At Grant Engine, we remain vigilent and focused on our mission of saving lives through improving the standard of care for patients in areas of unmet clinical need.
While this crisis has impacted all of us, we are channeling our focus to re-double our efforts for our clients both existing and new.
Please see the FDA guidance on Coronavirus Treatment Acceleration Program.
Below, please see latest opportunities. Stay tuned for updates!
AFWERX: Combating the Spread; Welfare of citizens; Readiness; Logistics; Industrial base impact; Medical; others.
DARPA: Standard SBIR programs available.
The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on the development of prototypes aimed to treat COVID-19 with the following focus area:
FOCUS AREA: Therapeutic(s) that can treat COVID-19. Treatments with potential application to the prevention of COVID-19 infection are desired. Therapeutics that can be administered in a non-hospital environment are desired.
The pandemic COVID-19, a disease caused by a novel coronavirus, continues to spread worldwide. As of March 25, 414,467 confirmed cases of COVID-19 have been reported worldwide, with 18,433 deaths from the disease (www.who.int), the total number of COVID-19 cases in the United States is 55,453 and total number of deaths is 737 (www.cdc.gov). Currently, there are currently no FDA-approved vaccines or treatments for COVID-19.
The goal of this RPP is to develop prototype countermeasures for the treatment of COVID-19.
- The expected technology readiness level (TRL) at start of the period of performance (POP) is 3/4 and at the end of the POP is TRL6 [TRL definitions: mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]
- The Offeror is expected to have, at the onset, a candidate therapeutic with non-clinical data (in vitro, tox, pre-clinical data, etc.) suggesting safety and/or efficacy
- The Offeror should have demonstrated manufacturing feasibility of the candidate therapeutic
- Offerors who have had at least one meeting with the FDA to discuss the regulatory strategy for their candidate(s) are preferred
- Repurposing commercially available, approved products or products in clinical development for related indications with demonstrated safety in humans are preferred
- Partnering with DoD investigators on pre-clinical testing in animal models is encouraged, where appropriate. [Note: Relationships with DoD laboratories must be brought forth as part of the Enhanced White Paper. MTEC members can access points of contact at Army laboratories on the members-only website.]
The expected deliverable at the end of the POP is a final technical report to support a Go/No go decision for the product to enter Phase II trials for the treatment of COVID-19 (see RPP for more details).
There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Awards (subject to change depending upon Government review of work completed). Note that any potential follow on work is expected to be awarded non-competitively to resultant project awardees:
- Manufacturing of therapeutics
- Further clinical testing of therapeuticsPOTENTIAL FUNDING AVAILABILITY:The U.S. Government (USG) Department of Defense (DoD) currently has available approximately $20 Million (M) of FY20 funds. Any potential follow-on funding is expected to be awarded non-competitively and negotiated based on outcomes, cost sharing, partner matching and estimates for additional study completion.The anticipated Period of Performance (PoP) is up to 8 months. Dependent on the results and deliverables, additional time may be added to the period of performance for follow-on tasks.It is expected that MTEC will make up to 5 awards to qualified teams to accomplish the statement of work.