1 of 16

U.S. Army Medical Research

and Materiel Command

June 14, 2017

Medical, Biomedical & Biodefense:

Support to the Warfighter Symposium

MG Barbara R. Holcomb

2 of 16

Mission and Vision

Responsively and responsibly create, develop, deliver,

and sustain medical capabilities for the Warfighter Lead the advancement of military medicine

MISSION VISION

3 of 16

Life Cycle Management Command

Focused on materiel and knowledge-based

medical solutions to:

• Improve downrange

health delivery

• Increase warfighter

readiness

• Improve fitness,

health, protection

and resilience

• Enhance recovery,

rehabilitation or

reintegration

COLLABORATIVE

COMMAND

WE SAVE LIVES

4 of 16

Global Presence

UNCLASSIFIED 4 of 20

Joint Trauma System JBSA, TX

Joint Trauma System Ft. Sam Houston, TX

5 of 16

Threats to Service Member Readiness

Combat Injuries

Hemorrhage

Head Trauma

Blast Injury

Lung Injury

Burns

Mental & Physical Stress

Physical Performance

Musculoskeletal Injuries

Cognitive Performance

Mental Health

Post-Traumatic Stress

Suicide

Endemic Diseases

Parasitic Diseases

Bacterial Diseases

Viral Diseases

Battle Sequelae

Loss of limbs

Loss of tissue

Loss of vision

Pain

Environmental Hazards

Heat and Cold

Altitude

Toxic Industrial Chemicals

Systems Hazards

Lasers

Noise

Nuclear, Chemical &

Biological Warfare Agents

Chemical Warfare Agents

Biological Warfare Agents

Nuclear/Radiological

6 of 16

Program Area Directorates (S&T)

Military Infectious Diseases Research

Program (MIDRP) • Vaccines & drugs to prevent parasitic diseases (malaria)

• Vaccines to prevent diarrheal diseases

• Vaccines to prevent viral diseases (dengue, hanta)

• HIV countermeasures (congressional mandate)

• Prevent & treat combat wound infections

• Protection from disease carrying arthropod vectors

• Countermeasures against emerging infectious diseases

Combat Casualty Care Research

Program (CCCRP) • Hemorrhage control and resuscitation

• Traumatic brain injury care

• Blood and blood products far forward

• Burn injury and organ support

• Tactical CCC interventions

• Extremity and maxillofacial trauma treatment

• Prolonged field care

Military Operational Medicine Research

Program (MOMRP) • Musculoskeletal Injury

• Blunt, Blast, & Accelerative Injury

• Behavioral Health, Wellness & Resilience

• Psychiatry & Clinical Psychology Disorders

• Health, Readiness & Performance in Austere Enviros

• Fatigue, Cognitive Health & Performance

• Human Operator Health & Performance in Complex Systems

• Environmental Toxicant Exposure

• Performance Nutrition & Weight Balance

• Directed Energy Health Hazards

• Biomedical Aspects of Human Perf Opt & Enhance

Clinical & Rehabilitative Medicine Research

Program (CRMRP) • Rehabilitation of neuromusculoskeletal injuries

• Regenerative medicine and transplants

• Sensory Systems (Vision, Hearing and Balance)

• Battlefield, acute and chronic pain management

Medical Simulation and Information Sciences Research Program (MSISRP) • Medical simulation

• Health information technology and informatics

• Medical capabilities to support disbursed operations

Program Area Directorates (PADs) – Functions

• Manage programs; do not execute programs

(do not perform research and technology)

• Fund intramural and extramural research and technology

• Responsible for both the problem set and the solution set

• Devise a research strategy (program) and fund research and

technology that fit the program

• Collaborate with industry, academia and professional societies

Program Coordinating Offices • CBRN Defense Coordinating Office

• DoD Blast Injury Research Program Coordinating Office

• Joint Trauma Analysis and Prevention of Injury in Combat

PA(R&T) Fort Detrick, MD

Principal Assistant for Research & Technology

Ft Detrick

7 of 16

Laboratory Competencies

U.S. Army Research

Institute of Environmental

Medicine

USAMRIID Ft. Detrick, MD

U.S. Army Medical Research Institute of Infectious Diseases

Walter Reed Army

Institute of Research

Infectious Diseases:

