Commercial Launch Planning on an Accelerated Timeline An emerging European biotech company 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 benefit to patients. As a result, the company faced a compressed timeline to build their [...]
Advanced Planning: Developing Supply Risk Mitigation Strategies Download the PDF Converge conducts a Manufacturing Supplier Risk Assessment and uses the results to build a Supplier Risk Management Plan. A commercial biopharmaceutical company was preparing for their second product launch when senior leadership acknowledged the need to prioritize the supply chain and manufacturing [...]
An emerging specialty biopharmaceutical company was preparing for the U.S. launch of their first drug product. Building out their supply chain would involve implementing a serialization program to meet Drug Supply Chain Security Act (DSCSA) requirements. While Supply Chain team members had commercial launch experience, they were not as familiar with serialization. A successful [...]
Emerging pharmaceutical companies frequently place responsibility for clinical supply chain management on their clinical operations team and CROs. This approach can work initially for small, resource-constrained organizations. However, it does not help companies build the internal capabilities, knowledge, and resources to successfully run their clinical supply chain over time as they grow. One [...]
Converge develops commercial supply chain business processes, commercial systems architecture & last mile strategies. Our client was an emerging pharmaceutical company focused on rare diseases, in clinical trials with an ultra-orphan drug. There were two competitive therapies also in development, so they began preparations for commercial launch on a compressed timeline to [...]
An innovative pharmaceutical company was awaiting FDA approval to launch its first commercial product. They were also increasing their clinical trial activities globally and advancing other programs into the clinic. The complexity of their global supply network was increasing. However, they lacked processes, knowledgeable resources, and organizational understanding of global trade compliance requirements [...]
A gene therapy company spent over a decade developing their first-generation product, partnering for many early development capabilities. Then when the product was moving into the final stage clinical development, they bought out the rights and now owned 100% of the molecule. However, with a lean organization who had limited CMC and analytical [...]
A cancer treatment company with a strong development pipeline had more than a dozen clinical studies in process and that number was growing. A lean team was managing everything and, like many emerging biotech companies, relied on CROs for many clinical operations activities. As those programs progressed through development, our client was dealing [...]
An emerging pharmaceutical company was preparing for its first commercial product launches with two products progressing through the clinic. Approvals and launch events were targeted within one year of each other. The products were similar in technology and formulation. The first anticipated approval was for a relatively smaller indication. The second was for a [...]
Introducing Demand & Operations Planning Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol changes affect enrollment rates, production volumes, regulatory activities, logistics and managing data. It makes planning particularly challenging for both clinical and commercial production. Our client was [...]