1. Hawaii Biotechnology Research: Interest Areas and Opportunities with the Department of Defense
COL Karl Friedl, PhD
Telemedicine & Advanced Technology Research Center
US Army Medical Research & Materiel Command
Frederick, MD

2. A hiatus exists between the inventor who knows what they could invent, if they only knew what was wanted, and the soldiers who know, or ought to know, what they want and would ask for it if they only knew how much science could do for them.
- Winston S. Churchill (1929)

3. Agenda Military medical research interests
Biomedical research in the DoD
USAMRMC organizational structure
Competitive funding opportunities
Hawaii Federal Healthcare Network Program

4. Technology Shortfalls: Fill the Gaps
Current Operational Concepts and Environment
Future Operational Concepts and Environment
Desired Capabilities
S&T Shortfalls
Needed S&T Work
Needed S&T Work
Capability Challenges
Capability Needs
Existing Tech or Non-Technology Solutions
Ongoing S&T Work
Existing Tech or Non-Technology Solutions
Capability Today
Capability Today

5. The Linear Approach to R&D Army Medical Product Development Life Cycle
Fed / DoD Needs
ICD
ICD
CDD
CPD
Opportunities, Gaps, & Resources
MDD A B
Program Management
Initiation C
Life Cycle
Funding
6.1
6.2
6.3
6.4
6.5
6.7
Ops & Maint $
Research, Development, Test, & Evaluation (RDT&E) $
Procurement $
DoD Funding Categories
6.1 – 6.3: Basic research, applied research, and advanced technology development
6.4 – 6.5: Program management activities
6.6: Program support including test and evaluation facilities
6.7: Improvements to existing operational systems
Vannevar Bush model
Basic research is a pacemaker of technological innovation but must be segregated to avoid premature thoughts of practical use
Joint Capability Integration & Development System Documents
ICD: Integrated Capabilities Documents
CDD: Capability Development Documents
CPD: Capability Production Documents

6. DoD Problem-solving Focus: Use-inspired Medical Research
Understanding underlying science creates rule base to help solve future problems
Low Emphasis on Fundamental Understanding
High Emphasis on Basic Science
Low Emphasis on Applications
Pure basic research (Bohr)
High Emphasis on Applications
Pure applied research (Edison)
Use-inspired basic research (Pasteur)
Revolutionary
Evolutionary

7. What are the DoD Medical Research Priorities. (Where do they come from
National strategic plans (e.g., Quadrennial Review – in progress!)
Secretary of Defense & other authoritative sources in the DoD and Services
Armed Services Biomedical Research Evaluation and Management
Near-term problems identified by field commanders & COCOMs

8. Secretary Gates' Press Briefing May 3, 2007
Apart from the war, this department and I have no higher priority than to ensure wounded servicemembers have the best care and facilities and ample assistance navigating the next step in their lives. That is what we intend to give them.

9. Current Priorities: Secretary Gates' Budget Briefing April 6, 2009
Recognize the critical and permanent nature of wounded, ill and injured, traumatic brain injury, and psychological health programs This means institutionalizing and properly funding these efforts in the base budget and increasing overall spending by $300 million. The department will spend over $47 billion on healthcare in FY10.

10. Enduring Challenges: Old Medical Threats, New Science
LIMB LOSS
SHELL SHOCK
HEMORRHAGE

11. Core Medical R&T Responds to Threats to Soldier Health and Performance
Endemic Disease Threats
Parasitic Diseases
Bacterial Diseases
Viral Diseases
Operational Stressors
Sleep Deprivation
Traumatic Stress and Situational Stressors
Physical Work Load
Cognitive Burden & Operational Complexity
Chemical/Biological
Warfare Threats
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
Noise
Environmental Hazards
Heat and Cold
Altitude
Toxic Industrial Chemicals & Materials
Inadequate
Medical C4ISR

12. Pharmaceutical Advanced Development Pipeline at USAMMDA
Pre-Clinical Phase Phase Phase Licensed
VACCINES
Adenovirus Type 4 & 7
HIV Prime-Boost
Dengue Tetravalent
(Proof-of-Concept)
(Proof-of-Concept Completed)
(License
Submitted)
Leish Drug, PentostamTM
Antimalarial-IV Artesunate
Topical Leishmania Drug
Antimalarial-Tafenoquine
Leish Rapid Diagnostic
ANTIPARASITIC DRUGS/Dx
Intranasal Ketamine
RBCs Extended Life
Cryopreserved Platelets
Freeze-Dried Plasma
COMBAT CASUALTY CARE

