The Fortrea Podcast
The Fortrea Podcast
Radiopharmaceuticals Trials: An Operational Playbook | Ep 2 | Timing Is Everything: The Importance of Logistics
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This episode of Radiopharmaceutical Trials: An Operational Playbook explores why logistics isn’t just a support function in radiopharmaceutical trials—it’s often the deciding factor in whether treatment can happen at all. From managing ultra-short half-lives to understanding the real impact of even small delays, it unpacks five critical questions shaping this high-stakes field.
Featuring expert perspectives, the conversation highlights the precision, pressure, and patient impact behind radiopharma logistics.
Host: Hector Herrero, Senior Director on Global Project Management at Fortrea
Participant: Graham McCarthy, MIAS Pharma
Hello everyone, my name is Héctor Herrero, I'm a senior director on Pre-Management atometria, working on radiopharmaceuticals for the last 15 years. Welcome to this podcast today. Before we jump in, I would like to present a quick picture. So imagine a patient arrives at the site early in the morning, fasting, anxious, ready to receive the treatment. The team is prepared, the scanner time is reserved, everyone is on a schedule. And then we receive or they receive a message. The shipment is delayed by 45 minutes. In many trials, that's frustrating, but the things can continue that day. In radio pharma, it can mean the dose is no longer viable, the visit must be rescheduled, and a patient loses a day or more and the treatment opportunity. So in this episode, we will unpack five practical questions. Why logistics is not just support, how the shot half-lives force new planning methods, what zero tolerance really looks like, who feels the impact first when something breaks and something does not go as expected, and why logistics often determines whether a patient can be dose at all. So welcome to this for Tria podcast. And um well, as I mentioned, in many clinical trials, um logistics can be seen as a support function, important, but operation in the background. In radio pharmaceuticals studies, this is a little bit different. Logistics isn't just supporting the science, it often determines whether the science can happen at all. So to explore why, I'm joined by Graham McCarthy, commercial director at MyAS Pharma, who is going to bring us a deep experience across the radio pharma ecosystem. Uh Graham, welcome.
SPEAKER_01Hello, Hector. It's very nice to meet you and thanks for having me.
SPEAKER_00Okay, would you like to uh briefly introduce uh yourself and your role at MIAS Pharma?
SPEAKER_01Yes, and my name is Gray McCarthy. I am the commercial director of MyAS Pharma, specialize in supporting companies, carry out their clinical studies, both for EU and UK markets, and also supporting clients as they move from clinical into commercialization. We hold our own licenses known as MIAs, which allows companies from, let's say, US or Canada, import the radio pharmaceutical products into the EU and be QP released so it can actually go to the study. So I suppose in dealing with sponsors, uh manufacturers, etc., we often help in these regulatory filings for the studies. We also get the site suspection ready and we also make sure that it's compliant with Annex 21. So again, there's no delays when it comes to scaling the studies up. My role within LIAS is to support pharma companies um to make sure they have everything in place from both a GMP and GBP perspective. So again, we're trying to make it as virtual and as streamlined as possible.
SPEAKER_00Thank you, Graham. Um, so let's go into the conversation. To to set the scene, Graham. When you look across different studies and sponsors, what's the most common misconception you see about radio pharma logistics?
SPEAKER_01There are three that come to mind. Um first, and I suppose the biggest misconception is the perception that airlines and customs agents will handle the shipment with greater sense of urgency than other products. Unfortunately, it's just not the case. And this lack of priority has a big potential impact on delivery timings for when it moves from the US or Canada into Europe. Another common misconception is thinking that the closest airport next to manufacturing site is the best option. Again, that's not always the case. So unless an airport has a direct route to the destination airport in the EU, the product may still have to go through a main hub and again cause needless delays. And the third and the most fundamental one is a few years ago there was a thing known as Annex 21 that was implemented within Europe, which means that for all studies or commercial products entering New York from a third country, it has to have a designated touchdown point known as a site of importation. So traditional sponsors would think that, okay, I'm doing a study in Germany, I can fly the product straight from the site into Germany. The reality is for our own studies, our site of importation is Belgium. So the product has to be factored in that it goes from the US into Belgium and then on to the third country.
SPEAKER_00So let's go into some details and start with the big one. So why isn't logistics uh just a support function in radio pharmaceutical trails?
