FlexPro achieved small molecule accelerated development status for the first time in this Fortune 100 company’s history.
Speed-to-market is of critical importance for this Fortune 100 pharmaceutical company, which develops products with potential sales of millions of dollars per month. Their research and development division has designed processes to accelerate the development of key projects, but it requires achieving accelerated development status through skilled project management.
The project leader suggested that the team request accelerated development status, but there was uncertainty about taking this path. Here’s the problem: No one knew what would be required of the team and what the true benefits would be. There was a good reason for this lack of knowledge. No small molecule project in the company’s history had ever been granted accelerated development status before.
In addition, it was clear that this project would need expert project management from FlexPro. The client needed subject matter experts, collaboration with stakeholders and sponsors, escalation of issues at key points in the process, and perhaps even a risk exercise.
Following the initial team meeting, the FlexPro team worked with the client’s department in charge of accelerated development and received valuable details that would help move the project forward quickly. FlexPro established a positive working relationship and a direct communication channel with a key client director, which lasted for the life of the initiative. With FlexPro serving as a project champion, the team took a huge step forward in meeting its aggressive submission timeline.
The team made the accelerated development request and it was granted, making it the first small molecule ever to achieve this status. In the end, the dossier was successfully submitted months earlier than would otherwise have been possible, opening up the potential to generate millions of dollars in incremental revenue for the company.
Looking back at the timeframe of the project, it had excellent speed-to-market and happened within a period of weeks. The client is quite happy with the project’s positive impact on their revenue and agility, as well as the level of professionalism and project management oversight from FlexPro.
This project demonstrates the successful execution of stakeholder management, getting a team through indecision by gathering appropriate subject matter expertise, escalating issues to move the project forward rapidly, and bringing in stakeholders/sponsors at exactly the right moments. It shows that FlexPro consultants will never hesitate to reach out, and a proactive approach to communication can bring many benefits to the client, as demonstrated in this case study.