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.
Converge provided support to the client’s US management as the Project Manager for the launch readiness effort. This included meeting weekly 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. For example, one such workstream was Commercial Packaging, Labeling and Artwork. Converge 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, as well as for retains and other needs. We helped the client establish a formal Sales and Operations Planning 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 the shipping solutions and qualification studies to ensure the integrity of the product was maintained.