Aishu-rayan/Pharmaceutical-Case-Competition

End-to-end strategy for MARA Therapeutics’ Phase III RESI trial of Ramafloxacin for MDR-TB. Scope: prioritize 6 African markets, select & sequence trial sites to accelerate enrollment, confirm regulatory and operational readiness, and define a path to post-trial access and commercialization supported by an activation roadmap and risk mitigations. # 2025 Gilead Pharma Case Competition ## MARA Therapeutics — Phase III RESI Trial Strategy **Team Members:** Aishwarya Narayan, Gitanjali Roy, Sadgee Panday --- ## 📋 Case Summary MARA Therapeutics, a global leader in infectious disease research, is preparing to launch the **Phase III RESI Trial** for **Ramafloxacin**—a novel small molecule drug targeting **multidrug-resistant tuberculosis (MDR-TB)**. The challenge: design a clinical trial site selection and implementation strategy across six African markets (Egypt, Ethiopia, Kenya, Morocco, Nigeria, and South Africa) to maximize enrollment efficiency while ensuring operational feasibility and a clear path to commercialization. **Key Context:** - MDR-TB remains a critical global health crisis with ~400,000 cases annually worldwide - The 6 target African countries represent a combined **19,930 treatable patients annually** - Success hinges on balancing high-volume markets for enrollment with high-function markets for post-trial distribution --- ## 💡 Our Proposal & Recommendations ### Market Prioritization After rigorous analysis of disease burden, regulatory maturity, supply chain feasibility, and commercialization pathways, we identified **four priority countries**: | Country | Rationale | |---------|-----------| | **South Africa** | Largest patient pool (10,920), established TB research infrastructure, prior trial experience | | **Nigeria** | Second-largest patient pool (5,755), growing clinical trial ecosystem | | **Morocco** | Advanced regulatory system (FDA/EMA recognized), expedited distribution pathways | | **Ethiopia** | Cost efficiency via government tax incentives, emerging manufacturing hub | *Kenya and Egypt were deprioritized due to enrollment risks, geographic concentration, and supply chain vulnerabilities.* ### 12-Site Portfolio — Three-Wave Activation Strategy We recommend a **12-site portfolio** deployed across three strategic waves: | Wave | Sites | Strategy | Timeline | |------|------- …