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An emerging European biotech was preparing to commercially launch its first product in the US. The FDA granted the innovative product a priority review given the potential for significant benefits to patients. As a result, the company faced a compressed timeline to build their US commercial supply infrastructure, and they did not have time to hire all the expertise in-house. Instead, roughly five months before the targeted PDUFA date, they partnered with Converge Consulting to establish the commercial supply capabilities required for their unique product to reach patients in need.
Working together as a fully integrated team, Converge helped this European biotech build and manage a US commercial supply network in under six months despite the added stress of the accelerated review timeline.
When the FDA granted approval, our team supported the successful launch of the client’s first product into the US market with commercial product available within five business days.
Converge’s experienced team began educating key client stakeholders on the full scope and timelines required for US commercial launch readiness. Working collaboratively with the client, we conducted a Readiness Assessment to determine which launch preparation activities were already underway and their progress against the target timeline. Results led to identifying key priorities and client agreement on short-term tradeoff decisions to ensure the product would be ready for delivery upon approval. These priorities and decisions were documented in a commercial supply chain launch strategy and time-phased roadmap.
Our initial planning activities quickly shifted to tactical execution as we built out the commercial supply chain infrastructure. The client used the roadmap and Converge’s senior advisors to efficiently delegate work. Together, we identified which activities the client would handle directly, which ones Converge would support, and which activities Converge would lead and execute.
For example, we provided support to the client’s US management as the Project Manager for the launch readiness effort. This included weekly meetings with Supply Chain, Quality, Regulatory, and CMC stakeholders, as well as supporting vendor meetings. In this role, we kept the overall effort on track.
Additionally, Converge mobilized experienced practitioners and subject matter experts to execute a range of launch-related workstreams, including Commercial Packaging, Labeling and Artwork. We led discussions with the packaging vendor to finalize artwork for the label and carton, as well as develop artwork management processes and governance. We built detailed T0 tactical launch-day plans and contingency plans to ensure label revisions and printing without delay. This included coordinating reviewer availability during the middle of the night and accessibility of printers on a Sunday morning to ensure the drug would be available to patients as fast as possible after approval.
We also selected the best fit 3PL for our client’s commercial model, working with the 3PL and packager to establish the serialization program and distribution procedures to ensure compliant patient delivery.
Our planning experts conducted a Supply & Demand Analysis, providing insights that helped the client decide how much drug product to package for launch and also for retains and other needs. We helped the client establish a formal S&OP process to manage overall supply chain planning in a way that accounted for significant demand uncertainties and risks.
Additionally, Converge’s trade compliance experts assisted in obtaining state licenses and evaluating whether to import utilizing a PLAIR or FTZ. Our logistics experts developed and executed shipping solutions and qualification studies to ensure product integrity.
