Army Biomedical Science and Technology Programs

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Army Biomedical Science and Technology Programs
COL Nancy Vause Director, Strategic Partnership
OfficeU.S. Army Medical Research and Materiel
Command DoD Funding Opportunities
Forum University of North Carolina, Chapel
Hill June 7, 2006
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U.S. Army Medical Research and Materiel Command
Advanced Technologies
Medical Logistics
Infectious Diseases
We deliver the best medical solutions, for today
and tomorrow, to enhance, protect, and treat the
Warfighter on point for the Nation.
Combat Casualty Care
Medical IM/IT
Medical Facilities Planning
Military Operational Medicine
Medical Chemical Defense
Medical Biological Defense
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USAMRMC PRESENCE AROUND THE WORLD
Legend Lab/Unit Research
Agreement Deployment Exchange
Program Collaboration
Global Force Health Protection Network
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CONUS-Based Organizations
USARIEM Natick, MA Nutrition and
Environmental Injury Prevention
USAMRICD APG, MD Medical Chemical Defense
USADTRD WRAIR Detachment Great Lakes, IL Military
Dental Research
WRAIR Silver Spring, MD Infectious Diseases
Combat Stress Chem/Bio
USAMMA Medical Materiel Life Cycle
Management USAMMDA Advanced Medical Materiel
Development USAMRAA Contract Support USAMRIID Med
ical Biological Defense USACEHR USAMRICD
Detachment Environmental Health Res.
USAMRD WRAIR Detachment Brooks City-Base,
TX Laser Bioeffects
HQ,USAMRMC Fort Detrick, MD
USAISR Fort Sam Houston, TX Combat Casualty
Care Burn Trauma
USAHFPA Falls Church, VA Health Care Facility
Planning
USAARL Fort Rucker, AL Objective Force Safety
and Survivability
USAMITC San Antonio, TX Information Systems
Maroon Laboratory Green Non-laboratory
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Military Infectious Diseases OCONUS Labs

• Products in Development
• (in response to Warfighters stated needs)
• Vaccines
• Plasmodium falciparum Malaria
• Diarrhea - Shigella flexneri, Shigella sonnei,
  Campylobacter, ETEC
• HIV Vaccine (multiple vaccines)
• Dengue, Hepatitis E, Plague
• Group B meningococcus
• Drugs
• Tafenoquine for Malaria Prophylaxis
• Topical Drug for Treatment of Leishmaniasis
• Artesunate for Multi-drug Resistant Malaria
• Diagnostics and Repellents
• Malaria Rapid Diagnostic
• Leishmania Diagnostics
• New Standard Military Insect Repellent

AFRIMS Bangkok, Thailand
NAMRU-3 Cairo, Egypt
NMRCD Lima, Peru
USAMRU Nairobi, Kenya
NAMRU-2 Jakarta, Indonesia
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Technology Discoverers

• U.S. Army Institute of Surgical Research
• Provides Combat Casualty Care medical solutions
  and products for injured Soldiers
• Home of the militarys only Burn Trauma Center
• U.S. Army Medical Research Institute of
  Infectious Diseases
• Lead lab for medical biological defense research
• BSL-4 laboratory (maximum containment) and
  patient care capability
• U.S. Army Medical Research Institute of Chemical
  Defense
• Lead lab for medical chemical defense
• Maintains unique chemical surety facility
• Telemedicine and Advanced Technology Research
  Center
• Information technology and telemedicine
  applications for forward care

• Walter Reed Army Institute of Research
• Lead lab for infectious disease research,
  expertise in combat casualty care, military
  operational medicine, chem/bio defense, and
  combat dentistry
• Two detachment laboratories and Special Foreign
  Activities in Thailand, Kenya, and Germany
• U.S. Army Institute of Environmental Medicine
• Lead lab for military nutrition, occupational
  medicine, and environmental physiology research
• Protecting Warfighter health in extreme
  environments and maximizing Warfighter
  performance
• U.S. Army Aeromedical Research Laboratory
• Improve Soldier/system integration and
  performance in aviation systems
• Evaluate and mitigate adverse effects of health
  hazards such as noise, repeated impact, stress,
  and fatigue

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Technology Developers and Providers

