Respiratory disease is a huge global issue, with asthma and chronic obstructive pulmonary disease (COPD) affecting hundreds of millions globally. COPD was reported by the WHO as the third-leading cause of death worldwide in 2019, causing 3.23 million deaths, with asthma causing a further 455,500. These numbers are only expected to rise as the global population grows and ages, which is just one reason for the increasing interest in inhaled medicines.
EPM speaks to Chris Allen, CEO of scientific consultancy and Contract Research Organisation (CRO) Broughton, which has just launched a new inhalation testing service. The service is aimed at pharmaceutical companies, generic drug manufacturers looking to reformulate existing products, and device manufacturers.
Can you explain how Broughton's new inhalation testing service differs from existing services in the market?
To bring an inhaled medicine product to market, a business needs expertise across many different disciplines, including product development and assessment, analytical testing, toxicology, stability, and quality control, alongside knowledge of the regulatory environment.
Broughton is a fully integrated pharmaceutical testing, consulting, and compliance service provider. While many other service providers focus specifically on multi-national pharmaceutical companies, we provide a more flexible service to any business innovating in the inhaled medicines area, including potential disruptors looking to bring novel device technologies to the pharmaceutical space. We specialise in working in collaborative cross-disciplinary teams in an agile and iterative way to support teams looking to innovate and challenge the status quo.
We offer our clients many of the services you would expect from a CRO, such as access to analytical method development and validation, on-site stability storage, extractables and leachables (E&L) testing, and toxicology consultancy support. However, we take this a step further by having expertise in product realisation and optimisation, clinical study management, project management, and regulatory submissions, meaning that our team can support at every stage of the process.
This holistic approach and integration allow Broughton to support through the product lifecycle, from product development to regulatory submission. Whether configuring a product to optimise its performance to meet the regulatory requirements or selecting materials to improve product stability and mitigate leachables from the container closure system, Broughton can streamline all the programme variables and reduce the time to market.
Chris Allen
What are some of the "new applications of inhaled medicines" that Broughton is exploring or hopes to explore with this service?
Inhalation therapy is a huge research area because it enables target organ delivery for conditions of the throat, lungs, and oesophagus. There are also advantages to exploring inhalation therapy for other conditions. Due to its ability to deliver the active with avoidance of enzymatic degradation and avoiding the first pass metabolism via the liver, inhalation therapy creates the potential to deliver lower doses, reducing systemic adverse effects.
Therefore, we are exploring how existing devices, such as dry powder inhalers (DPIs), pressurised metered dose inhalers (pMDIs), soft mist inhalers (SMIs), nasal sprays, and breath-actuated devices, can deliver drugs already approved in other dosage forms more effectively. This will broaden the applications of inhaled medicine products into new areas, such as for the delivery of pain relief medication.
How does the manufacture of inhaled medicines compare in sustainability terms with its counterparts?
pMDIs actually account for 3.9 per cent of the NHS’s annual carbon footprint, according to research. There are multiple areas of interest in terms of sustainability, including the incorporation of recyclable plastics into device design. However, there are some challenges. There can be a trade-off between designing robust, safe, and childproof devices and making them more sustainable — this is an area we will explore further with our clients.
We anticipate that many pharmaceutical businesses will start reformulating their medicines to avoid the use of hydrofluorocarbon (HFCs) as propellants. HFCs are potent greenhouses gases with global warming potentials (GWPs) of up to 3,350 times that of carbon dioxide. The cost of developing these new formulations, alongside the accompanying hardware, will be hundreds of millions of pounds, and manufacturers will be looking for partners to help them do so efficiently and cost-effectively.
What is the process for pharmaceutical companies when engaging with Broughton and making use of the new inhalation testing service?
Get in touch! The best way to reach us is via our website, over the phone or at an industry event. We regularly attend industry events like Respiratory Drug Delivery (RDD) and Drug Delivery to the Lungs (DDL).
Once you start working with Broughton, you will be assigned key contacts from within the business, such as a Technical Project Lead and a Project Manager, and also have a direct relationship with the relevant teams, be it the Analytical Lead conducting your testing, or the Scientific and Regulatory Consultants supporting your application. This makes it very straightforward to find out how your project is progressing.
How does Broughton plan to handle the demand for these services, given the heightened interest in inhaled drugs?
We have been growing consistently since our foundation in 2006 and are well-positioned to make this move. We’re approaching inhalation as a growth area and are positioned to scale to meet demand as it increases over the next few years.
Could you explain how Broughton's service helps to improve efficiency and reduce costs in the development and commercialisation of inhaled drug products?
Bringing an inhaled medicine product to market efficiently requires a huge amount of effort across multiple special disciplines. From method development and analytical study design, validation of analytical work, completion of shelf-life studies, toxicological investigation, efficient running of clinical trials and thorough E&L testing, as well as product optimisation and preparations for regulatory submission. Working with a provider that offers this breadth of services in-house with specialist subject matter experts who work collaboratively is a key element in bringing a product to market quicker — for example, studies may run concurrently, and any roadblocks or problems can immediately be addressed with the right experts.
How a project is managed, with in-depth strategic planning and good technical oversight, can make all the difference. When bringing a medicine to market, the incremental wins can add up to larger gains, creating a more efficient journey to market that is inherently less expensive.