2 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

An operator transfers influenza test samples into the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instrument 

for analysis. In just over one hour, the JBAIDS will report whether the samples contain 2009 H1N1 (Swine Flu) virus. The FDA granted 

CBMS the Emergency Use Authorization (EUA) in August 2009 for diagnostic testing of Swine Flu influenza during the declared 

public health emergency. The JBAIDS Swine Flu test is based on a test designed and used by the Centers for Disease Control and 

Prevention. It tests for the presence of three different viral genes.

On the cover: Dr. Ronald Clawson, Col. David 

Williams, Ltc. (P) Brian Gentile, Maj. Nizamettin 

Gul, and Ltc. Philip Smith lead CBMS in providing 

FDA-approved CBRN medical countermeasures 

for the Warfighter and the Nation. Photo Credits: 

CBMS. Air Force Image: SSgt. Jacob N. Bailey; 

Marine Image: Cpl. Kamran Sadaghiani; Navy Image: 

MCSN Andrew Brantley. (Defenseimagery.mil)

The CBMS Vision is to protect the Warfighter by maintaining 

uncontested global supremacy in CBRN medical countermeasures 

and diagnostics.

The CBMS Mission is to rapidly provide the Warfighter with safe, 

robust, affordable medical countermeasures against a broad spectrum 

of CBRN threats. CBMS uses government and commercial best 

practices to acquire FDA-approved CBRN medical countermeasures 

and diagnostics.

Air Force Staff Sgt. Shawn Weismiller. (Defenseimagery.mil)
www.jpeocbd.osd.mil

JPEO-CBD

3

CONTENTS

5 The Chemical Biological Medical Systems: Countering Current 

and Emerging CBRN Threats

10 Time-Temperature Indicators: Increasing Warfighter Confidence 

Decreasing Medical Logistics Load

14 A Discussion with Dr. Ronald Clawson

 18 Partnering to Meet Warfighter Needs

 22 CBMS In the News

Col. Daniel McCormick

USA

Col. Brett Barraclough

USA

Mr. Will Hartzell

USMC

Mr. Scott White

USN

Col. David Williams

USA

Mr. Rudolf Olszyk

USMC

Mr. Michael Abaie

USN

Col. Alan Burket

USAF
4 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

The Chemical Biological Medical Systems Joint Project 

Management Office (CBMS) leads the Department 

of Defense (DoD) in the advanced development of 

transformational Chemical, Biological, Radiological, 

and Nuclear (CBRN) medical countermeasures (MCM) 

for the Warfighter. This special medical edition of the 

Chem-Bio Defense Quarterly provides an overview of 

several key areas of interest within CBMS that reflect 

our proactive approach to mission accomplishment.

Established in 2002 and chartered in 2003, CBMS 

has achieved an unprecedented 7 FDA CBRN MCM 

approvals, licensures, and clearances; completed 14 

Investigational New Drug (IND) submissions to the 

FDA, including the first 2 electronic IND submissions 

by any DoD organization; completed an Emergency 

Use Authorization for the H1N1 (swine flu) JBAIDS 

assay within 83 days and completed 22 drug and 

safety trials. Building upon this impressive record, an 

additional 15 FDA approvals will be obtained in the 

next 5 years.

For current and emerging threats, CBMS focuses on 4 

thrust themes:

• Partnering: Proactive inter-agency, intra-agency, 

industry, and international / allied country 

partnering with a focus on unity of purpose and 

effort

• Regulatory compliance: Ensuring full compliance 

with the corollary DoD Defense Acquisition 

System and Food and Drug Administration (FDA) 

