Uro-oncology Clinical Development Plan Assessment

A biopharma company needed to assess the clinical development plan (CDP) implications for an asset in bladder cancer, prostate cancer. and renal cell carcinoma. This was needed to inform future investment decisions and business development (BD) activities related to the therapy.

To start, we conducted a robust assessment of the disease landscape and identified analogue therapies and trials.  We then conducted detailed assessments: For the analogues, we assessed a range of phase 2 and 3 trials, studying their patient populations, trial designs, durations, and key endpoints.  For the most relevant analogues, we developed case studies that mapped their journeys from phase 1 initiation to regulatory approval.  Leveraging this information, we then developed estimates of phase 2 and 3 trial duration, patient numbers, and total development costs for the client’s asset.  In addition, we identified regulatory precedents and potential considerations for planning.  Finally, we performed sensitivity analyses of key assumptions (number of patients, trial duration, cost per patient, etc.) to inform upper and lower bounds for subsequent planning efforts.

We provided the client’s BD team with a robust understanding of the likely clinical development costs for the asset, which helped guide investment decisions and informed BD negotiations.