Early Decisions To De-Risk The Transition To Combination Products

There is constant pressure to accelerate drug development timelines, which means always keeping an eye on costs and quality while navigating regulatory requirements.

There is no longer the option to speed the process through a less optimized containment and delivery system. Expectations and the competitive environment are changing in relation to three key factors: self administration, ease of use, and competition.

To address these changes, one could focus solely on drug development and risk unforeseen obstacles by leaving combination product and device considerations to later phases. Alternately, one could go to market with a simple containment system, but it may not meet patient needs. Finally, one could rely on multiple outsourcing partners to develop a combination product, which could complicate planning and lead to costly delays.

Download the full PDF to explore what you can do to overcome all this uncertainty and risk in injectable product development.