regulatory guidance

• Life cycle management: Use of government and 

commercial best business practices for program life 

cycle management

• Planning for the future: Through the management 

of evolutionary acquisition increments, ensuring 

the delivery of military useful and supportable 

capability enhancements 

As an illustrative example of one of these key 

themes, strategic partnering, CBMS participates 

on the Integrated National Biodefense Medical 

Countermeasure Portfolio Initiative. This initiative 

provides a structured organization and process that 

coordinates the U.S. Government’s efforts with respect 

to biodefense MCM development and procurement 

for the nation. Core Working Group Members driving 

this cooperative inter-agency effort include: the 

Biomedical Advanced Research and Development 

Authority (BARDA), the National Institute of Allergy 

and Infectious Diseases (NIAID), the DoD Chemical 

and Biological Defense Program (CBDP), the DoD 

Defense Threat Reduction Agency (DTRA), and the 

Joint Program Executive Office for Chemical and 

Biological Defense (JPEO-CBD). CBMS serves as 

the seated JPEO-CBD representative. Our expertise 

with both the DoD Defense Acquisition System and 

FDA advanced development regulatory process, e.g. 

the “Animal Rule,” makes us uniquely qualified to 

assist in the Initiative’s risk assessment and cost and 

schedule modeling. In addition to the Core Working 

Group, there are also a variety of Integrated Product 

Development teams that review the portfolios for each 

countermeasure and make portfolio recommendations. 

These recommendations are provided to advisory 

committees that make final decisions on portfolio 

composition, with the intent of minimizing duplication 

of effort across agencies and exploiting its members’ 

technological breakthroughs. 

CBMS has greater than 1,080 person years of 

experience related to the advanced development 

of CBRN MCM, spanning functional areas and 

core competencies, such as Acquisition/Program 

Management, Biological Sciences, Regulatory Affairs/

Quality Assurance, Contracting/Legal, Life Cycle 

Logistics, Operations, and Finance. This team of 

dedicated professionals is further enhanced through its 

diverse and cross-functional experiences as the team 

is comprised of Active Duty military, DoD Civilians, 

and DoD contractors, many of whom bring direct 

commercial experience to the team. In most cases, the 

professionals on staff are subject matter experts in their 

respective career fields, possessing an invaluable wealth 

of directly relevant technical knowledge. In this regard, 

the sum of the CBMS whole provides for a robust, 

experienced, and technically creative workforce. 

Additionally, CBMS has been able to structure itself 

so that all supporting functional areas are collocated. 

Of particular note, CBMS enjoys full-time, on-site 

dedicated support from a team of contracting 

professionals from the U.S. Army Space and Missile 

Defense Command and legal support from the U.S. 

Army Medical Research and Materiel Command.

CBMS has achieved unprecedented success and 

continues to overcome the evolving challenges of 

pharmaceutical advanced development through the 

fully integrated and parallel execution of the Defense 

Acquisition System and the FDA regulatory process. 

Our extensive organizational experience in this unique 

niche and our mission focus on CBRN MCM places 

CBMS at the forefront of protecting the Warfighter and 

nation.

In the CBMS articles that follow, you will learn 

more about the innovative products and technologies 

JPMO-CBMS has in advanced development to meet 

Warfighter needs. Our skilled professionals proactively 

work to develop the best CBRN MCM possible in our 

efforts to combat current and emerging threats. 

Please visit the Joint Program Executive Office for 

Chemical Biological Defense (JPEO-CBD) website for 

further details regarding the innovative work underway 

at CBMS and to view a multimedia presentation of our 

organization in action. 

CBMS : http://www.jpeocbd.osd.mil/packs/Default2.

