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The global combination product market has seen a tremendous amount of growth driven primarily by the rise in new therapies to address chronic diseases. Additionally, the demand for self-administered therapies is pushing the need for new, intuitive, user-driven delivery devices. Novel technologies are also contributing to this growth by offering opportunities to improve drug uptake, reduce pain, and improve patient compliance.

As pharmaceutical companies advance new therapies to market, their focus is primarily on the drug or biologic. However, consideration of the delivery device and the drug-device combination is essential for patient safety and regulatory approval. Without the proper foresight and planning, significant challenges on the device side arise, including complexities related to reliability, human factors, performance testing and process validations.

These challenges are often compounded by accelerated schedules after therapeutic efficacy has been demonstrated during Phase 1 and Phase 2 clinical trials. At these inflection points, there is significant commercial motivation to accelerate combination product schedules for Phase 3 trials and commercial launch. Unfortunately, many combination product development teams place too little emphasis on the device constituent part. This often results in prolonged device development activities and redo loops that significantly delay commercial milestones.

This webinar will help combination product developers clearly understand the device development process. The goal is for participants to understand the risk factors that may arise and put in-place mitigation strategies that will streamline the device development process. A key theme of this webinar will be placed on developing a clear and comprehensive plan to succeed in combination product development.

Eric Sugalski President and CEO, Archimedic

Eric Sugalski

President and CEO, Archimedic

Eric Sugalski is the founder and CEO of Archimedic. His background combines engineering, human factors, regulatory affairs, and business strategy. At Archimedic, Eric helps companies develop clear and comprehensive product development plans that are focused on the most critical risks. From human factors studies that inform the optimal product-user interface to Q-sub meetings that clarify the regulatory strategy, Eric helps companies weave technical, usability, clinical, regulatory, and commercial activities into a streamlined product development process. He earned an MBA from the Massachusetts Institute of Technology and a Bachelor of Science Degree in Mechanical Engineering from the University of Colorado. Eric also holds a part-time Lecturer position at the University of Pennsylvania in the School of Bioengineering.
Jennifer Riter Senior Director, Business and Technical Operations, West Pharmaceutical Services, Inc.

Jennifer Riter

Senior Director, Business and Technical Operations, West Pharmaceutical Services, Inc.

Jennifer L. Riter is Senior Director, Business and Technical Operations for the Services and Solutions organization at West Pharmaceutical Services, Inc., Exton, PA. She joined West in August 1996 as an Associate Chemist in the Quality Control group. Her experience blends knowledge of West’s components, containment and delivery systems with hands-on experience of providing technical support and analytical solutions for packaging, delivery systems and combination products to West’s multi-national customers. Ms. Riter is a member of the Board of Directors for the Lock Haven University Foundation, American Association of Pharmaceutical Scientists, Parenteral Drug Association, and Healthcare Businesswoman Association. She earned a Bachelor of Science Degree in Biology/Chemistry from Lock Haven University, Lock Haven, PA and an MBA in Pharmaceutical Business at the University of the Sciences in Philadelphia, Philadelphia, PA.