Transcript USAMRIID Overview APORA Mayers

UNITED STATES ARMY MEDICAL RESEARCH
INSTITUTE OF INFECTIOUS DISEASES
Biodefense solutions to protect our nation
USAMRIID Overview
APORA
Douglas L. Mayers, MD
Therapeutics Development Center
USAMRIID
www.usamriid.army.mil
03 Apr 14v.5
UNCLASSIFIED
"Serving to Heal....Honored to Serve"
Biodefense solutions to protect our nation
Disclaimer: The views expressed in this presentation are
those of the author and do not reflect the official policy or
position of the Department of the Army, Department of
Defense or the U.S. Government.
Acknowledgements: Thanks to COL Neal Woolen and
COL Stephen Thomas for allowing me to adapt an earlier
briefing and to my colleagues who provided input and
photographs.
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Objective
Biodefense solutions to protect our nation
• Provide an overview of USAMRIID capabilities
to potentially support APORA objectives
• Demonstrate ongoing USAMRIID activities in
Africa in support of the Ebola response in
West Africa along with ongoing CBEP training
for outbreak responses with African partners
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U.S. Department of Defense
Investment in Global Health
COL Stephen J. Thomas
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Typical Development of Materiel Solutions
Development
Spiral
USAMRIID’s involvement
spans early to advanced
development
Place in the
Mission Space
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US Army Medical Research Institute of Infectious Diseases
Mission
Provide leading edge medical
capabilities to deter and defend
against current and emerging
biological threat agents
Vision
To be the leader in the
advancement of medical
biological defense with world
renowned experts dedicated to
protecting our military forces
and the nation
Medical Biological Defense Insurance Policy for the Nation
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USAMRIID Mission Essential Task List (METL)
Provide World Class Expertise
in Medical Biological Defense
Prepare for
Uncertainty
Develop, Test & Evaluate
Medical Countermeasures
Rapidly Identify
Biologic Agents
Biosafety, Biosurety
& Biosecurity
Train & Educate
the Force
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World Class Subject Matter Expertise
127 Doctoral level scientists and medical professionals
Areas of Expertise
Professional Specialties
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Microbiology – 33
Veterinary Medicine - 22
Biology – 19
Medicine -12
Chemistry - 10
Biochemistry - 10
Project Management – 5
Toxicology - 4
Entomology – 3
Clinical laboratory - 3
Aerobiology - 2
Select Agent Management - 2
Regulatory Science - 1
Biosafety – 1
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Biological & emerging threat agents
Pathogenesis
Immunology
Pathology
Vector assessment
Diagnostics
Nucleic acid sequencing and analysis
Therapeutics discovery
Telemetry and Imaging
“Animal Rule” studies
Good Laboratory Practice
Vaccine development
Biosafety and biosecurity
Animal Care and Use
Training & education
24/7 subject matter expertise reach back capability
UNCLASSIFIED
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Biothreat Agents in USAMRIID Research
Category A
• Bacillus anthracis (Anthrax)
• Clostridium botulinum (Botulism)
• Yersinia pestis (Plague)
• Variola major (Smallpox*) & other pox viruses
• Francisella tularensis (Tularemia)
• Lassa Fever Virus
• South American Hemorrhagic Fever Viruses
• Hantaviruses
• Rift Valley Fever
• Ebola Virus
• Marburg Virus
Category B
• Coxiella burnetti (Q fever)
• Burkholderia pseudomallei
• Burkholderia mallei (Glanders)
• Brucella species (Brucellosis)
• Ricin toxin
• Staphylococcus enterotoxin B
• VEE, WEE, EEE (Equine
Encephalitis Viruses)
Category C
• Crimean-Congo Hemorrhagic
Fever Virus
* Only at the CDC Lab in Atlanta
• Yellow Fever
• Influenza
UNCLASSIFIED
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•Ebola Zaire Diagnostic Kit EUA
Available
For
Use
Today
In
Advanced
Development
•Tularemia Vaccine (IND)
•Venezuelan Equine Encephalitis (VEE) Vaccines (IND)
•Eastern Equine Encephalitis (EEE) Vaccine (IND)
•Western Equine Encephalitis (WEE) Vaccine (IND)
