Efficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient's homes. Undertaking this level of detail at scale requires a considerable range of resources, as well as the expertise to consider myriad factors in the design of clinical trial kits and their delivery and reclamation. Pharma's Almanac Editor-in-Chief David Alvaro visited Yourway at their Allentown, Pennsylvania headquarters to speak with Vice President of Client Services Fiona Geiger and discuss some of the inherent challenges in building clinical trials kits in the current landscape and how Yourway's integrated capabilities, expertise, and experience can minimize the challenges sponsor companies must face.
DA (DA): To start us off, can you give me a little bit of a refresher on clinical trials kitting and some of the fundamental challenges?
FG (FG): Kitting for clinical trials conjures up a number of different ideas. I think most people are familiar with kitting in the simplest terms of taking the investigational product (IP) and organizing it in a kit that is appropriate to the dispensing unit that will be given to a patient during the study. However, there's a range of other types of kitting as well; whether we're kitting up lab supplies or putting together a kit that includes not just the IP but also the ancillary supplies that are needed to administer the drug to the patient or to assess the drug's effects and study outcomes. There are also ancillary kits that might just be shipped separately or be required by the site for them to conduct the trial overall.
DA: I think the old image of a clinical trials kit is a single "study in a box" kind of concept containing every material needed for a trial. Is that model still valid or only in limited use cases?
FG: Honestly, I think that model is a bit outdated, and I can't really see that it is incredibly valuable today. I think the biggest challenge a "study-in-a-box" faces is that many of the IPs in contemporary clinical trials require rigorous temperature-controlled conditions that must be adhered to throughout the supply chain, from manufacturing and shipping through storage and, ultimately, administration to patients. That means that IPs have to be shipped in a temperature sensitive shipper under verified temperature control. But when you put everything for this kind of trial — including not only the IP but comparator and concomitant drugs and ancillary supplies — together in one kit, it becomes very large. Temperature-controlled shippers, for obvious reasons, cost considerably more than ambient shippers, and shipping a large kit containing all supplies under temperature control is very expensive. Ultimately, among the most significant costs in any clinical trial are the distribution costs. So it's always critical to figure out every way that you can minimize those costs, and that typically involves assembling a smaller kit containing the items that have to be temperature controlled and then using corrugate boxes and uncontrolled shipping for the other balance of materials.
At the end of the day, the idea of everything coming together in one box really doesn't work terribly well. But obviously, it still makes sense to combine like items and those that require the same temperature conditions into the same kit.
DA: Over the past couple of years, and particularly this year as a result of the COVID-19 pandemic, the industry has faced this major transition from more traditional site-based trials to decentralized trials with direct to patient services. How does that transition transform the notion or the approach to kitting?
FG: I certainly think that this shift to decentralized trials enhances the need for careful and prudent kit design even more. In a traditional clinical trial site or even a physician's office, there are many pieces of equipment and materials and ancillary items that are readily available. When you move that visit to a patient's home, you have to find a way to bring those things along. Depending on the trial protocol, there can be a huge range in the ancillary materials needed for each visit. You have to make sure that they're available to the home nurse who will conduct that visit. So it's critical to very comprehensively consider all of those details in advance much more carefully than you would in a regular doctor's facility. That requires very strategic thinking in terms of making sure that those are combined with the IP or with the lab draw material so that they can be delivered to the site for the visit. Additionally, the choreography is important in terms of assuring that all necessary materials are available at each visit, as an entire trial can be derailed by a delay in the supply of a single ancillary item.
Another important consideration is the fate of that equipment and material after it has been used or after completion of the trial. You don't want to be storing things there afterwards or leaving anything behind, especially in a patient's home, or for the home care nurse to have to haul equipment back and forth on each visit. You must ensure that they have exactly what they need for that visit — and only what they need for that visit — with all materials delivered in a seamless way for the home care provider. All of that complexity has increased the need to even more rigorously consider the items that can accompany the IP, the types of shippers, the boxes for returning equipment and supplies, the route by which samples will be transferred from the patients' homes to the laboratory — things that you may not have needed to work out if you were dealing with a clinical trial site, because they already have the equipment and systems in place to handle that every day for multiple trials, multiple patients and in multiple occasions.
