Tag | clinical trial supply emerging markets

Adrian Peskett, has worked at Pfizer for 11 years, initially involved in establishing a Global Clinical Supply Chain. The role included work to ensure alignment of global site processes and standards, as well as the development of demand planning tools across the supporting functions. For a year he then worked to establish an Asian Pharmaceutical Sciences business strategy for Pfizer. In 2008, he began working with the Clinical Supply Logistics group and has been involved in implementing the global distribution strategy, including management of Vendors, mapping the depot network and implementing a global brokerage

Gerald Clarke: Adrian, it’s almost been a defining trend in recent years in the clinical trial space that people are moving clinical trials increasingly to the emerging markets. What are the main reasons for this, and do you expect this trend to continue?

Adrian Peskett: From my experience, there are a number of both push and pull factors. One of the pushes is that we are quite saturated in the traditional clinical trial markets, and many companies are looking for alternative countries to do their clinical research in. Another factor is, of course, that there is a huge population in a lot of those other countries, a naïve population at times, and a population where the facilities are now getting better. The regulatory requirements and the Ministry of Health in a lot of these countries, they have put things into place which makes clinical trials possible where sometimes they hadn’t been possible before. And I think there is an element, where we’re all a business, so there’s an element of cost as well. I think generally, people now are looking at global clinical trials, which means including emerging markets, as well as the western traditional clinical markets.

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Clarke: What are the main challenges with working within emerging markets?

Peskett: Certainly from the perspective of a lot of the companies that I work with, or have worked for, language is one of the key challenges. So English is typically used as part of the communication – in some of the emerging markets, the level of English, perhaps, is not as strong. So that’s one of the challenges, to make sure that you understand what the clinical sites of the investigators are actually requesting from you, or indeed, the customs and the other regulatory authorities. But I think distance is another thing as well – a lot of the strategies are set up so that they are orientated away from the emerging markets, so you need to set up either new depots, or you will ship direct to site, but that distance obviously provides a logistical challenge to consider. And of course, then there’s a variety of physical conditions. So I’m talking really about the environment, and the challenges that that can bring, aligned with the infrastructure. So the infrastructure is not always as developed in some of the clinical sites, for getting the materials to the clinical sites. So that can provide an element of challenge as well.

Clarke: How can companies standardise strategy, while taking into account the needs for individual countries?

Peskett: It’s difficult, really. I think there are a number of elements, where strategy can be standardised. I think you can look at standardising, perhaps, who you work with as a courier, so that you have an understanding of how they work. You can standardise your labelling by getting a regulatory template in place for a particular country. You can look at perhaps even standardising your brokerage and your distribution strategies. So there are elements of the whole supply chain where you can actually standardise, but I think within that, you need to understand that you always have some variable flexibility that’s required. So with the labelling, for instance, depends on the product, as to what information you actually have to have on there. Equally, with the courier process, for instance, you will need different documentation as you come to do the importation. So you can have a more standard, holistic strategy, in how to actually manage your clinical trials, that includes the emerging markets, but I think you always have to be aware and cognisant that each individual country actually does have its own regulations, does have its own unique challenges, and that’s something that you will need to address on an individual protocol basis, depending on what materials are being used in that protocol.

Clarke: Adrian, why do you think that forecasting is so important in these emerging markets, and how can it help the clinical supply process?

Peskett: Forecasting is important from all perspectives, to be honest, with any parts of our business. Without a true forecast, then you’re always being reactive to whatever you’re doing, and as a result, inevitably, there’ll be unforeseen challenges, which will lead to delays, and if you haven’t forecast reasonably accurately, then that’s going to lead to potential problems further down the line. I think for the emerging markets, forecasting is just as important, if not more important, given the fact that, as I’ve already mentioned, that there are longer logistics challenges potentially in place, and certainly, importation, for instance, into certain countries, can take months to get those supplies in. And without effective forecasting about how that protocol’s going to run, then you will find that you will be short of supplies, and either having to manage them in a site to site basis, or even, going without supplies for patients.

Clarke: In what ways do you think that clinical trials supplies changed in recent years, and what technologies do you see as having the greatest benefit to CTS in the next five years?

Peskett: I think we’ve definitely seen a change, obviously, in the geographical spread of where the clinical trials are taking place. And I think that will continue as mentioned. I think it will continue to move to a more global basis. The technologies, as a result, have had to improve, in alignment with that, so I now see a lot more IRT protocols, rather than manual protocols that are in place. I see that we’re continuing to improve the inventory systems, within companies, and also to improve the information flows within the systems that we’re using. So over the next five years, I’d expect to see a lot more linkage between the CRO systems, the IRT systems, and between the courier systems, so we can get real visibility of where those supplies are, be they in a depot, be they in transit, or be they at a clinical site. And I can see that this will be pretty much the trend as we move forward – it’s to improve that visibility, so that we can actually have global visibility of where all the material is, how it’s being managed, and look at that across all of the countries that are involved.

Clarke: You’re speaking at the Clinical Trial Supply Europe event in Frankfurt this January – why do you think events like this are important?

Peskett: I think, really, because it builds a good platform of knowledge; importantly, it shares experiences to show people that you’re not alone in this process. I think it also offers the opportunity to network, and to establish some go-to people for help, and for queries if you’re facing a particular challenge. You know, are there other companies facing those same, similar sort of challenges? I think really, where we are with this part of the organisation within pharma, we are all focussed on ensuring that our patients receive those supplies, and I think that’s probably the most important thing that we do, is ensuring the patients get those supplies. And we can help each other in that. We’re not impacting any of our companies’ IPs, or any of the other aspects where we might be getting a competitive advantage. So this is an area where we can share information, where we can share learnings, where we really can use our network, and we can ensure the patients get that drug.

If you would like to find out more about this topic and the Clinical Trial Supply Europe conference in Frankfurt this January 21stto 23rd, visit us at www.clinicalsupplyeurope.com

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