With globalisation complicating the delivery of clinical trials, having a truly international sourcing company has become essential. Robert Donnell, head of business development at Durbin, talks about the value of global suppliers and the importance of price transparency and ethical partnerships.
Conducting an efficient and medically successful clinical study has become increasingly demanding for the pharmaceutical industry. And that’s particularly true when it comes to sourcing comparator drugs, an area where bad decisions can cost a sponsor company a great deal of time, effort and money.
It may be a relatively small part of the pharmaceutical R&D process, but it’s certainly not a simple one. All kinds of things need to be considered. These can include product availability, expiry dates, local regulation and the product’s source.
New guidelines from the International Society for Pharmaceutical Engineering aim to remove at least some of that complexity, but problems still remain. As a specialist pharmaceutical supplier, Durbin aims to reduce the costs to sponsors. The company has years of experience in procuring and delivering comparator products to trials based all over the world.
It has experience working with many of the top pharmaceutical companies, as well as navigating other local parts of the clinical supply chain. Here, head of business development Robert Donnell explains the importance of quality international sourcing.
What are the key problems and challenges associated with comparator sourcing?
R Donnell: The key challenge that we encounter is ensuring that we can meet the sponsors’ requirement for supply while maintaining a low cost base for the sponsor. That’s both what drugs and what documentation they need. Increasingly, as the supply chain gets more complicated, we’re seeing an increase in counterfeit goods
and other hazards.
The challenge we have is establishing secure, reputable supply chains either direct to manufacturers or through audited, approved wholesalers, and being able to get that stock for the sponsor company.
What expertise does Durbin have in solving those challenges, and what advice do you have to help sponsors overcome the challenges?
R Donnell: The last thing a sponsor wants to do is procure a product for a comparator that is either counterfeit or hasn’t been stored properly. What we bring to the marketplace is expertise of what has to be done. We have a network of suppliers across the globe. That network has been established for over 50 years and includes audited, approved wholesalers and suppliers across 110 different countries. They have to meet our standards. And that, combined with relationships with manufacturers and major pharmaceutical companies also allows us to buy direct from manufactures for sponsors willing to divulge trial information.
How does globalisation complicate the clinical trial process, and how can Durbin’s global sourcing strategy help overcome that?
R Donnell: It’s worth looking at things from a historical perspective. 40 years ago, you had trials in the US, and some trials in the EU. Moving forward from that, a global trial was one that happened in either the US, Canada or the EU. Now we’re looking at a truly worldwide trial industry with trial locations including Russia, China, the other BRIC countries, Eastern Europe, the Middle East and Africa. We all know that sponsors are going there for treatment-naïve populations and because the costs are lower. That brings a host of challenges to the clinical supply-chain routes in different ways.
If it’s a blind trial, where do they procure the comparator from? Do they use US drugs, or do they use European drugs, which can be up to 50% cheaper? How then do they get the drug across borders? What are the regulations? How do you get a single batch of drugs across the world? What documentation do they need? Each of these challenges comes with its own set of questions about how to get that documentation, how readily available the product is and whether or not it has to be procured directly from the manufacturer.
If you look at some of the biggest growth areas in trials where there isn’t necessarily a comparator used but there are standard care medications used, you see the issue. We could be procuring the same drug for an open label study in 20–30 different countries ranging from Thailand, Korea and the US to Turkey and others.
What any sponsor needs to do is to link in with that specialist provider in a global network, which can deliver them a product from an individual country while assuring quality. They also need to be able to ensure the possibility of securing it in a single batch direct from the manufacturer and then using that bulk purchase in a market or a country where there is price advantage, for instance, using a European drug rather than a US one.
Could you tell us some more about Durbin as a global company?
R Donnell: As trials become worldwide, sponsor requirements are for a supplier that can act globally. Durbin has been able to take its heritage of sourcing from over 110 countries and supplying to over 180, and using that background, experience and contact set to provide a global solution for clients in both sourcing and distribution.
Can you expand upon some of your specific experiences in countries like Asia, China and Russia?
R Donnell: One of our most interesting recent projects has been supplying medication for oncology treatment across South- East Asia. We were buying directly from the innovator in nine different countries, keeping those drugs in the country and, in some cases, shipping them direct to the site, in others to distribution centres. Durbin acted as the central hub for all order processing and approvals of those goods. That meant the sponsor had one simple interface to procure those drugs and we used our global network to ensure success.
Transparent pricing and good partnerships are obviously central to Durbin’s corporate mission. How do you go about negotiating price margins and building strong relationships?
R Donnell: For us, transparency pricing is just a feature of what we want to build as a company. At Durbin, we believe in creating a true, long-lasting partnership with our clients. We don’t think we could have this type of relationship without trust and openness. And it’s precisely because we want to be open and transparent, that we conduct our price negotiations so fairly.
We will let people know exactly what we paid for a certain product, what the route was, and then negotiate a mutually acceptable margin. What this does is identify to the sponsor that we are an ethical, responsible company. It gives them confidence that they are getting a good deal and that any discounts we negotiate are in their interests. Considering we have eight different operating divisions and a global network, we can use the power of Durbin to negotiate those discounts.