Leandro Moreira, Senior Vice President of Corporate Development, Yourway11.14.23
While the science underlying healthcare evolution is undeniably innovative, the foundational biopharma services that support and drive clinical trials—planning, procurement, project management, logistics, packaging and more—are also critical to their success and play a primary role in the advancement of human health.
And nowhere is the pace of growth and change in clinical trials faster than in the EU. Multinational clinical trials of EU origin have risen by 22% since January 2022, with an average of seven EU member states involved in any given study. As well, clinical trials have been widely, and nearly evenly, dispersed throughout the continent, with 17 % occurring in the northern EU, 25% in southern EU, 27% in western EU, and 31% in eastern EU. In 2022, there were 13,066 clinical trials in Europe, outpacing the entire Western hemisphere by more than 1,000 studies (11,935). It’s clear that the hallmarks of the EU clinical trial landscape are growth and integration.
Even the nature of therapeutic innovations demands integration of operational competencies. Personalized therapies are growing quickly, most notably cell and gene therapies (CGT), which have recently outpaced the commercialization success rate of small-molecule compounds by 34%. For CGT clinical trials, there are several operational and logistics challenges that can compromise study endpoints or successful patient treatment, including delays and temperature fluctuations. The various operational components and processes for these types of clinical trials are interdependent and non-siloed, requiring the highest levels of integration to ensure patient safety and treatment efficacy.
In such a dynamic milieu, it’s clear that operational integration of biopharma services is paramount to clinical trial success and continued therapeutic innovation. Even for the most basic of clinical trial formats, the additional challenges involved with coordinating studies across multiple EU member states (seven, on average, as stated above) cannot be overstated. Procurement must hurdle not only each individual set of national guidelines, but also the integrated EU transport regulations. Couple this with the rise in decentralized and remote trial formats, which involve extensive patient outreach and logistics, as well as the need for just-in-time packaging, storage, and transportation solutions, and the challenges can be overwhelming. A high degree of operational and logistical integration can be a deciding factor in clinical trial success under such pressures.
Clearly, temperature-controlled logistics and storage and transportation play a critical role in clinical trial success. These elements are a critical aspect of ensuring advanced therapies reach their intended patients at the right time, requiring precise coordination and handling of biological materials and involving numerous disparate stakeholders spread throughout the therapeutic process.
Leandro joined Yourway in 2018, leveraging over 20 years of Fortune 500-level experience in the transportation sector to implement initiatives that drive company growth. In addition to his wide-ranging leadership experience, Leandro is GMP, GCP and GDP certified. He frequently lectures at global industry events and US Department of Commerce business forums.
And nowhere is the pace of growth and change in clinical trials faster than in the EU. Multinational clinical trials of EU origin have risen by 22% since January 2022, with an average of seven EU member states involved in any given study. As well, clinical trials have been widely, and nearly evenly, dispersed throughout the continent, with 17 % occurring in the northern EU, 25% in southern EU, 27% in western EU, and 31% in eastern EU. In 2022, there were 13,066 clinical trials in Europe, outpacing the entire Western hemisphere by more than 1,000 studies (11,935). It’s clear that the hallmarks of the EU clinical trial landscape are growth and integration.
The importance of integration
Clinical trial sponsors in the EU have also had to navigate massive regulatory changes as the EU Clinical Trials Regulation (EUCTR) became available on January 31, 2022, and subsequently went into full effect in January 2023. EUCTR’s primary goal is to increase integration and coordination of clinical trials and regulatory bodies among EU member states.Even the nature of therapeutic innovations demands integration of operational competencies. Personalized therapies are growing quickly, most notably cell and gene therapies (CGT), which have recently outpaced the commercialization success rate of small-molecule compounds by 34%. For CGT clinical trials, there are several operational and logistics challenges that can compromise study endpoints or successful patient treatment, including delays and temperature fluctuations. The various operational components and processes for these types of clinical trials are interdependent and non-siloed, requiring the highest levels of integration to ensure patient safety and treatment efficacy.
In such a dynamic milieu, it’s clear that operational integration of biopharma services is paramount to clinical trial success and continued therapeutic innovation. Even for the most basic of clinical trial formats, the additional challenges involved with coordinating studies across multiple EU member states (seven, on average, as stated above) cannot be overstated. Procurement must hurdle not only each individual set of national guidelines, but also the integrated EU transport regulations. Couple this with the rise in decentralized and remote trial formats, which involve extensive patient outreach and logistics, as well as the need for just-in-time packaging, storage, and transportation solutions, and the challenges can be overwhelming. A high degree of operational and logistical integration can be a deciding factor in clinical trial success under such pressures.
Temperature control
Temperature-controlled storage and logistics have become central to healthcare and therapeutic development. Global refrigerated storage capacity grew by 32% from 2014-2020, accelerated by a 17% increase during the 2020 COVID-19 pandemic. Innovative new biological therapeutics including CGTs are driving temperature-controlled logistics growth, along with the need for global distribution of mRNA-based vaccines. Biologics have more than doubled as a percentage of therapeutic approvals since 2000 and continue to rise. CGT products alone now account for approximately 12% of clinical pharmaceutical pipelines, with more than 1,200 CGT clinical trials in the global pharmaceutical pipeline in just 2022.Clearly, temperature-controlled logistics and storage and transportation play a critical role in clinical trial success. These elements are a critical aspect of ensuring advanced therapies reach their intended patients at the right time, requiring precise coordination and handling of biological materials and involving numerous disparate stakeholders spread throughout the therapeutic process.
Smoother logistics
Now is by far the most dynamic and promising era in therapeutic development, an emerging epoch in healthcare improvement and acceleration. As innovative therapeutics grow in complexity, the biopharma services that act as the foundation on which they are realized must innovate and grow as well. As part of their continued commitment to partnering with and supporting those driving healthcare innovation forward, Yourway, a global provider of comprehensive clinical services, has recently opened a new flagship EU facility in Dublin, Ireland. Yourway’s Dublin depot provides a fully-integrated suite of biopharma operational competencies to support EU-based clinical trials, including full GMP compliance, temperature-controlled services and logistics, clinical packaging services, procurement, and regulatory support. Innovation is central to Yourway’s ethos, and the integrated service offerings of the new Dublin, Ireland GMP-depot exist to support and drive EU biopharma and global healthcare forward through the 21st century and beyond.
