March 12, 2018 PAP-Q1-18-CL-010
As clinical trials have become increasingly complex and expensive, drug developers are relying on external service providers to source clinical trial materials and deliver them to investigator sites and to the patient. Further reliance on outsourcing of all clinical trial supply and logistics tasks will drive strong growth in the market, which encompasses logistics, storage and transport of clinical trial materials — including investigational drugs, ancillary supplies and biological specimens — to and from clinical trial sites or patients’ homes directly.
Cell and gene therapies, immunotherapies and other personalized medicines have brought new hope to patients fighting cancer and other previously untreatable diseases. However, they present significant challenges for the clinical trial supply setup, as transit times are stringent and patient identification, visit scheduling and full end-to-end visibility at all times are critical to the success of these trials.
In addition, patient recruitment for clinical trials has become increasingly challenging in recent years.1 Drug developers racing to market with the first compound in a therapeutic class must recruit the statistically required number of patients as quickly as possible, particularly if other pharmaceutical companies are conducting competitive trials. As the industry has shifted its focus to orphan and other specialized drugs targeting narrow indications, finding patients in the US and Europe that meet trial criteria has become quite difficult. There has, as a result, been tremendous growth in patient recruitment in places such as Mexico, Russia, Ukraine and South Korea.
Technological developments are also impacting clinical trial logistics, both on the inbound and outbound sides. As more Point of Care (POC) diagnostic technologies are developed, there will be a shift in the future towards performing more and more local analyses and transporting less blood, tissue, urine and other samples to a central location for analysis. Data transfer and management of the devices will become critical factors to the success of clinical trials. These new POC devices can be potentially designed to analyze blood from a finger prick and transmit the data over the internet. If (or when) this happens, our market will be revolutionized. Central labs will rely less on blood collection, and will specialize in high-end esoteric analysis. The manner in which clinical data is collected will clearly be disrupted.
On the outbound side, the value of our shipments has increased dramatically as the number of expensive biologic drugs in development has grown. Some of these drugs can take up to two years to produce and are very difficult to replace. A single shipment of sterile vials can be valued at more than $10 million. Effective management of these shipments has, therefore, become more crucial than ever.
Advances in smart packaging solutions, including active and passive thermo-regulated products, ensure shipments remain within proper temperature ranges while en route and in storage to safeguard the shipment’s contents. GPS-enabled devices, including SENTRY, perform real-time tracking of a shipment’s location and condition, including motion, shock, battery life, and light exposure, all while sending SMS messages of any excursions or deviations. Sentry is accepted on over 95% of commercial airlines with technical acceptance by Civil Aviation Authorities in all regions. Our Global Control Center (GCC) in Mumbai monitors shipments to all of our regions across the globe. The Center transmits data through its proprietary MAESTRO operating system.
Because of our Sentry technology and GCC, we have, on numerous occasions, saved shipments that were misplaced or lost by commercial airlines. When a sample is lost or a patient misses a dose because a drug is not delivered in time, that patient may be removed from the trial. Marken’s advanced monitoring and track-and-trace technologies have therefore had a significant impact on patient retention and trial success rates.
Sponsor companies are also expecting third-party logistics providers to implement good distribution practices (GDP). In Europe, supply chain solutions must be aligned with requirements outlined in Annex 15, Chapter 6 regulations. Implementing best practices is achieved when manufacturers of clinical drug products work closely with supply chain solutions providers.
We are now required to validate and document the mapping of shipping lanes and develop contingency plans. Additional scrutiny is also being given to the temperature-controlled supply chains for clinical drug distribution. Supply chain safety, shipment integrity, and risk management/contingency planning are other important factors to be considered.
Patient centricity continues to be a real factor in designing trial protocols, with a focus on maintaining patient convenience. Patient surveys, patient groups, opinion leaders and enhanced tools to collect data will drive clinical trial reporting design, feedback, and ongoing data collection that is multi-directional and allows the definition of new endpoints at any given moment. The rapid acceleration of patient-centric home care is also presenting new challenges, as growing numbers of clinical trials include in-home patient visits. Mobile applications are common, and devices such as Apple Health are revolutionizing the way patients access their health records.