aspx?pg=180

A Message from the Joint Project Manager 

Col. David Williams

Joint Project Manager 

Chem Bio Medical Systems

Brig. Gen. Jess A. Scarbrough

Joint Program Executive Officer

Mr. Douglas Bryce

Deputy Joint Program Executive Officer

Mr. Scott Paris

Chief of Staff

Col. Jonathan Newmark

Deputy JPEO-CBD for Medical Affairs 

Ms. Brenda Besore

Director, Knowledge Management

Ms. Karan Williams

Director, Resource Management

Mr. Gary Olejniczak

Director, Current Acquisition

Ms. Camille Schumacher

Director, Future Acquisition

Mr. Darrell McCarthy

Director, Human Resources 

Ms. Patricia Estep

Webmaster

webmaster@jpeocbd.osd.mil

Editor, Chem-Bio Defense Magazine 

Mr. Julius L. Evans

Julius.Evans@jpeocbd.osd.mil

Contractor Support Provided by

Kalman & Co., Inc. and Camber Corporation

Mr. Steven Lusher

Senior Graphic Designer

Steve.Lusher@jpeocbd.osd.mil

Contractor Support Provided by

Goldbelt Raven, LLC

Ms.Cicely Levingston

Guest Editor

Cicely.Levingston@us.army.mil 

Ms. Lisa Calloway

Senior Graphic Designer

Lisa.Calloway@us.army.mil

Mr. Scott Brown

Senior Graphic Designer

Alan.Brown7@us.army.mil

Chem-Bio Defense Quarterly magazine is 

published quarterly by the Joint Program Executive 

Office for Chemical and Biological Defense. 

Articles reflect the views of the authors and do 

not necessarily represent the views of Chem-Bio 

Defense Quarterly, the Department of the Army or 

the Department of Defense.

To contact the editorial office:

Call: (703) 681-0701 

DSN: 588-9600

Fax: (703) 681-3439

Email: editor@jpeocbd.osd.mil

Articles should be submitted to:

Chem-Bio Defense Quarterly

5203 Leesburg Pike 

Skyline 2, Suite 1609

Falls Church, VA 22041

www.jpeocbd.osd.mil

Joint Program Executive Office
www.jpeocbd.osd.mil

JPEO-CBD

5

The Joint Project Management 

Office (JPMO) Chemical Biological Medical Systems (CBMS) 

rapidly provides the Warfighter with 

safe, robust, and affordable medical 

countermeasures (MCM) against a broad 

spectrum of Chemical, Biological, Radiological, and Nuclear (CBRN) threats. 

Chartered in April, 2003, CBMS remains 

a critical component in the Department of 

Defense’s (DoD) comprehensive national 

strategy to counter the threat of CBRN 

weapons of mass destruction. 

 CBMS, led by Joint Project Manager 

(JPM) Colonel David Williams, is composed of two subordinate organizations: 

the Joint Vaccine Acquisition Program 

(CBMS-JVAP) and the Medical Identification and Treatment Systems (CBMSMITS) Product Management Offices. 

Together, these product offices deliver 

CBRN MCM spanning the continuum of 

medical care from prevention and diagnosis to treatment.

The advanced development of CBRN 

vaccines and drugs starts with the identification of Warfighter requirements and 

capability gaps identified through the 

use of the needs-driven Joint Capabilities Integration and Development System 

(JCIDS). Based on the capability gaps 

identified by JCIDS, the Joint Requirements Office (JRO) documents these 

requirements. This includes identifying 

promising technologies within the DoD’s 

Joint Science and Technology Office, 

academia, industry and other federal agencies. CBMS then marshals its resources 

to develop and license CBRN MCM to 

meet these requirements. In so doing, 

CBMS complies with Food and Drug 

Administration (FDA) regulations (21 

Code of Federal Regulation) regarding 

product development and testing to ensure 

the safety and effectiveness of CBRN 

MCM for the Warfighter. A critical and 

unique component of the CBMS mission 

is, therefore, the integration of the DoD 

Defense Acquisition System, detailed 

in Department of Defense Instruction 

(DoDI) 5000.02, with mandated FDA 

regulatory processes. 

The FDA serves as the developmental and operational test and evaluation 

authority for the development of CBRN 

MCM. The flexibility inherent in the 

DoDI 5000.02 makes it possible for 

CBMS to tailor its processes to meet 

both DoD and FDA requirements. CBMS 

collaborated with the Department of 

Health and Human Services (HHS) to 

standardize the separate Technology 

Readiness Levels (TRLs) formerly used 

by both organizations and is currently 

working to standardize the Manufacturing Readiness Levels as well. This 

Cicely Levingston, Executive Special Assistant/

 Legislative Specialist, CBMS

Col. David Williams, Joint Project Manager, CBMS

CBMS is comprised of two 

subordinate organizations: 

The Joint Vaccine Acquisition 

Program (JVAP) and the 

Medical Identification 

and Treatment Systems 

(MITS). CBMS meets 

Warfighter needs through 

the development of FDAapproved CBRN MCM. 
6 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

synchronization of TRLs helped establish 

a unified measurement of technology 

maturity within the medical community. 

