Challenges in Adopting Drug Delivery Device Technology
By Iain Simpson, Associate Director, Global Medtech Practice, Cambridge Consultants
In my first column, I described the history of drug delivery devices and explained why they are likely to play an increasingly important role in the pharma/biopharma industry. This column focuses on some of the challenges the industry faces in adopting more advanced drug delivery technologies, as well as advanced injection devices — as this is where a lot of current activity is directed.
Many pharma companies consider drug delivery devices as a necessary evil — a means to an end to deliver drugs that cannot be administered orally, and for situations where market competition requires differentiation that cannot be achieved by the drug alone. Compared to the development of most other products, drug development is enormously risky. If the automotive industry had a success rate comparable to that of drug delivery, it would have gone out of business a long time ago. The pharma industry only survives because it can command high margins on drugs which support investments in R&D — commonly up to 20% of sales and can cover the high failure rates in drug development. So, it is understandable that pharma companies do not relish the prospect of adding further risk and cost to their drug development process by developing a device until they have some confidence that the drug is going to perform from efficacy and safety perspectives.
Accommodating Advanced Delivery Devices In The Pharma Development Process
In the past, most injectable drugs were launched in a syringe and vial format, a simple, proven technology which added little risk to the development and approval process. A more sophisticated device, such as a prefilled syringe or auto injector, can then be introduced after the product is launched as a lifecycle management activity, so investment in the delivery technology is only made once the drug has been proven. This approach does not hold up the approval and initial launch of the drug.
However, the competitive nature of some markets such as Rheumatoid Arthritis — coupled with the desire to provide drugs to treat chronic diseases in a format that enables self-administration — means that new drugs need to be launched in more sophisticated delivery systems. This usually requires the final delivery system to be evaluated in a Phase III study to generate usage data for the submission for approval. So there lies the problem — on one hand, the pharma company does not want to commit to a device until the drug efficacy and safety has been demonstrated, probably in a Phase IIb study. On the other hand, it might easily take at least a couple of years to develop a suitable delivery system to the point devices can be manufactured in reasonable quantities for the Phase II study. Furthermore, regulators have become concerned about the effect that changes in manufacturing processes might have on product performance, and have argued that devices used for late- stage studies should be equivalent, both in design and manufacturing process, to those intended to be used for commercial manufacture once the product is approved. For example, this might necessitate investment in automated assembly equipment for the clinical trial supplies, even though the required production volumes at this stage may not demand this. This will add further cost and time to a program prior to product approval. Further dialogue between pharma companies and regulators is required to clarify requirements and to find an acceptable way to meet regulatory needs without adding prohibitive costs and delaying innovative drugs from entering the market so they can provide benefit to patients.
Pharma Tackles Drug Delivery Challenge
The pharma industry and its supply chain have come up with a number of strategies to combat the challenge of developing combination injection products. First, several device companies now offer “platform” devices that can be adapted to meet the needs of a number of different drug programs, for one or more different pharma companies. This allows the device development costs to be recovered over a number of different products, and also allows more rapid introduction of the device technology either during clinical development or as a lifecycle initiative. This approach also means that pharma companies can focus on their traditional areas of expertise in drug discovery, development, manufacture, and marketing, and do not (necessarily) have to establish their own device capability. Second, most autoinjectors use a glass syringe as the primary drug containment. If this is the same type of syringe as has been used in earlier clinical development of the drug, or in the case where the autoinjector is to be used in lifecycle management or for the previous launched product — it allows an easier transition from syringe to autoinjector, as drug stability has already been demonstrated. Ensuring drug stability is a time-consuming and often rate-limiting activity in drug development.
Even with these “fixes”, the use of platform devices and glass-primary drug packaging is not always so straight forward. I will address the unique challenges that come with both approaches in my next column.
What barriers have you experienced in the adoption of drug delivery devices? Are there potential solutions to make combination product development easier — and how can these be implemented? Share your thoughts below.