Setting new clinical trial logistics standards

28-Jul-2017

Wes Wheeler, Chief Executive Officer of Marken, explains why bringing clinical trials to the doorsteps of patients is a significant trend in the pharmaceutical industry

Logistics providers must have extremely flexible global networks, highly trained personnel, supporting technology and extensive regulatory expertise to offer efficient, compliant and cost-effective services.

Patient centricity, complex regulations and the need for cost minimisation

As the pharmaceutical industry has evolved, the nature of clinical trials has changed. Evidence-based medicine, a patient-centric industry focus, the increased development of orphan drug candidates and the promise of next-generation patient-specific cell and gene therapies are all driving the growth of direct-to-patient sample delivery and pick-up.

Not only has the number of clinical trials increased dramatically in recent years — 33-fold since 2000, according to the National Institutes of Health — they are more complex.1 Global, multi-site studies with locations in numerous remote locations are common, particularly for orphan drugs. Trials are lasting longer to demonstrate enhanced efficacy compared with existing products and long-term safety for treatments targeting chronic diseases.2 Complicated dosing schedules, the use of adaptive trial designs and the growing percentage of temperature-sensitive biologic drugs further contribute to trial complexity.3

Clinical trials have also moved away from the investigator site and into the home, where patients not only receive treatment but have blood samples drawn and prepared for shipment. Clinical trials are brought to the patient doorstep, which requires the delivery of drugs and the pick-up of laboratory samples.

Sponsor firms have responded by outsourcing clinical trial activities to specialist providers that offer increased efficiencies and reduced costs. To achieve these goals, clinical logistics organisations (CLOs) must have flexible worldwide networks and highly trained personnel to ensure the seamless flow of shipments and information, as well as the reduction of waste and inefficiencies in the supply chain. This is despite increasing and varied customs regulations. Employment of state-of-the-art information, inventory, temperature control and other technological systems is also essential to providing the patient-focused delivery of clinical trial materials to any location in the world, on time and within specifications.

Meeting the need for direct-to-patient services

Today’s patients are highly educated about their diseases, possible treatments and the risks associated with participation in clinical trials.4 One consequence is an expectation that they will have input into the clinical trial process, which is leading to the realisation of patient-centric trials.5 Growing expectations for direct-to-patient (DTP) delivery is, in turn, a result of the move towards patient-centric trials. There are benefits to this approach: patient retention can be increased and protocol compliance can be improved.

DTP clinical trial material delivery and sample pick-up are also effective for studies involving orphan drugs, indications for patients who are dependent on a legal representative or family members (certain CNS and oncology indications), paediatric trials and those involving next-generation personalised medicines. These biohazardous materials require special handling under cryogenic conditions and typically must be delivered to the manufacturing site or back to the patient within 48 hours, often travelling through many countries with different regulations.

As greater numbers of these advanced therapies progress, it is imperative that clinical supply chains be appropriately designed and established. Unlike for conventional medicines, the logistics issues for commercial personalised medicines remain unchanged from those faced during clinical trials. Establishing an effective chain of identity is essential; a process must be in place to guarantee that each produced treatment is returned to the correct patient.6

Mapping out the supply chain for next-generation therapies and establishing the turnaround times for multiple materials from patients in many different locations is challenging but necessary. Interactions between the various points in the supply chain, and particularly between the CLO and all vendors, are crucial. Only logistics providers with extensive knowledge, experience and effective supporting technologies can meet these constantly evolving and complex needs.

Clear logistics standards for home-based clinical trials

At Marken, we embrace the industry’s focus on patient-centric clinical trials. We were the pioneer in developing DTP expertise and have been providing DTP services since 2012. Since then, we have managed the largest portfolio of active DTP trials in the industry, including global trials with more than 15000 patients. Marken currently supports DTP services involving more than 1600 investigator sites in 45 countries around the world.

In early 2017, we took additional steps to support both patients and pharmaceutical industry customers involved in DTP trials. In April 2017, we launched Marken’s 24/7 call centre to meet the logistics needs of patients participating in home-based clinical trials.

Patients can contact a specialist at the call centre to schedule a pick-up or delivery. These specialists are trained for each clinical protocol. Specialists additionally provide instructions to Marken’s operators and drivers on a case-by-case basis. As a result, the call centre enhances our ability to provide home services, while also ensuring strict compliance with each clinical protocol and all relevant regulatory requirements. This investment is just one of several efforts Marken is taking to improve the clinical trial process for our clients and their patients.

More recently, in June 2017, we launched our Direct to Patient (DTP) White Book Industry Guide, a resource that provides our clients with clear logistics standards for DTP trials. The Industry Guide contains information on how to set up DTP trial services, including the delivery of clinical trial materials directly to the patient’s home, home pick-up and delivery of collected biological specimens, data protection and the return of unused or expired clinical trial materials to ensure compliance with industry and regulatory standards.

