Articles

Newsletter Fall 2018 - Dean E. Calcagni, M.D. on Beyond the NIH - Other Federal Medical R&D

 

Colonel, U.S. Army (retired)

Head, Defense and National Security Practice

 

Not counting the NIH, the U.S. Federal government spends more than $1.5 billion each year on medical research and development.

 

The lion’s share of this funding is in the U.S. Department of Defense (DOD), and the lion’s share of DOD funding is in the U.S. Army Medical Research and Materiel Command (USAMRMC).

 

The USAMRMC is located in Ft. Detrick (Frederick), Maryland. The USAMRMC is primarily involved in medical research and development, but it also performs medical information management, medical logistics management, and health facility planning.

 

Before diving into a review of the USAMRMC’s research programs, it is important to recognize that the USAMRMC (and all federal R&D organizations) take much longer to develop a relationship with than the commercial sector. However, once a relationship is firmly established, it can be a long-lasting one.

 

USAMRMC Research Programs

 

• Military Infectious Diseases Research Program: Protect the U.S. military against naturally occurring infectious diseases by developing FDA-approved vaccines, drugs, and diagnostic assays, as well as EPA-approved vector control protection systems (to prevent the transmission of infections by insects, ticks, etc.).

 

• Combat Casualty Care Research Program: Reduce mortality and morbidity resulting from battlefield injuries by developing new life-saving strategies, new surgical techniques, biological and mechanical products, and the timely use of remote physiological monitoring.

 

• Blast Injury Research Coordinating Office: Addresses critical medical research gaps in blast-related injuries, especially in traumatic brain injury and post-traumatic stress disorder. The program is addressing the new concept of "reset" for Warfighters in redeployment, ensuring return-to-duty readiness (or healthy return to civilian life for citizen Soldiers). One of the program's major areas of focus is to improve battlefield medical treatment capabilities to mitigate neurotrauma and hemorrhage.

 

• Military Operational Medicine Research Program: Develop effective countermeasures against stressors and to maximize health, performance, and fitness. The program’s mission is to protect the Soldier from head to toe, inside and out, at home, and on the battlefield.

 

• Clinical and Rehabilitative Medicine Research Program: Implement long-term strategies to develop knowledge and materiel products to reconstruct, rehabilitate, and provide definitive care for injured Service Members. The ultimate goal is to return the Service Member to duty and restore their quality of life.

 

• Medical Chemical and Biological Research: Support the mission of DOD’s Chemical and Biological Defense Program to provide chemical and biological defense capabilities in support of national military strategies.

 

• Medical Simulation & Information Sciences Research Program: Coordinate emerging military medical simulation and health information technologies/informatics research across all stakeholder communities, as well as transfer research solutions and knowledge to meet Military Health System goals.

 

Congressionally Directed Medical Research Programs (CDMRP)

Congress has entrusted the USAMRMC to manage and execute appropriated funds for Congressional special interest (CSI) medical research, development, test and evaluation efforts, and procurement activities. The CSI appropriations are not requested by the DoD, but are added to the DOD budget by Congress. From 1990 through 2015, the USAMRMC has executed CSI program appropriations totaling over $14.8 billion.

Currently Funded CDMRP Programs


·   Alcohol and Substance Abuse Disorders

·   Amyotrophic Lateral Sclerosis

·   Autism

·   Bone Marrow Failure

·   Breast Cancer

·   Duchenne Muscular Dystrophy

·   Epilepsy

·   Gulf War Illness

·   Hearing Restoration 

·   Joint Warfighter Medical 

·   Kidney Cancer 

·   Lung Cancer

·   Lupus

·   Military Burn

·   Multiple Sclerosis

·   Neurofibromatosis

·   Orthotics and Prosthetics Outcomes

·   Ovarian Cancer

·   Parkinson's Disease

·   Peer Reviewed Alzheimer's

·   Peer Reviewed Cancer

·   Peer Reviewed Medical

·   Peer Reviewed Orthopedic

·   Prostate Cancer

·   Reconstructive Transplant Research

·   Spinal Cord Injury

·   Tick-Borne Disease

·   Tuberous Sclerosis Complex

·   Vision


 

Advanced Development at USAMRMC

 

The advanced development process takes promising technology from USAMRMC laboratories, the industrial base, academia, and other government agencies to U.S. Forces. The process encompasses the testing required for FDA approval or licensing, as well as the fielding of the finished product.

Product/Project Managers (PMs) guide the advanced development of medical products for the U.S. Army Medical Department (AMEDD), other U.S. Services, the Joint Staff, the Office of the Secretary of Defense, and the U.S. Special Forces community. PMs address critical readiness issues identified in user-requirement documents to meet cost, schedule, and performance objectives. Tailored procurement, rapid prototyping, and a variety of cooperative and contractual arrangements with academia and industry are among the current acquisition procedures used.