Parasitic, Bacterial, Viral

Vector Control

TBI Neurotrauma & Brain Dysfunction

Psychiatry & Clinical Psychology Disorders

Fatigue, Cognitive Health & Performance

Behavioral Health, Wellness, & Resilience

Blunt, Blast & Accelerative Injury

Human Performance Optimization/

Enhancement – Psychological

WRAIR Forest Glen, MD

USARIEM Natick, MA

TATRC Ft. Detrick, MD

Telemedicine and

Advanced Technology

Research Center Bacterial Diseases

Viral Diseases

Biological Toxins

TeleHealth

Health Information Technology

Medical Simulation

& Training Systems

Medical Intelligent Systems

Musculoskeletal Injury

Performance Nutrition & Weight Balance

Human Performance Optimization/

Enhancement – Physiological

U.S. Army Institute of

Surgical Research

USAISR Ft. Sam Houston, TX

Hemorrhage, Shock, & Coagulopathy of Trauma

Pain

Pre-Hospital Tactical Combat Casualty Care

Critical Care Delivery

Endovascular Hemorrhage Control

Prolonged Field Care

Medical Aspects of Directed Energy

Maxillofacial Trauma

Extremity Trauma

Ocular Trauma

Burn Injury

U.S. Army Medical

Research Institute of

Chemical Defense

USAMRICD Aberdeen PG, MD

Traditional & Emerging Chemical Threats

Biological Toxins

USACEHR Ft. Detrick, MD

U.S. Army Center for Environmental Health Research

Environmental Toxicant Exposure

Systems Biology

U.S. Army Aeromedical

Research Laboratory

USAARL Ft. Rucker, AL

Human Operator Health &

Performance in Complex Systems

Blunt, Blast & Accelerative Injury

En Route Care Environment

Crew Survival in Military Helicopters

& Combat Vehicles

Medical Aspects of Directed Energy

Human Performance Optimization/

Enhancement – Cognitive

8 of 16

MRMC role in USG Zika response

Additional

Research Sites

Tanzania

Uganda

Cameroon

Nigeria

Mozambique

Cambodia

Vietnam

Philippines

Bangladesh

Bhutan

Nepal

Mongolia

WRAIR & USAMRIID

USAMRD-W

Washington

State

USAMRD-K

Nairobi, Kenya

USAMC-

AFRIMS

Bangkok,

Thailand

USAMRD-G

Tbilisi, Georgia

» Institutional Expertise

» Overseas Platforms

» Enduring Strategic Partnerships

» Complimentary Missions

» Zika PIV vaccine

» Surveillance (human and vector)

» Diagnostics (LRN)

» Characterization (pre-clinical)

» Rapid detection assay (SBIR phase 3)

» Safe blood supply

9 of 16

CG, USAMRMC and

Deputy for Medical

Systems,

ASAALT

MG Barbara Holcomb

Principal Assistant for

Acquisition (PAA)

(Medical Milestone Decision

Authority)

Dr. Kenneth A. Bertram

Project Manager – Medical Evacuation Mission

Equipment Package

• Patient Handling Systems

• Future Vertical Lift

• Medical Evacuation Telemedicine

• Unmanned Aerial Evacuation

Project Manager – Integrated Clinical Systems

• Clinical Technologies

• Image Management Systems

Project Manager –

Neurotrauma & Psychological Health

• Drug Treatment

• Diagnostics

• Knowledge Products

Project Manager – Pharmaceutical Systems

• Antiparasitic Drugs

• Virus, Bacteria, and Parasite Vaccines

• Blood Products

• Infectious Disease Diagnostics

• Pain Management

Project Manager – Medical Support Systems

• Combat Casualty Care

• Ground & Air Evacuation Systems

• Preventive Medicine Systems

• Cold Chain Management Systems

• Medical Prototype Development Lab

Project Manager – Medical Devices

• Commercial and Developmental Medical Devices

USAMRMC Program Management Organization

Project Manager – Tissue Injury & Regenerative

Medicine and Program Manager – Advanced Tissue

Biofabrication Manufacturing Innovation Institute

• Cellular Therapies

• Knowledge Products

Project Manager – Enterprise Information

Technology Systems

• FDA-compliant IT systems Project Manager – Hyperbaric Oxygen

• Knowledge Products

08MAY17

USAMMA USAMMDA

Office of the PAA

10 of 16

CAE delegated Medical Milestone Decision

Authority (MDA) to the USAMRMC

Principal Assistant to Acquisition

Per ISSA, and DHA Acquisition

Documentation, USAMRMC Principal Assistant

to Acquisition Sr. Consultant to CAE

USAMRMC CG, Deputy for

Medical Systems, ASAALT

USAMRMC CG ISSA w/ DHA

Director for implementation of

R&D programs

DoD’s Medical RDA Enterprise

Research Materiel Solution

Analysis

Tech Maturation

& Risk Reduction

Production &

Deployment

Operations &

Support

ICD

MDD

ICD

A

CDD

B

CPD

C

Program

Initiation

Engineering &

Manufacturing Development

Component

Acquisition

Executive

(also DHA

MDA)