•Smallpox Vaccine (cell culture derived vaccinia virus)
•Botulinum Antitoxin (human & horse)
•Vaccinia Immune Globulin
•Ribavirin
•Joint Biological Agent Identification and Detection System (JBAIDS)
•Anthrax Gammaphage Diagnostic
•Antibiotic Treatment of Pneumonic Plague and Inhalational Anthrax
•H5N1/H1N1 JBAIDS Influenza Diagnostic Kit (510 k/EUA)
•rPA-Based Anthrax Vaccine
•Botulinum Neurotoxin Bivalent Vaccine
•Plague Vaccine (F1-V)
•Staphylococcal Enterotoxin B Vaccine
•Hantavirus Vaccines
•Ricin Vaccine
•Ebola/Marburg Vaccine
•ST-246 for Treatment of Smallpox
•Human Monoclonal Antibodies to Botulinum Neurotoxin Types A, B and E
Products in
Development
•Ebola/Marburg Therapeutics
•73 Diagnostic Assays Submitted to the FDA for pre-EUA review
•Next-Generation VEE, EEE and WEE Vaccines and therapeutics
•Burkholderia Vaccines and Therapeutics
•Arenavirus DNA Vaccines
•Crimean Congo Hemorrhagic Fever Virus DNA Vaccines
•Monoclonal antibodies for treatment against Ebola virus
•Polyclonal antibodies for treatment against lethal viruses
•Establishing FDA indications for moxifloxacin treatment
•Development of NHP models to address clinical controversies associated with
prevention and treatment of select agent infections in humans
•GSK944 Murine and GLP NHP Efficacy Studies for tularemia
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USAMRIID Experience with Ebola
Legacy Research Program
• USAMRIID leverages basic science platforms and high level
containment capabilities to conduct basic science
investigations of high-consequence pathogens such as
Ebola to advance the development of medical
countermeasures to mitigate the threat (bioterrorism,
accident, natural)
Kikwit Outbreak: 1995
• Personnel augmented an international team conducting field
investigations to identify the natural reservoir
Cote D’Ivoire WHO Field Investigation: 1996
• Unique field study that looked at high canopy species of
animals, not sampled from previous studies
• Field laboratory for necropsy and immunohistochemistry
and immunocytochemistry sample analysis
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Anti-Ebola virus
Therapeutic Portfolio Development
Biodefense
ANTIVIRAL solutions to protect our nation DISCOVERY
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
TKM-100802 (siRNA)
(IV)
AVI-7537 (PMO+)
(IV)
BCX4430
(IM)
Favipiravir (T-705)
(Oral)
AL-First Generation
(Oral)
Influenza
Respiratory Syncytial Virus (RSV)
Zmapp
In Vitro/
Rodent Screening
AL-Second Generation
(Oral/IV)
Alnylam GalNac-RNAi conjugate
(IV/IM)
Gilead Nucleotide analogs
Different indications
RSV
AstraZeneca/Merck/&Lilly Non-nucleotide
AV/Nucs
PTC AV
Oncology
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Anti-Ebola virus
Vaccine Portfolio Development
Biodefense
VACCINE solutions to protect our nation DISCOVERY
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
ChimpAd3 vector bivalent (VRCEBOADC069-00-VP)
ChimpAd3 vector monovalent
(cAD3-EBO Z)
rVSVΔG-ZEBOV (BPSC1001)
AdVac®+MVA-BN®
rVSVN4CT1
DNA vaccines
1st generation Adenovirus vaccine
Non-human Primate Data
2nd generation AdHu5-GP vaccine combined
with Adhu5-IFN-α delivered into airway
VLP-Filovirus Trivalent
VRP(VEE)-Filovirus Trivalent
BNSP333-GP
INAC-BNSP333-GP
BNSPΔG-GP
Rodent Screening
Recombinant baculovirus encoding GP
protein
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Rapidly Identify Biologic Agents
Biodefense solutions to protect our nation
USAMRIID is part of the National Laboratory Response
Network
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Led qualification testing for numerous laboratories across the United States for
use of Food and Drug Administration Emergency Use Authorized Ebola assay
Received and analyzed samples from US personnel and animals suspected to
be infected with Ebola virus
USAMRIID is part of the Cooperative Biological Engagement
Program (CBEP); supports Biological Weapons Convention
Article X (Cooperation and Assistance)
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Engaged with host nation capacity development effort in Liberia prior to
Operation United Assistance
Established laboratory capability, in collaboration with National Institute of
Allergy and Infectious Diseases, at the Liberian Institute of Biomedical
