To support the design of an Integrated Development Plan (iDP) and protocol for an iron overload candidate for a first-in-human clinical trial, and select Key Opinion Leaders (KOLs) and investigator sites.
Phesi’s Trial Accelerator™ platform was used to ensure a comprehensive analysis of the competitor landscape and all relevant protocols, sites, countries and indications
- Phesi’s predictive modelling identified the optimum site number to be 20 (rather than up to 75, as initially suggested by the CRO)
- We also identified the ideal lead investigator in Lebanon (who was not known to the client or CRO)
- The enrollment period was reduced from a baseline projection of 22 months to 16.5 months
The client saved an estimated $1.8M by deploying top performing sites. Sales potential increased by $1.8Bn by identifying opportunities for orphan drug status in Myelodysplastic Syndrome (MDS) and Beta Thalassemia. Significant investment was secured from two major pharma companies, increasing market cap and growing share value by 10x.