CBMS focuses on improving current 

industry standard development times for 

the advanced development portion of the 

acquisition process. This development 

timeframe is largely due to complex and 

phased animal and human testing associated with medical product development 

and the challenges unique to the development and manufacturing of vaccines and 

drugs. Despite these challenges, CBMS 

exceeds industry standard metrics by 

exploring ways to shorten our development schedules and total life cycle costs 

while continuing to provide the finest 

medical capabilities to the Warfighter as 

cost effectively as possible. 

 In its short 8-year history, CBMS has 

emerged as the world leader in innovative 

CBRN MCM advanced development. 

In particular, CBMS has achieved an 

Emergency Use Authorization, 7 FDA 

approvals, completed 14 submissions for 

Investigational New Drugs (IND), and 

developed 2 enabling technologies. Key 

to these accomplishments are partnerships 

with other U.S. agencies and allied governments, compliance with DoD and FDA 

guidelines, use of both commercial and 

government best practices, and situational 

awareness of technology when planning 

for current and emerging threats. Additionally, CBMS has been able to structure 

itself so that all supporting functional 

areas are collocated. CBMS enjoys fulltime, on-site support from a team of contracting professionals from the U.S. Army 

Space and Missile Defense Command and 

legal support from the U.S. Army Medical 

Research and Materiel Command.

The Joint Vaccine Acquisition Program 

(CBMS-JVAP)

 The CBMS product office chartered 

to develop, acquire, and stockpile FDAlicensed vaccine products for the DoD is 

the Joint Vaccine Acquisition Program 

(CBMS-JVAP). Lieutenant Colonel 

Philip Smith serves as the Joint Product 

Manager and leads the CBMS-JVAP 

team efforts.

 The CBMS-JVAP mission is the 

advanced development of vaccines to 

protect DoD personnel from the effects 

of Biological Warfare Agents (BWA). 

In addition to acquiring FDA-licensed 

vaccines, CBMS-JVAP is engaged in the 

development of filovirus vaccine, plague 

vaccine, and botulinum vaccine. CBMSJVAP, in fulfilling defense needs of our 

Warfighters and the nation, meets or 

exceeds the quality standards established 

in current Good Manufacturing Practices 

(cGMP), Good Laboratory Practices 

(GLP), Good Clinical Practices (GCP) and 

FDA requirements for safety and efficacy.

 Vaccines fill a vital need in the full 

spectrum of Warfighter CBRN MCM 

protection. Vaccines help to maintain 

combat force effectiveness by preventing 

The flexibility of the DoD acquisition process as described in the DoDI 5000.02 makes it possible for CBMS to tailor its processes 

to meet both DoD and FDA requirements while partnering with other agencies and governments for CBRN MCM advanced 

development. CBMS led the collaboration with HHS in standardizing TRLs and MRLs to be used by both organizations.
www.jpeocbd.osd.mil

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7

Vaccine Adsorbed and the Smallpox 

vaccine save the federal government 

more than $60M annually. Agreements 

with the National Institute of Allergy 

and Infectious Diseases (NIAID) allow 

CBMS-JVAP access to technical expertise in animal model and assay development resulting in decreased program 

cost, schedule, and risk. CBMS drives 

to increase product quality, decrease 

cost, and accelerate program schedule by 

aggressively transitioning technologies 

from Defense Advanced Research Projects 

Agency (DARPA) to reduce the time a 

vaccine remains in clinical trials. 

 CBMS-JVAP’s impressive portfolio 

of products fielded to the Warfighter 

include the Anthrax Vaccine Adsorbed 

(AVA:Biothrax®), the Smallpox vaccine 

(ACAM2000®), and the Vaccinia Immune 

Globulin, a treatment for rare adverse 

reactions to the smallpox vaccine. The 

CBMS-JVAP advanced development 

portfolio includes a plague vaccine, a 

illness and death resulting from exposure 

to biological agents. Once a Warfighter is 

vaccinated, this “biological body armor” 

can protect him/her for periods ranging 

from 18 months to decades. Without vaccines, the ability to sustain combat power 

would rely solely on physical protection, 

detection of agents, a long medical logistics tail, and treatment of exposed people. 

