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, Marketing, Quality and Compliance are introduced.
Among the preparations, several critical IT-related questions need consideration:
- Will our current manual processes support us as a commercial organization?
- What systems and processes do we need to support launch?
- When must various enterprise solutions be in place? And when should each be selected and implemented?
- Should we purchase individual best-in-class systems or invest in an integrated solution suite?
- Should we build capabilities for near-term commercialization or invest now to enable future scale?
- How can we best resource these projects to support readiness by the target launch date?
An information technology roadmap, or IT Roadmap, is an effective cross-functional tool to assess IT readiness, identify gaps in the technology infrastructure, align future technology investments with business objectives, and evaluate team ability to adapt to change.