Research (LIBR)
LIBR Laboratory is currently equipped to analyze up to 90 samples per day with
a single shift
USAMRIID has years of experience in operational support to
deployable laboratories and in fielding mobile laboratories for
applied research
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Theater Army Medical Laboratory and Area Medical Laboratory training support
and strategy development for biological agent identification
Applied research during JBAIDS development for field investigation of Anthrax,
Plague, and Tularemia outbreaks in animal populations
"Serving to Heal....Honored to Serve"
Testing/Outbreak Response Past and
Present
Biodefense solutions to protect our nation
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Current Mission: Training
Sustainment, Material
Resupply, EBOV Clinical
Testing, Reporting, QA, EUA
maintenance
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July 2014/ongoing : Onground initial assessment/
gap analysis
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Past: Establishment of new
Battle Rhythm, integration of
Laboratory Administrative
Phase, and closing loop on
the reporting cycle (PHCP to
Laboratory to PHCP/Contact
Tracing Response)
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Testing/Outbreak Response: Future
Biodefense solutions to protect our nation
• Maintain Current Mission
• Add Pathogen Sequencing
• Add Multiplex Testing for
multiple pathogens
• Upgrade Laboratory
Infrastructure and Physical
Plant
• Sustain Laboratory OPs For
Future Outbreak Response
• Maintain specimen bank
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Training / Education / Consultation
Biodefense solutions to protect our nation
Publications
Core Training Courses
• Medical Management of
• Medical Management of Biological Casualties (MCBC)
Biological Casualties Handbook
• Textbook of Military Medicine:
Medical Aspects of Biological
Warfare (2007)
• Joint Pub (FM 8-284) Treatment
of Biological Warfare Agent
Casualties
– USAMRIID personnel consulted on strategy development for
Liberian crisis response
• Field Identification of Biological Warfare Agents (FIBWA)
– USAMRIID trained multiple deploying lab teams on Ebola
specific assays and EUA kits
Other Operation United Assistance Support
• Personal Protective Equipment (PPE) Mobile Training
Teams (MTT)
– 4738 personnel trained / 1880 man hours
• Dead Body Management:
– Assisted with strategy development
– Special studies to determine agent viability in a decedent
• Patient Transport
– Assisted with risk assessing operations / strategy
development
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East Africa Clinician Training
Biodefense solutions to protect our nation
• Uganda (UG) Trainings
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Kampala
Fort Portal
Masaka
Arua
Mbarara
• Kenya (KE) Trainings
– Nairobi
– Kisumu
• Training Activities
– Hands-on training with protective equipment
– Lectures from subject matter experts (including those experienced in Ebola
outbreaks)
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Training Follow-Up
Biodefense solutions to protect our nation
• Site Assessments
– Focus on knowledge, attitudes, practices of staff
– Survey of grounds and of facility workers
• Observations by Team
– Facility grounds clean
– Key stakeholders supportive of improved infection control standards
• Changes Seen and Reported
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Increased engagement with MoH to facilitate coordinated outbreak response
Increase in CME training (particularly on Ebola material)
Initiation of disease surveillance system
Development of lab safety manual
Protective equipment procurement
Handwashing stations installed within facility
"Serving to Heal....Honored to Serve"
Maintain Safety, Security, and Surety Standards
Biodefense solutions to protect our nation
• During this outbreak, USAMRIID provided training and consultation
across the broad spectrum of PPE and infection control
recommendations for tasks that ranged from patient care to crowd
control; primary focus was on laboratory operations and patient care
• Averaged 90-120 days per year, over the last 3 years with an inspector
in the Institute (passed all inspections!)