13. Joint Force Health Protection Capability Gap Medical R&D
OVERARCHING NEEDS:
Maintain a Healthy & Fit Force
Protect Personnel in the Field
Diagnosis for Early Treatment
Rapid Return to Duty
Military Infectious Diseases Research Program
Vaccines
Prophylaxis/treatment drugs
Diagnostics/prognostics
Vector control
HIV countermeasures (Congressional mandate)
Combat Casualty Care Research Program
Meet Demands on First Responders
Reduce the Number of Deaths on the Battlefield
Limit Brain Damage
Improve Medic, Provider, and Team Training
Restore Full Function
Improve En Route Care
Reduce Morbidity and “Died of Wounds” Rate
Clinical Trials
Military Operational Research Program
Prevent, Detect and Treat Mental Health Problems and mTBI (Concussion)
Prevent/Mitigate Blast, Blunt, Ballistic, and Impact Injury
Reduce Attrition in Basic Combat Training Due to Injury and Mental Health Problems
Prevent/Mitigate Injury from Environmental Exposures to Heat/Cold/Altitude and Toxic Chemicals and Materials
Sustain Soldier Performance
Medical Biological Defense Research Program
Vaccines and pre-treatments
Small molecule therapeutics
Next generation diagnostics
Animal model development
Broad-spectrum therapeutics
Medical Chemical Defense Research Program
Nerve agent pre-treatments
Therapeutics for nerve agents
Therapeutics for vesicant injury
Diagnostic assays/technologies
Clinical and Regenerative Medicine Research Program
Improve Prosthetic Function
Enhance Self Regenerative Capacity
Improve Limb/Organ Transplant Success
Create Fully-Functioning Limbs/Organs
Blast Injury Program Coordinating Office
Develop Medical Standards for Individual and Combat Vehicle Crew Blast Protection Systems
Elucidate the Mechanism of Blast-Induced Brain Injury
Improve Diagnosis of mTBI
Effectively Communicate Blast-Related Research Across the DoD
Reset
Advance Treatment Options 13 13

14. Key Blast Injury Research Topics
(FY07-10 Investments)
Injury Prevention ($183M)
Blast Loading
CFD Simulation
Observed
Pathology
FEM Simulation
Test Conditions
Existence and mechanism of non-impact, blast- induced mTBI?
Drugs to prevent and treat blast-related hearing loss
Analysis of combat injuries and PPE performance (JTAPIC)
Multi-effect blast injury models to improve protective equipment
Resilience enhancement and prevention of PTSD R x
Hair Cell
Antioxidant Defenses
Tissue engineering and prosthetics
Return-to-duty Standards
Recovery of function
Reset ($141M)
Before
After
Diagnostics and neuroprotectant
drugs for TBI
Hemorrhage control & blood products
Treatment of psychological trauma
Damage control orthopedics
Pain management
Acute Treatment ($437M)

15. DoD Blast Injury Research Extends Back to World War II
Nuclear &
conventional explosions
Los Alamos & Albuquerque
Cave blasts
Armored Med Res Lab

16. New Science and Technology Options:
Modernization of Military Medical R&D
“Laying the tracks for the train”
Prevention
(Mitigate Risk)
Acute Treatment
(Mitigate Injury)
Reset
(Mitigate Disability)
Personalized Medicine
Diagnostics
Regenerative Medicine
Individual Resilience
Provider Training
Individual Retraining
Biomedical Standards
Wound Care
Advanced Prosthetics
Injury Surveillance
Optimized Interventions
Return-to-Duty Standards
Systems Biology Methods
Advanced Training Technologies & Neuroplasticity
Computational Bioengineering, Biomaterials & Nanotechnologies
Electronic Health Record Outcomes Research

