Article: The Italian Clinical Trials Landscape
By Maurizio Orlandi |
Originally published in Pharma Board Room on June 6, 2016.
What have been the main changes in the pharmaceutical logistics market that World Courier has had to adapt to?
The requirements for quality and compliance have increased significantly over the past decade. World Courier was well prepared for this shift, and it took a lot of work to make the preparations needed to be fully responsive to increasing demand for quality, compliance activities, and risk minimization. To do this we had to tailor our structure to reflect the changing market needs, and adapt our time and resource allocations significantly. Of course, this trend is global, not just Italian.
It is also important to recognize the global biotech and biopharma industry has increasingly externalized logistics capabilities in recent years, which has also led to a change in the way that we service them. Until a few years ago World Courier was mostly shipment oriented, whereas today our central focus has expanded to include a much greater degree of logistics and additional services. Shipment or service driven, our goal is to be a partner of the biopharma industry as a whole, and our structure, investments, and operational guidelines are all developed with our customers’ needs for the present and foreseeable future in mind. Moreover, as we learn our customers’ business and logistics goals, we strive to leverage our global network, highly trained personnel, and our expertise in the field to design and execute supply chain programs that mitigate risks, maximize returns on investment, and advance global healthcare.
What makes Italy different from other European logistics markets?
In Italy we have some very unique rules unlike anything seen elsewhere in the EU. Some of these are for the better, ensuring greater regulatory control at critical junctures; others however are quite burdensome, and the same result might be accomplished with much more straightforward regulation.
For a small issue you might have to study four or five local laws, and multiple agreements between the central government and regions to understand how to interpret a particular issue in a specific situation. Of course, the situation is further complicated by Italy’s regional healthcare systems, and the variations in how healthcare is managed across them. An example, importing biological samples to be tested at a central lab here in Italy requires that a number of very specific and particular rules and filings are made, especially when coming from outside the EU. As per World Courier policy, we will normally only approve shipping once all of the documentation is in order; the requirements are complex, but meeting them is our daily challenge and we are always pleased when our colleagues elsewhere in Europe fail to realize that it is much more complex to carry out certain functions in Italy, as it means that we are doing our job seamlessly.
Uniquely, World Courier Italia has joined the Italian biotech association, Assobiotec; what do you hope to accomplish with your new membership to this association?
Being directly involved in the association means that we are able to listen to biotech professionals and share our point of view, our expertise, and give some indication of what things are actually like in the field. Other members have their own perspectives on each issue, and we believe that in some cases ours can be somewhat different and bring some additional insight into some problems. As a logistics company, we may have different thoughts on how a certain problem can be solved, if a certain strategy is feasible, logical, or cost effective. By having an input into association discussions, we hope that the resulting policies or solutions can be made stronger, and at the same time that we can learn from the other member’s experience and they can learn from ours.
World Courier strives to be aware of our clients needs, and to do so we focus on maintaining strong client relationships; however, joining Assobiotec means that now we are part of a forum where we can be a part of the discussion at an early stage, with no direct commercial incentive. Thus, joining this association was a strategic commitment to understanding the industry emerging needs and challenges as early as possible.
"World Courier strives to be aware of our clients needs, and to do so we focus on maintaining strong client relationships."
How many of your clients are Italian? Is there more inflow or outflow?
We have more global customers based outside of Italy for sure. Certainly Italian companies are investing more in innovation now than ever, but there are some economic restraints on the public sector and they may be required to use cheaper options. This is a limitation on having Italian customers. There are of course many Italian companies and academics doing clinical trials at present; however, relatively few are global, multi-center phase III trials at this point in time.
To wrap up, World Courier is a global force in healthcare logistics. But Italy has a few big players, Ferlito and Bomi for example. What are you doing to maintain your competitive edge?
World Courier’s ultimate goal is to move medicine forwards by bring an added value to the industry as a whole. For example, we supply home healthcare opportunities by arranging direct-to-patient clinical trial services at the global level. We are currently exploring the regulatory situation in Italy for this, which is of course quite complex. World Courier has long understood that the shipments we manage can be life-saving for patients and very costly for the manufacturers, that’s why we rely on our expertise and top-class logistics to ensure the integrity of trial products all the way to the point of patient administration. In this sense, our direct-to-patient services will be a natural extension of our current role, as we attempt to do our part to support the industry wide shift towards home-care and home based clinical trials, which of course could help to achieve significant savings in overall healthcare and drug development costs, and improve the patient experience.
In terms of competition, World Courier has set the standard for quality healthcare logistics for 46 years now, and we will surely continue to do so in the future. We have always made the necessary investments to deliver an unparalleled standard of service, and our patient centric approach drives us to work to remove barriers to care, increase access to clinical trials, and connect patients to vital treatments when and where they need them.