• U.S. Army Medical Materiel Agency
• Medical product acquisition, technology, and
  logistics support
• COTS materiel developer
• U.S. Army Medical Materiel Center, Europe
• Medical logistics manager

• U.S. Army Medical Materiel Development Activity
• Medical device, pharmaceutical, and biological
  product development
• U.S. Army Medical Information Technology Center
• Enterprise IT systems acquisition and sustainment

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USAMRMC Core ST Programs

• Congressional appropriations that are in the
  Presidents budget
• Funded primarily by Army and DoD RDTE
• Responsive to rigorous requirement determination
  process
• Research proposals reviewed for scientific and
  programmatic merit
• Goal is the best possible medical products to
  deliver the best possible medical care for the
  deployed Soldier

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USAMRMC Core ST Programs
Military Infectious Diseases 27
Med Chem Defense 15

• Military Infectious Diseases
• Medical readiness
• Vaccines
• Biotechnology
• Prophylaxis/treatment drugs
• Diagnostics/prognostics
• Vector control
• Medical C4ISR
• HIV countermeasures

Combat Casualty Care 10
Med Bio Defense 31
Military Operational Medicine 17

• Medical Chemical Defense
• Medical management ofCW casualties
• Medical readiness
• Drug prophylaxes/pretreatments
• Diagnostics/therapeutics

• Combat Casualty Care
• Lightweight medical equipment
• Medical C4ISR
• Trauma care
• Health monitoring diagnostic technology

• Medical Biological Defense
• Vaccines/therapies
• Field-portable diagnosticsystems
• Medical readiness
• Biotechnology

• Military Operational Medicine
• Soldier selection sustainment
• Soldier performance
• Warrior system modeling
• Health hazards protection
• Diagnostics/prognostics
• Health monitoring

Programs managed by Defense Threat Reduction
Agency (DTRA)
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Fort Detrick Home of National Interagency
Biodefense Campus
Partners already located at Fort Detrick DoD
US Army Medical Research Institute of Infectious
Diseases and Armed Forces Medical Intelligence
Center Department of Agriculture National
Institute of Allergy and Infectious Diseases
building under construction Department of
Homeland Security groundbreaking June 06 Centers
for Disease Control (soon)
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Fort Detrick Home of National Interagency
Biodefense Campus
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USAMRIID Unique National Asset within DoD

• UNIQUE PEOPLE AND EXPERTISE
• 35 years safely handling worlds deadliest
  pathogens in biocontainment
• Majority of Nations biomedical experts in
  infectious aerosols
• Majority of Nations subject matter experts on
  biological warfare (BW) threats

• UNIQUE FACILITIES
• Aerobiology labs
• Biosafety Level (BSL)-4 labs
• The Slammer The only BSL-4 patient care suite
  in the Nation
• 16-bed BSL-3 capable clinical research ward
• National Reference Laboratory for confirmatory
  identification of BW agents

• UNIQUE CAPABILITIES
• Aeromedical Isolation Team 8-person deployable
  team
• Worldwide disease outbreak investigations and
  medical consultations
• Incident response education/training including
  CME BW casualty care training
• Definitive identification of BW threats for
  Laboratory Response Network
• FDA-regulated pre-clinical and clinical
  evaluation of candidate medical products

USAMRIID is an essential component of a National
system to develop medical countermeasures to BW
threats.
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Interagency Biological Defense Programs at Ft.
Detrick
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Walter Reed Army Institute of Research (WRAIR)

• Expertise
• Vaccine and drug discovery and development
• Molecular biology of bacterial, viral, and
  parasitic pathogens
• Neuroscience
• Facilities
• Vaccine Pilot-Scale Production Facility
• Current Good Manufacturing Practice/Good
  Laboratory Practice-compliant operations
• Viral, bacterial, and recombinant vaccines
• De Novo Microarray Laboratory
• Production of custom cDNA print microarrays for
  analysis of gene expression and translation
• Capabilities
• CW drug discovery and preclinical development
• Vaccine scale-up