The DTP White Book Industry Guide leverages the experience we have gained during the successful support of numerous DTP trials. We believe that clients will benefit from the increased visibility into local requirements and be more prepared to establish effective protocols for DTP trials.

Hybrid services for full trial support

In addition to expanding our services to facilitate direct-to-patient clinical trials, we are also committed to improving our offerings for more traditional clinical trials occurring around the world. In May 2017, we introduced a new hybrid logistics service that leverages our position as a wholly owned subsidiary of United Parcel Service (UPS). This hybrid service will be the first in which the specialty and integrator services are owned by the same parent company, ensuring seamless integration, superior visibility and dedicated customer care.

By utilising the UPS global transportation network, including its expansive airline, the need for access to commercial aircraft is significantly reduced. As a result, we are able to improve both quality and value provided to clients. For instance, one client has shipments of biologic materials collected by Marken in sites across Russia. The samples are consolidated in Moscow and then transported using the UPS airline directly from Moscow to Cologne, Germany, and then to other European cities. Marken manages the entire service process and employs the most cost-effective transport modes and lanes. Customers in the UK, continental Europe and Mexico have also signed up for hybrid logistics solutions.

We also offer a hybrid reverse logistics service for the efficient return of reusable packaging and tracking devices that leverages the UPS network and minimises reverse logistic costs for non-critical items. With its access to the UPS transportation network, Marken is able to move empty cartons and components much more cost-effectively than pharmaceutical and packaging companies and other CLOs.

In essence, we are the clinical subsidiary of UPS. As part of UPS, we are able to continue to provide our specialty logistics services while also expanding our offerings to include hybrid and integrator services. As a result, we can provide our clients with more full-service solutions. Whenever possible, we will leverage the global transportation network and solutions capabilities of UPS to provide improved service and greater value.

Supply chain visibility and security

The efficient and effective management of supply chains cannot be achieved without the use of advanced technologies and IT systems. Interactive response technologies (IRT) make it possible to reduce medication waste, ship much smaller quantities and minimise labelling needs.3 Tracking and managing supply chain data is also enhanced, resulting in improved supply chain intelligence that allows for the optimisation of material deliveries and the reduction of costs.

Sentry technology, created exclusively for Marken, is one example of advanced tracking technology that provides significant added value for our customers.6 This GPS technology allows real-time tracking of a package’s location and monitoring of any exposure to temperature variations, vibration, light and shock. It also enables us to focus on the 'last mile'. For instance, for cell and gene therapies that must be processed within a short period of time, packages containing the Sentry technology can notify the manufacturing site by text when the delivery is 10 miles away and when it passes through the plant gate.

In fact, the technology has been central to the prevention of product damage and losses for many clients. We have been able to prevent product damage resulting from temperature excursions and product loss caused by the misplacement of packages. Airlines have been notified to move packages that were not maintained at the correct temperature. We also offer our Sentinel technology, which works in combination with the Sentry technology to provide information for each component within a shipment, such as multiple samples from a single patient or multiple vials for a multidose treatment for a given patient.6

Making it happen

With a state-of-the-art GMP-compliant depot network and logistic hubs in 45 locations worldwide for clinical trial material storage and distribution, we at Marken are the leaders in biological sample shipments. We manage 50000 drug and biological shipments every month — at all temperature ranges — in more than 150 countries. Our complete focus on the pharmaceutical and life sciences industries and emphasis on patient-centric services also make us the leader in DTP services. Other offerings include biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualification, and GDP, regulatory and compliance consultancy services.

With these capabilities and our position as a wholly owned subsidiary of UPS, Marken is well positioned to enhance the support of complex, global clinical trials. We are eager to explore all opportunities to develop new offerings that will provide enhanced solutions and expand our geographic reach.

We will continue to work strategically with our clients and all other external partners to meet the growing needs for DTP biological sample management and provide logistic solutions for personalised therapies, as well as the economical reuse of advanced packaging materials.

References

  1. clinicaltrials.gov/ct2/resources/trends
  2. aspe.hhs.gov/sp/reports/2014/ClinicalTrials/rpt_erg.pdf
  3. W. Wheeler, “Clinical Logistics — Meeting the 21st Century Cures Challenge,” Pharma’s Almanac (2017).
  4. www.clinicalleader.com/doc/how-to-develop-patient-centric-clinical-trials-in-the-internet-age-0001
  5. N. S. Sharma, “Patient Centric Approach for clinical trials: Current Trend and New Opportunities,” Perspect. Clin. Res. 6(3), 134–138 (2015).
  6. A. van Strien, “Dissolving Boundaries in Worldwide Clinical Trial Logistics for Biological Samples and New Therapies,” Pharma’s Almanac (2017).
  7. Companies

Related Content

At the heart of it
At the heart of it