17. Chemical Biological Defense Program Threat Focus
Advanced Threats
pathogens engineered to increase resistance, transmissibility, and virulence
Traditional Threats
intracellular bacterial pathogens (e.g., plague)
viral hemorrhagic fevers (e.g., ebola)
Enhanced Threats
“bioprospecting” of virulent strains in nature
cultivating virulent strains in the laboratory
Emerging Threats
natural diseases (e.g., pandemic flu, malaria)
multidrug and vaccine resistant pathogens

18. www.tmti-cbdefense.org; ww.fedbizops.gov
Chemical Biological Defense Program: Transformational Medical Technologies Initiative
Develop broad-spectrum countermeasures and novel technology platforms (one drug, many bugs)
Pursue countermeasures targeting common disease pathways or enhance the host’s immune system
Integrate best efforts within government, academia, DoD, biotech industry, and small and large pharmaceutical corporations
Provide seamless “end-to-end” product development
Eliminate capability gaps by adding promising candidate technologies to the pipeline
ww.fedbizops.gov

19. The Changing Operational Environment “Low level Persistent Conflict” General Casey, 14 Aug 07

20. & International Health
The Changing Operational Environment “Low level Persistent Conflict” General Casey, 14 Aug 07
Stability Operations
& International Health

21. Medical Research and Related Programs in the DoD
DARPA (e.g., DSO)
CBDP/DTRA (e.g., TMTI)
SOCOM (BISC)
VA-DoD sharing (e.g., JIF)
NIH joint efforts
Other Agencies
DCoE for PH and TBI
DCoE for Vision
USAMRMC
ARO
NMRC
ONR
AFMOA
AFRL
AFOSR
Services

22. Medical Research and Related Programs in the DoD
DARPA (e.g., DSO)
CBDP/DTRA (e.g., TMTI)
SOCOM (BISC)
VA-DoD sharing (e.g., JIF)
NIH joint efforts
Other Agencies
DCoE for PH and TBI
DCoE for Vision
USAMRMC
ARO
NMRC
ONR
AFMOA
AFRL
AFOSR
Services
ASBREM

23. Armed Services Biomedical Research Evaluation & Management
The ASBREM Committee shall:
Review medical RDT&E program plans and accomplishments for quality, relevance, and responsiveness to military operational needs, the needs of the Military Health System, and the goals of Force Health Protection
Review program plans and budgets in support of the various guidance documents relevant to National Security and to the missions and functions of the Department of Defense
Provide coordination, recommendations, and support to DoD Executive Agencies and other DoD officials as requested, directed, or otherwise appropriate

24. Medical Research and Related Programs in the DoD
ASBREM
Joint Technical Coordinating Groups
1 Med Training Systems & Information Tech
2 Military Infectious Diseases
3 Chemical Defense
4 Biological Defense
5 Military Operational Medicine
6 Combat Casualty Care
7 Radiation Effects
8 Clinical and Rehabilitative Medicine

25. Defense Health Program: GDF Enhancement
MISSION DESCRIPTION AND BUDGET ITEM JUSTIFICATION: This Program Element (PE) funds Advanced Component Development of medical products that are regulated by the U.S. Food and Drug Administration (FDA) and the accelerated transition of FDA licensed and unregulated products and medical practice guidelines to the military operational user through clinical and field validation studies. Projects in this PE are designed to address areas of interest to the Secretary of Defense and to close medical capability gaps associated with the Joint Force Health Protection Concept of Operations (JFHP CONOPS) and are complementary to research conducted by the Army, Navy and Air Force in analogous PEs. Projects include Trials for Accelerated Transition of Modeling and Simulation Technology for Medical Training/Education/Treatment; Trials for Accelerated Transition of Medical Technology, Practice Guidelines and Standards; Medical Products – Advanced Component Development; and Medical Information Technology Development.
$198 M

26. Congressional Special Interest (CSI) RDA Programs
About 50% of USAMRMC Funding Each Year Is Congressionally Directed
Function of Congressional Special Interest (CSI)
Research:
Sponsor good science using Congressional appropriations that are not in the President’s budget
Responsive to the intent of Congress, managed to maximize military relevance
Process:
Proposals peer reviewed for scientific merit prior to award
Programs executed by extramural awardees and USAMRMC laboratories and acquisition offices
Program Managers:
USAMRMC Research Area Directorates (33%)
U.S. Army Medical Materiel Development Activity (USAMMDA – 9%)
Congressionally Directed Medical Research Programs
Telemedicine and Advanced Technology Research Center
TATRC 29%
CDMRP 32%
Core R&T 33%
Advanced Development 9%
Core
Effort
39%

