Supply for your supply chain

Pressures are mounting on clinical trial supply chains. Ariette van Strien of Marken discusses the new logistical challenges faced by pharmaceutical companies with Jack Wittels, and outlines the solutions available.

More distant locations for investigator sites, an increase in the ratio of biological to small molecule drugs, and tightening FDA and EMEA regulations are all affecting logistical processes within clinical trial supply chains. Pharmaceutical companies are having to adapt to the new market, and, for many, this involves venturing into unchartered territory.

"If you were to ask a pharma company how much they spent on logistics a few years ago, the chances are they wouldn't have been able to give you an answer," says Ariette van Strien, senior vice-president of commercial operations at Marken, a global clinical supply chain solutions provider. "They would have subcontracted it out to third-party vendors and left it at that. Now, FDA scrutiny means they have to be a lot more selective in the vendors they use - the pharma companies bear responsibility for the quality of the products delivered.

Rethinking strategies
The increasing number of biologics poses the greatest challenge to pharmaceutical firms. The drugs have strict time and temperature parameters that must be maintained during shipment. Within these stringent criteria, pharma companies must also find the most economical shipping option.

"With the continuing shift of clinical trials to more remote locations, and the number of biologics expected to increase, clinical trial supply chain logistics look set to become increasingly complex."

"It's forcing them to think in a lot more detail about their packaging," says van Strien. "They're having to choose between active packaging solutions [when shipments are connected to an external power source providing temperature monitoring or, in more sophisticated models, exothermic and endothermic reactions for temperature regulation], and passive packaging solutions [no electricity supply]. Staying up to date with this market is absolutely vital; it's the only way pharmaceutical companies can ensure the best quality and most cost-effective solution."

While this may be the case, many pharmaceutical companies are finding that investing time and money in keeping up with these new markets is not economically viable. This is one area where Marken enters the picture. Founded over 30 years ago, the company specialises in life science shipments, supporting over 49,000 investigator sites in 150 countries, and has depots in six of the seven continents.

"We have a strong team of logistics regulations and pharmaceutical experts, giving us unparalleled expertise in the sector," says van Strien. "Pharmaceutical companies have to ask themselves whether it really makes sense to have their own in-house group to invest time and resources to figure out the best solution for a complex supply chain, when we could solve their problem far more efficiently."

A one-stop shop
Marken offers the life science industry a fourth-party logistical service (4PL), acting as a one-stop shop for supply chain management; handling distribution models, ensuring regulations are met, and selecting and managing any additional necessary vendors. In addition to reducing time and administration costs, Marken also uses its global presence to cut financial outgoings for pharmaceutical companies, particularly when shipping to more remote locations.

"Companies usually send between eight and 15 shipments to set up investigator sites at the beginning of a trial," explains van Strien. "We consolidate the material wherever possible, so, in this case, we would reduce the number of shipments to three or four and store the supplies in our regional hubs. From there, we can send them to the investigator sites in the quantities they need, rather than overloading them with materials that end up going to waste, which often happens. This reduces material and logistical costs for the pharmaceutical company."

With the continuing shift of clinical trials to more remote locations, and the number of biologics expected to increase, clinical trial supply chain logistics look set to become increasingly complex. As van Strien summarises: "Pharmaceutical companies use Marken when they need know-how in getting a product from A to B." This level of expertise, once considered a luxury, is becoming a necessity.