Patient-centric focus in new therapy areas
There are lots of very interesting new and developing therapy areas to keep an eye on throughout 2023, but there has unquestionably been a spotlight on ‘biopharmaceuticals’ for a number of years. The European Medicines Agency (EMA) uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are “based on genes, cells, or tissue engineering.” These innovative medicines are used to treat the root cause of many complex diseases in areas such as rheumatology and oncology, but are also used in cardiology, dermatology, gastroenterology and neurology, among others. Within this field biosimilars also now have a very important role to play in the democratisation of healthcare, enabling more global access to treatments at a lower cost.
The major challenges in biologics however are both the high treatment costs – largely driven by complex manufacturing processes – and complications with transport/storage and drug administration. Factors such as a need for low temperatures during shelf-life storage and a requirement to deliver in high volumes, often by intravenous infusion, are all challenges that need to be addressed in the near future if these treatments are to be fully democratised.
To fully realise the opportunities in this space and to improve access for a wider range of patient and income groups there is a need to simplify the manufacturing processes and produce formulations that can be stable at higher temperatures, while also simplifying the therapy administration process.
The ‘market pull’ is for simple, at home, self-injection of therapies such as oncology treatments that would have previously only been available as a large volume infusion in a hospital or healthcare setting. This in turn has highlighted a drive for new delivery systems such as high-volume injectors and wearable, on-body delivery systems, that can meet the requirements for routine self-administration of more concentrated and viscous biologic therapies.
The key factor to developing devices to suit this need is through a combination of deep understanding of mechanical requirements and trade-offs to accommodate increased formulation viscosities and higher payloads. Careful behavioural science input into the device design is also key to ensure that the device solutions are easy to use as well as being safe and effective.
In 2023 we can expect to see a continued focus on novel technologies for delivery of higher payloads/viscosities for self-injection, as well as a continued demand for other low-cost devices to suit generic therapeutic applications for both the respiratory and injectables markets.
Brennan Miles, Head of Drug Delivery.