Over the last five years what are some significant advances in technology, supplies, logistics and processes that are helping pharmaceutical companies manage their clinical trials more effectively.
Dave Barnes, Chief Executive Officer, Velesco Pharmaceutical Services: As Velesco’s focus is on supply of early stage supplies, the area in which we have seen huge leaps is cold chain supply management. Mostly in terms of improved packaging and monitoring. That having been said there’s only so far that technology can take you; you have to make sure that all the personnel involved in the supply chain, especially at the study sites, not only know how to use the technology but understand why doing so is very important.
A second advance has been a rise in the number of clinical CROs who specialize in specific therapeutic areas. We tend to find that such CROs are better at communicating clinical trial material requirements to study sites than the larger CROs. This is especially true with cold chain shipments.
If you had to choose, is there a single most important factor that needs to be considered to make clinical trials successful?
Barnes: From Velesco’s limited, clinical supplies perspective, the training of study sites to ensure that their personnel truly understand the importance of managing the receipt and storage of study drugs especially for cold chain supplies. The amount of time spent investigating missing or alarming temperature recorders is frequently more than the time spent preparing and shipping those supplies.
Claus Feussner, Senior Vice President Vetter Development Service: Of course, it is difficult to single out any one specific factor and say it has the level of importance to make a clinical trial successful or not. After all, the process of clinical development and manufacturing is a complex one and dependent on a variety of factors. This is particularly true as the complexity of individual drug substances has increased and, in turn, has aff ected all parties involved in the handling and processing of these substances. What I can say is that a well thoughtout preparation can have a significant influence on the overall success. The key factor here is making the right decision regarding the selection of partner(s) you choose to work with. A partner that is strategic in its approach to clinical manufacturing can greatly influence key factors such as timelines, quality and costs. These elements are essential for a faster and more comprehensive approach to reliable pharmaceutical products and improved quality of patients’ lives, from early clinical trials on through to long-term market supply. When selecting a partner to support drug product manufacturing, we see four core pillars critical to the selection process: level of experience, cultural fit, corporate stability and long-term resources.
Has the opening of new markets around the world made clinical trials easier or more difficult to manage? Are they harder in terms of logistics or easier in terms of bigger patient populations?
Barnes: It’s interesting, we see a lot of companies planning to use overseas locations because of larger patient numbers and lower cost but who, after much reflection, end up doing their studies in the USA because of the time and complexity of going abroad.
One aspect of this decision making that doesn’t get much attention is the need to include key opinion leaders in clinical programs and they are almost all based in the USA and/or Western Europe.
Feussner: No one would question that the global pharmaceutical market has always been complex. Of course, new markets and demographic changes usually enhance this complexity and lead to new demands on pharmaceutical processes in clinical production. First and foremost, new regulatory aspects and expectations of different customers and their cultures must be considered. Also, in terms of the supply chain, complexity increases with additional markets and, therefore, becomes more multi-faceted. This is especially true with issues such as flexibility in timing or delivery handling. That is why as a clinical manufacturer, it is important to know and understand new markets and their requirements and deal with them by adapting your processes or widening your service portfolio.
What has been the impact of contract service suppliers to the clinical trials marketplace?
Barnes: In a word, innovation. CROs need to set themselves apart from not only other CROs but also from the internal groups in pharma companies. Being such a conservative, highly regulated environment it is tempting to always do things as they have been done previously (unless the FDA opines otherwise). I see contract service suppliers driving new ways of doing things, bringing efficiencies to this field.
Feussner: Simply put - a greater focus on core competencies. Trustworthy especially one-stop shop contract service partners have the distinct advantage of looking at the entire process and knowing not only the underlying technical mechanisms, but also the associated pharmaceutical production processes. As such, they can provide a holistic framework for a high-level of quality clinical manufacturing with customized and innovative manufacturing processes and analytical methods. They can also deal more effectively with different market situations and their resulting trends; providing essential input for a faster approach to reliable pharmaceutical products that benefit both the customer and the patient. This allows sponsor companies to better focus on the drug discovery process itself and not have to worry about the development of a manufacturing process. Both parties bring their individual experience and expertise to the table in a complementary manner that leads to a successful clinical trial.
In the next five years, what do you as see as some of the advances that will help pharma companies manage trials more effectively and with less cost?
Barnes: For Velesco, real time transmitting of cold chain shipment conditions would be huge. By removing the need for study sites to download data from temperature loggers the amount of time spent on deviations, investigations and follow-up would be dramatically reduced.
Feussner: No doubt, digitalization is one of the key advances in helping companies manage their clinical trials in a more effective manner. Applying digital innovations can be helpful tools in supporting the production and supply planning processes for pharma and biotech companies and their strategic partners alike. But digitalization is also becoming increasingly important in the development of application systems, for example, how products interconnect digitally and the associated expectations of end-users such as the medical staff and patients through self-medication. This ‘connectivity’ will help increase patient adherence. As a clinical manufacturer, we also see further developments in the use of innovative and flexible manufacturing technologies to further optimize effective production for small batch sizes. While clinical manufacturing today is still dominated by filling in vials due to the years of expertise and the comfort level of biopharmaceutical companies, we see a trend away from vials and towards a greater use of prefilled syringes.