– CDC, FDA, USDA, DOT, NRC, AALA, CLIA, CAP, AAALAC, DAIG, MEDCOM
– BWC (Biological Weapons Convention) transparency visit July 2012
• National SME in lab safety, surety, and security
– Battelle, Boston University, USG, ROK, Japanese labs have consulted USAMRIID
"Serving to Heal....Honored to Serve"
Positive Outcomes and Challenges
Biodefense solutions to protect our nation
Positive impacts / Aspects to sustain:
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Data availability to support investigational product Emergency Use Authorization process provides
diagnostic and therapeutic solutions that are otherwise not available
Research laboratory flexibility rapidly put resources on providing solutions for real-world problems
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Validated need to maintain contingency response capability in research laboratory
Established an enduring early Ebola diagnostic capability that did not exist for Liberians or relief
workers; informs supportive care decisions to improve prognosis
Leveraged existing training programs and in-house subject matter expertise to immediately
provide quality input to planning and readiness for deploying forces
Just in time training was effective; may be necessary for unique low-frequency missions
Program of Instruction (POI) development, review, and approval was rapid and enhanced quality
of product
Challenges / Aspects to improve:
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Diverting research resources, to outbreak response, strains the workforce; necessitates
supportive concurrence from higher headquarters and funding agencies
Logistical challenges at the LIBR (deteriorating infrastructure, resupply, sample security/viability,
process changed numerous times)
Level of host nation engagement at the LIBR (host nation personnel availability)
Training had to be delivered to units, not yet equipped with PPE; required MTT to carry all training
supplies
"Serving to Heal....Honored to Serve"
Summary of USAMRIID Operational Support
Biodefense solutions to protect our nation
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Application of the 6 METL Tasks
– Medical Countermeasure Research
• Facilitated Emergency Use Authorization process for prioritized investigational products
– Rapid Diagnostics
• Provided reference laboratory testing and support laboratory validation
• Supported host nation capability and capacity development
– Training / Education / Consultation
• Provided PPE, dead body management, patient care, and patient transport training or
consultation
• Leveraged core training programs and informational products
– Safety
• Provided training and consultation on infection control
– Subject Matter Experts on Ebola Virus
• Provided agent-specific consultation
• Conducted special projects to address various operational questions
– Prepare for Uncertainty
• Rapidly responded to an outbreak with Joint, Interagency, Intergovernmental, and
Multinational (JIIM) partners
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USAMRIID provided non-standard skill sets and solutions to operational
problems
"Serving to Heal....Honored to Serve"
Ebola’s Unique Challenges
“An Atypical Mission”
Natural Reservoir Unknown
• Difficult to break cycle of human contact with natural reservoir if reservoir is unknown
• Fruit bats suspected, but not proven / Bush meat is considered an elevated risk
No Approved Therapeutics / Vaccines / Diagnostics
• Requires Emergency Use Authorization (EUA) of Investigational Products
• Required materiel solutions not in mass production and readily available
Rapid Diagnostics for Patient Management
• Clinical signs and symptoms similar to other diseases
• Informs patient isolation decisions, patient care strategy, therapeutics selection, and public health
strategy
• Number of laboratory assets required for timely sample analysis
Infection Control
• Low infectious dose necessitates increased level of emphasis on protective barriers; elevated
protective posture for Ebola is not part of core skill training
• Patient care, patient transport, sample management, sample analysis, waste management, relief
worker safety, protecting the public (personnel returning from Liberia)
"Serving to Heal....Honored to Serve"
Ebola’s Unique Challenges
“An Atypical Mission”
Dead Body Management
• General procedures are not tailored for handling bodies infected with highly infectious pathogens
Managing Public Perception and Reaction
• Liberian public had to welcome U.S. military presence
• U.S. public had to accept risk of personnel returning from mission
Operating in a VUCA Environment
• Volatile, Uncertain, Complex, Ambiguous
• Requires Joint, Interagency, Intergovernmental, Multinational (JIIM) solution
• Requires synchronization of effort and harmonization of objectives
Standard Materiel Solutions And Procedures: Inadequate
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Meeting the Challenge
Biodefense solutions to protect our nation
• Leveraging knowledge and experience with Ebola virus
moved USAMRMC and USAMRIID into a non-standard role
– Non-Standard Materiel Solutions
• EUA diagnostic kits and therapeutics
• Unique Personal Protective Equipment (PPE) acquisition
– Knowledge and Information to directly shape Concepts of
Operations
– Mission support training preparing U.S. military personnel to
work in an Ebola environment
– Personnel on the ground
• Operation United Assistance (OUA) laboratory support
• Host nation diagnostic laboratory capability and capacity development
"Serving to Heal....Honored to Serve"
Ebola Response Objectives
Biodefense solutions to protect our nation
Force Health Protection: Deliver best available therapies and diagnostics with defined
processes ensuring safe use and regulatory compliance
Laboratory Operations: Provide sustained capability to reliably detect Ebola RNA
and sustained capability to provide clinical lab services overseas
Training: Train personnel supporting overseas missions and domestic
Ebola preparedness on specific health threats and protective measures
Medical Logistics: Provide required medical equipment and
supplies to sustain mission in Liberia
Research & Development: Advance
development of Ebola vaccine and therapeutic
drug candidates
Endstate:
Responsively and
responsibly create,
develop, deliver and
sustain medical
capabilities for the
Ebola humanitarian
assistance mission.