27. Medical Advanced Development
Supporting Commands
USAMMDA
U.S. Army Medical Materiel Development Activity
USAMMA
U.S. Army Medical Materiel Agency
Defense Medical Logistics Center
Pharmaceutical Systems
Applied Medical Systems
Integrated Clinical Systems
Medical Devices

28. Core Medical R&T Supporting Laboratories
USAARL
U.S. Army Aeromedical Research Laboratory
USAISR
U.S. Army Institute of Surgical Research
USARIEM
U.S. Army Research Institute of Environmental Medicine
Combat
Casualty
Care
18.3%
Military
Operational
Medicine
17.1%
Infectious Diseases
23.6%
Medical
Biological
Defense
25.5%
Chemical
15.5%
USAMRIID
U.S. Army Medical Research Institute of Infectious Diseases
USAMRICD
U.S. Army Medical Research Institute of Chemical Defense
WRAIR
Walter Reed Army Institute of Research
U.S. Army Medical Research Unit - Nairobi, Kenya
Armed Forces Res Inst of Med Sci, Bangkok, Thailand
US Army Medical Research Unit, Heidelberg, Germany
US Army Dental and Trauma Research Detachment
US Army Medical Research Detachment
US Army Center for Env Health Med

29. FY09 Funding Opportunities:
FY09 Funding Opportunities:

31. Medical Research and Related Funding Programs in the DoD
DARPA (e.g., DSO)
CBDP/DTRA (e.g., TMTI)
SOCOM (BISC)
VA-DoD sharing (e.g., JIF)
NIH joint efforts
Other Agencies
DCoE for PH and TBI
DCoE for Vision
USAMRMC
ARO
NMRC
ONR
AFMOA
AFRL
AFOSR
Services
Small Business Innovative Research
Small Business Technology Transfer
(SBIR/STTR)

32. KEY TATRC Initiatives and Portfolios
Robotic rescue & evacuation
Shelf stable diagnostics & vaccines
Blood products & blood safety
Natural orifice transluminal endoscopic surgery
Advanced medical imaging
Distance medical training & simulation
Operating room of the future
Prosthetics and human performance
Regenerative medicine & biomaterials
Virtual environments
Computational models
& tools
Human/soldier phenome
Performance & injury
prediction models
Cell phone-based systems
Remote biomonitoring
Global Biosurveillance
Health information portal
unified EHR
Research data cube/ medical outcomes
Pharmacovigilance
e-HEALTH
MEDICINE IN AUSTERE
ENVIRONMENTS
DIGITAL
WARRIOR
INTEGRATIVE
MEDICINE
HOSPITAL
OF THE
FUTURE
Optimal healing environments
Advanced pain management
Complementary and alternative medicine
Neuroplasticity/resilience
Genomics/personalized medicine

33. TATRC Portfolios Joint Technical Coordinating Group
1. Medical Information & Training Technologies
4. Infectious Diseases
5. Military Operational Medicine
6. Combat Casualty Care
8. Clinical & Rehabilitative Medicine
Psych Health
Dr. Shore
Resilience & Retraining
MAJ Brininger
Simulation
& Training
Technology
Mr. Wiehagen
Bio-Monitoring
Technologies
Dr. Lai
Medical
Robotics
Dr. Gilbert
Advanced
Prosthetics
Mr. Turner
Human Performance Optimization
Dr. Cardin
Medical
Imaging
Technologies
Dr. Pacifico
Health
Information
Technologies
LCDR Steffensen
Computational
Biology
Dr. Reifman
Genomics
/ Proteomics
Ms. Stanley
International
Health
Ms. Barrigan
Nano-Medicine &
Biomaterials
Dr. Grundfest
Regenerative
Medicine
Dr. Lai
Infectious
Disease
Dr. Carney
Medical
Logistics
Mr. DePasquale
Blood Products & Safety
Mr. Malloy
Head
& Spinal Cord Injury
Dr. Curley
Vision
Mr. Read
Trauma
Dr. Broderick
Acoustic Trauma Dr. Holtel
Slide 33 of 12

34. Hawaii Federal Health Care Network (AKAMAI II) – FY10 Competitive RFP
AKAMAI II supports applied research, development and deployment of telehealth and healthcare technology, biotechnology, clinical informatics, VA/DoD systems interoperability, to improve access and the quality of care to service members, their families, and impacted communities. With a focus on programs that align closely with military medical requirements, a competitive process will be used to provide funding in Hawaii to develop advanced medical technologies and biotechnology research critical to our nation's military medicine and the warfighter. Priority will be given to innovative collaborations between Hawaii-based industries and the Department of Defense. Outside partnerships that help to bring unique expertise to research in Hawaii to solve military medical problems will also be an important factor.

