Victoria Morgan, West Pharmaceutical Services, explains how drug delivery devices have revolutionised the patient experience.
Skinny jeans are a bit like marmite for the British reader and peanut butter and jelly sandwiches for the American reader: you either love them or hate them. Whilst the current female fashion in the jeans department is for tight jeans which sit on the ankle, many jeans trends have dictated the way we purchase this wardrobe staple over the past few decades. From bell bottoms in the 1960s, flares in the mid-1970s, drainpipe jeans in the 1990s through to the skinnies of today, we are all subjected to trends, whether we choose to follow them or not.
The same is true in healthcare in that we see distinct trends in the way medicines are offered to patients and patients have distinct preferences for their disease management; most importantly patients have never been more firmly rooted in pharmaceutical development considerations. From implants revolutionising the choice of contraceptive dosing - to pens for top-up insulin injections at the dinner table - significant steps forward have been made in health management thanks to patient preference. Such steps have been supported by pharmaceutical companies to help improve patient compliance and for their medications to stay ahead of the competition.
A plethora of applications
We are familiar with medical devices enabling choice for health management, from the availability of slow-release hormonal implants (such as Implanon) for managing contraception through to devices for monitoring and treating diabetes, such as Dexcom’s constant glucose monitor and Eli Lilly’s Trulicity autoinjector for treatment. In the area of cancer treatment, the first small volume wearable, OnPro, which is used to automatically administer Neulasta (to treat neutropenia), has also capitalised on the use of device technology, enabling most patients to spend the day after strong chemotherapy in the comfort of their own homes. So, across a range of therapies, we see monitoring and drug delivery devices improving a patient’s disease management.
Greater demands
It is important to note that the small molecule and commercial biologic therapies are dominated by pens and autoinjector devices, but the demands of new biologic molecular entities are asking for more. Newer biologics need packaging which is less likely to cause an interaction with the drug. In addition, they often need higher volumes, higher viscosities, sophisticated functionality and a range of delivery profiles. Couple the demands of the molecule with that of the payer (better health outcomes) and the patient (home administration and less frequent injections), and it becomes clear that alternative delivery solutions are very much in demand.
Whilst pens and autoinjectors are still produced in their millions annually, growth in this sector is due to therapies such as Eli Lilly’s Trulicity which, while still using an autoinjector, offers a decreased injection frequency. Larger syringes of up to 2.25 mL and cartridge-based systems are also driving autoinjector designs, which ultimately offer a patient a wider treatment choice, and release formulators from the confines of having to formulate the drug to <1mL.
Cartridges - the way forward?
Prefilled syringe systems remain the primary packaging option for drug containment, but we are seeing growth in cartridges as the primary container, which can only be a growing market as drug delivery volumes increase. The trend of moving from intravenous to sub-cutaneous route of administration is also driving the need for cartridge-based systems.
One such system is West’s SmartDose drug-delivery platform, which offers options for subcutaneous delivery of up to 10mL doses via a prefilled cartridge system, as seen in Figure 1. Such a system enhances the patient experience while removing costs from the healthcare system by removing the patient from hospital. For a patient to be able to manage their own care in their own home, at a time of their choosing, is empowering. Alexion recognises the need for patient choice as they recently disclosed that they are planning to offer a subcutaneous version of their new Ultomiris drug, which will be offered in a SmartDose device.
As we look at the way regulators have approached the approval of new combination product therapies, they require a more holistic approach to the data, so emphasis is placed on how the drug and device work in harmony to reach drug delivery goals. Combine this approach with the fast track, early approval of products, and the decision of how to deliver the drug is forced earlier into the development cycle.
Early development
Devices are now entering clinical studies and early emphasis on this, as well as human factors and clinical data, are putting developers in a good position for a smooth regulatory approval, even if final dose and format is unfinalised. Having a holistic mindset by incorporating the delivery device as early as possible into the development process may well decrease the risk of delays through the whole development cycle. As competition around market share is fierce, speed to market is key, whether you are developing a small molecule, a vaccine, a biologic or a biosimilar.
Another important consideration with reducing risk in the drug development process is that of understanding where the greatest risks lie and mitigating them upfront. From device feasibility and closure integrity testing, stress and human factors tests, scaling from clinical studies to commercial quantities and training for call centres and failure investigation, there are many potential pitfalls along the way. Add in the need for a deep regulatory understanding and it is obvious to see why delay risks are plentiful, no matter who the developer.
Integration
Integrating these process parts and partnering with a supplier who can handle the outsourcing requirements, as well as guide you through the steps is a sensible decision to make early in the drug development process. West’s Integrated Solutions program provides such a service, offering great expertise in combination product development. West has the first and only commercially available large volume wearable device approved as a combination product with Amgen’s Repatha.
As we see a broader range of companies successfully bring their molecules all the way to commercialisation, the need for partnering with experts in their own niche field will only become more important. Integration of external suppliers and being open to supplier partnering can benefit many types of companies, whether you are a smaller company showing great drug formulation and development expertise, but you are device lean, or you are a larger pharmaceutical company with in-house expertise across the complete development chain, but you cannot support specific project timelines.
