The Medical Technology Enterprise Consortium (MTEC) was excited to announce a Request for Project Information (RPI) focused on the use of systems biology approaches to: i) better understand drug-resistant infectious diseases at their molecular, cellular, and systems levels, and ii) identify new potential products and develop them into prototypes for the diagnosis and treatment of these diseases. MTEC’s systems biology initiative is focused on utilizing an integrative rather than reductionist approach to understand how biological systems function and interact as a whole. The goal of this initiative is to design an integrated and collaborative research and prototype development portfolio leveraging known or emerging knowledge of the regulatory processes of resistance mechanisms with the purpose of integrated validation, and prototype development with follow-on translation into clinical use.
Cellular Therapy for the Treatment of Hemorrhagic Shock (CTTHS)
MTEC announced a Request for Project Proposals (RPP) aimed to support a Phase II clinical study to evaluate the safety and efficacy of a cellular therapy in the treatment of hemorrhagic shock in severely injured patients. MTEC sought proposals from entities developing technologies for cell therapies that can be used to treat the inflammatory complications that arise after traumatic injury. This request is not looking for cell therapies that can be used to achieve hemostasis. The intent of this action is to forward at least one cell therapy prototype into a Phase II clinical trial. Therefore, the products being brought forth must be ready to enter the clinical stage within a short window and have all of the regulatory requirements for an IND application prepared for submission as a minimum. The focus of this effort is on the actual clinical study.
Prototype Development for Extracorporeal Life Support (ECLS)
MTEC announced a revised solicitation focused on developing a lightweight, rugged, user-friendly extracorporeal life support (ECLS) device. The U.S. Army Medical Research and Materiel Command (USAMRMC) envisions potential future battlefield scenarios of prolonged field care, which will result in the presentation of critically ill patients with acute lung injury (ALI) and acute kidney injury (AKI) far-forward on the battlefield. MTEC is seeking the development of a lightweight, rugged, user-friendly ECLS device prototype that provides an innovative solution to integrating carbon dioxide (CO2) removal and renal replacement therapy (RRT) into a single ECLS device with the ability to use each mode separately. This combination device increases its practicality on the battlefield, where every ounce of weight and cubic foot of space is coveted.
Prototype of Joint Evacuation and Transport Simulation (JETS) System
MTEC posted an announcement for a Request for Project Proposals (RPP) focused on Operational Architectures (system and technical) to Support Military Medical Training Simulations – the development of architecture models that will be used to guide the construction of integrated simulations and training modules for the Joint Evacuation and Transport Simulation (JETS) system, which is utilized throughout the Department of Defense’s (DoD’s) medical departments.
Prototype Acceleration (PA)
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 (BMI)
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.
Regenerative Medicine (Regen)
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.