between risk analysis, FMEA and design requirements
  • How risk management and human factors play a key role in new product development
  • Leveraging clinical and post-market surveillance data to develop robust product designs
  • Lessons learned from using a RM closed loop approach to ensure safety and effectiveness

10:10 am Quick Fire Debate: How Should You Address Regulatory Changes?

Synopsis

Following the morning’s presentations, the audience will have the opportunity to ask panellists their burning questions, debate and share their experiences, addressing key themes such as:

  • How to handle adverse events reporting during post-market surveillance
  • It’s no longer a device – combination products as a whole
  • What does EU-MDR mean to your launch plan in EMEA and beyond?
  • The importance of your usability and functionality studies ahead of approval
  • Post-approval changes – what the FDA expects from you

10:40 am Speed Networking

11:20 am Morning Coffee

Agility: From Formulation to Connectivity

11:50 am How Quality Can Help Drug and Device Teams to be Agile

  • Leonel Vanegas Director, Global Quality Devices & Combination Products, Merck

Synopsis

  • How to become agile and flexible anticipating formulation changes beforeNDA/BLA filings
  • Progresses from pre-filled into a different presentation format – the considerations and data you’ll need to demonstrate to the regulatory agencies
  • The role of quality and CMC during drug-device combination products evolution

12:20 pm Quick Fire: How to Lay a Solid Foundation to Support a Robust Injectable Design

  • Erik Jin Engineering Fellow, Combination Products & Device, Celgene

Synopsis

This interactive panel debate will discuss what makes a combination product/injectable device successful. The audience will also have the opportunity to ask the panel experts their burning questions. Topics will include:

  • Why early device design is critical to a product success and what to think about during commercialization
  • When you should consider next generation development
  • A competitive landscape analysis vs user case – it’s a bottom-up approach

12:50 pm Networking Lunch

1:50 pm Panel Discussion: Human Factors Considerations for Connected Injection Devices

Synopsis

The panel will discuss various topics related to Human Factors considerations for designing and evaluating connected injection devices, including:

  • How to identify and mitigate against use-related risks associated with connectivity and associated software applications
  • How to evaluate and validate connected injection devices within the user’s ecosystem
  • How to identify the best set of user interfaces for your connected injected devices (e.g., embedded, smartphone, tablet, desktop)
  • How to account for device customization, the changing role of lay users, and implications for use-related risk

2:40 pm Selecting a Digital Health Partner to Deliver Business Value with Connected Devices

Synopsis

  • The racing game into connectivity: Real commercial benefits of connected devices
  • Who they should partner with?
  • How to build a fully integrated connected ecosystem with your stakeholders and patients and risk considerations

3:10 pm Expertise Talk: Device Development Using In-Silico Techniques within an FDA Framework

  • Timothy Quigg Senior Mechanical Engineer, Crux Product Design Ltd

3:40 pm Device Design Consideration to Support Novel Formulations and Advanced Medicinal Therapy Products

Synopsis

  • The rise of highly viscous and high concentration products – challenges to delivery routes
  • Can injectable device be a viable format?
  • Engineering hurdles and breakthroughs
  • Pain management for patients

Session Reserved for Program Partner

4:10 pm Mastermind

Synopsis

Connected device was the 2018 buzzword amongst drug and device developers. In 2019 we have seen a lot more initiatives and projects going live.

It’s clearly not just an add-on app, so what should we consider and what is the business case behind a connected device?

In this session we will split the audience into groups to develop a new connected device, with lifecycle management in mind:

  • Your intended user and therapy designation
  • Who are your stakeholders?
  • Who should be involved – internally vs externally
  • Regulatory landscape
  • Risks and opportunities

4:45 pm Chair’s Closing Remarks & End of Day 1