Periodic Reporting for period 1 - Quality2Cells (TimeLapseReader for Quality Control of Immune Cells used for Cell-Based Therapies)
Reporting period: 2016-08-01 to 2017-01-31
- Identification of KOL, early adaptors and potential customers
- Online survey and interviews
- Market research and business plan development
- Elaboration of regulatory requirements
- Key parameter requirements and first specification criteria for the instrument adaption
The feasibility study has substantiated and confirmed the technological and commercial viability and importance of the planned innovative project „Quality2Cells“. Many publications show that cell-based therapies have the potenial to make large contribution towards patients and thus effective manufacture of cell-based products is essential. However, there is an urgent need to define manufacturing requirements, including QC assessments and thus, this highly innovative project will continue.
Due to the results of the feasibilty study the instrument adaption time, costs, and risks may increase compared to first assumptions. Besides T-cells, ibidi will also focus on the therapeutic cells hematopoietic stem cells (HSC) and thus, the “Quality2Cells” project will address a much bigger market size in the CBT field. All efforts will be focused to establish a complete QC solution based on the automated instrument “TimeLapseReader” in combination with ready-to-use kits, slides, and reagents. Phase 2 application is under preparation.
• Identification of KOL, early adaptors and potential customers for interviews and online survey.
• Performance of interviews and an online survey to elaborate the application of therapeutic cells, technical features of the TLR and its adequate pricing structure.
• Development of a realistic business plan, including risk assessment, competitor and FTO analysis, and market entry strategy.
• Elaboration of regulatory requirements for approval by EMA and FDA.
• Compiling of key parameter requirements and first specification criteria for the instrument adaption.
Taking these above-mentioned conclusions into account means that the instrument adaption time, costs, and risks may increase compared to first assumptions. However, with the additional focus on the therapeutic cells HSC the Quality2Cells project will address a much bigger market size in the CBT field. All efforts will be focused to establish a complete QC solution based on the automated instrument “TimeLapseReader” in combination with ready-to-use kits, slides, and reagents.
Changes to the objectives
There are no changes to the original objectives. During the feasibility study, it was possible to specify the projects framework and to define specific objectives for the planned Phase 2 application. The objective of the “Quality2Cells” Phase 2 project remains (i) to commercialize a complete QC solution that meets regulatory requirements and (ii) to perform all dissemination and communication activities to prepare various communities for a quick uptake into the CBT market.
Expected potential impact
Quality2Cells has the chance for significant reduction of inadequate CBT resulting in reduced health costs and higher safety for patients. As a direct beneficial consequence a larger number of patients can be treated with the new technologies because the risk of adverse effects is relatively lower and the chance of cure is increased. Reduction of risk and cost will support the acceptance of CBT with physicians, patients and regulatory authorities such as EMA and FDA.