A New Mindset For Combination Product Development

By Asmita Khanolkar, Senior Director, Cambridge Pharma, SMC

Based on the learnings from the pandemic, it is time to emphasize the changing mindset towards a forward looking design and development process for combination products. The new outlook for the pharmaceutical industry is very different to the one we knew prior to the pandemic. The new normal encompasses rapid development of treatments and new regulatory pathways to support the urgency towards faster times to clinic. Treatments are now administered outside of the traditional hospital care settings, including clinical studies conducted at home. We see a dramatic shift from one size fits all towards rising personalized medicine. Novel therapies considered too complex and complicated previously are now available in the hands of patients, and there is an unmet need for enabling device technology that can handle the challenging formulations. Finally, global digital transformation is modernizing the overall healthcare experience.

Moving forward, as we balance the time-to-market and risk for novel therapies, we cannot but anticipate changing mindset in areas of combination device development focused on enabling device design for challenging applications for optimizing delivery, patient-centric interfaces for self-administration to eliminate user errors and integrated drug-device development iteration cycles to minimize any risks for clinical outcomes; highlighting the technological paradigm shift and focus towards developing combination products at pandemic speed.