SPEAKER_01Well, look, logistics uh is so vital because radio pharmaceutical products simply can't be stockpile. It's uh adjusting time model. So essentially, when it's manufactured, a dose has to be shipped to the other side of the world and administered to a patient within the given time frame and the K rate of the product. So basically it has to factor in manufacturing cycles, carrier timings, customs, quality, and even clinical side opening hours. Usually, what we see with most of our studies, everything has to be done within a 96-hour time limit. So basically, as part of the study, it's so vital having the right disk partner identified so you can work with them to plan the rel, get all the critical steps out of the way, and make sure there's door-to-door from either customs, IOR, and final final mile to make sure there's continuity. Um and I suppose back to the initial question, why it's not just a support function. As um as the clinical studies scale, it's really important to see the logistics vendor as your partner so they can actually change routes and scale with you so they can get around capacity issues.
SPEAKER_00When you're advising uh you're giving advice to sponsors or sites, what's the earliest moment in the study design where logistics needs to be on the table?
SPEAKER_01The earlier the better, but not in isolation. Usually the quality vendor, like a MyS or someone like this, should be involved. Um on paper, something might look straightforward, but logistically, uh a country may not be the easiest location to get a product into. Um, there might be extra licenses required to bring a product in. Um by involving the logistics partner early in the process, it gives more flexibility and time to plan and carry out mock shipments who have product. So you can actually test all processes in the supply chain and including both communication process, transport, and even from the site, using the material to calibrate machines to show if actually from a fundamental level everything is set up correctly.
SPEAKER_00I think one thing which is important to mention is when logistics becomes part of the of the product design, or the study design, they better say, it of course changed a little bit the accountability. So, what are the operational metrics you watch most closely? Um, and how should the sponsors uh think about them?
SPEAKER_01Well, from a logistics perspective, solely, um being on time for the study is expected. Um, and I suppose there's the reason around having mock shipments as part of the setup. But the main metrics really is if a product has only 96-hour shelf life, one metric is collection time from manufacturing site, and the second metric will always be the delivery time that's been agreed in the SLA with clinical site. So it means that there's anything that happens in the mean, and these contingencies can be put in place.
SPEAKER_00So um let's talk a little bit about the scientific reality that drives all mostly all of all of this um logistical consideration, right? Which is the the short half-life or not short half-life, uh that uh of course change everything. So, uh, in your opinion, how do the this short half-life change how a studies need to be planned?
SPEAKER_01So in planning, it's always kind of consider um direct flights rather than any redirects. Make sure your logistics partner have custom agents are available at all mid-airports, and make sure you send your documentation in advance so you can check with customs in advance, see the clear status, the using directly with the clinical team, and inform your QP at the at the status of the shipment, just to make sure that the full batch gets the patient in time.
SPEAKER_00Okay, can you give us uh a simple example of of what this the game means uh operationally? Okay, no, not the the not the physic uh background, of course, but for for the planning reality.
SPEAKER_01So typically the most common material that we see coming from the US, Canada, or other third countries has a half-life of about 96 hours. So, an example, a product is made in a manufacturer and it's using a patient on a Monday. So when a product is made, they it's generally made at a more concentrated level than it needs to be at the time it enters the patient. So operationally, the logistics vendor has to work around this time frame to make sure the medicine gets from the manufacturing site to the clinic or can't be used. That means the patient's suffering. So basically, the logistics vendor will always have to tie on with the manufacturers, customers, um, QP clinical team, and has to do clear lines of communication in place. Um it doesn't always go straightforward. Um I suppose from a planning reality is if there's any delays, it means that a vendor will look at alternative routes to make sure it gets the site in time.
SPEAKER_00And and you, you know, one thing I would like also to mention here is we are not really talking um only about the injection. Uh we are talking about imaging slots, blood draws, uh monitoring windows. Um there are you know a lot of things which can be really impacted if the planning is not done properly here. So it is really, really important that everything here is is uh really very well reviewed and discussed before we really start, right? So uh well this also of course brings us to the to the phrase that probably all of you are hearing a lot when we are talking about radio pharmaceutical studies, uh, which is the zero tolerance for delays. So, what does zero tolerance for delays really mean in practice, Rapon?
SPEAKER_01In in zero tolerance, like what we what we generally encounter is in all our studies, we always ensure that we validate our shipping routes. So we have clear planning, communications, fallbacks, and um lines of escalation between sponsors, pinnacle teams, and the QP to minimize risk. Now, there is a chance always of a force-major event. That's always going to be out of your control. But I suppose to support zero tolerance, what we find is a lot of the transport vendors being used would have live GPS trackers fitted. So at least that gives direct communication. So if something does happen, it can either either contingencies can be put in place or the clinical team can be let know just to make sure a patient isn't suffering at the hospital.
