The Pharmaceutical Testing Industry is constantly evolving owing to regulatory standards and advancing strategies. Discover how you can adapt to these challenges in this expert overview.
From big pharma, through contract development and manufacturing, to Copley, Paul Martin, our Head of Business Development, has evolved a unique perspective on enabling customer success. Here he shares practical insights into the pressures shaping pharmaceutical development today, how testing strategies are evolving, and what customers are increasingly expecting from their technology partners.
What would you say are the biggest challenges facing the pharmaceutical industry?
At an industry level, one of the biggest challenges is the inherent complexity of developing medicines that are safe, effective, and commercially viable.
Delivering new medicines is time-consuming, expensive, and demanding work. It involves negotiating multiple technical, ethical and financial hurdles alongside ever-changing global supply chains and pricing structures. Unfortunately, government policies, societal pressure, and skewed perceptions often make all these tasks harder.
That pressure is felt at every level of the industry. For an analyst working on orally inhaled nasal drug products (OINDPs), optimising workflow and sample throughput may top the list of difficulties. For lab management, evolving regulations and finding staff with the necessary skill set are likely to feature.
The net result is an intense need to work smarter. Cutting waste, lowering costs, and addressing ethical and environmental impacts is a job for everyone, from bench scientist to industry suppliers.
Recent success reformulating metered dose inhalers (MDIs) is a great example of a good news story that showcases the industry at its best. It’s not the first time MDIs have been reformulated – there was experience to draw on from the switch away from CFCs following the signing of the Montreal Protocol (1987). In addition, the core science underpinning MDIs has advanced considerably in recent decades, particularly our understanding of aerosol formation, particle size measurement and device-formulation interactions. With these foundations, a well-defined regulatory approach and effective collaboration (notably with propellant suppliers) low global warming propellants (GWPs) have been commercially realised far faster than many would have predicted. A win for the industry and for the climate.
What makes inhaled drug delivery such an important area, and which technical breakthroughs do you think could make the most difference to patient outcomes?
Starting my career in respiratory at GSK really opened my eyes to the realities of how patients use inhalers. I saw first-hand how challenging it can be for patients to use inhalers correctly and consistently, highlighting the importance of device simplicity.
Chronic Obstructive Pulmonary Disease (COPD) is amongst the top five causes of death globally and remains incurable. However, symptomatic relief can dramatically improve quality of life, so we need to deliver it well. That combination of clinical importance and technical challenge is a major reason why inhaled drug delivery continues to interest me.
In terms of technical breakthroughs, we’re currently seeing a lot of work on the inhaled delivery of large molecules including gene therapies and I’m excited to see the long-term outcomes. Realising this technology will be tough, from formulation through to the development of suitable analytical tools. But the result could be a cure for common respiratory diseases such as COPD and asthma which would be transformative. The potential impact on patients, and on healthcare providers, would make all the current efforts worthwhile.
I’m also enthusiastic about the potential of smart and connected device technology. Poor patient technique and adherence means that too few users gain the full benefits from the medicines we already have. Health tracking is so routine now and there is considerable potential for OINDPs that a) empower patients to monitor their own use more effectively and b) deliver the information that healthcare providers need to optimise patient outcomes.
On a more personal level, a close relative received a diagnosis of COPD, bringing the need for effective respiratory medicines into sharper focus. Developing my career in this area has always felt worthwhile and being part of the close-knit community associated with it is also a plus.
Based on your experience across the industry, what has most influenced how you support customers today?
I have always been commercially minded, but I learned early on that I am at my best when working collaboratively. Moving into roles where I could support customers as part of a wider team suited me better.
The most important lesson I have learned about supporting customers is the value of being open and honest. Take the issue of inhaled dissolution testing for example, a topic that we’re now asked about regularly.
Does the industry need inhaled dissolution testing?
Yes, if you’re following the predominantly in vitro route to regulatory approval outlined in FDA Product Specific Guidances for many common OINDPs. But if not, it isn’t a necessity, though the results in collaboration with other advanced in vitro techniques may enhance information gathering in pre-clinical development helping to de-risk clinical programmes.
And are there established or compendial inhaled dissolution testing methods?
No, but we do have an apparatus that has produced valuable data, and that will avoid the need for an in-house solution or external contract testing services.
For customers, this type of transparency is far more helpful than someone suggesting they have all the answers. It allows realistic discussions about what is possible, what is still evolving, and how best to move forward based on individual needs.
