Case Study Category: Service Area

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.

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.

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.