SPEAKER_00Talking a little bit more about potential uh fails in this process. So who is impacted first?
SPEAKER_01Unfortunately, it's always the patient because ultimately at the end of it, the whole purpose of the entire study is to treat patients.
SPEAKER_00Yeah, that that patient first impact is really, really important. We always need to keep that in mind. So, in a conventional trial, a delay can be an inconvenience, of course, could delay, could lead to some you know problems for the patient. But here a delay can mean the patient simply can be dosed that day. And not in all studies with radiopharmaceuticas, but in many studies with radiopharmaceuticas, we are talking about oncology patients. And you know, uh, when these patients really need the treatment, these patients are in a very difficult uh situation in many cases. So when the patient is impacted first, the human side can get lost in operational discussions. Why, uh in your opinion also, Graham, why does logistics often determine whether a patient can be those? I think we have already mentioned some of these topics, but I think it might be worth also to ask this question.
SPEAKER_01There's limitations around manufacturing schedule. So basically, usually um products coming from third countries might be midweek manufacturer or it could be weekend manufacturer. So it means that um it limits on how much material can actually come into Europe and it also limits the amount of releases that can happen at a given day. So there's limitations at the clinical side as well. So I suppose the limitations is so, for example, let's say I start a study and there's um two doses a month. If it gets past a certain threshold, you might need to look at alternative airlines, might need to alternate airports. Um, and again, it is a big limitation because everything has happened in that same specific timeline.
SPEAKER_00If you uh have to describe this as um as a chain, you know, because of course there are multiple steps here in all this process. What are in in your opinion the the weak links that most often break in this chain? Could be release timing, transport, less mile delivery, side readiness.
SPEAKER_01It's always going to be the airline because it's the one part that's out of control of the chain. You can have contingency plans in place, but reality is that internal that external factor is your biggest risk.
SPEAKER_00Okay, so one thing I would like here to mention for for all of you listening. So here is um uh a quick checklist that you can sanity check before first patient in when we are uh setting up our radio pharmaceutical study in any site. So, do we really have a backward plan from injection time to manufacturing and release? Is there a single escalation path with name, contacts, and decision authority about what to do if something unexpected happened that is really, really relevant? Is the site dosing day uh? So have we discussed with the site how all the process is going to be done, right? And who is going to be uh the responsible person for each of those steps? The receipt of the of the IMP, the preparation, the administration, and then imagine if needed, samples uh draw if needed, etc. And in all of these cases, thinking holistically about all the logistics. What are the two or three practices that you will highlight at the most that are the most uh important one to improve uh all these uh potential issues in the dosing process?
SPEAKER_01So, first choose your logistics vendor um wisely and involve them in the planning. So this is going to you know help to get to new countries, help scale, look in new routes. Um spend time up front doing your um mock shipments because again, it works through all the potential pitfalls and challenges that you know using hot material so you can actually see is the process working. Um work with companies like yourselves um so we can at least get the quality and licensing elements out of the way. So again, it doesn't make any delay to your studies. Um and then obviously um as a sponsor and have as a sponsor work really closely with clinical teams to have as clear a forecast as possible.
SPEAKER_00Yeah, Graham, this has been uh really, really clear and a great reminder that radio pharmaceutical trials logistics is uh a patient safety issue, a data integrity issue, and a study feasibility issue all at once. So before we close, I want to pull out three takeaways for this for listeners. One, uh plan bar works from the patient and protect the activity window. That's really, really relevant. Always keeping the patient in mind. Two, treat handoffs and escalations as part of the protocol, not uh something that, well, we will see what will happen. That is something we will need to plan ahead. Third one, we need to measure success by also successful dosing, not just by delivering on time. So before or from the time point where we deliver until the dosing is actually delivered, not delivering only the IMP, there could be uh items which could really impact the patient. So, well, uh Graham, thanks for joining us. This has been incredibly clear and a great reminder that in radio pharmaceutical trials, logistics is another piece of the patient safety. Logistics can be a safety issue, a data integrity issue, a study feasibility issue, all at once. And we need really to be very clear on this.
SPEAKER_01Thank you, Hector. I've really enjoyed this conversation and hopefully it helps the teams give logistics the attention it deserves.
SPEAKER_00Okay, thank you everybody everybody for listening. If if you're working in radio pharma, you're on the sponsor side, a CRO, a manufacturing side, an imaging center, please share this episode with your operations and study teams. And if you would like more conversation like this, please subscribe to the For Trio podcast. Until next time, take care.