If you could pass on one piece of advice to inhalation/pharmaceutical scientists, what would it be?
Collaboration is key. Pharmaceutical products are complex, as are the systems required to bring them successfully to market. No single person, or even a small team can excel in every aspect.
Building a trusted network of experts that you can rely on for complementary support is crucial. Having the right people to turn to, whether for formulation, testing, regulatory insight or data interpretation, makes it much easier to navigate challenges efficiently and with confidence.
In my experience, the most successful projects are those where teams recognise early on that collaboration is not a weakness, but a strength.
From your perspective, what makes Copley a compelling partner for laboratories working with OINDPs?
For me, there are three distinct factors.
First the Copley name is synonymous with OINDP testing. Having worked in OINDP development services, I routinely toured clients around laboratories containing multiple, integrated Copley test set-ups. I was keenly aware of the company’s central role in the industry and the extent to which customers rely on its equipment. That level of trust, particularly in such a highly regulated environment, reflects a strong track record of technical credibility and responsiveness to evolving customer needs.
Secondly, Copley combines deep application understanding with a broad range of well-supported testing solutions. For laboratories, having access to reliable tools that genuinely fit the application, alongside the expertise to use them effectively, is increasingly important as testing requirements become more demanding and workflows more complex.
Finally, it is the people and the culture. Copley’s values of Excellence, Innovation, Ownership and Care, align closely with what I already knew of the team before I joined. This alignment matters, because it underpins how consistently customers are supported and how the company continues to develop.
How do you stay close to evolving customer needs and industry priorities in your role at Copley?
My role has a high degree of variety with plenty of opportunity to stay connected to both customers and the wider industry. No two days are the same.
When I’m in the UK, my time is often split between internal discussions and customer meetings, alongside keeping up to date with the latest research and developments in pharmaceutical testing. Understanding how requirements are evolving, both technically and regulatorily, is essential to support customers effectively.
Internationally it’s all about ensuring that our network of trusted distributors deliver a consistent level of support for our customers, wherever they’re working. I also represent Copley at global industry events, another important part of the role. Just after joining, I attended the Medicon Valley Inhalation Symposium in Lund, Sweden and more recently I was in India presenting on solutions for better IVIVCs (in vitro-in vivo correlations). Rounding off the year at DDL is always a highlight and every event is a valuable opportunity to connect.
Overall, my role is structured around relationship-building, technical insight and a strong emphasis on understanding what customers need now, and what they are likely to need next. In other words, it’s optimally shaped to spearhead our responsiveness to evolving customer need.
What do you see as unique about Copley’s approach to supporting customers?
Many people know Copley for its strength in OINDP testing, but what may be less widely appreciated is the breadth of the portfolio. Our range extends to over 1,000 products covering everything from powder characterisation and semisolid drug release, to hardness, disintegration, and dissolution testers for oral solid dosage alongside our established OINDP testing range.
For me, this breadth is important because it allows us to focus on understanding the problem a customer is facing and steering them towards an optimal solution. With some companies, business development is about convincing customers that your one product is the right one. With a broader range there is scope to tailor what you offer to individual requirements and equally helpfully, to provide a complete, fully integrated solution, rather than a partial one.
It also means we can support customers with more complete, integrated testing solutions, rather than addressing challenges in isolation, which is increasingly valuable as workflows and expectations continue to evolve.
What’s your overarching perspective on the role of testing in supporting pharmaceutical development today?
A successful pharmaceutical industry benefits us all, so for me, helping customers to progress more quickly and efficiently is genuinely rewarding. The more you understand pharmaceutical products, the more you appreciate the work that goes into even the cheapest analgesic. Consistent performance is often taken for granted, but it’s built on rigorous science and careful attention to every step of the manufacturing process.
Since joining Copley, I’m seeing the industry through a new lens, focusing on the testing equipment that underpins success. Testing ultimately provides information and that information is essential to drive research, ensure efficient manufacture and safeguard product quality.
Reducing the time, cost and complexity of accessing reliable data has a real impact on the rate at which products get to market, and the resources required to get them there.
If you are navigating challenges around productivity, data integrity or evolving testing requirements, you are not alone. These are topics that come up regularly in conversations with laboratories across the industry. If you would like to discuss your situation or explore potential approaches, please share a few details below and Paul or another member of the Copley team will be in touch.
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