What is a Statement of Work (SOW)?

Many Department of Defense (DoD) non-dilutive funding opportunities require applicants to submit a statement of work (SOW) as part of the application process. However, while most applicants will be familiar with the Hypothesis/Specific Aims format of a White Paper or Technical Proposal, many people may not be familiar with the SOW’s purpose or Objectives/Tasks/Milestones/Deliverables-oriented structure. The SOW information presented here is focused on biomedical and human systems technologies rather than “line” or non-medical technologies. However, as biomedical ...

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FY19 Update: Congressionally Directed Medical Research Program (CDMRP) Peer Reviewed Medical Research Program (PRMRP) Funding and Annual Topic Area Changes

A great source of non-dilutive funding for small business concerns (SBCs) and Universities is the Congressionally Directed Medical Research Program (CDMRP summary). CDMRP currently has 32 research programs, which includes the Peer Reviewed Medical Research Program (PRMRP). There are also 50 topic areas in the PRMRP that your company can apply for in FY19. These topics are selected ...

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Top 7 Funded Congressionally Directed Medical Research Programs (CDMRP): 2009-2019 Funding History per Program

The Congressionally Directed Medical Research Programs (CDMRP) offer a great way for small biomedical research companies that are unfamiliar with the Department of Defense (DoD)-associated funding opportunities and application processes to ease into broadening their funding sources to include DoD resources. CDMRP is a congressionally funded special interest set of programs that are managed by the DoD. The CDMRP fills research gaps by funding high impact, high risk, and ...

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Foreign Organizations: Grant and Contract Eligibility

“Can my company, that is based in Canada, apply for a small business innovation research (SBIR) grant [or Department of Defense (DoD), or Congressionally Directed Medical Research Program (CDMRP), or National Institutes of Health (NIH) funding]?” For SBIR – typically no, as SBIR funds go only to small, independent U.S. businesses based on their ownership and control. For the DoD and CDMRP – typically yes, as long as J-1 Visa requirements are met and your country does not meet ...

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Technology Readiness Level (TRL) Connections to Early Drug Discovery and Development (TRLs 1-3: Pre-Concept)

Previously we wrote about Biomedical and Line (non-medical) Department of Defense (DoD) Technology Readiness Levels (TRLs) and medical countermeasure (MCM) TRLs and discussed how a technology may develop through each TRL stage. Here, we will provide additional details on how biomedical TRLs apply specifically to early discovery and development (i.e., TRLs 1-3) drug, biologic or vaccine decision points for new chemical entities (NCE).

DoD biomedical-related technologies require TRL definitions ...

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DoD Technology Readiness Levels (TRLs) for Medical Countermeasures (MCMs)

We have introduced Biomedical and Line DoD Technology Readiness Levels (TRLs) and discussed how a technology may develop through each stage of the TRL scale for biomedical products such as medical devices. In this article, we will focus on how biomedical TRLs have been adapted for use with medical countermeasures (MCMs) and the unique requirements for development of MCM products, such as drugs and biologics.

Medical Countermeasures (MCMs)

Medical countermeasures (MCMs) are developed to prepare, protect ...

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Biomedical DoD Technology Readiness Levels (TRLs): Medical Devices

Previously, we briefly introduced Biomedical and Line DoD Technology Readiness Levels (TRLs) and discussed how a technology may develop through each stage of the TRL scale. Biomedical TRLs can be further categorized into TRLs for pharmaceuticals (drugs, biologics, and vaccines), medical devices, medical information management/information technology (IM/IT) and medical countermeasures (MCMs) following the FDA Guidance on Product Development under the Animal Rule. In this article, we will focus on biomedical DoD TRLs for medical devices.

Classification: Drug ...

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U.S. Navy Biomedical and Human Systems Communities of Interest (COI)

The Department of Defense (DoD) and other military assisting Federal Agencies have a large and diverse community of subject matter experts (SME) who are eager to collaborate with industry and universities. These extraordinary SMEs are driven to accelerate new and novel dual-use technologies forward to clinical and operational settings. There are thousands of healthcare providers in 167 DoD medical treatment facilities within the U.S. (59 Navy MTFs); tens of thousands of researchers in the

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Biomedical and Line DoD Technology Readiness Levels (TRLs)

Technology readiness assessments (TRA) are widely utilized by the U.S. Department of Defense (DoD) to determine a technology’s readiness for use in acquisition programs and projects (see the U.S. Government Accountability Office’s Technology Readiness Assessment Guide). The TRA frequently uses a maturity scale – technology readiness levels (TRLs) – that are ordered according to the characteristics of the demonstration or testing environment under which a given technology was tested at defined points in time. ...

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