The global health crisis has disrupted drug discovery and development in myriad ways. Still, if pharmaceutical firms and their partners are to keep coming up with potentially life-saving new treatments, the clinical trial industry must go on, relying on logistics firms and other service providers to maintain trial continuity.
Outsourcing-Pharma (OSP) discussed the evolving clinical trial supply chain with Alex Guite (AG), vice president of services and alliances for World Courier. The leader of the specialty logistics services firm shared thoughts on how the landscape is changing, and what lies ahead.
OSP: You’ve been serving the clinical trial industry for some time—could you please provide some perspective on how the industry has evolved in recent years (leading up to the pandemic)? What kinds of available technologies, market conditions, demands for specific therapies and other factors have driven change?
AG: Today’s researchers are delivering innovations in personalized medicine and advanced therapies that help patients live longer, healthier lives. The products being developed are often costly, complex to manufacture, and usually temperature-sensitive; they are more and more frequently designed to treat small, geographically dispersed populations suffering from rare or orphan diseases.
If a treatment is not delivered to the patient at the right time and in the right condition, its potential efficacy is irrelevant because the patient gains no benefit. This highlights the importance of having a well-established logistics plan that is equipped to manage risk and the unique characteristics of the therapy.
For instance, it’s critical to protect the viability of cell and gene therapies – both for the manufacturers who produce them and the patients who rely on them. For cell therapies, their short shelf-life and resulting logistics complexity often require shipping and storage at cryogenic temperatures.
Recognizing this evolution, World Courier established the largest global network of qualified cryogenic charging stations, which provide greater access to cryogenic shipping solutions close to patient and manufacturing locations.
As therapies become more personalized so, too, have clinical trials for some of the rarest diseases. World Courier has seen rising interest from manufacturers to bring clinical trials directly into the homes of patients.
Direct-to-patient (DTP) clinical trials can reduce the need for patients to travel for treatment, make it easier for researchers to recruit and retain patients for their studies and broaden the eligible population of those who can receive treatment. The shift to these DTP clinical trials has been accelerated by COVID-19; the redirection of healthcare capacity towards treating COVID-19, stay-at-home orders and patients’ infection concerns meant that DTP was a critical part of the toolkit to keep patients in their trials during COVID-19.
OSP: It goes without saying that COVID-19 has created some formidable, unprecedented challenges for trials, especially regarding trials’ physical locations, travel and logistics. Could you please share your perspective on the various impacts? In what ways are sites and sponsors finding they can (or must) make adjustments to continue?
AG: COVID-19 has introduced many unprecedented challenges across the healthcare landscape, particularly for the nearly 80% of clinical research sites that have reported their clinical trials have been put on hold or canceled.
To restart these trials and prevent any others from being disrupted, our logistics programs must be highly flexible, ensuring our manufacturer partners can operate as close to business-as-usual. The risk if this isn’t achieved is that manufacturers lose progress in data collection of their clinical trials, the health of patients—both those participating and those waiting for these treatments—could be adversely affected.
One of the biggest challenges that COVID-19 has introduced is shipping products across international borders, particularly as certain areas in “hot zones” have limited passage to prevent further spread of the virus. To overcome this we’ve been able to maintain air connectivity, even as commercial flight availability was reduced, by booking space on airlines across a range of international and cargo carriers.
Establishing contingency plans allows us to pivot based on the latest conditions and product needs. In fact, through our carrier-agnostic approach and contingency planning, we haven’t declined a single shipment, ensuring every patient has access to their critically needed treatment – despite the pandemic’s challenges.
OSP: I understand your company can offer advice and assistance on transitioning to a decentralized, DTP approach. Could you please share the ways in which your firm helps that?
AG: World Courier has a 50-year history of maintaining supply channels in times of public health crisis or transport disruption. Our teams engage with customers to walk through their decentralized supply chain step-by-step to identify pinch-points; this collaboration is a part of our regular course of business but is particularly important during COVID as manufacturers must be prepared to navigate and address unique sets of challenges.