Component

Acquisition

Executive

Service Logistician / USAMMA

Principal Assistant for Research &

Technology Principal Assistant for

Acquisition

Risk-Based Management

Handoff

USAMMDA/USAMMA – External PMs

USAMRMC & Other DoD Laboratories

PM focus:

• Transitioning promising solutions from S&T

• Prototyping & finalizing development

• Testing and manufacturing

• Ensuring -ilities (e.g., maintainability, sustainability, etc.)

• Primary partners – industry (including small business) • Other partners - academia, OGAs, and intramural laboratories)

Dru

gs/

Va

ccin

es

FD

A

Requirements File to FDA Phase 3 Phase 2

Candidate Discovery

Approach Definition

Candidate Optimization

Product Launch

Life-Cycle Management

Clinical Trials

Phase1 Preclinical

First in Human

Post launch review

File NDA / BLA / PMA

Commit to

Phase III

Candidate Selection

NDA/BLA Approval Launch

FDA

11 of 16

Products in Advanced Development

Freeze-Dried Plasma

Device to

eliminate the

risk of disease

transmission

of pathogens

Whole Blood Pathogen

Inactivation Cryopreserved

Platelets

Improved platelet

Intracavitary

Non-Compressible Hemorrhage

Control Agent

Burn Treatment Skin Repair Anti-Malarial IV Artesunate

Non-invasive

medical device to

identify & assess

internal brain

injuries

Lab Assay for TBI

Topical

Anti-Leishmanial

Drug

FDA approved

Resuscitative Endovascular

Balloon Occlusion of the

Aorta (REBOA)

FDA Cleared 2016 -Balloon

catheter to stop bleeding

Battlefield Pain Management

12 of 16

Burn Resuscitation

Decision Support System

– Mobile (2013)

Oxygen Generator

Field Portable (2014)

Soft-walled

Shelter for

CSH/FH (2017)

Improved First Aid Kit

Generation II (2014)

Medical Evac

Mission

Essential

Package (2015)

Steam Sterilizer Field

Portable (2016)

Environmental Sentinel

Biomonitor (2016)

Products Fielded Since 2010

Modular Lightweight Load-carrying

Equipment (MOLLE)

Medic Bag (2014)

Adenovirus Type 4 & Type 7 Vaccine (2011)

13 of 16

OPERATIONAL MEDICAL LOGISTICS

STRATEGIC MEDICAL LOGISTICS

Provide Medical Materiel Life Cycle Management and Logistics Solutions

to the Warfighter Across the Full Spectrum of Health Care Missions Worldwide

Acquire, field, distribute, centrally manage,

sustain/maintain and dispose of medical products,

supplies and equipment from the tech-base,

advanced development, or from commercial sources

Once developed, medical materiel must be managed throughout its lifecycle – procured, transported,

stored, maintained, inventoried, placed in assemblages, and disposed of when no longer useful.

US Army Medical

Materiel Center –

SW Asia

(USAMMC-SWA)

6MLMC 6th Medical Logistics Management Center

Ft. Detrick, MD

(ADCON)

6MLMC

Deployable

Teams

Forward Area

Repair –

Medical

(FRAM)

Medical

Logistics

Support Team

(MLST)

Medical Logistics Commands

USAMMA U.S. Army

Medical Materiel Agency

Ft. Detrick, MD

USAMMCE U.S. Army Medical

Materiel Center – Europe

Pirmasens, Germany

USAMMCK U.S. Army Medical

Materiel Center – Korea

Camp Carroll, Korea

14 of 16

Biological Select Agents and Toxins (BSAT)

Executive Agent Responsible Official (EA/RO)

DoD EA/RO for BSAT Biosafety - Key Roles and Responsibilities:

• Lead Agent for all DoD Biological Select Agents and Toxins (BSAT) Biosafety matters.

• Unified DoD interface with regulatory arms of CDC + USDA to identify and resolve issues.

• Provide Biosafety oversight of DoD BSAT laboratories, standardized joint inspection program.

