Our client was a clinical-stage biotech in the process of early stage planning for the launch of its first drug, a small molecule treatment for a rare endocrine disorder. However, the company had no internal experience building a commercial data infrastructure to support product launch. Alacrita was engaged to provide the biotech with a roadmap which could be implemented by the in-house team independently.
The consultant who led the project had recent first-hand experience of a data infrastructure build in another biotech company. Recognizing that the roadmap needed to be educational for the client as well as practical, we started by agreeing with the client the business purpose for the infrastructure and listed the internal functions and decision-making processes that would be informed once it was operational. We mapped the critical data interfaces across the company and with key business partners. For each key input to the data infrastructure, the roadmap described the source(s) and value of the information, data handling and integration challenges, and identified specialized third party vendors where appropriate. Critical outputs, including the required analytics were listed for key internal customers such as senior management, investor relations, finance, marketing, sales operations, compliance and CMC/supply chain. The roadmap also included a detailed timeline to launch, with budgets required for each element of the build. The roadmap enabled the client to confidently build the commercial data infrastructure in a systematic and timely fashion, and to make the appropriate resources available in real time.