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Medical Technology Enterprise Consortium (MTEC) -- Biomanufacturing for Regenerative Medicine (Biomfg)
The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership that collaborates with industry and academia to facilitate research and development activities in cooperation with the U.S. Army Medical Research and Materiel Command (USAMRMC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives: (a) biomedical research and prototyping; (b) exploration of private sector technology opportunities; (c) technology transfer; and (d) development of intellectual property (IP) and follow‐on production.
This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC support of the USAMRMC Clinical and Rehabilitative Medicine Research Program (CRMRP). Strategic oversight for the award(s) supported by this RPP will be provided by will be provided by Joint Program Committee 8 (JPC‐8)/CRMRP.
The JPC‐8/CRMRP, DHA J‐9 R&D Directorate, and OASD(HA) have identified a need for regenerative medicine prototype development efforts and manufacturing technologies. Current Good manufacturing practice (cGMP) quality is a requirement by the FDA and European Medicines Agency to provide patients with clinical‐grade products that are safe and have defined quality characteristics. However, standardization and robust manufacturing techniques are lacking in regenerative medicine, which will continue to impede progress in advancing regenerative medicine based technologies and treatments toward the clinic.
Based on this, the major objective of this RPP is to develop scalable, production‐ready, commercial prototypes and processes for cell, tissue, or organ bioengineering technologies that will overcome current challenges and enable successful cGMP manufacturing and clinical translation of regenerative medicine based therapies. Technologies of interest include, but are not limited to (see Section 2 for more details):
1. Bioreactors to enable efficient and cost‐effective cell and tissue expansion for regenerative medicine products
2. Cell, tissue, and product preservation for regenerative and personalized medicine
3. Large scale manufacturing and quality assurance of regenerative medicine‐ based products
4. Dynamic and innovative quality assurance strategy for regenerative medicine manufacturing
Deadline for White Papers: March 18, 2019
Offerors must be MTEC Members in good standing.