The importance of consistency in future-proofing pharmaceutical R&D

Dr David Lewis, director of aerosol research at pharmaceutical company Chiesi, discusses how the company is focusing on new technologies to advance drug discvoery and future-proof innovation. 

Maintaining global consistency is an important part of the investment in technology, both in the laboratory and across research and development (R&D) locations. Replicating the same instrumentation and methods across sites allows different locations to easily share data and information, work, collaborate, and transfer methods more efficiently.

In my role, it is important for me to ensure Chiesi knows as much as possible about inhaled drug delivery. In order to stay ahead in our research, we established the Chiesi Chippenham site, where we have a team dedicated to developing products at the cutting-edge of aerosol science, and focused on advancing inhalation technology and drug discovery.

Forward thinking

With the pharmaceutical landscape fast evolving and companies becoming increasingly global in their approach to research and development, now is the right time to be re-evaluating our industry and the steps we must take to secure its future.

It is becoming vital that pharmaceutical companies integrate forward-thinking strategies to achieve excellence and use their growing knowledge to make decisions quickly. Working closely with academics is essential to completing research effectively and efficiently. The strong collaboration between pharmaceutical researchers, instrumentation companies, and academics is the foundation of success. This is true whether the predicted results are achieved or not, and it helps scientists to decide which projects are promising enough to pursue.

It is critical to promote not only the generation of scientific evidence, but the dissemination of knowledge among the scientific community, the public, and academic institutions. Working closely with academic collaborators, supporting their research, and gaining insights that can lead to scientific breakthroughs are a vital part of research. These relationships are a key part of Chiesi’s ability to discover new innovations in aerosol science.

In addition to our internal scientists, we work closely with academic researchers, providing them with both funding and access to sophisticated instrumentation in the Chippenham laboratory to complete their research. These relationships help keep experts on top of the latest findings in pharmaceutical research and maintain consistency across all R&D locations. Without this consistency across various sites, it would be more challenging and time-consuming to transfer methods and information.

To optimise our understanding of inhalation drug delivery, we need to be several years ahead, so that a product could be launched on the market in that timeframe. That means we need to be 20-30 years ahead in the research to make it happen. Continual adaption is crucial in this industry; we need to be in an area where everyone else thinks what we are doing is impossible. Collaborating with other researchers around the world is the key to helping the industry step over the line into something people do not believe exists.

Invest in instruments

Chiesi has an entrepreneurial culture, so we’re always looking to new technology to see how it can improve current and future pharmaceutical product pipelines. We are therefore responsible for future-proofing the science behind our work as much as possible. It is simply not viable to be working on technology that is not going to be supported later; laboratory instrumentation and software applications need to be compatible tomorrow as well as today. This is particularly important with regards to the ever-evolving regulatory landscape.

Instruments play a fundamental role in a company’s ambition to expand and challenge their findings in drug discovery research. The goal should always be to broaden your laboratory’s technological capabilities and find new innovations.

For us, this means pushing the developments in inhaled drug delivery. To maximise the productivity of our scientific research, we need instruments that both complement and enhance our techniques. Advanced technology can improve both current and future pharmaceutical product pipelines and provide competitive advantages in the pharmaceutical industry which, as we know, is incredibly time-sensitive. If we interact with many different instruments, we get a bigger picture to make better-informed decisions.

My team in Chippenham is continually working to develop products at the cutting-edge of aerosol science, with a focus on pressurised systems. That means we must work as efficiently and effectively as possible for maximum output and constantly evaluate our methods. In 2008, we invested in new Acquity Ultra Performance Liquid Chromatography (UPLC) technology, coupled with mass detectors and informatics software, with the aim of reducing analytical bottlenecks in the workflow.

For example, we identified that using Process Analytical Technology (PAT), a single cycle of an experimental procedure that was performed multiple times a day took more than nine hours to complete. The majority of this time was taken up with sample analysis, where run time for each sample set took longer than six hours. 

By investing in improved hardware, it was possible to simplify workflow and reduce sample set analysis time by more than five hours. The investment eliminated paperwork and automated data processing, therefore facilitating data approval, data auditing, decision making and project management.

The results comprised faster assay run time, higher sensitivity and high-speed assay development through automation. This meant fewer delays, efficient workflow, and elimination of paperwork, contributing a significant time saving of seven hours for each experiment cycle. The improvements in instrumentation capabilities helps researchers stay focused on pushing the boundaries of drug discovery and keeps the industry in touch with the future.

Replicating the same instrumentation and methods across our sites also improves the ability of different Chiesi locations to easily share data and information, work and collaborate more efficiently, and transfer methods and people between sites. Maintaining this consistency will make future research collaborations between the locations faster and easier.

Software and data

Building a paperless laboratory from the ground up at our Chippenham site meant that we could avoid paper costs, build in all lab approvals with 21-CFR compliant e-signatures, and minimise all bottlenecks. Laboratory operations can be streamlined significantly by using powerful software suites for instrument control, scientific data management, scientific search, network integration, and compliance management.

Such investment results in substantial benefits, particularly in terms of speed, automation and advanced data tools. Faster laboratory workflows enable a higher level of data output, and automation prevents costly errors from manual data input and transcription. Additionally, all information can be saved as document meta data in structured formats, improving data searchability while helping reduce costs, accelerate decision making, improve laboratory effectiveness, and get products to market faster.

Data is the backbone of pharmaceutical research, and as scientists, we are all on a quest to gather and analyse as much as possible to give ourselves a much richer picture of our results. We need to process, interpret, visualise, and compare the most complex data, and turn it into meaningful information quickly and simply. We need our information and collection of data to be date stamped and show traceability and readability, which is why we are so invested in informatics. It allows us to process data quickly and efficiently so that it can be organised and controlled. This enables us to evaluate and compare recent and archived results, for example, and use this to answer questions.

The capabilities provided by the software we use enables standardisation and full integration without the complex, costly and time-consuming deployments often encountered with traditional information management solutions. This is valuable because, like all companies, we want to avoid large disruptions to the data-integration systems and the related costs, additional infrastructure, inevitable disruptions to workflows, and logistical issues.

Encouraging advancements in R&D

Success in drug discovery requires seeing both the bigger picture and the long-term possibilities. The research data gathered along the process holds great value, and it is important to invest in resources today that will make it easier to use that data in other ways in the future – because it has implications not only for today, but also tomorrow, next year, and many years from now.

Quality instrumentation and software allows scientists to maximise the applicability of their research – and the innovations that result from it. It improves our ability to work closely with other researchers and laboratories, as does the collaborative corporate culture that is so crucial to the future of aerosol innovation.

Chiesi’s collaborative work with academic researchers allows us to provide them with funding and access to instrumentation in the Chippenham laboratory, and to work together on research that can lead to scientific breakthroughs. Moreover, the integration of the Chiesi Chippenham site and Chiesi’s other R&D centres has allowed us to advance our pre-clinical, clinical, and registration programs.

The pharmaceutical industry needs to stay ahead of the game in order to deliver tomorrow’s medicines. In pharmaceutical research it is important to continually build new ideas and work with new technology. We never want to get to the point where we think we know and understand everything possible. We always need to challenge the ways in which we explore drug delivery, instrumentation, interpretation, data processing methods or combinations thereof.