DA: During the kit design process, who are the critical voices whose input is critical to ensure that the kit is designed to allow maximize its efficiency and practicality for the users?
FG: For me, it typically starts with the clinical supplies folks at pharma and biotech companies, who are the ones that focus really on the investigational product. Then it's typically the clinical team who need to weigh in on the ancillary items and other more nuanced considerations. The clinical teams bring insight from the site's perspective or the patient's perspective, and so their voice is very, very important. For decentralized trials, the other important piece companies don't always kind of think about is the logistics or transportation piece in coordination with the home care provider: How will that all work together? Will they stop in at the site? What if the site is too far away? Who will be bringing them the kits and other materials? Are those materials and the way that they're packaged designed to be easy for the provider to transport just for one visit?
In the past, we could kit for a patient for all of their visits, or a group of visits, and leave it at the site. Of course, that doesn't work very well if you're going to take one visit at the patient's home, another visit at the site, a third somewhere else. It's important to really understand the protocol, the design of the patient visit, the whole course of their treatment. Not to mention understanding where those visits are going to occur, what is needed as an output of those visits, and what lab tests are necessary. With all of that understanding, we can then determine how to unify everything in terms of supplies, investigational product, procurement, and delivery. The clinical team, the clinical supplies team, transportation logistics, home care providers — we really need to hear from all of them and understand how they're going to do their jobs and how all of those roles interact. Finally, we can work out how to serve all of those needs by selecting the best packaging strategy possible.
DA: To that point, how important is it to have comprehensive sourcing strategies and long-term relationships with suppliers to be sure not only that you have all of the necessary components for a kit, including the comparative drug and ancillaries, but also that you can deliver them to the site or to patients at the same time?
FG: That has definitely been a challenge this year. We have seen how important it is to have a history of purchasing these items, to have sourced them repeatedly and to have relationships not just with suppliers or wholesalers but also directly with manufacturers to understand their manufacturing timelines and cycles. A lot of these items can end up in short supply when something like COVID-19 happens, obviously, but even under normal circumstances at different times of year. We've seen this in the past; for example, when Puerto Rico suffered from Hurricane Maria, manufacturing facilities in Puerto Rico stopped being able to manufacture. That resulted in a widespread shortage in some of the components and materials that were manufactured there, like saline IV bags.
In order to reliably get allocations for those items, you have to have been purchasing them or to have a buying pattern that gives priority to your allocation, and that has been very important for us this year. It also makes it possible, within a two-, three-, or five-year study to supply the same items over and over again; so it's also critical to anticipate and forecast what will be needed down the road and make sure that you're ahead of any shortage that might occur. It's vital to have a strategy for that, to have the right relationships, and to have backup plans for those relationships.
DA: To what extent do customers benefit from or access further synergies or efficiencies from accessing kitting services from Yourway that offers an integrated provision of services across the value chain?
FG: In most cases, sponsor companies need to access kitting and packaging services from one provider and storage and distribution from another. One of Yourway's differentiators is that we also have the transportation component within our company. That changes how we think about things, because we're considering the big picture from the start. What is the transportation going to look like? What type of shipper would be used from that depot? What type of truck or van will be used or what movement will happen? How much will it cost to ship that shipper across the world? What will the site do with that shipper after they're finished with it? Because that's something else that we hear from sites: "I've got 20 of these single-use shippers sitting out back. We don't even know how to get rid of them. Can you come collect them for us?" We get requests like that all the time.
Yourway's integrated offering allows us to consider things holistically, going beyond just focusing on what the physician or the nurse will use to administer the drugs to patients but also how we can consistently deliver materials to a site without overburdening the site with materials or increasing the costs and overhead of reclamation.
If you're oversupplying ancillary materials, you have to pick those up and retain them at the end of the study. You need to ensure that you're thinking about that in the same way you would think about IP that has a short supply or an expensive component, because a lot of these ancillaries are very expensive. At Yourway, we aren't only focused on the packaging and kitting and delivery out to sites. We interact with these sites daily, as well as transporting materials all over the world and clearing products through customs. The synthesis of that component with all of these other considerations constantly feeds back into our organization in terms of lessons learned and ways to enhance our services. Put simply, it is just a perspective that other providers won't have.