The Feasibility Study allowed to design the trial protocol and the trial work plan, and to elaborate a business plan for LOUISA-3D production, marketing, and commercialization.
The protocol of a multicenter international prospective diagnostic study was designed. The trial will involve 4 main cancer centers: P.S.Donato Milan University (IT), Vienna Medical University (AU), H. de la Ribera, Valencia (ES), and County H. Falun (SE), and will be leaded by Prof. Sardanelli. 600 subjects will be enrolled and LOUISA-3D will be investigated in terms of sensitivity, specificity, neoadjuvant therapy monitoring, patient compliance, and reading time. Statistical analysis, informed consent, good clinical practice, personal data protection, and adverse event management were considered.
A 3 years trial plan was developed, with 8 workpackages, each with measurable objectives and clear deliverables. Trial management, start-up, monitoring and data management, technical and research support, and dissemination were defined. A GANTT chart with 21 milestones, and a detailed costs table were issued. Key subcontractors (technology suppliers, research partners, and management consultants) were identified, pursuing best value for money, and involved in the plan design.
Business Plan. A detailed analysis of the breast imaging technology market, acquired by a specialized company, showed significant business opportunities for the introduction of new and safe modalities. SWAT, regulatory, intellectual property and risk analysis were performed. The business strategy was defined, including: production modality, suppliers and costs, product lifetime and maintenance, price policy, placement policy, and marketing plan. A financial plan was developed for the 3 years of trial and 5 following production years, including: P&L, balance sheet, and cash flow.
