When another consulting firm’s project manager left this client hanging on a tight deadline, FlexPro stepped in to rescue this project and drive it to success.
This small biopharmaceutical company employs fewer than 50 full-time employees and manufactures biologics for the treatment of hospital infections. At the time of this case study, it had four drug products in development with one lead product in a Phase 3 clinical study that had been granted a breakthrough therapy designation from the Food and Drug Administration (FDA).
The investigational new drug (IND) application had been filed previously and a biologics license application (BLA) was planned in two years. The timing for this IND amendment submission was critical to the Phase 3 study and was a key milestone towards a successful BLA submission. The breakthrough therapy designation from the FDA created extra incentive to achieve the submission target goal and stay on track to corporate strategy.
The primary challenge was that the company resources were extremely scarce to write and review a full CMC (chemistry, manufacturing, and controls) IND amendment with a limited budget and tight timelines. The team had functional duties to balance with the amendment activity requirements.
Previously, the company engaged with a project manager (PM) from a FlexPro competitor who attempted to create an IND amendment submission plan, but that firm made no progress with the team. After three months, the result was a poorly structured plan and very limited participation from the team. This team needed more expertise to get this project back on track and complete this extremely important company milestone.
When the company engaged with FlexPro, the project target date was fast approaching in under 60 days. The amendment required substantial updates to both the drug substance and the drug product Module 3 sections.
FlexPro had to overcome substantial hurdles with the team:
This project involved numerous stakeholders. These included:
In a broken process, the transition to success requires expertise and quick action. FlexPro, as the project management firm, created a plan for a project rescue and took these actions:
With FlexPro’s project management expertise, the team started building trust and confidence to see the project through to a successful end. FlexPro’s process of creative problem-solving changed the project outlook from one of doubt to a successful resolution.
Each team member could understand where things stood along the way, which meant each knew exactly what their role was and when they needed to speed things along to meet an individual target date. This had the side effect of preventing scope creep because everyone saw the absolute importance of hitting their own deadlines, as well as the final deadline.
The decision to quickly engage with FlexPro completely reversed the project momentum and got the team back on track. The IND Amendment was submitted to the FDA on time. This resulted in the on-time release of the clinical product for the Phase 3 study.
Reversing the course of a project is extremely difficult. It requires a tremendous amount of experience, knowledge, and advanced interpersonal skills. FlexPro’s team of PMs, along with the use of industry processes, has proven to establish trust and gain cooperation with clients’ project teams. The team has extensive knowledge to implement the necessary tools for success.