Dengue Human Infection Model (DHIM)
MTEC announced a solicitation focused on accelerating ongoing development by USAMRMC of a dengue human infection model (DHIM) regulated by the U.S. Food and Drug Administration (FDA) that aims to safely and reproducibly create uncomplicated dengue infections in human volunteers using live, attenuated, well-characterized dengue virus (DENV) challenge material. The DHIM will be achieved when each of the four DENV challenge strains (serotypes 1-4) is characterized via FDA Phase 1 clinical studies.
Brain Machine Interface Prototype Development for Vision Restoration
MTEC announced a solicitation focused on the clinical, prototyping, and manufacturing needs to develop a visual prosthesis that addresses capability gaps for vision restoration and rehabilitation. Specifically, this research opportunity seeks to develop an innovative solution for prototyping an appropriate brain-machine interface.
Research focused on support areas of regenerative medicine manufacturing and prototyping that require development and harmonization into reproducible, consistent procedures which could stand the test of U.S. Food and Drug Administration (FDA) approval. This emerging area of medical technology and innovation suffers from the lack of standard manufacturing procedures that support this combination product line. This initiative is intended to have a period of performance of up to 5 years. Outcomes from this award are anticipated to result in well-defined and sufficiently advanced prototypes and manufacturing that may be included in regulatory applications seeking FDA approval.
Proposals were sought in five categories of potential areas of improvements. MTEC believes all of these areas currently present roadblocks to regenerative medicine prototype development and product manufacturing that will need to be addressed over the life span of the funding. These are as follows:
- Development of universal, defined culture media for regenerative medicine;
- Bioreactors to enable efficient and cost-effective cell and tissue expansion for regenerative medicine products;
- Cell, tissue, and product preservation for regenerative and personalized medicine;
- Large scale manufacturing and quality control of RM-based products;
- Dynamic and innovative quality control for regenerative medicine manufacturing.