Keynote Address: Towards New Devices or New Formulations?

Many therapy considerations come into play as we dive deeper into this question, however the key factor surrounds the patient benefits and a positive solution in a combination product. The demand for patient-centric combination products is growing. The proliferation of new therapies and the decentralization from hospital to home care are two trends that drive this need. The cost of therapy for chronic diseases and even rare diseases with smaller patient population necessitates moving to home care and self-administration of complex formulations. Today’s complex formulations including biologics and long acting injectables are difficult to administer and involve challenges with the formulation delivery. Predictable Consistent delivery is required for consistent pharmacokinetics and therapeutic efficacy. Innovative enabling technologies and solutions are required to overcome some of these delivery challenges and have a positive impact on patient compliance and lifestyle. The talk will address the need for Integrated Development Approach to accommodate Iterative Development of both the drug and device early-on and some techniques and technology approaches to overcoming some of the challenges and facilitate successful clinic and patient results.