Planning for Success: Key Considerations When Developing your Combination Product

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Summary
Speakers

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.

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.

Jorge Capurro

Director of Engineering, Archimedic

Jorge has been involved in medical devices and drug delivery for over 18 years. As Director of Engineering, he leads the engineering team and works directly with clients to achieve overall technical project goals. He started his drug delivery journey in the academic setting during graduate studies at Drexel University. In 2010, he began his professional career at Johnson & Johnson (J&J - Animas Corporation) with the exploration, design and prototyping of medical devices for accurate and precise insulin delivery. He has developed unique methods to measure and analyze dose accuracy and precision to differentiate the performance of insulin pumps. He has authored publications and presented findings at international conferences. In 2018, he joined Takeda Pharmaceuticals to lead the development of an on-body electromechanical combination product for immunoglobulin therapy drug delivery. He has a deep understanding of device development (including developing a product development process) in a pharmaceutical setting, device regulatory strategy for clinical trials and commercialization, innovation strategy, market access strategy, and program and stakeholder management.