Advanced Planning: Developing Supply Risk Mitigation Strategies

By |2022-05-20T15:00:55-04:0002/09/2022|

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 [...]

Info Sheet: IT Roadmaps for Commercial Launch

By |2021-04-08T12:51:45-04:0004/08/2021|

After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for their first commercial launch. As this organizational transformation nears, the focus of the IT organization shifts from infrastructure and help desk support to business enablement as new functions like Sales, Medical Affairs, [...]

Benefits of Early Launch Planning

By |2021-03-18T14:03:38-04:0003/03/2021|

Preparing for commercial launch is a complex process for most any life science company. Adding to the challenge, many emerging life sciences companies operate as very lean organizations with limited resources. Specialty products in particular can be one-of-a-kind and require unique launch processes and procedures. In some cases, team members are also doing it [...]

Info Sheet: Cell & Gene Therapy Services

By |2022-04-13T15:13:00-04:0003/02/2021|

PDF Available > Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and gene therapies (CGT) requires rethinking traditional business models [...]

Global Trade & Logistics: The Other Side of Compliance

By |2022-08-09T09:12:29-04:0002/22/2021|

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 [...]

Building the Downstream Commercial Supply Chain for Launch

By |2022-02-08T10:26:15-05:0008/28/2020|

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 [...]

Info Sheet: Commercial Launch Transformation

By |2021-03-19T11:55:40-04:0001/01/2020|

PDF Available > Biopharmaceutical firms face an array of challenges in commercializing innovative therapies. This info sheet explains how Converge helps firms navigate the business challenges involved in Commercial Launch transformation. Business risk is high. There are daunting technical hurdles, evolving regulatory requirements, and you need to invest significant capital before success is assured. [...]

Current Trends & Challenges in Commercial Supply Chain Launch Preparation

By |2021-03-19T12:57:02-04:0012/09/2019|

Converge Supply Chain Series event on 2/13/20 Current Trends & Challenges in Commercial Supply Chain Launch Preparation In preparing for commercial launch, emerging life science companies face unique obstacles due to clinical, regulatory, operational and market uncertainties that can cause delays or inhibit success of the launch altogether. Current business strategies and patient outcomes-focused [...]

Scaling Clinical while Preparing for Commercial Supply

By |2022-02-08T10:28:14-05:0009/17/2019|

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 [...]

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