"Serving to Heal....Honored to Serve"
Force Health Protection
Task
Develop and
facilitate
processes for
use of
unlicensed
(investigational
and emergency
use authorized)
candidate
drugs,
vaccines, and
diagnostics
with positive
benefit: risk
ratios.
COL Stephen J. Thomas
Line of Effort
Identify
needs,
regulatory
pathways
Issue
policies,
protocol
processes
Objective
Deploy
Sustain
DoD has access to the
best available therapies
and diagnostics with
defined processes
ensuring safe use and
regulatory compliance.
• Emergency Use Authorized Ebola
assay
• IV Artesunate anti-malarial
• Ribavirin (Lassa)
• Post-exposure prophylaxis
• Synchronize with Clinical Practice
Guidelines
"Serving to Heal....Honored to Serve"
Laboratory Operations
Biodefense solutions to protect our nation
Task
Identify CONUS
and OCONUS
laboratory and
diagnostic
testing
requirements.
Leverage SMEs
to identify
solutions. Synch
communications
and activities
amongst CONUS
and deployed
assets.
Line of Effort
Ebola
diagnostics
CONUS &
OCONUS
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COL Stephen J. Thomas
Clinical
lab
needs
Maintain
supply of
critical
reagents
Objective
Explore
supporting
clinical
trials
Sustained capability to
reliably detect Ebola
RNA. Sustained
capability to provide
clinical lab services
OCONUS. Real time
understanding of
diagnostic needs.
Emergency Use Authorized RT-PCR
Assay
Support Liberia Institute of
Biomedical Research (LIBR) and
Navy mobile lab reagent needs
Support 1st Area Medical Lab (AML)
(Ebola / environmental testing)
Support USAMRIID missions
"Serving to Heal....Honored to Serve"
Training
Biodefense solutions to protect our nation
Task
Develop
relevant
curriculum and
execute training
of DoD
personnel
deploying with
OUA and
supporting
CONUS
preparedness.
Line of Effort
Develop
curriculum
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Certify
and
deploy
trainers
Objective
Train
Trainers
and
Units
Sustain
and
Update
Training
Personal Protective Equipment (PPE)
Tropical and preventive medicine
USAMRIID Field Identification of
Biological Warfare Agents (FIBWA)
course modified to OUA-specific
requirements
DoD personnel
supporting OCONUS
missions and domestic
Ebola preparedness are
knowledgeable of
specific health threats
and know how to
protect themselves
against said threats.
Training deployers
COL Stephen J. Thomas
"Serving to Heal....Honored to Serve"
Medical Logistics
Biodefense solutions to protect our nation
Task
Provide
Medical
Logistics
expertise and
resources in
support of
OUA. Explore
supporting
Interagency
needs.
COL Stephen J. Thomas
Line of Effort
Provide
deployment
packages.
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Develop
plans for
in-theater
support.
Meet
OCONUS
PPE needs.
Objective
Support
lab
reagent
re-supply.
DoD elements
supporting OUA are
medically equipped,
supplied, and
sustained throughout
the mission.
Personal Protective Equipment
Ebola PCR critical reagent resupply
Fulfill line item requests in-theater
Medical equipment
• Sustainment/retrograde
"Serving to Heal....Honored to Serve"
Research & Development
Biodefense solutions to protect our nation
Task
Coordinate
vaccine and drug
R&D activities
within MRMC.
