POOLING SUPPLY CHAINS


What is the current supply chain set-up that you’re dealing with?


My current role is a bit multifaceted; I’m leading the supply chain group here at Constellation Pharmaceuticals that includes predominantly clinical trial supply. I have a couple of people on the team who manage trial supply and vendors for clinical trial material for global studies. We’re also working on setting up a commercial product launch, so we are doing vendor selection, mapping, and timelines, etc. We also manage logistics for both domestic and international logistics for API and drug products, and then we also do vendor sourcing, vendor selection, and then vendor management and ongoing business strategy.


Can you break down what supply pooling is and how it fits into the overall clinical trial supply strategy? This is a way for clinical trial sponsors to better maximise the clinical trial materials (CTM) supply they have. This is to look at the material we have and keep it as generic as possible to support as many trials as possible and reduce costs and waste. This gives you flexibility for studies that haven’t been fully planned yet, or for studies where you don’t yet understand the enrolment rates. For a traditional trial, what most sponsors will do is label whatever they need for that trial, specifically for that trial. If they need 1,000 vials, they will print 1,000 labels for that product. The problem is, that label is just for that trial, whereas supply pooling means that you can hold some back so whatever is left over can be for future trials. It’s a way to shorten lead time – because lead times for labelling runs can sometimes be several months, supply pooling often helps to shorten that time.


How can supply pooling help prevent waste and cut costs?


In terms of reducing costs, the cost reduction you get will be not wasting drugs. Let’s say you


“Let’s say that you are several months into a trial, and it gets cancelled. If you’ve already put a label on the product, then it’s essentially wasted.”


82 | Clinical Trial Supply Handbook


are several months into a trial, and it gets cancelled. If you’ve already put a label on the product, then it’s essentially wasted, whereas if you engage more supply pooling models, then that investigational medicinal product (IMP) is easier to redirect to other trials. One of the big benefits is time to respond. If you have a base label with an expiration date and other CTM- specific information but not the trial number, you can then design smaller ancillary labels that can be applied to those vials. The vendors are really the prime ones who can help you out with that. Some vendors can have it ready for you in a couple of weeks. A lot of the vendors will have capabilities to do just-in-time labelling for this need. Getting vendors involved is helpful as they can guide you to something that’s helpful; the main idea is to be flexible and creative.


What kind of distribution models work well with supply pooling set-ups? With supply pooling, it’s more about the inventory set-up as a whole because you need to ensure that inventory is stored in sufficient levels at each of the depots. This is where the vendors will be able to guide you with their own experience in this area.


How has the pandemic affected your work? It’s mainly impacted us from an enrolment standpoint. More patients are hesitant to take part in a trial that requires frequent visits to a clinic. In the early days, there were some issues with the vendors who were dealing with staffing and capacity issues, but that levelled out. Then, as time went on, the clinical supply vendors got back on track.


What kind of innovation is really shaking up the industry?


A couple come to mind. I keep waiting to see more on e-labels. If there’s a way to have more minimal labelling on the drug, and get a website to show your patients the full investigational information of the drug, that would make shipping a lot easier. I haven’t really seen it much at this point yet. Then there is direct-to-patient (DtP). There has been a lot of talk about what we discovered globally throughout the pandemic, so these are the two things I would like to watch and that I think will be become a bigger part of the industry in the future.


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