All of these degrade the fighting force and 

add significant burden to theater medical 

resources.

 Use of commercial and DoD best 

practices to minimize life cycle costs is a 

vital factor in the CBMS-JVAP equation 

for vaccine development success. Leveraging these practices accelerates schedules and minimizes risk. Additionally, 

CBMS-JVAP partners with other U.S. 

agencies and allied governments in product development. Our agreements with 

the Department of Health and Human 

Services (HHS) Strategic National 

Stockpile for the procurement of Anthrax 

botulinum toxin vaccine, and a filovirus 

vaccine. CBMS continues to aggressively 

explore opportunities to partner with 

allied countries for all CBRN vaccine 

advanced development efforts.

The Medical Identification and 

Treatment Systems (CBMS-MITS)

The DoD requires the capability to 

provide lifesaving MCM against CBRN 

threats through drugs, biological products, 

and diagnostic system capabilities. In 

response, the Medical Identification and 

Treatment Systems (CBMS-MITS) was 

charted to develop, stockpile, and field systems of FDA approved drugs and devices 

to protect Warfighters and the nation from 

CBRN threats. In so doing, three individual programs were unified under CBMS in 

2003 to form CBMS-MITS: 

• The Medical Chemical Defense 

Advanced Development Program, 

which was formerly managed by the 

CBMS has accomplished 7 FDA approvals, completed 14 IND submissions, and developed 2 enabling technologies in its 8-year history. 
8 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

U.S. Army Medical Materiel Development Activity (USAMMDA) of 

the U.S. Army Medical Research and 

Materiel Command (USAMRMC)

• The Joint Biological Agent Identification and Diagnostics Systems Program, 

formerly managed by the Joint Program 

Office for Biological Defense (JPO-BD)

• The Critical Reagents Program, also 

formerly managed by the JPO-BD 

CBMS-MITS faces a herculean challenge in rapidly providing the Warfighter 

and the nation with robust, affordable, 

FDA-approved, life-saving CBRN MCM 

drug and diagnostic system capabilities. Lieutenant Colonel Brian Gentile, 

CBMS-MITS Joint Product Manager, 

spearheads the CBMS-MITS team in the 

advanced development and acquisition 

management of FDA approved products. 

CBMS-MITS serves as the lifecycle 

product manager for a number of FDAapproved fielded CBRN MCM products to 

include: 

• Joint Biological Agent Identification 

and Diagnostic System (JBAIDS) 

integrated system for detection, rapid 

identification, and diagnostic confirmation of biological agents

• Convulsant Antidote for Nerve Agents 

(CANA) for the treatment of nerve 

agent-induced seizures

• Antidote Treatment Nerve Agent Autoinjector (ATNAA) containing atropine 

and 2-PAM for the rapid treatment of 

nerve agent poisoning 

• Soman Nerve Agent Pretreatment 

Pyridostigmine (SNAPP) to enhance the 

effects of other nerve agent antidotes. 

The CBMS-MITS system-of-systems 

approach to CBRN MCM development 

requires both pre and post-exposure treatments. For example, the pretreatment 

drug SNAPP is only effective when given 

prior to nerve agent exposure while other 

fielded chemical agent countermeasures 

require administration immediately after 

nerve agent exposure.

Advanced development efforts include 

Bioscavenger (BSCAV), which fulfills an 

urgent capability gap in the Warfighter’s 

defense against existing and emerging 

nerve agent threats. BSCAV is a prophylactic that readily counters nerve 

agent toxicity in the blood before these 

poisons exert their deadly effects. Other 

advanced development efforts include the 

Advanced Anticonvulsant System (AAS), 

the Improved Nerve Agent Treatment 

System (INATS), Inhalation Atropine 

(IA), and Medical Radiation (MEDRAD) 