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USAMRICD Collaborative Research Facility Resources
Allows principal investigators external to
USAMRICD to conduct research related to XCSM
exposure, facilitating successful external
collaborative efforts
COLLABORATIVE RESEARCH PROGRAM Resources
COLLABORATIVE RESEARCH FACILITY (CRF, Bldg 3156)
ICD RESOURCES (on a case-by-case basis)
Neat agent
Small animals
Blood sample collection (in vivo)
Dilute agent
Nonhuman primates
Core research technologies
Select large animals
RBC AChE analysis
Visiting PI lab available
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Congressional Special Interest (CSI) Programs

• Congressional appropriations that are not in the
  Presidents budget
• Responsive to intent of Congress, managed to
  maximize military relevance
• Research proposals reviewed for scientific and
  programmatic merit prior to award
• Programs executed by universities, industry,
  military services, other federal agencies, etc.

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CSI Programs Management
TATRC 27
CDMRP 43

• Congressionally Directed Medical Research
  Programs (CDMRP)
• Breast cancer
• Prostate cancer
• Ovarian cancer
• Neurofibromatosis
• Other diseases

RADs 20
Adv Dev 10

• Research Area Directorates (RADs)
• Research projects that enhance core programs

Telemedicine and Advanced Technology Research
Center (TATRC)

• Medical information technologies
• Other advanced technologies

• Acquisition Directorate
• CSI products in advanced development

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Teaming Relationships
USAMRMC Deployable Teams REF RFI FAST PMs
Contractors

• Facilitating

• Expediting

• Linking

Industry
Seeking Good Ideas that make a difference
Rapid Development
Rapid Equipping (Teaming)
International Markets
Warrior Medic Soldier Products
Rapid Sustainment (Teaming)
Academia
Disposal
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Opportunities for Academia

• Partnership Mechanisms
• Cooperative Research and Development Agreements
  (CRADAs)
• Material Transfer Agreements (MTAs)
• Patent License Agreements
• Clinical Trial Agreements
• Test and Evaluation Agreements
• Technical Assistance Agreements
• Partnership Intermediaries
• Educational Partnerships
• Research Funding Mechanisms
• Contracts
• Grants
• Small Business Innovation Research (SBIR)
• Small Business Technology Transfer (STTR)
• Broad Agency Announcements (BAA)
• Telemedicine and Advanced Technology Research
  Center (TATRC)
• Congressionally Directed Medical Research Program
  (CDMRP)
• Cooperative Agreement (CAs)

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Technology Transfer

• USAMRMC Office of Research and Technology
  Applications (ORTA)
• Coordinates all intellectual property licensing
  from federal sector to nonfederal parties on
  behalf of USAMRMC laboratories
• Laboratory ORTA offices coordinate
• CRADAs
• MTAs
• Interagency Agreements (IAAs)
• Nondisclosure Agreements (NDAs)
• Other technology transfer transactions
• Memorandum of Agreement (MOAs)
• Memorandum of Understand (MOUs)

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Broad Agency Announcements (BAAs)

• Main Command mechanism for solicitation and
  support of mission-related extramural research
• Solicits research ideas from educational
  institutions, nonprofit organizations, and
  private industry
• Awards contracts, grants, and cooperative
  agreements
• Provides a general description of the Command's
  research programs, identifies specific areas of
  interest, and defines evaluation/selection
  criteria
• Limited funding also available for conference and
  symposium support
• Process
• Pre-proposals submitted at any time, with
  decision in 3060 days
• Full proposals requested by USAMRMC and should be
  submitted within 90 days of notification
• Award decision made within 180 days
• Length of time requested for support should be
  consistent with the nature and complexity of the
  proposed research
• Dates
• Command BAA is continuously open
• Program-specific BAAs are issued for specific
  solicitations and have limited timeframes

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Army Research Office Managed Programs (SBIR)

• Small Business Innovation Research (SBIR)
• Process
• Army advertises interest in specific research
  topics
• Proposals reviewed for military relevance,
  technical merit, innovation, potential for
  commercial exploitation, and staff qualifications
• Successful proposals awarded Phase I support for
  6 months (up to 100K) and successful Phase I
  projects compete for 2 years of support for Phase
  II (up to 750K)
• Dates
• Three solicitations per year
• Solicitations open DecemberJanuary, JuneAugust,
  and SeptemberOctober
• Contracts awarded in May, November, and February

