Handling the logistics of a shipment throughout the supply chain is a complex process – one that requires collaboration and clear communication among all stakeholders involved. With various obstacles to circumvent, ensuring a shipment gets to a site or patient in a timely manner is vital to the success of a trial. So what are the fundamentals to a successful shipping strategy?
Clinical Supply expert, Ayelet Weissbach, spoke to Arena International to provide her input. As the clinical logistics leader at OPKO Biologics in Israel, Weissbach coordinates the logistics of sending the drugs to package and label vendors, as well as to the relevant sites. In this interview, she tells Arena International some of the challenges she faces on a regular basis, and reveals some of the best practices she’s learnt when shipping clinical supplies.
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Clinical Trials Arena: What are some of the challenges you face in shipping to sites?
Ayelet Weissbach: The number one challenge is the numerous regulatory barriers we face on a regular basis. It all starts from when you ship supplies from the manufacturer to the pack and label vendor. If the manufacturer is in Europe and the pack and label vendor is in the US, you have to meet the requirements set by the FDA, submitting the relevant documents and so forth. Even sending supplies within Europe can be laborious.
When it comes to shipping supplies, if you have an IRT (interactive response technology) system that works well, that’s great; the system manages the supply, it knows what’s located at each depot and each site, and it can also predict what the patients will need. Therefore, the setup of the system is crucial. You have to know the study, you have to think about all potential obstacles that can crop up along the way, which is difficult to pre-empt. If you don’t, and a problem occurs when the trial is running, a lot depends on how you can mitigate the situation in real time.
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CTA: Could you give an example of that?
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By GlobalDataAW: Let’s say you have two types of drugs in a clinical trial. Now, there’s a chance the two drugs can replace one another, but that wasn’t considered a possibility when the IVRS was set up. For instance, you instructed the system to give one patient Drug A and another Drug B, but if Drug B is missing, the system won’t dispense anything else.
If in a clinical trial, there’s a problem with one of the batches of Drug B – say, the release is delayed – then you may run into a shortage. If the IRT wasn’t set up correctly, you’re in a bind because there isn’t enough IP to dispense. If a patient comes to a site and they can’t receive any IP, you’ve failed.
CTA: In such instances, how do you guard against unforeseen events?
AW: First, you have to work very closely with the manufacturing team on timelines and requirements. Calculate what you have and when it will run out (this also relates to Operations, as the quantity you have depends on patient recruitment timelines) to ensure you have the new material when you need it – ahead of time. However, there are some shortcuts you can attempt to avoid a similar scenario; first, assess how you can squeeze the timelines for the release. Let’s say, for instance, the IP has not been released, you may be able to send it under quarantine from the manufacturer to the pack and label vendor. If you can get the vendor to agree, they can pack under quarantine either keeping it with them, or sending it to the depots.
Nevertheless, it’s important the IP doesn’t leave the depot to the sites, as they cannot receive the IP if it hasn't been released. This is especially the case if you have a blinded study and all the types of IP look the same. Whether this is controlled by an IRT or manually, you need to make sure this is monitored very tightly. But this is one way to squeeze timelines. Everything can be packed and labeled at risk – and this is a risk – just sitting and waiting at the depot or at the vendor. As soon as you receive approval that the batch is released, you can send it through to the sites. You can potentially save a lot of time (weeks) by doing just this, as the whole process is long and arduous.
CTA: What are some of the key considerations professionals should take into account when transporting supplies?
AW: As I alluded to previously, be aware of each country’s rules and regulations. Ensure you have all the documents in place and that all demands are met before you do anything. You don’t want to be faced with the situation where your IP sits at an airport in the US because the FDA didn’t have all the documents and therefore won’t release it. It’s always beneficial to have someone locally based, who knows the rules and regulations and understands the mentality.
Choosing the right courier is another factor that must be considered. Deciding which courier to choose for bulk shipments – or any kind of shipment for that matter – is extremely important. Everyone knows you have regular couriers and premium couriers. Naturally, you pay more for premium couriers, but at least you know what kind of service you’re getting. If for some reason the IP is delayed somewhere, you can rest assured the courier is taking care of it. For bulk shipments in particular, premium couriers are ideal.
Lastly, divide the bulk shipment into at least two shipments to reduce the risk. If you lose a bulk IP batch, this has the possibility to have a major impact on your clinical trial, and create delays. Therefore, you need to be very careful when you ship the IP.
CTA: Although in your role you mainly coordinate shipments to locations outside of Israel, for the companies that have active sites in the country, what should they consider when transporting supplies to sites?
AW: From a regulatory standpoint, Israel is not an easy country to navigate as they have tough requirements. When it comes to Israel, the thing to remember is: When someone says no, it doesn’t mean you can’t do it. If you look for another way, chances are you’ll find it. The point is not to be discouraged, not to give up; there is always a way to get things resolved.
Ultimately, logistics is all about the people. If you find the right people and develop strong working relationships wherever they’re based, you get things done.
