Commercial Launch Planning on an Accelerated Timeline

By |2024-02-06T10:20:01-05:0002/13/2023|

Commercial Launch Planning on an Accelerated Timeline PDF Version 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 [...]

Advanced Planning: Developing Supply Risk Mitigation Strategies

By |2024-02-06T10:05:52-05:0002/09/2022|

Advanced Planning: Developing Supply Risk Mitigation Strategies PDF Version 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 mandates [...]

Implementing a Serialization Program Successfully on the First Try

By |2024-02-06T10:06:36-05:0001/18/2022|

Implementing a Serialization Program Successfully on the First Try PDF Version 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 [...]

Improving Clinical Supply Chain Management by Establishing End-to-End Visibility

By |2024-02-06T10:10:38-05:0008/09/2021|

Improving Clinical Supply Chain Management by Establishing End-to-End Visibility PDF Version 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 [...]

Building Supply Chains & Systems for High-Touch Operating Models

By |2024-02-06T10:16:39-05:0008/04/2021|

Building Supply Chains & Systems for High-Touch Operating Models Converge develops commercial supply chain business processes, commercial systems architecture & last mile strategies. PDF Version 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, [...]

Global Trade & Logistics: The Other Side of Compliance

By |2024-02-06T10:13:19-05:0002/22/2021|

Global Trade & Logistics: The Other Side of Compliance PDF Version 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 [...]

Ensuring the Path to Compliant Analytical Methods

By |2024-02-06T10:27:14-05:0011/06/2020|

Ensuring the Path to Compliant Analytical Methods PDF Version 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, [...]

Clinical Supply Management Improved with Single IRT Solution

By |2024-02-06T10:18:11-05:0010/30/2020|

Clinical Supply Management Improved with Single IRT Solution PDF Version 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 [...]

Building the Downstream Commercial Supply Chain for Launch

By |2024-02-06T10:19:44-05:0008/28/2020|

Building the Downstream Commercial Supply Chain for Launch PDF Version 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 [...]

Scaling Clinical while Preparing for Commercial Supply

By |2024-02-06T10:31:40-05:0009/17/2019|

Scaling Clinical while Preparing for Commercial Supply Introducing Demand & Operations Planning PDF Version 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 [...]

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