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Army Research Office Managed Programs (STTR)

• Small Business Technology Transfer (STTR)
• Companion to SBIR, with requirement that work
  must be performed by small businesses in
  collaboration with nonprofit organizations
• Phase I, up to 100K Phase II, up to 750K
• Dates
• Solicitation open MarchApril
• Contracts awarded in August

• SBIR/STTR Statistics (FY05)
• Phase I 49 topics, 550 proposals received, 99
  funded, 5.2M
• Phase II 34 awarded, 24.0M

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Congressionally Directed Medical Research Program

• Investment Strategy
• Congressional Special Interest topics
• Training and research resources
• Research
• Innovation-based
• Traditional (R01-, P50-type awards)
• Translational
• Clinical
• Process
• eReceipt Online Proposal Submission
• Pre-proposals may be required for some programs
• Proposals undergo peer review (science and
  budget) and programmatic review (relevance and
  budget)
• Variety of award mechanisms used
• Dates
• Solicitations close May/June for most awards

• Statistics (FY05)
• gt5,000 proposals received
• 670 new grants awarded
• Total managed portfolio of over 3,500 active
  awards, in the order of 1.8B

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USAMRMC Outreach Efforts

• Historically Black Colleges and
  Universities/Minority Institutions (HBCU/MIs)
• USAMRMC and Army outreach efforts exist to
  strengthen relationships with HBCU/MIs
• Goals are to increase awareness and participation
  of HBCU/MIs in research opportunities
• Particular interest in joint efforts by major
  research universities and HBCU/MIs
• Multiple HBCU/MI-specific awards offered via
  CDMRP
• Other Outreach Efforts
• Hispanic Serving Institutions
• Tribal Colleges and Universities
• Small Business
• Historically Underutilized Business Zones
• Small and Disadvantaged Businesses
• Woman Owned
• Veteran Owned

• Statistics
• Approximately 18M awarded in FY05 to HBCU/MIs
• 20M in FY06, so far

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Working with USAMRMC

• Strategic Partnership Office (HQ, USAMRMC)
• Facilitates USAMRMC interactions with industry,
  academia, and other DoD and federal agencies
• Assistance in establishing formal programmatic
  collaborations
• Office of Small and Disadvantaged Business
  Utilization
• Assists small businesses in competing for USAMRMC
  procurements
• Education and outreach activities (including
  HBCU/MI)
• Fort Detrick Business Development Office
• Information on procurement opportunities and
  resources (BAAs, SBIR, etc.)
• Support for access to emerging technologies
• Assistance in developing opportunities for
  business, business collaboration, and small
  business subcontracting prospects

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Educational Programs

• Oak Ridge Institute for Science and Education
  Research Participation Program in Maryland (ORISE
  Maryland)
• Academic community member can participate in
  USAMRMC and other military programs, projects,
  and activities worldwide
• Available to faculty, students at all levels
  (high school thru doctoral), and post-doctoral
  trainees
• National Research Council Research Associateship
  Program
• Science, Technology, Engineering and Math (STEM)
  Initiatives
• Science and Engineering Apprentice Program (SEAP)
• 8 week summer program for high school students
• Gains in the Education of Mathematics and Science
  (GEMS)
• Summer program for middle school and high school
  students
• College science/math/engineering majors serve as
  near-peer mentors in USAMRMC laboratories
• Maryland Governor's Workforce Investment Board -
  Bioscience Task Force Educational Summit
• Policy and program initiatives to increase
  biomedical science and technology science skills
  of Maryland workforce

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Internet Resources

• U.S. Army Medical Research and Materiel Command
• https//mrmc.detrick.army.mil
• U.S. Army Medical Research Acquisition Activity
• http//www.usamraa.army.mil
• Broad Agency Announcements (BAAs)
• Program Assistance Announcements (PAAs)
• Congressionally Directed Medical Research Program
• http//cdmrp.army.mil
• Telemedicine and Advanced Technology Research
  Center
• http//www.tatrc.org/
• Office of Research and Technology Transfer
• https//technologytransfer.detrick.army.mil/
• Fort Detrick Business Development Office
• http//www.fdbdo.com
• USAMRMC Small Business Opportunities
• http//www.mrmc.smallbusopps.army.mil
• Tutorial for Academia, Sample Winning Proposals
  Included
• Advanced Acquisition Forecast (Contracting
  Opportunities)

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Internet Resources (cont.)

