2025 Gilead Pharma Case Competition
Theme: Clinical Trial Site Selection & Commercialization Strategy
Problem: To support a Phase III trial for an MDR-TB treatment, MARA Therapeutics needed a strategic, scalable plan to select clinical trial sites across Africa. The challenge was to balance feasibility, regulatory readiness, patient accessibility, and long-term commercialization potential.
Approach: Our team designed a structured evaluation model combining epidemiology, site infrastructure, investigator experience, regulatory maturity, and operational risks. We applied a weighted 70/30 site- vs. country-level framework, created a Core + Satellite site mix, and built a country-specific risk mitigation plan to ensure predictable trial execution.
Solution: We delivered a balanced Africa trial network with 8 core sites and 6 satellite sites, giving MARA access to more than 1,200 eligible MDR-TB patients, exceeding the protocol requirement of 300–500 participants. The roadmap enabled efficient activation timelines, stable enrollment, and a clear pathway for future commercial rollout in LMIC markets.