• Develop standardized Biosafety guidelines for all DoD BSAT registered labs.

• Conduct Biosafety technical review of protocols/procedures across DoD BSAT laboratories; harmonize

changes across DoD.

• Communicate policy and procedural changes, support training, and conduct regular assistance visits to

DoD BSAT-registered labs.

• Develop a Quality Management system for all BSAT-related DoD products.

• Identify best practices in Biosafety from DoD laboratories and interagency community; identify scientific

gaps.

• Synergize biosafety and biosecurity initiatives.

DoD EA/RO for BSAT Biosecurity - Key Roles and Responsibilities:

• Delegation of Authority to Executive Agent Responsible Official is in staffing.

• Merge Biosecurity into existing Biosafety governance framework for unified oversight and synchronized

mission execution to minimize risk of BSAT operations.

Army Directive 2016-24; Department of Defense Biological Select Agent

and Toxins Biosafety Program; July 25, 2016

Executive Agent for Biosecurity; Secretary of the Army designated by

Deputy Secretary of Defense, January 3, 2017

15 of 16

Congressionally Directed Medical Research Programs

(CDMRP)

CONGRESSIONAL PROGRAMS:

• Manages extramural research programs

directed by Congress

• Started in 1992 with Breast Cancer,

now 27 programs

• Congress specifies disease area,

CDMRP determines research

strategy and competitively selects

the best projects

• Unique public/private partnership

encompassing the military, scientists,

disease survivors, consumers, and

policy makers

• Funds high-impact, innovative medical

research to find cures, reduce the

incidence of disease and injury,

improve survival, and enhance the

quality of life for those affected

DoD PROGRAMS:

• Manage extramural and intramural

portfolios for Program Area Directorates

(PADs)/Joint Program Committees

(JPCs) advancing their missions

DIRECTOR:

• Col Wanda Salzer

*CDMRP is assisting with the execution of a specified portion of these appropriation(s)

Military Focused

• Alcohol & Substance Abuse

Disorders

• Defense Medical R & D

• Epilepsy

• Joint Warfighter

• Military Burn

• Orthotics & Prosthetics

• Peer Review Orthopaedic

• Psychological Health/Traumatic

Brain Injury

• Reconstructive Transplant

• Spinal Cord Injury

• Vision Research

National/Military Relevant

• Alzheimer’s

• Amyotrophic Lateral Sclerosis

• Autism

• Bone Marrow Failure

• Breast Cancer

• Duchenne Muscular Dystrophy

• Gulf War Illness

• Lung Cancer

• Multiple Sclerosis

• Neurofibromatosis

• NET Parkinson’s

• Ovarian Cancer

• Peer Reviewed Cancer

• Peer Reviewed Medical

• Prostate Cancer

• Tuberous Sclerosis Complex

Congressional

Appropriations

Vision Setting

Program

Announcement

Release

Pre-Application

Receipt

Pre-Application

Screening &

Invitation

Application

Receipt

Peer Review

Awards

Management

1-7 Years Programmatic

Review

Funding

Recommendation

Approval

Authority Decision

Negotiations

• Alcohol and Substance

Abuse Disorders

• Amyotrophic Lateral

Sclerosis

• Autism

• Bone Marrow Failure

• Breast Cancer

• Duchenne Muscular

Dystrophy

• Epilepsy

• Gulf War Illness

• Joint Warfighter Medical

• Lung Cancer

• Military Burn

• Multiple Sclerosis

• Neurofibromatosis

• Neurotoxin Exposure

Treatment Parkinson’s

• Orthotics and Prosthetics

Outcomes

• Ovarian Cancer

• Peer Reviewed Alzheimer’s

• Peer Reviewed Cancer

• Peer Reviewed Medical

• Peer Reviewed Orthopaedic

• Prostate Cancer

• Reconstructive Transplant

• Spinal Cord Injury

• Tick-Borne Disease

• Trauma Clinical

• Tuberous Sclerosis Complex

• Vision

Additional Supported

DoD Programs

• Defense Medical R & D

• Defense Medical R & D

Restoral

• Psychological Health and

Traumatic Brain Injury

16 of 16

Resources for our Business Partners

• Office of Small Business Programs

http://www.mrmc.smallbusopps.army.mil/

• New Product Ideas Web Portal

http://mrmc-npi.amedd.army.mil/

• Guide to Working with Us

https://mrmc.amedd.army.mil/index.cfm?pageid=work.overview