• U.S. Army Small Business Office
• http//www.sellingtoarmy.info
• Small Business Innovation Research (SBIR)
• http//www.aro.army.mil/arowash/rt
• http//www.dodsbir.net/sitis/
• Small Business Technology Transfer (STTR)
• http//www.aro.army.mil/arowash/rt/sttr/sttr.htm
• http//www.acq.osd.mil/sadbu/sbir/solicitations/so
  licit.htm

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Points of Contact

• USAMRMC Strategic Partnership Office
• COL Nancy Vause
• Phone [phone]
• E-mail nancy.vause_at_amedd.army.mil
• USAMRMC Small and Disadvantaged Business
  Utilization (HBCU/MI Outreach)
• Mr. Jerome Maultsby
• Phone [phone]
• E-mail jerome.maultsby_at_amedd.army.mil
• USAMRMC SBIR/STTR Program
• Ms. Mary Smerk
• Phone [phone]
• E-mail mary.smerk_at_det.amedd.army.mil
• Fort Detrick Business Development Office
• Mr. Darryl Rekemeyer
• Phone [phone]
• E-mail darryl.rekemeyer_at_fdbdo.com

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Points of Contact (cont.)

• Office of Research and Technology
• Applications
• HQ, USAMRMC
• Dr. Paul Mele
• Phone [phone]
• E-mail paul.mele1_at_us.army.mil
• Ms. Sara Baragona
• Phone [phone]
• E-mail sara.baragona_at_us.army.mil
• U.S. Army Aeromedical Research Laboratory
• Ms. Diana Hemphill
• Phone [phone]
• E-mail diana.hemphill_at_amedd.army.mil
• U.S. Army Medical Research Institute of Chemical
  Defense
• Mr. John Blische

Walter Reed Army Institute of Research Dr.
Claudia Golenda Phone [phone] E-mail
claudia.golenda_at_us.army.mil U.S. Army Center for
Environmental Health Research Dr. Thomas
Gargan Phone [phone] E-mail
thomas.gargan_at_amedd.army.mil U.S. Army Research
Institute of Environmental Medicine Mr. Chris
Joyce Phone [phone] E-mail
christopher.joyce_at_amedd.army.mil U.S. Army
Institute of Surgical Research Mr. Richard
Jocz Phone [phone] E-mail
rick.jocz_at_amedd.army.mil Telemedicine and
Advanced Technology Research Center Dr. Robert
McCarthy Phone [phone] E-mail
mccarthy_at_tatrc.org
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BACKUP SLIDES
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Rationale for Army Biomedical ST Investment

• Soldiers are our most precious and vulnerable
  resource
• Essential for mission effectiveness
• Most vulnerable warfighting/peacekeeping asset,
  susceptible to
• Impaired judgment and vigilance
• Reduced task proficiency
• Disease/battle and nonbattle injuries
• Significant cost driver
• Recruitment and retention
• Health and fitness
• Training and leadership
• Force projection and protection

Medical modernization enables effective force
projection Medical readiness is the foundation to
Soldier capability and deployability Investment
supports all aspects of Soldier as a system
medical, as well as physiological, cognitive, and
physical performance
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Threats to Soldier Health and Performance

• Operational Stressors
• Sleep Deprivation
• Traumatic Stress and Situational Stressors
• Physical Work Load
• Cognitive Burden Operational Complexity

• Endemic Disease Threats
• Parasitic Diseases
• Bacterial Diseases
• Viral Diseases

• Chemical/Biological WarfareThreats
• Bacterial Threats
• Viral Threats
• Toxin Threats
• Nerve Agents
• Vesicant Agents
• Blood Agents

• Combat Injuries
• Hemorrhage
• Head Trauma
• Blast Injury

• Systems Hazards
• Laser
• Blast
• Biomechanical Insults and Stresses

• Environmental Hazards
• Heat and Cold
• Altitude
• Toxic Industrial Chemicals Materials

