Ensuring the Path to Compliant Analytical Methods

By |2020-11-10T15:23:54-05:0011/06/2020|

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 [...]

Clinical Supply Management Improved with Single IRT Solution

By |2020-10-30T11:09:36-04:0010/30/2020|

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 [...]

Building the Downstream Commercial Supply Chain for Launch

By |2020-11-10T15:30:01-05:0008/28/2020|

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 [...]

Scaling Clinical while Preparing for Commercial Supply

By |2020-11-10T15:31:53-05:0009/17/2019|

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 [...]

Managing the Unexpected in Commercial Launch Planning

By |2020-11-10T15:33:09-05:0004/12/2019|

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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