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.

Consulting - May 29, 2024

Network Capability Analysis

By kingdesign

A well-established midsize company had recently acquired a range of rare disease products. It needed to determine whether those products would fit within its existing localized supply chain set-up in Europe. Our team conducted primary and secondary research to understand the products’ distribution requirements and the company’s existing capabilities. Based on our subsequent fit/gap analysis, we concluded that the company’s existing network would work effectively, though it would need a few minor adjustments. We then supported the client through the process to a successful launch.

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.

Consulting - May 29, 2024

Supply Chain Scan

By kingdesign

A small biotech with one product in its commercial portfolio was planning to expand sales all over Europe after initially only selling in the Nordic region. It needed to determine if its supply chain would be up to the task from a performance, cost, and compliance standpoint. AIM conducted an initial data-gathering process, then led a workshop with senior leaders to discuss the findings. In our final report, we concluded that their chosen strategy was correct, but they were formally out of compliance in the UK. We offered guidance to get into compliance and provided ongoing support for the rollout across Europe.