Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert

By Trisha Gladd, Editor, Life Science Connect

Legislative changes, the patent cliff, and global expansion are forcing pharmaceutical companies to review their existing business models and adjust them in order to remain competitive. Gone are the days when pharma can depend on blockbuster drugs to carry them to financial heights; instead, successful pharmaceutical companies are taking a different approach and looking to demand to determine their next step in drug development and supply chain management.

Michael Trocchia, Supply Chain Global Lead for Cell Therapy Products at Novartis

For Novartis’ Michael Trocchia, this demand has resulted in a new role as the Global Supply Chain Lead for Cell Therapy Products. In this article, he discusses the challenges associated with managing the supply chain for a temperature-sensitive product and what best practices he applies in order to contribute to Novartis’ ability to maintain a top spot in big pharma.

Think Globally, Execute Individually

A successful supply chain strategy is at the core of any great pharmaceutical company. After all, what good is it to make a life-saving product if you can’t get it to the people who need it? This is why Trocchia says having a robust sales and operation planning process (S&OP) in place is one best practice he highly recommends. As part of this strategy, the executive/leadership team within a company regularly meets to review projections and determine a single operating plan that takes into consideration the demands of the customer, the company’s strategy, and the overall business plan.

“If you don’t have a robust forecast, then you can’t have a robust process. You’re either making too much or not enough of your products. So having that process in place is your bedrock,” says Trocchia about S&OP. He adds a company should also have an enterprise resource planning (ERP) system in place to support the S&OP process, as well as inventory control. “Any CEO is going to want to know how much product you have, when it expires, and how much you project for next month. You have to have a system in place that easily supports all of those processes, so you can access that information at the touch of a key.”

Once the product is ready to go to market, Trocchia says the Novartis supply chain is run on a global basis.  As he explains it, instead of thinking on a country-by-country basis, one global plan is formulated and then it is executed country by country. “When a new drug comes to market, we integrate that into our existing supply network using our Supply Support Team, or SST, which forms initially on a global basis. There’s a global leader and they cover a cross functional team that has regulatory, marketing, and supply chain experts in the various countries,” he says. “These tactical teams actually put the process in place locally to launch the product. They figure out from a headquarters point of view how we’re going to move the supply, what the supply points are going to be, what the launch is going to be, the timing around that, and the regulations regarding transporting the material to and around the related countries.” The first few countries to launch are usually the bigger ones like US, Japan, and some or all of Europe. In each location, a local SST is formed and they figure out what they’re going to do to launch it in that country.

When it comes to transporting that product, anyone in supply chain management knows that regulations will certainly be one obstacle that will need to be overcome. Trocchia says, for this, Novartis has global consultants, as well as local people in every country in their network, who they can tap into for expertise. Every product and its shipping lane are analyzed to make sure they’re in compliance with the regulations of the countries where the product is being shipped and received. In addition to global regulations, another strategic challenge Trocchia has to overcome is maintaining a specific—and very cold—temperature during shipment.

New Ventures Bring New Challenges

In August 2012, it was announced that the University of Pennsylvania and Novartis would form an alliance to study and commercialize novel cellular immunotherapies using chimeric antigen receptor (CAR) technologies. As a result of this commitment to develop cell therapy products, a new area for Novartis, Trocchia was faced with challenges he’d never encountered in his previous position of Director of Supply Chain Project Management. “My new role in cell and gene therapy is very specialized . The first thing I had to do was figure out what the challenges were of transporting cell and gene therapy products  and we have identified several issues.,” he explains. Trocchia found the most difficult challenge was temperature control. Cell therapy products are frozen and have to be kept at a temperature of -140 degrees Celsius throughout shipment. To accomplish this, he says Novartis uses cryogenic storage dewars, which are essentially large thermoses cooled  with liquid nitrogen. The liquid nitrogen maintains  the temperature of the product for 7-10 days.

The sensitive nature of cell therapy products also presents challenges that, if not overcome properly, can endanger the patient who receives them. “We’re currently dealing with autologous products, which means we’re actually taking cells from a patient, treating those cells, and then getting them back to the exact same patient. That’s not trivial.” He adds the chain of identity is key because those products are being brought in with hundreds of other patients’ products. They always have to identify where that product is and it has to be labeled properly. “There can never be a mix-up,” says Trocchia. “That’s top priority.”

Invest In Your People

When structuring a supply chain business model, there are many external factors that need to be considered, such as suppliers, customers, and distributors. However, a critical factor in increasing operational efficiency is also your internal team. As exhibited by the supply chain support team tasked with forming a strategy for each country in the Novartis global network, a wide range of expertise is utilized. This diversity in background and experience is what Trocchia believes is imperative for success. “You have to have good people and you have to have a plan for how you’re going to keep your staffing at optimal experience,” he says. “Make sure you have a good mix of backgrounds. This means hiring people who’ve taken on more than just supply chain—production, finance, quality management—and then bring all those experiences together and use them well.”

Part of the shift toward a new strategy in pharma includes relying on innovation to come up with new ideas and new products. Innovation is driven by the people within a company, so by hiring the right people and making them a priority, a company builds a network of employees who are dedicated to a common goal and are driven to achieve it.  And as one of the top-ranked best drug companies by Forbes in 2013, it seems Novartis is doing just that.