Planning For Success: Key Considerations When Developing Your Combination Product

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 helps 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 is placed on developing a clear and comprehensive plan to succeed in combination product development.