I-Corps: Matrix-Enhanced Delivery of Cell Therapy

该项目的智力价值在于为一种新的和有前途的基于细胞的疗法创建商业化计划，其最初的目标应用是治疗局灶性软骨缺损。该技术被称为基质增强细胞递送（MED-Cells），因为它采用基于生物材料的方法来改善移植后细胞的植入，存活和功能。该项目的科学基础已经在PI的实验室中奠定，然而，将该技术转化为临床的关键差距是定义和制定产品概念，以专门满足重要的医疗需求，并制定适合已确定市场的商业化计划。在这个I-Corps项目中，该团队将利用客户分析来定义和解决基于细胞疗法商业化的关键问题。要解决的问题包括客户群及其需求的定义，拟议产品的价值主张，以及商业化的前进道路。该项目更广泛的影响在于它有可能产生的先进生物疗法的开发和商业化路线图。MED-Cell方法是一种平台技术，I-Corps计划可能有助于识别新的潜在应用。识别正确的目标应用程序和目标客户以及他们的需求和期望的过程将有助于确定最有可能产生商业成功产品的产品开发路径。重要的是，许多经验教训将普遍适用于先进的生物产品，因此该项目有可能为快速发展和极具前景的再生医学领域提供信息。基于细胞的治疗和类似生物产品的技术正在迅速发展，同时确定如何将这些有前途但复杂的产品最好地引入市场至关重要。此外，通过对I-Corps团队的培训，该计划可能会对他们实验室技术开发中的未来产品商业化工作产生影响。从长远来看，该计划进行的技术商业化培训将为生物医学产品设计和开发课程提供信息，从而加强对未来学生的培训。

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.