This project benefited from work executed in 6 tasks, of which the results were presented in a feasibility report (project deliverable) and consolidated in a sound business plan.
Task 1: Market study and risk assessment. The potential of StemCell2MAXTM Med was established by determining the market and most relevant target areas. We have defined unmet needs, developed marketing and pricing strategies, analysed reimbursement policies and generated sales forecasts. We have identified competitive development and trends, opportunities and threats in the market.
Task 2: IP management. To maintain the strong position for StemCell2MAXTM Med and protect the extensive know-how present within StemCell2MAX, we have performed a freedom-to-operate analysis.
Task 3: Regulatory landscaping and clinical trial design. For this task we have consulted an experienced regulatory expert to identify regulatory demands. The regulatory guidelines for StemCell2MAXTM Med implementation have been described and incorporated in an extensive regulatory strategy, including clinical grade manufacturing and quality requirements. Additionally, the clinical trial design has been explored.
Task 4: Financing and deals. In this task we have developed a funding strategy for the development of StemCell2MAXTM Med. Multiple financial scenarios have been taken into account, including the overall investment need for validation. We have identified possible partnerships and other funding opportunities.
Task 5: Partner search. This task was dedicated to making an inventory of interested partners for clinical validation, with a main focus on Europe (but also including the USA and Asia). The partners have been investigated for their willingness to support the implementation of StemCell2MAXTM Med, their power to accelerate the implementation of StemCell2MAXTM Med and the means necessary to convince them.
Task 6: Business plan consolidation. This task has consolidated the input from tasks 1-5 in a sound business plan focused on the clinical application of StemCell2MAXTM Med. It includes information on goals and ambitions for this application, business and IP strategy, business model, market size and dynamics, logistical analyses, technical and operational planning, SWOT analysis, investment plan and financial forecasts.
Based on the results of this feasibility study, we have concluded that the development of the Good Manufacturing Practices (GMP) version of StemCell2MAXTM Mix will enable its use as a manufacturing platform for different clinical applications. Following GMP development, a comprehensive analysis of the different potential clinical markets clearly indicated that the company should focus primarily on the development of StemCell2MAXTM Med for the field of HSC transplantation. The remaining markets should be tackled by licensing deals, either directly with other companies developing their own products or with manufacturing service providers that would use StemCell2MAX’s GMP platform for HSC-based advanced medicinal products.
