May 29, 2018 PAP-Q2-18-CL-002
The clinical trial paradigm has shifted. Of the over 270,0001 clinical trials that are currently underway worldwide, a growing percentage offer patients the option of receiving their medical visits in their home rather than having to travel to an investigator site. Approximately 24% of pharmaceutical companies are moving to virtual or partially virtual trials, and another 33% are expected to start site-less trials in the near future. By 2019, 50% of pharma companies will conduct virtual trials.
The growth of Direct-to-Patient/Direct-from-Patient (DTP/DFP) supply chain services in recent years has been a response to the focus on patient-centric trials and medicines. These services allow clinical trial materials to be delivered directly to a patient’s home and biological samples picked up with minimal interruption to a patient’s lifestyle. Offering a DTP option enables pharmaceutical companies to increase recruitment rates, particularly for trials where many patients live in remote locations or are too ill to visit a doctor’s office. For instance, for the hundreds of cell and gene therapies in development, DTP services often predominate because these treatments are very personalized and often target late-stage cancer patients. DTP services can also increase patient compliance, which in turn prevents the loss of trial participants.
In this new era of clinical logistics, however, the supply chain may be one of the most vital links between the manufacturer and patient. For any clinical trial, it is critical that patient privacy and protection be maintained at all times, and this becomes a challenge when the supply chain reaches the home. No one can know which patients are receiving the investigated drug, the comparator or placebo. Marken has demonstrated its ability to effectively manage drug product delivery and biological sample pickup to/from patient homes and has resolved the patient privacy issue. Pharmaceutical companies are becoming comfortable with the DTP service, and eventually we believe the majority of clinical studies will be conducted in this manner.
As the clinical trial industry moves toward more personalized treatments, Marken is ensuring its services evolve for these more complex and specialized trials. DTP services are the fastest-growing part of our business. We currently manage over 1600 DTP shipments per month in 51 countries, and that number continues to steadily increase. As the clinical logistics subsidiary of UPS®, we are able to leverage the UPS network to improve the efficiency of our DTP services.
In this new era of clinical logistics, the supply chain will be the only link between the manufacturer and patient.
Our hybrid service introduced in 2017 is one example where we combine our expertise and capabilities in managing deliveries over the last mile with UPS airline and ground operations. Our ability to use UPS aircraft in conjunction with commercial airlines has dramatically reduced the cost and improved the quality of our services.
In February 2018 in direct response to the exponential growth of home-based clinical trials in the past few years, we launched another unique new service that in this case makes use of the nearly 5,000 The UPS Store® locations across the United States. Nurses and drivers are now able to drop off clinical trial samples at the nearest The UPS Store® instead of needing to find the next available commercial flight at the closest airport — a cumbersome, expensive and often frustrating process.
Approximately 84% of the U.S. population lives within 10 miles of a The UPS Store® location in the United States. All locations have the capability to handle pre-packed, pre-paid shipments at all temperature ranges, including ambient, refrigerated and even frozen samples that require dry ice. In addition, The UPS Store® locations offer UPS Next Day Air® service and early morning delivery to the central and regional labs — as early as 6 AM in some cases — from many origins, which can reduce delivery times by 6–12 hours.
Marken will manage the booking of shipments with UPS in order to ensure protocol compliance, patient data blinding and data encryption as required for clinical trials.
In addition to offering our new drop-off service, Marken is developing a global home-based nursing network to supplement our existing DTP/DFP services. This new service will allow Marken to streamline the compliant delivery of clinical trial materials to patients’ homes and collect biologic samples in accordance with client’s clinical protocols.
Currently, Marken works with three nursing providers and a separate group of specially trained drivers who must follow the same protocol and good distribution practices (GDP) requirements. Instead of having two people arrive at a patient’s home, the new service will allow nurses, who will manage the entire patient visit. Marken is building its own nursing network that will offer clients new services that may include intravenous infusion, blood draws including safety lab samples, biologic sampling such as pharyngeal and oral mucosal swabs as well as the clinical assessment of vital signs and other
mobile-based electronic data collection.
The new services will integrate with Marken’s proprietary Maestro™ operating system for comprehensive shipment tracking from booking through delivery. Our existing 24/7 Patient Communications Center (PCC) in Philadelphia will also be offered to enhance DTP services. Nurses will also be able to drop bio sample boxes at nearby The UPS Store® locations for direct shipment to the central laboratory.
Challenges to DTP/DFP clinical trials remain, and Marken is committed to effectively managing and constantly improving services to address these challenges. Efforts are ongoing to reduce the cost of in-home services; the combination of home nursing and logistics services is not inexpensive compared to traditional trials in which patients visit a doctor’s office. We need to continue to reduce the costs and make DTP/DFP services more efficient.
Data protection is an evolving issue, as discussed above. As FDA reviews larger numbers of DTP/DFP trials, we expect that regulatory requirements will be introduced to ensure data protection. One possibility is a requirement that logistics software be subjected to additional legislation. We are prepared if this happens.
Marken is also focused on making the DTP/DFP process as easy as possible for our clients and their patients. We have invested in highly trained drivers who are capable of following clinical trial protocols. Our Viseo smartphone application allows patients to see when the driver is arriving, his/her certification number and when their shipment has been finished; they can also rank their driver, which allows Marken to keep track of performance. This type of real-time driver traceability can translate into improved patient expectations and confidence with DTP trials and reduce the number of rescheduled deliveries and delays.
Marken also continues to expand its physical network. In December 2017, we opened our sixth location in India (Ahmedabad), and in Q1 2018 we opened an additional kit building facility in Shanghai, China and a new operational hub in Stuttgart, Germany.
Currently, we are working with various vendors to develop a branded and patented “smart box” that will contain a GPS device and be patient-friendly and easy to handle. We also have plans for further technology development to ensure tighter control and end-to-end visibility, variations of GPS trackers, new devices that communicate by Bluetooth or other means and smart packaging solutions. These advances will enable Marken to further minimize the risks associated with the clinical supply chain.
The market, patient pool and technology available in supply chain solutions and clinical trials have shifted. Streamlined logistics and simplified patient-centric services are the key to success for the complex clinical trial industry. As the independent, clinical subsidiary of UPS, we are working closely with the company to find additional ways to leverage the UPS network.
Marken has actively managed supply chain solutions for DTP trials since the 2012 inception of the DTP service and was the first to introduce DTP services. We continue to anticipate the future needs of our clients and their patients. We recognize that the supply chain is the most important link in today’s clinical trials and are committed to covering trial materials to the last mile without putting them, the trial or patients at risk. With our growing experience in DTP/DFP trials, coupled with our history of high-touch, personalized service and our UPS network, we will be able to reach populations in remote geographies and home-based clinical trials with an unwavering commitment to patient safety and privacy.
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.