NDA Submission Sequencing

At the recent Vegas PPM conference, I shared a case study highlighting the importance of nuanced modeling for strategic decision-making.

The scenario involved deciding whether to sequence NDA submissions for the two indications or file them in parallel. After completing a successful Phase 3 trial for Indication A, the team faced two options:

➡️ Wait for Indication B’s trial to finish and file both NDAs together (parallel filing).

➡️ File the NDA for Indication A immediately and submit Indication B later (sequential filing).

The team created a model that incorporated several critical features to evaluate the two options. These are illustrated in the attached images:

🟩 Picture 1: This image shows the parallel filing option, where Project A waits for Project B to complete its trial, and the sequential filing option, where Project B waits while Indication A proceeds to NDA submission.

🟧 Picture 2: A complicating factor was that the trial durations for both projects were uncertain. If Project A finished early while Project B was delayed, a parallel filing could result in a significant waiting period. Conversely, if Project A was delayed, it might align better with Project B’s timeline, making a parallel filing more viable.

🟨 Picture 3: Dynamic market model. This part of the model accounted for the value difference between being first or second to market. First-to-market scenarios offered significant business case advantages, while second-to-market scenarios reduced value.

🟥 Picture 4: Heatmap of outcomes. The final visualization showed maximum wait times and value differences between the two filing strategies under various scenarios. This heatmap clearly showed the trade-offs and helped the team evaluate which strategy would yield the best results.

The Outcome

By proactively modeling these scenarios, the team was ready for the outcomes of the trials and could act quickly when real data became available. The analysis helped them anticipate challenges and prepare a clear strategy based on the trial results, ensuring they moved forward with confidence.

Summary

This case study highlights the immense value of incorporating uncertainties, dependencies, and market dynamics into decision-making. The model provided a realistic and trustworthy representation of the project, allowing the team to evaluate trade-offs, anticipate challenges, and make informed decisions.

Simple or static tools like Excel are not equipped to handle this level of complexity. Advanced modeling tools enable teams to simulate real-world scenarios, provide actionable insights, and build trust among stakeholders by ensuring transparency in assumptions and calculations.