Process Knowledge Management  Analytic Tools Case Studies Clinical Development Strategy CML Drug Development Commercialization Strategy Diagnostics Industry Strategy Franchise Strategy NSCLC Treatment Pathway Portfolio Prioritization Reimbursement and Pricing Strategy Diagnostic Assay Global Launch Global Insulin Strategy Global Manufacturing Capacity Forecast New Product Forecast in Developing Countries Progress Assessment for a Global Health Organization Case Study CML DRUG DEVELOPMENT: When an emerging biotechnology company with a promising tyrosine kinase inhibitor (TKI) suitable for multiple patient populations needed a strategy to maximize clinical development dollars and generate positive returns, Health Advances was the firm of choice. SITUATION Health Advances was engaged to develop a clinical and commercialization path to maximize the revenue potential of a novel multi-targeted tyrosine kinase inhibitor (TKI) for the treatment of chronic myelogenous leukemia (CML). Health Advances was engaged to develop a clinical and commercialization path to maximize the revenue potential of the client's novel multi-targeted TKI. KEY QUESTIONS TO ADDRESS What are the most relevant label indications for the compound? What specific positioning argument could and should be made to maximize clinical and commercial success? What is the most appropriate development path to rapidly build clinician enthusiasm? How is the treatment landscape expected to evolve given recent launches and the development pipeline? What is the realizable market potential for a novel TKI? HEALTH ADVANCES APPROACH AND FINDINGS To understand potential positioning opportunities for the client's compound, the team conducted extensive primary research to determine the current treatment paradigm and identify the unmet needs in CML. Detailed surveillance of the competitive landscape allowed the team to place the client's compound in context with other agents in development. This work indicated that the client's compound likely had broader Bcr-Abl inhibitory function than initially appreciated and also likely hit other relevant signaling pathways, a finding with important implications on subsequent development and commercialization recommendations. The team developed a forecast model to demonstrate the impact of the identified product positioning opportunity. Finally, the team developed a comprehensive set of recommendations for the client to pursue. IMPACT Health Advances refocused the client's program on a much broader indication than originally considered, expanding the overall market opportunity, while minimally impacting development time. Under the development scenario recommended by Health Advances, the client's compound had greater than twice the realizable revenue potential relative to earlier benchmarks. The team also identified several low-cost, but important steps that the company could take to accelerate adoption once the product reached the market.

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