Stage-Appropriate Quality Systems

By |2020-10-22T12:18:12-04:0010/22/2020|

Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]

Improving Demand & Supply Planning for Emerging Life Science Companies

By |2020-09-25T09:09:06-04:0009/24/2020|

Improving Demand & Supply Planning for Emerging Life Science Companies Todd Applebaum, Managing Director Our Demand & Supply Planning Maturity Model aligns key aspects of the planning process to each company's lifecycle. Improving demand and supply planning is crucial for Life Science companies. This is especially valuable when dealing with [...]

4 Trends in Commercial Supply Chain Launch

By |2020-09-14T12:03:18-04:0009/14/2020|

Building a commercial supply chain to launch a new product is always a high-wire act. Supply Chain leaders must balance preparing the supply network and launch materials with the uncertainties of clinical development and regulatory progress. In addition, they must manage the risks of commercial uptake and demand. These challenges hold true whether [...]

Clinical Supply Agility: Expect the Unexpected

By |2020-10-20T10:23:00-04:0009/10/2020|

Webinar with 4G Clinical on 10/8/20 Download the Webinar Recording There are constantly unforeseen risks inherent when planning for clinical supply. For instance, when the COVID-19 pandemic began, there was concern that supply chains would be disrupted. Overall supply chains remained operational but questions remained on how to manage [...]

Building the Downstream Commercial Supply Chain for Launch

By |2020-08-31T10:42:02-04:0008/28/2020|

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 [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2020-10-02T10:05:28-04:0008/18/2020|

CMC QA/The Quality System Webinar on 9/30/2020 Request the Recording Request the Presentation Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place.  By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The [...]

Info Sheet: Commercial Launch Transformation

By |2020-08-28T13:17:13-04:0001/01/2020|

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. The challenge [...]

Scaling Clinical while Preparing for Commercial Supply

By |2020-09-22T14:23:15-04:0009/17/2019|

Scaling Clinical while Preparing for Commercial Supply Introducing Demand & Operations Planning Service Areas: Supply Chain, CMC, Clinical Operations, Commercial Launch, Finance Lifecycle Stage: Clinical Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol [...]

Why Is Demand & Supply Planning in Life Sciences so Difficult?

By |2020-09-22T14:48:28-04:0007/25/2019|

Event: September 12, 2019 @ 5p Why is Demand & Supply Planning in Life Sciences so Difficult? Demand and Supply Planning is a critical business process for companies moving through clinical development and commercialization. In addition to typical challenges, emerging and growing life science companies face unique obstacles due to clinical, regulatory, [...]

Managing the Unexpected in Commercial Launch Planning

By |2020-09-22T14:51:55-04:0004/12/2019|

Managing the Unexpected in Commercial Launch Planning 2 Treatments, 1 Timeline Service Areas: Commercial Launch, Supply Chain, Quality, Enterprise IT Solutions, Commercial Systems, CRM, Medical Affairs Lifecycle Stage: Clinical Our client was an emerging biopharmaceutical company formed to commercialize a rare disease treatment in late-stage [...]

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