On-Time IND Amendment for Biopharmaceutical Client

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.

Results at a Glance:

  • Built trust within the team through clear communication and focused solutions.
  • Nurtured high levels of collaboration, transparency, and accountability.
  • Completed a successful project within an extremely short timeframe.
  • Delivered study drug batches to the clinic at exactly the right time.

 

Background:

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.

Challenge:

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:

  • There was doubt within management whether the milestone date could be reached, but it was still deemed critical to the ongoing study and a future NDA submission target.
  • The project team lacked confidence that the milestone date was realistic.
  • The project team members worked remotely in different regions and could not be co-located.
  • The project team members were subject matter experts with limited availability for writing the Module 3 sections.
  • The IND Amendment status update tool was confusing and lacked buy-in from the project team.
  • FlexPro inherited an unclear communication plan that was extremely confusing to the project team.

 

Stakeholders:

This project involved numerous stakeholders. These included:

  • Head of Project Management
  • VP, Technical Operations
  • Exec Director, Manufacturing Operations
  • Director, Analytical
  • Regulatory Affairs Head (Consultant)
  • CMC Regulatory (Consultant)
  • Reg Affairs Operations (Consultant)
  • CMC Reviewer (Consultant)

 

Process:

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:

  • Reengaged the project team: FlexPro’s proven process involved interviewing the subject matter experts to diagnose the problem areas and brainstorm ideas for a sustainable process. 
  • Clarified roles and responsibilities within the process.
  • Redesigned a clear status update plan: FlexPro’s expertise was employed to improve the tool in Excel and create a framework for clear status updates on a daily basis.
  • Accelerated the rate of success: It was important for FlexPro to build short-term wins and begin to change the mindset. These wins directly impacted the project team’s perception of whether the milestone date was achievable. The positive change led to greater team engagement.
  • Tracked and resolved issues quickly: To not lose momentum, it was very important to resolve any project issues as quickly as possible. This required FlexPro to proactively look for any upcoming constraints and resolve them in ad hoc meetings with the appropriate parties.

 

Results

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.

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