Inadequate Medical C4ISR
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Soldiers Health Life Cycle
TRAINING UNIT READINESS
SOLDIER ENHANCEMENT CASUALTY PREVENTION
DEPLOY
COMBAT INJURY DISEASE NON-BATTLE INJURY (DNBI)
HEALTHY FIT FORCE
U
S
A
THEATER INTERIMDATA REPOSITORY
CLINICAL DATA REPOSITORY
Theater Medical Information Program
(TMIP) CHCS-II-T
M
Composite Health Care System (CHCS)-II
R
PRE- DEPLOYMENT
M
DEPLOYMENT
FORWARD MEDICAL CARE
ACCESSION
C
ENROUTE CARE
CARE OUTSIDE THEATER
THEATER HOSPITALIZATION
TRANSCOM Regulating and Command and Control
Evacuation System (TRAC2ES)
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Medical Science and Technology (ST)
Technology Readiness Assessment
Novel Concepts and Emerging Technologies
Prototype Maturation and Demonstration
Production and Distribution
Applied Research Translates Research to Solutions
for Military Problems
System Development and Production

• cGMP pilot lot production
• GLP safety and efficacy studies
• Endpoints of clinical or surrogate efficacy
• Stability studies initiated
• Pre-IDE meeting and IDE prepared and submitted
  for Class III device
• 510(k) preliminary data suggest substantial
  equivalency to predicate device

• Pre-IND meeting
• IND prepared and submitted
• Phase 1 clinical trials
• Investigation of Class III device in clinical
  trials
• Safety demonstrated
• Production technology demonstrated
• 510(k) - data demonstrate substantial equivalency
  to predicate device

• Phase 2 clinical trials
• Investigation of Class III prototype in clinical
  trials
• Safety and evidence of efficacy demonstrated
• Final dose, dose range, and schedule established
• Pre-Phase 3 meeting
• Phase 3 clinical study plan or surrogate test
  plan approved
• Class III device design validated and final
  prototypes produced
• 510(k) final prototype produced and tested

• Phase 3 clinical trials
• Investigation of final Class III prototype in
  clinical trials
• Safety and efficacy demonstrated
• Process validation completed
• Facility PAI completed
• Pre-NDA/BLA/PMA meeting
• NDA/BLA/PMA/510(k) prepared, submitted, and
  approved

• Marketing and distribution
• Postmarketing studies
• Postmarketing surveillance

• Generate/test hypotheses and experimental designs
• Synthesize candidate countermeasures
• Identify sites and mechanisms of action
• Device components and design identified
• Initial proof of concept

• Technological assessment requirements identified
• Non-GLP formulation, dose, and pharmacokinetic
  studies
• Non-GLP safety and efficacy studies
• Assays/procedures for GLP/GCP studies identified
• Device design history file/review initiated

TRLs 13 TRL 4 TRL 5 TRL 6 TRL 7 TRL 8 TRL 9
TRLs-Technology Readiness Levels.
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OrganizationUSAMRMC is Part of the Military
Health Service System
HQ, Army Medical Command (MEDCOM) Army Surgeon
General
Army Medical Department Center School
Army Medical Research Materiel Command

• Regional Medical Commands
• Europe
• Great Plains
• North Atlantic
• Pacific
• Southeast
• Western

Army Center for Health Promotion Preventive
Medicine
Army Dental Command
Army Veterinary Command
Medical Surveillance, Readiness Operational
Support
Research, Development, Acquisition Logistics
Global Health Care Delivery
Education Training
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USAMRMC Functions
CG, MEDCOM
CG, USAMRMC
Support the Warfighter on Point for the Nation
Medical Research, Development, and Acquisition
(RDA)
Medical Logistics
Medical IM/IT
Medical Facilities
Cradle-to-Grave Medical Materiel Acquisition
Transforming Army Medicine
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HBCU/MI-Specific Awards Mechanisms at CDMRP

• Breast Cancer Research Program
• HBCU/MI Partnership Training Award
• Prostate Cancer Research Program
• HBCU Collaborative Partnership Award
• Collaborative Undergraduate HBCU/MI Student
  Summer Training Award
• Ovarian Cancer Research Program
• HBCU/MI Collaborative Research Awards