For instance, COVID-19 has made some points of care limit hours or close down entirely to manage the spread of the virus. Patients may also be reluctant to leave their homes after being concerned about potential exposure in hospital settings.
Our manufacturer partners have recognized these concerns and are encouraged that a DTP approach for clinical trials would allow continued patient access to much needed treatments. In fact, a recent World Courier study found that 46% of clinical trials and treatment shifted from a hospital site to a DTP point of care.
Additionally, we work with customers to prepare contingency options so they have steps they can take to maintain access to therapies when it may not seem feasible – such as what to do when a pharmacy is not open as scheduled. These contingency plans offer customers peace of mind knowing they are supported in any circumstance.
OSP: Can you think of any obstacles trial teams are facing that are maybe preventing them from being more accepting of or able to increase their use of decentralized trial solutions?
AG: There is often a hesitancy to shift to a new approach when an existing one is serving its intended purpose. Now, COVID-19 has introduced a whole new level of complexity and uncertainty attached to change—like moving to DTP clinical trials.
Additionally, DTP is not a “one-size-fits-all” approach; it requires customization not only based on the manufacturer’s product but also each individual participant, how prepared they are to manage what’s required of them and where they live. For instance, shifting to a DtP approach in some countries may pose regulatory challenges, which may cause manufacturers to enter a lengthy process of seeking legal counsel and applying for waivers. Additionally, clinical trial sponsors may be concerned about having staff transport therapies to vulnerable patients.
While these obstacles are present, World Courier is working with manufacturers to address them head on. With offices in more than 50 countries across the globe, we can help our partners navigate regulatory concerns and develop alternate plans when needed, so patients maintain access. We also supply our drivers with personal protective equipment (PPE) and implemented a contact-free pick-up and delivery process.
While these process modifications are temporary, they are in line with World Health Organization guidance on social distancing, use of PPE and infection control, and help ease the burden COVID-19 has put on pharma logistics.
OSP: During the COVID-19 pandemic, how does shifting to such solutions benefit sites and sponsors?
AG: During COVID-19, a DTP approach can help sites of care keep patient exposure levels low and allows them to direct all resources to treating COVID-19 cases and patients in need of urgent care. Delivering treatments directly to the patient’s home benefits clinical trial sponsors by protecting product integrity, decreasing costs and minimizing disruption across the supply chain.
OSP: How does such a shift benefit patients?
AG: A DTP approach allows for drugs to be delivered and administered in the patient’s home and/or biological samples to be uplifted from the patient’s home. This enables patients to follow the current guidance of public health officials (i.e., social distancing and self-isolating), accommodates the re-direction of healthcare capacity towards COVID-19 treatment, as well as accounting for patients who may be reluctant to enter healthcare settings in the current environment.
It is also possible that the individuals participating in a clinical trial are the very immunocompromised, vulnerable people for whom COVID is most dangerous, making it all the more important they are able to keep accessing care but safely and from home.
OSP: What do you think the clinical trial landscape will look like down the road, years after the COVID-19 pandemic has subsided?
AG: Pharmaceutical logistics has always required widespread cross-border and cross-agency collaboration, and pharmaceutical companies should continue to collaborate with authorities and government officials to ensure patients can get medications in a time of crisis. As we look to the future, we believe it will be more critical than ever that pharmaceutical manufacturers develop logistics plans that are more bespoke and customized to individual patient populations.
Looking to the future, the World Courier study found that 76% of manufacturers anticipate using a DTP approach moving forward.
Manufacturers should look to trusted logistics partners with a proven track record of successful contingency planning – inclusive of maintaining air connectivity and the time and temperature requirements of a specialty drug product – to help them navigate challenges like COVID-19 and maintain patient access to therapies. Clinical trial sponsors that are prepared, flexible and collaborative will be best positioned to navigate any other future challenges.