countermeasures. The AAS, a developmental effort conducted in partnership 

with HHS, is anticipated to replace the 

currently fielded CANA. The INATS, 

which will protect against a broad spectrum of nerve agents, is anticipated to 

replace the ATNAA. The INATS project 

will expand label indications for SNAPP 

beyond Soman to include additional 

nerve agents, NTA’s, and emerging 

threats. CBMS-MITS coordinates with 

members of an international working 

group, the Medical Countermeasures 

Working Group (MCWG), on the INATS 

developmental effort for the purposes of 

interoperability, burden sharing, decrease 

in schedule, and risk reduction. Through 

the use of the CBMS Broad Agency 

Announcement, the IA effort advances 

CBMS maintains a finger on the pulse of technology through interactions with other U.S. Agencies, academia, industry, and allied governments. Here, Brigadier General Jess Scarbrough (Center), Joint Program Executive Officer for Chemical and Biological Defense, and members of CBMS visit a vaccine manufacturing facility in Frederick, MD.
www.jpeocbd.osd.mil

JPEO-CBD

9

the state of the art by assisting industry’s 

advanced development efforts directed 

toward a dry powder atropine inhaler 

to treat mild but persistant nerve agent 

symptoms.

The Medical Radiation (MEDRAD) 

advanced development effort, less than 

two years in existence, is relatively new. 

There are no current FDA-approved products to treat the acute radiation syndrome 

resulting from radiological or nuclear 

events. CBMS-MITS bases its system of 

systems approach on three pillars: prevention, diagnosis, and treatment. In close 

collaboration with other federal agencies, 

CBMS-MITS is developing MEDRAD 

countermeasures through integration of 

complementary technologies which act by 

minimizing radiation injury and promoting 

tissue repair in order to fill the MEDRAD 

capability gap. CBMS-MITS is well 

poised to overcome the obstacles of technology integration and cost in the development of MEDRAD countermeasures.

CBMS-MITS also manages DoD’s 

Critical Reagents Program (CRP) whose 

mission is to develop, validate, and field 

critically needed specialty biodefense 

reagents and assays. These activities and 

products support biological environmental detection and biological human 

diagnostic systems that identify a variety 

of threat agents which cause deadly 

diseases such as anthrax and plague. The 

CRP assays and reagents are essential 

components of multiple fielded, frontline diagnostic and detection platforms 

and serves as a foundation for our 

national biological defense capabilities. 

The CRP was organized in 1998 and has 

been supplying assays and reagents for 

identifying biological threats since 1999.

The Future for CBRN MCM

CBMS is the leader in developing and 

acquiring innovative CBRN MCM for 

the Warfighter on time and on target. Our 

aggressive forward leaning approach 

to product development requires that 

we work with partners worldwide and 

capitalize on the benefits of “unity-ofeffort” when there is “unity-of-purpose.” 

Using government and industry best 

practices, we tailor our processes to 

meet FDA and DoD Defense Acquisition 

System requirements while continuously planning for current and emerging 

threats. The future of CBMS includes the 

development of novel countermeasures 

to fulfill Warfighter requirements as well 

as innovative ways to improve currently 

fielded ones. Key future Evolutionary 

Acquisition Increments, in the form of 

product improvements, currently under 

way at CBMS will decrease program cost 

while increasing product performance. 

These efforts include:

• Time/Temperature Indicators (TTI): 

TTI are small devices placed on temperature sensitive product units that experience the same thermal history as the 

product vial or packet. These indicators 

will aid the supply chain and Warfighter 

to determine, at a glance, whether or not 

a product remains safe and effective, 

has exceeded temperature requirements 

and may no longer be effective.

• Multi-dose Formulation: Multi-dose 

formulation changes involve the inclusion of more than one dose of vaccine 

within each vial versus the current one 

dose per one vial production method. 

This change will decrease the logistics 

footprint in terms of storage as well as 

decrease production costs.

• Increased Formulation Stability: The 

development of thermo stable products 

will reduce cold chain, or temperaturecontrolled supply chain, requirements; 

thereby, resulting in decreased logistical burden and cost savings.

• Item Unique Identification (IUID) 

Application: The IUID is an asset 

management system that will facilitate 

documentation in electronic health 

records, assist in product recalls and 

adverse event reporting, improve 

supply chain management and reduce 

inventory management costs.

