Carolina Galicia explains how World Courier Mexico has strengthened its leadership position for clinical trials logistics and leveraged its cutting-edge transport and warehousing capacities to better meet the needs of pharmaceutical companies and handle the supply chain management of their high-value, highly specialized commercial products.
How has World Courier Mexico been developing over the last two years?
Our recent results have been extremely promising. In 2015, we have been able to display and even exceed the growth rate we were targeting, and we hold the ambition to further grow 30 percent in 2016. To nurture this growth, we rely on the outstanding competitive advantages that World Courier boast at a global level, which have been further heightened since we integrated with AmerisourceBergen in 2012.
Globally, World Courier is for instance fully compliant in transport requirement of the three most important quality standards that are relevant for clinical trials and commercial products: Good Clinical Practice (GCP), Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) [often referred to as GxP, e.d.]. Our customers can also access investigational pharmaceutical depots located in 14 strategic and emerging markets, many of them in Latin America. As pharmaceutical companies are increasingly looking at service providers that can offer a multinational service network, we are also able to leverage our international network of over 140 offices in more than 50 different countries.
While it used to exclusively concentrate its efforts on clinical trials, World Courier has recently been entering the commercial product market. How successful have you been in penetrating this new, competitive market in Mexico?
I am particularly glad to announce that, a few months only after we effectively entered the commercial product market in Mexico, we have already closed a commercial agreement with one pharmaceutical company. In the meantime, many other pharma players have already been displaying a real interest in benefitting from our solutions, so we expect that many more customers will join us within the upcoming months.
As we are already able to comply with the demand and the regulatory requirements of these customers, our strategy is to develop this new offering without further investing in our current warehouse and transport capacities. Historically, World Courier used to be exclusively focused on clinical trials logistics, which usually imply more stringent quality, regulatory, and temperature requirements than for commercial products. Considering this specify, we now look at leveraging this expertise and cutting-edge capacity to specifically target the highest-end of the commercial product logistic demand, such as biotech treatments or APIs, whose manufacturers are particularly interested in the high-value services we can deliver. As a result, our market approach at the moment is more focused on high-value products than on a volume model, although we of course look at expending our current client basis.
We consider this historical specialization in clinical trials our best competitive advantage as we now enter the commercial products market. While many of our competitors have to upgrade the standards, processes and warehousing capacity, World Courier on the contrary arrives in this market from a most exigent part of the value chain, and is already ready to comply and exceed the most exigent demand of our new commercial product customers.
Nevertheless, we have already invested substantial resources to train our associates in order to better meet the needs of our clients in this specific market segment. We have also been recently increasing our participation to local events and conferences throughout the country to raise awareness around this new service offering. Finally, the Mexican affiliate now holds an in-house business development team to develop new, local commercial product partnerships, while for clinical trials most of our contracts were usually handled at international level.
Even for the most specialized companies within the pharmaceutical landscape, cost-efficiency now becomes one of the most important parameters. How do you balance this increasing focus with your highly specialized offering?
Rising R&D costs, increased competition among manufacturers of all sizes, and difficult pricing negotiations are indeed driving manufacturers to be more careful in their resources allocation. As a result, manufacturers constantly search for ways to be more cost-efficient in both clinical and commercial operations, seeking optimal value to streamline development costs, timing and processes. This cost pressure is also transferred to the industry’s service providers, while – obviously – pharmaceutical companies are not ready to lower their expectations towards our service delivery.
World Courier value proposition is clearly based on the utmost quality of our transport and warehousing capacity. As a result, our solution offering isn’t the cheapest in the market place: it is truly our service excellence that sets us apart from the competition. In this regard, it is then crucial we manage to create close enough relationships with our potential customers to be able to truly showcase the unique value we can deliver to them.
When we start negotiating with new clients, they oftentimes point out that our service costs may be higher than some of our competitors. Nevertheless, as soon as they come to our facility and truly gauge the incredible quality of our processes and the utmost specialization of our transport and warehousing capacity, they then acknowledge that World Courier is the only logistic company that can truly meet their exigent needs.
What have been some of the recent innovative solutions that you have launched in Mexico?
An unbroken temperature chain is essential to both patient safety and product success- and it demands flawless execution in everything from the transport route selected to the packaging used to maintain product integrity across all conditions. In today’s increasingly complex environment, more products require temperature-sensitive transport than ever before, and we expect this need to further gain in importance as biotech treatments already represent around 20 percent of the total products sold within the global pharmaceutical market.
