Scaling for Clinical While Preparing for Commercial

The Ask

An emerging biologics company initiating a global Phase III clinical trial of their orphan drug engaged Converge to improve clinical supply management while laying the foundation for future commercial supply planning. The goal was to help the Tech Ops team develop inventory and planning strategies, identify necessary changes, and implement a new scalable planning process.

The Impact

The work not only provided visibility and enhanced understanding of the former planning process, but also helped identify important areas of business uncertainty. This was critical for developing a planning model unique to the dynamics of this client’s business.

D&OP was a paradigm shift for this client and made a substantial improvement in their ability to plan and react to the inevitable demand and supply changes. The disciplined process equipped their team to discuss risks and opportunities, as well as make decisions with important clinical, manufacturing, and financial implications.

Our client is now progressing in the clinical and technical development of their lead product candidate. D&OP outputs and analytics keep the organization aligned on the strategic plan and ensure cross-functional coordination as they prepare for growth and commercialization.

DHC’S Approach

Converge’s team of experienced industry veterans designed a stage-appropriate planning process that involved developing targets for inventory and safety stocks, providing supply and demand modeling and analytics, aligning the organization around roles and responsibilities, and providing support for day-to-day supply management and planning.

The first step was to understand the client’s virtual supply network. We built alignment on critical supply and demand assumptions and visually mapped what was currently in place. This brought transparency to cross-functional roles and day-to-day planning activities across Clinical Operations, Clinical Supply, Quality and CMC.

Then, we established Demand & Operational Planning (D&OP) designed to address questions like:

When do we need to begin API production?
How much material do we need to allocate for clinical demand vs. other activities?
Can we wait until top-line data is available before making significant investments in the next production run?
How can we support the sequence of countries expected to enroll patients?
Where should we position supply?
If enrollment accelerates/slows, what will the impact be on supply, inventory & production requirements?

Ultimately, we continue to partner with the client to support their clinical and commercial supply planning, extending the capabilities and bandwidth of their in-house team by leading the execution of day-to-day planning activities and enhancing the D&OP process as it evolves into a key business forum for operational and financial decisions.