Case Study Category: Supply Chain & Infrastructure Development

Emerging / New Market Entrant - May 29, 2024

Design & Build a Rare Disease Supply Chain in Europe

By kingdesign

A US-based start-up biotech with a European HQ in Switzerland was preparing for its first launch in Europe. It did not have supply chain capabilities in Europe, and it needed support to design the supply chain and prepare it for commercialization. Our team designed and built an outsourced supply chain in Europe with capabilities for the EU and ex-EU geographies without commercial infrastructure. We developed a strategy mapping the financial and physical product flow options, including cost impacts. We also outlined the “last mile” options across markets, including hospital vs. retail and the potential use of infusion centers and home care. Finally, we led selection of a 3PL partner to support pan-European distribution, including order-to-cash.

Mid-Size / Large - May 29, 2024

Extend a Distribution Network Into a New Region

By kingdesign

A US-based midsize biotech company had an oncology product with standard cold-chain requirements for storage and distribution and medium volume expectations. The company needed to establish a commercial distribution network in a new region, Europe. It needed to determine the supply chain requirements, develop the optimum strategy, and implement a distribution network throughout the continent. Our team helped with this entire process. We collected the “last mile” requirements in the major markets, analyzed all relevant parameters across functional areas, and created a commercial distribution strategy. Company leadership endorsed our strategy immediately and tasked us with moving forward with the implementation, including partner qualification, selection & contracting, as well as ongoing project management.

Emerging / New Market Entrant - May 29, 2024

Early Access Supply Chain Set-Up

By kingdesign

A company was bringing its first product to Europe in a phased launch program. It needed a manufacturing and distribution infrastructure to support Named Patient / Early Access Programs (EAPs), to be followed by a commercial distribution system in most western European countries. We helped the client establish its supply chain strategy for the entire region and set up the supply chain elements of its EAPs. In addition, we selected a specialized EAP partner and 3PL partners. Overall, our efforts helped to ensure continuous and compliant supply to patients across regulatory approval, as well as the transition from clinical to full commercial supply.

Mid-Size / Large - May 29, 2024

Fast-Track Distribution Network Build-Up

By kingdesign

A successful, globally active one-product company had experienced record growth using an emergency distribution set-up. The company needed a commercial distribution model to be developed and implemented within a compressed time frame. It would need to be capable of supplying all countries in the EEA and it had to include storage, distribution, and a fully-fledged order-to-cash cycle. Our team analyzed and confirmed the company’s commercial distribution strategy. With the client’s team we selected, qualified, contracted , and implemented key supply chain partners in a tightly controlled program. After helping the client successfully launch its new distribution model, we continued to support ongoing optimization.

Cell & Gene - May 29, 2024

Allogeneic Cell Therapy European Supply Chain

By kingdesign

A US-based clinical-stage company was preparing to launch its first allogeneic cell therapy in Europe. It had no European supply chain capabilities, so it needed support to design and prepare the commercial supply chain. Our team helped design and set-up the supply chain, along with just-in-time packaging, QP release, and distribution processes. We also established the chain of identity and related labeling processes, selected and contracted with a European CPO and 3PL partner, helped ensure inspection readiness, supported the company’s successful EMA submission preparation, and provided ongoing support during the start-up phases.

Emerging / New Market Entrant - May 29, 2024

Commercial Volume Allocation Management

By kingdesign

A small US-based biotech company was preparing to launch its first product in Europe. The company needed to develop a commercial volume allocation management process that would ensure product availability for all their patients. We analyzed the company’s needs and then selected and modified an industry-accepted process for it to use, custom-tailoring it to their requirements. The client achieved its objectives, getting the system it needed with continuous analysis of sales forecasts, sales volumes, as well as market forecast data.