MTEC posted a Request for Project Proposal for Solicitation Number: MTEC-17-02-Prototype Acceleration (PA) efforts that focused on advancing novel prototype technologies into the next major stage of development/milestone dependent upon their current maturity. Examples of the next major stage of development/milestone include, but are not limited to: late animal testing and regulatory filing, manufacturing, next clinical trial, regulatory approval, etc.
Combating Antibiotic Resistant Bacteria (CARB) Request for Project Information
The use of antibiotics saves millions of lives each year around the world. Unfortunately indiscriminant use and lack of compliance with treatment guidelines have led to conditions for accumulation of mutations in bacteria that have caused drug resistance, resulting in a significant decrease in the number of available drugs effective to treat both rare and common bacterial infections. The rise in antibiotic resistance threatens various aspects of life, including both human and animal health, the agriculture industry, the economy, and the treatment of post-surgical infection from elective and life-saving medical procedures. Therefore, there is a critical need to develop novel antibiotics, other therapeutics, and, vaccines to combat infection by antibiotic-resistant bacteria and improve medical surveillance and diagnostic tests for the identification and characterization of antibiotic-resistant bacteria. Advancement in these areas will hopefully make a major impact by strengthening national and international healthcare for humans and animals, public health, agriculture practices, food safety, and research, development and manufacturing.
Permanent Vascular Repair (PVR)
MTEC announced a Request for Project Proposals (RPP) focused on Permanent Vascular Repair (PVR) – the development of products that can serve as permanent arterial and/or venous grafts for reconstruction and repair of traumatic injuries.
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.