Consulting - May 29, 2024

Creation of an Operational Sales and Operations Planning (S&OP) Process

By kingdesign

An EU-based start-up was launching multiple products in parallel. It was leveraging a virtual supply chain to sell products in various forms worldwide, either direct or via licensees. The company needed better visibility into supply and inventory levels (as well as scrap risks) in a very complex environment that included a large network of partners and widely varying approval and launch situations across markets. Our team helped the client create an operational S&OP process to provide the visibility it needed. We aligned with executive leaders on their goals and expectations, and subsequently assessed and enhanced the client’s understanding of S&OP / Integrated Business Planning. This was followed by a workshop to define metrics, as well as to design the approach and materials for monthly demand / supply meetings. Lastly, we provided training in running operational S&OP / IBP processes and went through a 12-month cycle of monthly support to refresh data repositories and fine-tune the process with the client’s team.

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.

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.

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.

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.