 

PM Pharmaceutical Systems Project Management Division (PSPMD):Centrally manages the development and acquisition of drugs, vaccines, diagnostics, repellents, blood products, and resuscitative fluids. It fields products for prevention, diagnosis, and treatment of infectious diseases and injuries contracted during military operations.

• Other PMs

- PM Medical Support Systems: Manages products supporting field medical treatment facility infrastructure, preventive medicine, pest management, combat casualty care support systems, military operational medicine, and ground and aeromedical casualty evacuation vehicles.

- PM Medical Materiel Solutions: Manages devices in trauma and emergency medical care, medical transport, general surgery, recovery, and general medical care.

 

• Office of Regulated Activities: A multidisciplinary team of regulatory affairs and clinical compliance professionals dedicated to support the mission of developing FDA-regulated medical products for the Warfighter. This office provides full-service oversight and consultation for regulatory, clinical, non-clinical, manufacturing, data management, and biostatistics support for FDA-regulated drug, biologic, medical device, and combination products.

 

Doing business with USAMRMC

 

Broad Agency Announcement (BAA): Solicits extramural research and development ideas. It includes research areas of interest; general information; evaluation and selection criteria; and proposal/application preparation instructions. The USAMRMC BAA is a continuously open announcement; pre-proposals/pre-applications and proposals/applications may be submitted at any time. Work funded through the BAA is generally in the form of a grant or a Cooperative Agreement.

 

Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR):

Each government department conducting research and development (R&D) must by law set aside several percentages of their program for SBIR/STTR programs. USAMRMC is no exception and makes dozens of SBIR/STTR awards each year.

 

The SBIR is intended to help certain small businesses conduct research and development. Funding takes the form of contracts or grants. The recipient projects must have the potential for commercialization and must meet specific U.S. Government R&D needs.

Phase I, the startup phase, makes awards of "up to $150,000 for approximately 6 months support [for] exploration of the technical merit or feasibility of an idea or technology."

Phase II awards grant "up to $1 million, for as many as 2 years," in order to facilitate expansion of Phase I results. Research and development work is performed, and the developer evaluates the potential for commercialization. Up to 2014 Phase II grants were awarded exclusively to Phase I award winners in 2014. The DOD, NIH, and U.S. Department of Education are allowed to make "direct to Phase II" awards.


The STTR uses a similar approach to the SBIR program to expand public/private sector partnerships between small businesses and nonprofit U.S. research institutions. The main difference between the SBIR and STTR programs is that the STTR program requires the company be partnered with a non-profit research institution (e.g., university), which must be awarded a minimum of 30% of the total grant funds.

 

MTEC: USAMRMC awarded an Other Transaction Agreement (OTA) to the Medical Technology Enterprise Consortium (MTEC). The OTA is a flexible procurement instrument that provides an "enterprise partnership" between the government and a consortium of technology developers/providers in a specific medical research and development domain. This agreement is designed to facilitate mutually beneficial collaborative research and development activities for medical prototype development between the government and industry/academia. It is also intended to attract nontraditional defense contractors. 


OTA organizations are exempt from Federal Acquisition Regulations (FAR), which maintains an arms-length relationship between the government and industry. The OTA consortia model allows for the government and industry to work more as partners in advancing technologies of mutual interest. With this type of OTA organization, the following do not apply: Competition in Contracting Act; Bayh-Dole and Rights in Technical Data; Contract Disputes Act; Procurement Protest System; FAR; DFARS; Department of Defense Grants and Agreements Regulations (DODGARS); and others. 

 

FedBizOps: Opportunities solicited through Broad Agency Announcements (BAAs), Request for Proposals (RFPs) and Request for Quotes (RFQs) can be found on FedBizOpps. When conducting a search, be sure to use USAMRAA DODAAC- W81XWH. 

 

Solicitations for contract actions expected to exceed $15,000, but not expected to exceed $25,000,000, are issued on FedBizOpps. 

 

Tech Transfer Office: The USAMRMC Office of Research and Technology Applications (ORTA), otherwise known as the Technology Transfer Office, coordinates all intellectual property licensing on behalf of all USAMRMC's subordinate laboratories from the federal sector to nonfederal parties. The ORTA office at each subordinate laboratory coordinates Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), Interagency Agreements (IAAs), Nondisclosure agreements (NDAs), and other technology transfer transactions.

 

 

Final Thought: The process of interacting with USAMRMC can be daunting. Kinexum’s Defense and National Security Practice section can assist you in developing a long-term relationship with USAMRMC that will be mutually rewarding both for you and the USAMRMC.