Improve
synchronization
of efforts across
DoD medical
countermeasure
space. Facilitate
development
and fielding
solutions.
Line of Effort
Explore DoD
support to
leverage
R&D
activities for
Ebola
response.
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COL Stephen J. Thomas
Identify
strategic
partnerships
and engage.
Objective
Support
R&D
activities in
West Africa
and CONUS.
Provide
SME
and
counsel
to FHP.
Ebola vaccine
and drug
candidate
development
was advanced to
support OUA,
West Africa
outbreak
response, and
domestic
preparedness. Be
part of a Whole
of USG solution.
Research & Development Working Group
(MRMC, CBDP, MCS, USU)
USAMRIID: pre-clinical testing
WRAIR: clinical testing
Support clinical trials in West Africa
"Serving to Heal....Honored to Serve"
Future Relevance to US Military of Lessons Learned
from Current Ebola Outbreak
Biodefense solutions to protect our nation
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“The global security environment presents an increasingly complex set of
challenges and opportunities to which all elements of U.S. national
power must be applied.” (p. 1)
Primary Missions of the U.S. Armed Forces
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#10, “Conduct Humanitarian, Disaster Relief, and Other Operations……U.S. forces
possess rapidly deployable capabilities, including airlift and sealift, surveillance,
medical evacuation and care, and communications that can be invaluable in
supplementing lead relief agencies, by extending aid to victims of natural or manmade disasters, both at home and abroad…..” (p. 7)
Pandemics: State Fragility’s Most Telling Gap? By Frederick M.
Burkle, Jr.
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“A nation-state’s capacity to govern effectively faces no stiffer test than its ability to
manage infectious disease crises.” (p. 105)
“75 percent of epidemics during the last three decades have occurred in countries
where war, conflict, and prolonged political violence have crippled their capacity to
respond, leaving their neighbors and the world vulnerable.” (p. 106)
“Epidemics and pandemics are always public health emergencies. They easily
elude a compromised health system and can rapidly cause confusion, fear, and
chaos, and send populations fleeing across unprotected borders.” (p. 106)
"Serving to Heal....Honored to Serve"
Why Prepare for Uncertainty?
Biodefense solutions to protect our nation
WMD EVENT
OR
INFECTIOUS DISEASE
OUTBREAK
Highly
Contagious
Environmentally
Stable
High
Infectivity
High
Morbidity
and/or High
Mortality
Enemy Exploitation of Biological Agent
Characteristics or Natural Evolution
Days to weeks to manifest maximum effect
"Serving to Heal....Honored to Serve"
UNCLASSIFIED
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Rapid Response to Surprise
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Leverage a robust biological threat agent technology base
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Maintain active diagnostic and surveillance systems
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Provide rapid genomic sequence analyses of unknown threats
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Expand on state-of-the-art vaccine and drug discovery & development
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Construct DNA vaccines based on threat agent genetic sequence
Produce neutralizing antibodies against threat agents
Use high-throughput drug screening with authentic biothreat agents
 Leverage industry’s vast chemical and clinical candidate therapeutic
compound libraries
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Accelerate efficacy testing in animal models
 Incorporate new imaging technologies for near real-time anatomical and
functional assessments of MCM interventions
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Develop MCM for multi-drug resistant pathogens
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Leverage FDA approved drugs for biothreat indications
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Prepare Pre-Emergency Use Authorizations for MCM
Flexible and scalable capabilities to rapidly respond to
emerging threats
UNCLASSIFIED
"Serving to Heal....Honored to Serve"
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Keys to Success
Biodefense solutions to protect our nation
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Maintain a vigilant readiness to respond to infectious disease outbreaks that
threaten the local and international communities
Maintain a flexible and scalable capability and capacity to respond to
infectious disease threats
Maintain research flexibility and ability to surge effort toward current crisis
situations
Embrace JIIM solutions to these complex problems and smoothly integrate
into combined workforce
Maintain ability to mobilize high-impact low-density subject matter expertise
and skill sets when needed
"Serving to Heal....Honored to Serve"
USAMRIID
Biodefense solutions to protect our nation
Uniquely prepared to support high
consequence pathogen infectious disease
outbreaks
Must maintain flexibility to respond to the
uncertainties of tomorrow’s challenges
"Serving to Heal....Honored to Serve"