The complexities of a global direct-to-patient (DTP) program, particularly in the last mile, require a supply chain solutions provider with the ability to anticipate potential points of risk, that has proven contingency plans in place, and offers complete tracking transparency to monitor shipments in real time as part of an end-to-end visibility solution, while respecting all applicable patient privacy laws.
Because of the sensitivity and value of clinical drug products, end-to-end visibility is extremely important, particularly for DTP services, to ensure that the administered drug is safe for the patient. We have plans for further technology development to ensure tighter control and end–to-end visibility, variations of GPS trackers and smart packaging solutions.
We have experience with thousands of DTP shipments since starting this service in 2012. We are currently managing and coordinating DTP/Direct from Patient (DFP) services for over 80 clients around the world. In addition to our Patient Communication Center — a 24-hour, 7-day-a-week call center based in Philadelphia (USA) dedicated to the logistics needs of patients who participate in home-based clinical trials — Marken recently introduced an online interface, Viseo, which offers patients the ability to track their home deliveries of clinical trial materials and the pickup of their biological specimens via their mobile devices or personal computers.
With a simple click, patients can view the driver’s name and follow his/her progress right up to their front door. A photo of the driver shows exactly who will ring the doorbell with the Marken delivery or pickup. The on-screen rating option after delivery provides direct and immediate feedback on the service and experience of the patient. This type of real-time driver traceability can translate into improved patient expectations and confidence with DTP or DFP trials and reduce the number of rescheduled deliveries and delays.
Compliance with data protection laws is another challenge. The General Data Protection Regulation (GDPR) goes into effect in the EU on May 25, 2018. The regulation has strict rules about how personal data may be used and how it must be protected and sets a 4% administrative fine, up to the greater of €20 million or 4% of global annual turnover in the prior year for noncompliance. Many organizations will need to make significant investments in basic tools to comply with GDPR requirements. We have actively ensured that all of our data protection, privacy, and IT infrastructure are in full compliance with not only the GDPR regulations but all patient privacy rules and guidelines worldwide.
Recent ransomware attacks show a increasingly important threat to pharma and logistics companies. A leading pharmaceutical company was hit by the rapidly spreading Petya ransomware in 2017. Several other attacks throughout the year impacted manufacturing and formulation operations, shipment tracking, data collection and time-sensitive services, and even just this month, another global logistics company was impacted by a significant data breach. In this instance, we were able to rescue hundreds of shipments from that provider’s warehouse. Our ATA transmission and IT infrastructure are designed to withstand such attacks.
At Marken, we are committed as an integrated clinical trial logistics provider to supporting our customers with value-added services. For instance, as the independent, wholly-owned Clinical Supply Chain subsidiary of UPS, we have launched a hybrid service in 2017 that combines our expertise and capabilities in managing deliveries over the last mile with UPS airline and ground operations. The hybrid service enables the booking of shipments in Marken’s proprietary MAESTRO operating system, managing them from origin to destination while using the UPS network in a seamless and effective manner.
We also continue to further develop our position as the dedicated one-stop, full-service clinical supply chain solution provider for the pharmaceutical industry. Just recently, we announced the opening of an additional kit-building facility in Shanghai, China and a new operational hub in Stuttgart, Germany. In December 2017, Marken announced the opening of our 6th location in India (Ahmedabad). We continue to expand, grow and extend the services and additional value that we provide to our clients and the clinical supply chain. The next step in our DTP journey will be the development of our own nurse network. We are also investigating the possible future application of autonomous vehicles, drones and block chain technology to continue on our innovative path.
Wes joined Marken in 2011 to transform the company, which has grown to more than 40 locations in 19 countries throughout the world. Wes joined the pharmaceutical industry in 1989 with Glaxo (now GlaxoSmithKline) and has served as CEO / President at four different companies. Prior to 1989, he worked for 12 years as an engineer for Exxon (now ExxonMobil). Wes holds a bachelor of science degree in mechanical engineering from Worcester Polytechnic Institute and a masters in business administration with an emphasis in finance.
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