To assist pharmaceutical companies with the packaging selection process, last summer World Courier launched its Climate Optimization Research & Engineering (CORE) Labs. Science-led and data-driven, CORE Labs is a solutions center focused on helping manufacturer partners evaluate, validate and select the right climate-controlled packaging solutions for each specific product and often for a specific route.
Our CORE Labs researchers have also created a specific packaging solution that drives significant performance enhancement — Cocoon – specifically designed for API, clinical trials supplies and sensitive commercial drugs. Thanks to its unique honeycomb vacuum-insulated panels, Cocoon can maintains temperature up to 40 percent longer than comparable products on the market while weighing up to 30 percent less. This powerful combination of lower weight and higher performance greatly contributes to eliminate the need to sacrifice quality for cost. Finally, Cocoon’s passive system requires no external power source during transit, which is more cost-effective and ecologically friendly than for active packaging systems.
As the logistics specialist for clinical trials in Mexico, do you feel clinical trials activities have been recently picking up in the country?
Clinical trials activities in Mexico have been indisputably increasing over the past years, as pharmaceutical companies now benefit from the recent agreement signed between IMSS [Mexico’s main social security institution] and Cofepris, which finally opened the doors to conduct clinical activities among the institution’s patient population. More importantly, Mexico’s public stakeholders have been also improving the country’s regulatory framework to ensure pharmaceutical companies and clinical trials sponsors can more easily and more swiftly conduct clinical trials activities in Mexico. This is particularly true for clinical trials’ approval timelines, which have been greatly reduced over the last two years.
Nevertheless, conducting trials in multiple geographies also produces a number of regulatory issues that still need to be addressed by pharmaceutical companies and CROs. Each country has its own clinical-trial regulatory requirements, and those regulations are constantly changing. Failing to adhere to regulations can derail timelines and budgets, so vigilantly monitoring market-specific requirements is absolutely crucial. In this regard, World Courier can assist its Mexican and international clients with permit applications, customs clearance and brokers and import duty advancement to expedite clearance, which contributes to both make Mexico a more attractive clinical destination and our customers’ clinical trials more cost-efficient.
What are the new services you have been adding to your clinical trial portfolio?
“From a global perspective, two of the biggest obstacles to conduct a successful clinical trial are patient recruitment and retention”
From a global perspective, two of the biggest obstacles to conduct a successful clinical trial are patient recruitment and retention. To address this issue, some trial sponsors have been recently developing and implementing a trial process that is truly shaped around patients’ daily behaviors – and then conducted at these patients’ homes [called “Direct to Patient” or DTP model]. This model has proven increasing patient recruitment by up to 60 percent and helping maintain patient retention at over 95 percent, by creating significant time saving and reducing constraint for the patients. With the DTP model, the drug development community can also gain access to a wider patient population, rather than focusing only on patients located near clinical sites or health clinics. Finally, this model is particularly optimal for trials involving geriatric and pediatric patients, but also for rare and chronic diseases.
Nevertheless, managing such a decentralized process requires precision in coordinating clinical staff, clinical trial product and patients. In 2015, World Courier entered into a partnership with the Medical Research Network (MRN) to create a more highly integrated model for community-based clinical trials. This collaboration has enabled us to offer a unique Home Trial Support (HTS) service that makes at-home clinical study participation easier than ever. Our HTS service notably includes a fully qualified nurse who visits the patient in their home and performs all medically necessary trial protocols (infusion, collecting blood/urine samples), while World Courier also delivers and retrieves any related materials to the patient’s home. Finally, World Courier now offers Cubixx®CT, a small access-controlled refrigerator that stores drug products in the patient’s home. Cubixx®CT can store medication at an optimal temperature, track its usage and provide reports to researchers.
What are the objectives you want to reach over the next two years?
The core of our activities will remain centered on clinical trials, but one of our foremost priorities is to expand our customer basis in commercial product services. Considering our unique value offering and the interest that locally implanted pharmaceutical companies have already been displaying, I am confident new customers will soon choose World Courier as their partner of choice for handling their high-quality, high-value treatments. Given this demand, we also think at further investing in Mexico and developing an additional warehousing footprint in the country, which will be used for both commercial and clinical trials products.
Overall, World Courier’s fundamental mission really is to become part our clients’ eco-system and genuinely share their goals and objectives. Many pharmaceutical companies in Mexico are still looking for binding a reliable partnership with a highly specialized, healthcare logistic expert, which also boasts a high-quality, international network – and World Courier totally fits this picture!