Cell & Gene - May 9, 2025

Ongoing Part-time Support in Artwork and Serialization for (Start-up) Biotech Companies

By Lujain Mousa

The effective and efficient management of artwork and (operational) serialization processes is essential in any biopharma company, including (start-up) biotechs. These specialized activities rarely require full-time resources, which is a challenge for especially start-up companies. AIM supports multiple clients with flexible and long-term arrangements providing expert guidance on artwork compliance, implementation of serialization processes meeting global standards, and advisory on evolving requirements and process optimization. This model gives clients access to specialized expertise precisely when needed without the overhead of full-time positions. Employees can focus on other core activities while ensuring compliance in these technical but essential areas, providing continuity throughout their growth journey.

Interim Professionals - May 9, 2025

Team Extension at Midsize Biopharma for 9 Months

By Lujain Mousa

Following an acquisition that doubled their product portfolio and expanded their international footprint, this midsize bio-pharmaceutical company needed expert help with global definition, set-up and implementation of harmonized downstream supply chain processes. AIM delivered an experienced resource who integrated seamlessly with the client’s team and met the exact project needs. After 9 months, the client was ready to manage their critical downstream supply chain activities with the newly defined and implemented processes, positioning them for sustainable growth.

Consulting - May 29, 2024

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

By Lujain Mousa

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.

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.

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.