35. Basic Steps to Innovation in the Hawaii Federal Health Care Network
Come up with a concept that would be immensely important to the DoD, if successful
Secure the intellectual property
Publish the seminal supporting article in peer reviewed literature
Conduct the initial risk mitigation studies (e.g., toxicity) that will encourage investors

36. Hawaii Biomedical Research Advantages and Dual Use Applications for DoD
Stable population (~1.2M)
Unique healthcare system and DoD-VA sharing of facilities (great starting point to optimize practices)
Distributed across islands (e.g., model of remote health care access)
Chronic health care concerns, even though a state with the best longevity (e.g., preventive medicine interventions and personalized health care/personal empowerment opportunities)
Modest size makes manageable testbed and model system and increases cooperation in the islands

37. AAMTI: Pediatric Telecardiology Referrals with Echocardiographic Validation
Pacific Rim Pediatric Heartsounds Trial: Store and Forward telcardiology with echocardiographic validation
Simultaneous
Multi-site Phonocardiography: A simplified heartsound
Improved heartsound signal analysis using simultaneous multi-site phonocardiograms in children
Pediatric Multi-site Phonocardiography: Automated interpretation of pediatric heartsounds
Telecardiology evaluation of newborns with heart murmurs using simultaneous, multi-site phonocardiography
AMEDD Advanced Medical Technology Initiative

38. Janus – DoD and VA Common Data View

39. Pacific Asynchronous Tele-Health (PATH) Teleconsultation
Telehealth Services -VA Pacific Islands Health Care System (VAPICS)

40. Telehealth Voice Therapy in Remote Regions in the Pacific Basin
ICU Multipoint Military Pacific Consultation Using Telehealth (IMMPACT)
Telehealth Voice Therapy in Remote Regions in the Pacific Basin

41. Environmental Medical Surveillance (CBI “wet ware” / “canary”)
Cell Matrix Chips for Air/Water Monitoring of Toxic Chemicals
Principal Investigator: Kevin Chinn, PhD; Cellular Bioengineering, Inc.

42. Cell-based Treatments
Treatment of Peripheral Vascular Disease by Adipose Derived Stromal Cell Injection
Principal Investigator: Paul Kosnik PhD; Tissue Genesis, INC.
Development of Technologies for Bioengineered Tissue Repair
Principal Investigator: Mark Mugiishi, MD; Cellular Bioengineering, Inc.

43. Nanotechnology Capabilities
RAIDER: Rapid Adverse Identifier for Drugs and Evaluation Resource
Principal Investigator: Joanne S.M. Ebesu, Ph.D.; Oceanit
SEM image of nanoarray functionalized with antibodies

44. Development of the versaHSDI system – Colon
Automated disease detection
Video reconstructed colon model
Local 3D rendering
3-D rendering software development to enable and develop Computer Aided Diagnosis and in situ pathology for colon cancer detection

45. Neurophysiologically-based Performance Monitoring and Enhancement Devices
Intelligent PTSD Classification and Treatment-Augmentation Technology
The device will utilize off the shelf technology and Archinoetics developed hardware to produce an integrated, unobtrusive monitoring/communication capability.
Warfighter Physiologic System Interface Research

46. Broadband Respiratory Virus Surveillance

47. SimCenter Hawaii Technology
Enabled Learning and Intervention Systems
Virtual Reality Applications for Health Care Education and Training

48. TATRC Science & Engineering Research Support
Dr. Stan Saiki, Chief, TATRC Hui
Dr. Chuck Peterson, Chief Scientist
Ms. Jessica Kenyon, Chief, TATRC West
Mr. Ron Marchessault, ORTA