At Arena’s 2015 Clinical Trial Supply conference in Princeton, New Jersey, pooling supplies for clinical trials was the source of intense debate. David Gilliland, director, Clinical Supply Operations at Daiichi Sankyo, led a presentation on the very topic, and spoke to CTA to discuss the advantages of pooling supplies.
Clinical Trials Arena: Why should companies pool supplies?
David Gilliland: Well the benefits are obviously reduced manufacturing needs and bulk supply. You also have reduced packaging needs because now you’re pooling inventory across the programme levels. So overages are managed across a Program level (multiple protocols) rather than across each Protocol individually. Conventionally, when you supply a protocol you have to build an overage because you don’t know what the rate of recruitment is going to be, especially early on where there could be significant variability. As you go through the study you can continually assess recruitment and reduce the overages, but if you pool across protocols at the programme level then your overage is at the programme level and not the protocol level. That significantly reduces your shipments and your storage needs, making costs come down as a consequence, not just for manufacturing and packaging, but also shipments costs, storage costs, and so forth. It also supports the sites as they have limited storage capacity, and further reduces potentials for stuck out this reducing any potential for patient risk. The process then becomes more streamlined; you have fewer issues to deal with, such as having multiple product lots and multiplelots that have different expiry dates, if you do have to update an expiry date, you reduce that requirement considerably, especially in large and extensive studies, and so the overall cost reductions are significant. In one programme at Daiichi Sankyo we estimated significant cost savingsby as much as 50 percent.
The other thing I would mention is that we actually have one project manager who ran the entire programme, indicating significant efficiencies. Typically, you would have multiple project managers running many of the protocols, so it reduces the need for resource as well.
CTA: Would you say the pooling of clinical supplies is not a practice that companies commonly use?
DG: No, it’s not, and this is an industry issue. I think the capabilities or the solutions that clinical supply operations can bring to the clinical programme level are significant, but typically overlooked, as clinical supply operations are usually pulled in very late into discussions, so usually it is at the protocol level. However, if they’re involved at the programme level, these situations can be dealt with upfront, and the benefits could be realised that much sooner. It’s really within the organisations to address their approach.
CTA: Are companies in that sense missing out on an opportunity to streamline processes?
DG: I would say so, yes. A lot of companies are missing out on this opportunity, however it takes having good knowledgeable staff to manage the process, so that they have expertise of IRT systems, how to manage inventory and overall study planning, and being able to make good judgement calls. As long as you have good knowledgeable staff, there is no system that can ever replace that, no matter how good it is.
CTA: What are the challenges you’ve encountered when adopting this kind of strategy?
DG: I think convincing your own internal teams. From a regulatory perspective, we didn’t have that big a challenge. I know other companies that have tried to do this do have internal concerns. From a quality perspective, some had never come across this before, at least domestically, so they had a lot of concerns. We went through the process in a lot of detail with them,and I think one of the biggest buy-ins for them was that it reduced their work burden because we reduced their batch records by two-thirds and that’s a significant saving in resource. However we also established checks and balances in our procedures at the outset which gave a great deal of confidence to the Quality organization.
CTA: Can you provide a real life example?
DG: A pooling strategy was suggested within Daiichi Sankyo quite a few years ago and we were looking for a programme that matched this model and indeed one came along. Initially we wanted to change the packaging designs upfront, but as the study designs evolved, we finally got to a situation where we were at least able to manufacture packaging that matched all the protocol needs within the Program. Once you have that that’s a significant piece of what you need because if the packaging doesn’t match then there’s practically no hope of being able to pool in the manner in which we wanted to (late assignment of common patient kit inventory), so it does require that everything matches.There may be cases where you need to manipulate the packaging somewhatas the benefits are pretty huge at the end of the day, not just costs and supply but on reducing potential for stock outs, which reduces patient risk. At the end of the day we have a commitment to our patients and they are the most important aspect of the study. The challenge for us was gearing up for the start dates; having multiple protocols which don’t always start at the same time, and there are issues at the tail end of any programme that we have to deal with. But just getting started and getting the buy-in is the biggest challenge overall while still meeting study start dates.
CTA: Going forward, where does Daiichi go now in terms of this programme? Also, what advice would you give other companies looking to pool supplies?
DG: I think one thing we’ll be looking at upstream will be IVRS vendors – can they really do what they claim they can do? That was a hurdle for us. It took a lot of time and effort when we challenged the IRT systems, it wasn’t doing what they claimed it could do, so we had a heavy involvement in trying to sort that out, but we eventually did. The labelling considerations and regulatory requirements, we had good knowledge of what the needs were, but we employed the Clinical team, CROs and regulatorysupport because there can be different interpretations on what the regulations really mean. We wanted to make sure we dotted our ‘I’s and crossed the ‘T’s. As long as you do your homework upfront the benefits downstream makes for a system that is more easily managed. Like I said, we have one project manager overseeing operations at a Program level and I think that’s pretty significant.