The intellectual merit of this project lies in the creation of a commercialization plan for a novel and promising cell-based therapy, with an initial target application of treating focal cartilage defects. The technology is called Matrix-Enhanced Delivery of Cells (MED-Cells) because it applies a biomaterials-based approach to improving the engraftment, survival, and function of cells post-transplantation. The scientific foundations of the project have been laid in the PI's laboratory, however, a key gap in translating this technology to the clinic is defining and formulating a product concept to specifically meet a significant medical need, and developing a commercialization plan that is appropriate for the identified market. In this I-Corps project the team will utilize customer analysis to define and resolve key issues in the commercialization of cell-based therapies. Points to be addressed include definition of the customer base and their needs, the value proposition of the proposed product, and the commercialization path forward.
The broader impacts of this project lie in the roadmap for the development and commercialization of advanced biological therapies that it has the potential to generate. The MED-Cell approach is a platform technology, and the I-Corps program may help identify new potential applications. The process of identifying the correct target application and target customer, as well their needs and expectations, will help to define the product development path that is most likely to yield a commercially-successful product. Importantly, many of the lessons learned will be generally applicable to advanced biological products, and therefore the project has the potential to inform a rapidly-growing and highly-promising field of regenerative medicine. The technology for cell-based therapies and similar biological products is advancing swiftly, and it is critically important to concurrently determine how such promising but complex products are best introduced to the market. In addition, through training of the I-Corps team, this program is likely to have impact on future product commercialization efforts that arise from technology development in their labs. In the longer term, the training on technology commercialization undertaken by this program will inform classes on biomedical product design and development, and therefore will enhance the training of future students.
Our technology is called Matrix-Enhanced Delivery of Cells (MED-Cell). It applies a biomaterials-based approach to improving the engraftment, survival, and function of cells post-transplantation. Adult progenitor cells (e.g. bone marrow-derived stem cells) are isolated from patients and are embedded in hydrogel microbeads (100-300 µm diameter) consisting of defined protein and polysaccharide composites. The microbead material is designed to direct the function of the embedded cells, while also protecting them during and after delivery to a patient. Our initial target application is the treatment of cartilage defects in the knee, which are a major clinical problem. This indication represents an unmet clinical need because none of the current surgical techniques are able to reliably achieve regeneration of organized hyaline cartilage. We believe that cell-based therapies will change the way medicine is practiced in a number of key therapeutic areas. Already there are a small number of such products on the market, and a variety of follow-on products are in the clinic and preclinical pipeline. However, the currently available therapies are hampered by inconsistent results and unclear efficacy. There are a variety of technical reasons that these first generation products are suboptimal, and the MED-Cell technology directly addresses several of these key issues. This NSF I-Corps project examined the customer space and commercial potential of the MED-Cell technology. A team consisting of the Principal Investigator, an Entrepreneurial Lead, and an expert Mentor participated in the intense I-Corps curriculum. The specific objective of this I-Corps project was to evaluate the commercial feasibility of the MEDcell technology. The program accomplished that objective. The key outcome of the I-Corps program was an analysis of the customer need for the MEDcell technology, as well as mapping of the commercial path. The overall decision was a "no go" on current commercialization, however further development of the technology was deemed promising.
