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Combination Products Conference

Now offering a preconference Primer on October 14


Session 6: Technical and Regulatory Considerations for an On-Body Injector

Session Chair(s)

Darin Seth Oppenheimer, DrSc

Darin Seth Oppenheimer, DrSc

  • Executive Director, Device & Digital Health Solutions
  • Merck & Co., Inc., United States
How will healthcare wearable technology advance opportunity for the pharmaceutical industry regarding drug delivery? Advancements in delivery technology can be perceived as a significant advancement in medication delivery, but any advancement can be met with challenges along the way. This novel technology is not free of some of the basic hurdles that have challenged delivery systems in the past such as pain, technological complexity, physical dexterity or cognitive challenges, and needle phobia, all of which can have a significant impact into your wearable technology strategy.

This session will discuss the evolving landscape surrounding wearable drug delivery technology from a bench to bed side approach, and the opportunities and challenges of developing these products from a technical, regulatory, and clinical application.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Analyze regulatory expectations and best practices for developing a successful product
  • Discuss the technical, regulatory, and clinical opportunities and challenges with on-body wearable delivery systems
  • Expectations on the Evolving Regulatory landscape and challenges of on-body injectors
  • (Bonus Content) Case studies and learnings how these types of products are utilized in the clinic

Speaker(s)

Suraj  Ramachandran, MS

Opportunities and Challenges with the Evolving Regulatory Landscape for On-body Injectors and Wearable Devices

Suraj Ramachandran, MS

  • Director, Regulatory Affairs
  • Merck & Co., Inc, United States
Karen D Kazak, MS

Opportunities and Challenges with the Evolving Regulatory Landscape for On-body Injectors and Wearable Devices

Karen D Kazak, MS

  • Principal Regulatory Scientist
  • Eli Lilly and Company, United States