Our Vision is a U.S. Military Force that has a full medical countermeasure capability to fight and win in any CBRN battlespace worldwide.
The Chemical, Biological, and
Radiological Memorandum of
Understanding (CBR MOU)Medical Countermeasure
Consortium (MCMC) Working
Group
COL Russell E. Coleman
Joint Project Manager
Medical Countermeasure Systems
Russell.e.coleman.mil@mail.mil
UNCLASSIFIED
Enhancing International CBR
Defense Through Collaboration
• The Chemical, Biological, and Radiological Memorandum of
Understanding (CBR MOU) is an agreement between Australia, Canada,
the UK, and US which:
– Serves as a legal vehicle for the establishment of collaborations between
foreign governments
– Facilitates burden sharing of resources between nations in a constrained fiscal
environment
– Encourages development of common practices and standardization between
international programs, and efforts to achieve program interoperability
• CBR MOU Vision: Enable Warfighters to prevent, protect, and respond to
global CBR threats in any environment or mission.
• CBR MOU Mission: Collaborate to identify, develop, field, and sustain
capabilities to prevent and respond to CBR events; protecting our
Warfighters and citizens in contemporary and future operating and
security environments.
Value of the CBR MOU to
Industry
• The CBR MOU, as a legally recognized agreement, facilitates the
sharing of resources (funding, personnel, information, reagents,
etc) between the Defense and Public Health departments of the
four nations. This benefits industry by:
– Increasing funding available for product development
– Providing more defined requirements for the development of medical
products
– Enhancing and diversifying government technical expertise to make more
informed product development decisions
– Facilitating concurrent regulatory approval of products by the FDA and its
foreign equivalents
– Reducing the amount of time necessary to identify and attain rare /
constrained strains, reagents, or other resources held internationally
• Resource sharing can occur through a number of different
mechanisms under the CBR MOU
– Project Agreements (PA), Cooperative Research and Development
Agreements (CRADA), Material Transfer Agreements (MTA), etc.
Organization of Efforts Under
the CBR MOU
•The CBR MOU is divided into four working groups:
Assess
Inform
Protect
This provides
information regarding
the risk and threat from
CBR and provides a
common four nation
view that informs the
priorities for
collaboration.
The ability, whether in
terms of military
capability or in support
to decision makers in
the broadest sense, to
decide what to do prior
to, during or after a CBR
event.
Affording options to
protect people,
equipment and
infrastructure from the
effects of CBR.
Lead Nation:
US National Lead:
Dr. Erik Burnett
(SOCOM)
Lead Nation:
US National Lead:
Dr. Eric Moore (DTRA)
- Physical Products
MedCM
Consortium
Affording options to
protect people,
equipment and
infrastructure from the
effects of CBR.
- Medical Products
Lead Nation:
Lead Nation:
US National Lead:
US National Lead:
Dr. Chuck Bass (DTRA) COL Andrea Stahl
(MRMC)
CBR MOU Leadership
Highest decision-making
body; responsible for
establishing strategic
direction for all CBR
MOU activities.
US POC: Hon. Andrew
Webber
Assess
Working
Group
Steering
Committee
Program Officers, Requirements Officers,
Executive Officers and
Medical Requirements Officers
Inform
Working
Group
Protect
Working
Group
Intermediary committee
responsible for interface
between strategic and
tactical CBR MOU groups.
Also, responsible for
funding decisions related
to MOU work.
US PO: Dr. Ben
Petro
TRLs
US MRO: COL Mark
Bohannon
MCM
Consortium
The Medical Countermeasure
Consortium (MCMC)
• Establishes and facilitates collaborations across all technology
readiness levels to strengthen our collective preparedness for CBR
threat agents, emerging infectious diseases, and pandemic
influenza
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•
Utilizes risk and threat analysis to establish essential horizon scanning, discovery science
and technology (S&T), and advanced development priorities
Emphasis on outcomes with goals to be achieved in a five year time frame; improving the
transition of knowledge, technology, and capabilities to the Warfighter
Focus on increased effectiveness and efficiency of S&T collaborations while measurably
reducing overhead costs.
Six priority areas have been identified within the MCMC
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−
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Antimicrobial Resistance (Task 1)
Diagnostics (Task 2)
NTAs (Task 3)
Filoviruses (Task 4)
Bioscavengers (Task 5)
Ricin (Task 6)
Task 1: Antimicrobial Resistance
(AMR)
• Purpose: To facilitate collaboration related to the development of
MedCMs and supporting technologies targeting AMR bacteria and
expedite the delivery of novel medical systems against pathogens of
concern.
