AUTHOR: Nina Vas | Vice President, Clinical Distribution, Cell and Gene Supply Chain
Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.
Over the past several months, the industry witnessed changes in clinical trial distribution models to increase the resiliency of the supply chain. Many clinical trial supply chains adopted direct-to-patient (DTP) models and home health care services to address travel restrictions, vulnerable patient populations and sites canceling or delaying in-person appointments. As patient engagement in clinical trials continues to evolve, 34–52 percent of clinical trial investigators expect clinical trial decentralization approaches — such as new site models, online recruitment, home nursing and DTP trial supply — to increase.¹
This trend of sponsors and investigators widening the scope of their clinical supply chain strategy — thereby mobilizing their ability to pivot, when required, to the needs of the product, patient and environment — is key to quickly resolving potential disruptions. To achieve resilience in uncertain times, pharma and biotech companies are encouraged to establish a partnership with a clinical supply chain solutions company that offers a flexible clinical trial distribution strategy with DTP solutions in combination with a state-of-the-art depot network. Such a partnership would also help companies identify possible risks along the entire clinical journey.
A flexible distribution network for an evolving trial ecosystem
More specifically, a partner with a global network to address current challenges — such as border closures and a reduced number of commercial flights — would have the resources to get preconditioned packaging solutions, clinical trial products and equipment to difficult-to-reach labs and patients around the world.
Since the beginning of the pandemic, Marken has played a key role in enabling urgent flow paths, in addition to monitoring shipments and establishing contingency actions throughout the clinical trial ecosystem. Leveraging the strength and reach of the UPS Healthcare network makes it possible for Marken to deliver clinical drugs via flights, despite halted or suspended commercial international air traffic. The strength of the Marken-UPS network ensures depots are part of a seamless supply chain, allowing for stored clinical trial materials and drug products to be delivered quickly and with less risk for interruption, therefore improving the ability to shift strategies mid-trial, as required.
With temporary closures of sites and patient scheduling changes due to quarantine guidelines, many clinical trials required pivoting to a decentralized approach, including initiating regional depot strategies to ensure sufficient supplies and drugs are on hand when needed. Decentralized distribution, including DTP, widens the scope of the supply chain strategy.
Prior to the pandemic, DTP was emerging as a patient-centric strategy for delivering drugs to patients, enabling fewer site visits and decreasing burdens on clinical trial participants. Yet, according to an analysis from November 2019, fewer than 40 percent of companies expected virtual trials to be a major component of their portfolio.1 Now, for pharma companies facing the challenge of distributing clinical products to home-bound patients, incorporating DTP solutions will be a necessity to keep patients enrolled in trials and studies on track.
Marken advises pharma companies to add DTP to protocols during trial set-up for increased agility and implementation when needed. Marken’s project management and operations teams are trained in more than 80 countries across EMEA, APAC, the U.S. and LATAM to not only provide DTP solutions, but also to balance and leverage regional and central distribution strategies within Marken’s depot network or established central pharmacies, depending on country regulations. As the situation continues to evolve, Marken continues to meet changing regulatory framework, industry demand, and trial and patient level needs.
Increasing agility for future resilience
Each clinical trial has its own supply chain with its own challenges. Whether pharma and biotech companies are operating on a domestic or global level, as mentioned previously, resilience in managing the impact of the current crisis starts with a partner that can implement a flexible supply chain strategy. The ability to execute rapid decisions and implement solutions with critical shipments during a crisis requires agility. Supply chain agility can be centralised, regional or DTP, with depot networks adapted to support multiple solutions.
Focused on mitigating disruption, Marken was the first to invest in the combination of DTP services, regional supplies and distribution, as well as smart packaging solutions to power clinical trials throughout the COVID-19 pandemic. Marken continues to source global alternatives, including the UPS network and local commercial carriers, in and out of impacted countries to ensure that hospitals and patients receive their critical drug supply within the necessary time and temperature requirements.
Companies that act quickly to tackle current challenges and turn them into opportunities will make themselves more efficient and resilient, not only to today’s COVID-19 pandemic, but also to future crises and potential threats. Marken’s flexible clinical trial distribution strategy, and advanced depot and logistics network can help pharmaceutical and biotechnology companies avoid clinical trial disruption now and in the future.
Xue, J, et al. (2020). Clinical trial recovery from COVID-19 disruption. Nature Reviews Drug Discovery 19, 662-663 doi: https://doi.org/10.1038/d41573-020-00150-9
Marken is a wholly owned subsidiary of the UPS Healthcare division. With Polar Speed and Marken included, the UPS Healthcare division staffs 128 locations with 5500 employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 56 locations worldwide, while maintaining the leading position for Direct to Patient and Home Health care services, biological sample shipments and biological kit production. Marken’s dedicated 1500 staff members manage 100,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.
CONTACT: Christine Noble, firstname.lastname@example.org, www.marken.com
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