March 8, 2017 PAP-Q1-17-CL-011
Marken is a leading patient-centric supply chain logistics organization with a complete focus on the pharmaceutical and life sciences industries. Its state-of-the-art GMP-compliant network includes 10 GMP-compliant depots and 45 world- wide logistic hubs for clinical trial material and investigational medicinal prouct storage and distribution, in addition to direct-to-patient (DTP) services and 50,000 monthly shipments of time- and temperature-sensitive drug and biological shipments at all temperature ranges in more than 150 countries, Marken also offers biological kit production; ancillary material sourcing, storage and distribution; shipment lane verification and qualification; and GDP, regulatory and compliance consultancy services.
Marken operates a global network of clinical supply chain services to meet the increasingly complex demands of its clients, with no geographic boundaries. The company is poised to explore the possibilities for new offerings to clients, particularly with regard to expanded drug-distribution solutions. Marken is also well positioned to widen its global network as the company continues to expand into regions of interest, such as the Middle East and Africa, as well as achieve further penetration into Asian markets and Eastern Europe.
One clear trend in the clinical trial space is a move away from the investigator site to the patient’s home, which requires DTP services. Homecare networks are now responsible for not only patient treatment, but also for drawing, centrifuging and (if necessary) freezing of blood samples — all while the patient is at home. Latest advancements include extracting biopsies through the blood versus tissue samples,which will further increase the viability of adding DTP services to clinical trials. Logistics providers like Marken must have extremely flexible networks of their own with highly trained personnel who can work closely with these global homecare networks and establish appropriate schedules that ensure timely sample pick- up and delivery at a very diverse number of locations.
Marken became aware of this trend early on and began providing DTP services beginning in 2012. Consequently, they are a pioneer in developing DTP expertise. The challenges posed by the growing preference for in-home care ecame the platform for Marken’s focus on patient centricity. Currently the company offers DTP services associated with over 100 active clinical trials that involve more than 1,200 investigator sites. The primary issue is the patient’s privacy, and if the provider is a data processor or data controller, each needs different levels of control.
The growing need for patient-specific clinical trial logistic services can also be attributed to the rapidly expanding interest in next-generation therapies, particularly CAR-T and other cell and gene therapies. In particular, autologous, or patient-specific, cell therapies pose challenges with respect to turnaround times and chain of identity to ensure that the advanced therapy medicinal product (ATMP) is returned to the correct patients.
One of the biggest challenges is establishing an effective chain of identity. When ATMP is being shipped from investigator sites, hospitals or apheresis centers to the manufacturing site and back to the patient, there must be a process in place to guarantee that neither the samples or ATMP are at risk at any moment. Each sample and therapy is so unique that it must be tracked down to the tube or vial level.
Marken applies its exclusive GPS tracker technology, Sentry, as a first approach to addressing this issue. The company has also developed a Sentinel solution that will work in conjunction with the original GPS tracker to provide information for each component within a shipment, such as multiple samples from a single patient or multiple vials for a multi- dose treatment for a given patient.
To be most effective, however, technologies like the GPS tracker and the newer version under development requires that Marken be actively involved in the setup of clinical trials with complex, patient-specific logistic requirements in order to allow complete feasibility assessments at the start of each trial.
Requirements such as these promising therapies are moving to commercialization and must also be considered. As these therapies become commercially available, the logistics issues remain unchanged from those faced during clinical trials. Planning, months in advance of the expected launch date, is a must to ensure a successful outcome.
Overall, therefore, interactions between the various points in the supply chain — hospitals, clinics, manufacturing sites, logistics companies, etc. — for next- generation medicines have a significant impact, and effective communication between the supply chain organization and all vendors is essential. A comprehensive network that can support all of those components is also a critical component.
Updated Good Distribution Practice (GDP) regulations have aided in the development of innovative and temperature- controlled solutions, very often related to new packaging solutions. GDP also addresses the issue of maintaining accurate documentation and proof of temperature control, which were formerly one of the weakest links in the supply chain. Today, the industry needs more environmentally friendly solutions while still maintaining rapid turnaround times and temperature control.
The real challenge today is managing the large number of packaging types available in the face of the need to be greener and provide rapid turnaround times. The question is no longer just, “How do you trans- port drug products and APIs from one site to the other?” but also, “How can you safely and cost-effectively reuse these advanced packaging solutions within a network that includes both centralized and decentralized aspects?” Regarding inventory management, how many boxes is a key factor to a successful logistics strategy. Clearly the provider must monitor expiration dates of different packaging components and ensure compliance.
The new focus on return logistics presents challenges. The packaging must be perfectly clean and appropriately conditioned. Marken made these investments several years ago to build a network with the right capabilities and to identify geographically strategic locations in each region. In order to optimize the return logistics, clear GPS tracking must be in place to ensure the returns to either one client or multiple clients, as per the client agreement and needs. Investments were also made in quality systems to ensure that the procedures and equipment are properly managed and maintained. The company is also further boosting capabilities in the reusable packaging area; it is easier and more cost-effective to move empty cartons and components for special shippers and to do so at a price that makes reusable solutions sensible. Both pharmaceutical and packaging companies are turning to service providers like Marken that have very specific knowledge and network leverage that enables the economic delivery of this type of service. Marken has extensively developed all of this as a resolution to a key pain point for clients.
Marken is well positioned to expand its support of complex, global clinical trials. The company’s expertise makes it possible to meet the growing needs of patient homecare by delivering drug products just in time. Marken will continue to enhance further patient-centric services for our clients, including DTP management and assistance with logistic solutions for personalized therapies and economical reuse of advanced packaging materials. Marken maximizes efficiency and enhances service offerings while continuing to specialize in the high-touch, personalized services that the company is known for in providing supply chain solutions for clinical trial materials and sensitive drug shipments.
Ariette van Strien is Marken’s voice of the customer, having spent 25 years in the clinical research industry, with the last six years developing new services for Marken, spanning sales, marketing, business development, and global operational and project management roles. Having worked on the central lab and clinical side, Ariette brings a unique perspective from this portion of the supply chain. Ariette has a diploma as a National Public Relation Consultant, a Superior French Language degree from the International College of Cannes, and a baccalaureate of modern languages and biological sciences.