• Program: National interests in and requirements for AMR are diversecollaborative efforts are prioritized by:
– National requirements
– Portfolio and capability analysis
– State of the AMR threat
• Scope: Collaborations are organized into 4 overarching areas:
– Antimicrobial Target Discovery- S&T
– Mechanisms of Resistance / Persistence- S&T
– Immunomodulation- S&T / Adv. Dev.
– Novel Antimicrobial Approaches- S&T / Adv. Dev.
Current AMR
Collaborations
Fielded System
Current Collaboration
Technology Readiness Level (TRL)
9
Novel Bacterialdirected therapies
8
7
6
Antimicrobial Target
Discovery
5
Immunomodulation
4
Mechanisms of
Resistance /
Persistence
3
2
Not in current
program of work
1
Pathogen- Directed
Therapies
Host- Directed
Therapies
Task 2: Point of Care
Diagnostics
Purpose:
Collaborate to develop technologies which
enable the earliest diagnosis as fast as
possible. Diagnostics are a priority for both
defense and public health efforts,
especially against priority pathogens and
agents of concern.
MCMs are most effective when diagnosis is
earliest !!!
Program:
-R&D and validation of rapid clinical
diagnostic tools
- COTS systems (short horizon) (FilmArray)
novel technologies (5-7 yr)
- Diagnostic targets (e.g. presymptomatic
biomarkers
- Bioinformatics : data analysis,
management, translation
MedCM
Diagnosis
Prognosis
Task 3: Bioscavengers
• Purpose: Develop a prophylactic and therapeutic medical
countermeasure capable of protecting Warfighters against exposure to a
broad spectrum of nerve agents
• Program: Collaborate on and invest in emerging and advancing
technologies that show promise as prophylaxes and are therapeutic
against nerve agent exposure
• Scope: To work towards a bioscavenger therapeutic that is:
• Protective against a broad spectrum of agents
• Useful for pre- and post- exposure scenarios
• Administered via IV and/or non-IV route(s)
• Manufactured through affordable and scalable processes
• Approved by US, UK, CA and EU regulatory bodies
Task 4: Filovirus
• Purpose: To manage the coordination of Filovirus MCM Development and Supporting
Technologies across defense and public health departments of all MOU nations
• Program: The US, UK and CA have identified a requirement to develop medical
countermeasures (MCMs) to establish force protection against Filoviruses.
–
–
•
UK and CA collaboration with the US DoD advanced development programs for Ebola
and/or Marburg viruses
Coordination of supporting S&T technologies, animal models, and resources such as
standardized reagents, challenge materials and assays
Scope: Coordination and Integration of S&T, Advanced Development, and Supporting
Technologies to mitigate Filovirus.
1. AVI-7288- Therapeutic/PEP for Marburg
2. TKM-100802- Therapeutic/PEP for Ebola
TKM-NP-718m siRNA – Therapeutic/PEP for Marburg
3. Favipiravir- Broad Spectrum Therapeutic for Influenza and Ebola
4. Trivalent Filovirus VLP – Vaccine/PEP for Ebola/Marburg
1. Trivalent Filovirus VRP – Vaccine/PEP for Ebola/Marburg
2. Trivalent Filovirus VSV (Profectus rVSVN4CT1)- Vaccine/PEP for Ebola/Marburg
3. ZMapp – Therapeutic/PEP for Ebola
Task 5: Non-Traditional Agents
(NTAs)
• Purpose: To integrate information from, and directions of, Nations’
programs to identify, assess and develop optimal therapeutic strategies
for two classes of high priority NTAs.
• Program: AUS, CA, US, and UK have identified two classes of NTA as
priorities and have active programs investigating MCM and therapeutic
strategies for these NTAs
• Scope: Coordination of S&T, Advanced Development and supporting
technologies to facilitate (for both NTA classes)
1.Characterisation of NTA toxicology
• Human toxicity estimates relevant to MedCM
• Mechanisms of toxicity and directed medical intervention
2.Assessment of in-service medical interventions
• What is the best advice we can give now and in 3 – 5 yrs?
3.Identification of deficiencies in current medical intervention and
development of novel or re-purposed MCM
• What do we want to do, with what and by when?
4.Identification of triggers to treat (chemical diagnostics)
• For therapy initiation and optimal medical management
Task 6: Ricin
• Purpose: Ricin is readily accessible, can be highly toxic, and
there are no approved MCMs or diagnostics for ricin. Task 6 will
work to assist each nation to fulfill this capability gap.
• Programs: AS, CA, UK, and US have all identified ricin as a high
priority agent and all have active, funded, ricin MCM programs.
Vaccine
Exposure
Event
Diagnostic/
Detection/
Intel
Therapeutic
• Scope: Collaboration on the development and licensure of antiricin MCM(s), with concurrent prioritization of animal model
development work efforts