Early decisions to de-risk the transition to combination products

The pressure to accelerate timelines for drug development is constant. This means you always have to keep your eye on costs and quality while navigating regulatory requirements. Speeding the process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing:

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

So what can you do to overcome all this uncertainty and risk?

Make progress with a better approach

Companies like yours are realizing that a better approach is needed— one where you consider delivery systems in parallel with drug development to help guide your combination product strategy. By doing this, you’ll facilitate planning throughout the product life cycle. This includes aligning clinical and commercial expectations, product life cycle management and the ability to plan for changing regulations.

With this approach, you can address the following key challenges and considerations that stand between you and commercial success:

Navigating a regulatory landscape for combination products that can make planning difficult;
Choosing the right presentation for your drug at the appropriate time;
Managing supply chain complexities.

Growing demand for combination products

Approximately one-third of all medical products under development today are combination products— representing an area of rapid growth and great opportunity for drug developers. Industry experts attribute this growth to the rising prevalence of chronic diseases, the biologics market, technological advancements and demand for self-injection devices.