• Alternate Drug Delivery Technology: 

CBMS is researching new drug delivery technologies that will provide alternatives to intramuscular injections of 

drugs and vaccines. Examples include 

skin patches and inhalation devices.

The JPMO-CBMS has a diverse 

product line of CBRN MCM under 

advanced development by a world class 

team of military, government civilian, 

and contract personnel. Through our use 

of DoD and commercial best practices, 

we expertly combine FDA regulations 

with DoD acquisition policies to rapidly 

provide transformational CBRN MCM 

materiel solutions for current and emerging threats to our Warfighters, our nation, 

and the world.

CBMS has numerous product improvement efforts under way such as Time Temperature 

indicators that will be placed on individual products. 
10 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

The Chemical Biological Medical 

Systems (CBMS) Joint Project 

Management Office is responsible 

for developing Medical Countermeasures 

(MCM) through the implementation of 

the Defense Acquisition Management 

System to protect and treat Warfighters 

against the incapacitating and/or lethal 

effects of chemical, biological, radiological and nuclear (CBRN) threats. Many 

of these MCM are carried by individual 

Warfighters for immediate, emergency 

use. By their very nature, most MCM 

are sensitive to temperature extremes. 

Exposure to these temperature extremes 

can decrease the stability of the product, 

thereby negatively effecting it’s safety 

and efficacy; yet the Warfighter in possession of these products has no way to 

know if his or her product is still safe and 

effective. In the past, product life cycle 

managers provided conservative operational use guidance for these products, 

resulting in the disposal of CBRN MCM 

that were still safe and effective. For 

example, the Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP) product 

is stable for 10 years in refrigeration, yet 

operational guidance for SNAPP states 

that the product must be used or discarded 

within 3 months once issued to an individual Warfighter. 

The Medical Identification and Treatment 

Systems Joint Product Management Office 

of the Chemical Biological Medical Systems 

(CBMS-MITS) is tackling this challenge by 

field testing the use of Time-Temperature 

Indicators (TTI) on CBRN MCM. TTI are 

self adhesive devices placed on individual 

CBRN MCM vials or packets. TTI contain 

temperature sensitive materials that undergo 

a predictable color change based on heat 

exposure over time. This technology is 

already in use by the World Health Organization (WHO) on their vaccines and by the 

Department of Defense (DoD) on cartons of 

Meals Ready to Eat (MRE). 

CBMS-MITS is identifying TTI that 

closely model the thermal sensitivity of 

each CBMS CBRN MCM to provide a 

visual warning of potentially heat-damaged products in the global theater. 

By Tim Belski, Pharmaceutical Manager, Medical Identification and Treatment Systems

Medical Countermeasures such as Reactive Skin Decontamination Lotion (RSDL) are carried by individual Warfighters for 

immediate, emergency use.
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11

TTI will:

• Increase the Warfighter’s confidence 

that his or her CBRN MCM is ready 

when needed

• Reduce wastage and maximize the 

re-use of heat-sensitive products by 

preventing the disposal of products not 

compromised by heat.

The TTI will also assist in the supply 

chain management of these CBRN MCM 

by providing information on product quality at the basis of issue level. This information will be used to determine when to 

order more CBRN MCM. 

The need for temperature monitors on 

vaccine vials was first identified by WHO 

in 1979 to address the problems with 

shipping heat sensitive vaccines to many 

areas of the world where temperatures 

regularly exceed 100°F. By 1999, WHO 

had identified an appropriate TTI technology and released specifications for TTI for 

all vaccines used in developing-country 

immunization programs. 

Since implementing TTI on vaccine 

vials, WHO has been able to:

• Prevent delivery of heat-damaged 

vaccines 

• Reduce the discard of usable vaccines 

when heat exposure occurs

• Allow vaccines to be safely transported 

beyond the cold chain without ice, minimizing logistics and increasing outreach 

capabilities

• Better manage vaccine stocks by 

determining which vials have experienced some heat exposure (but are 

still good and should be used first).

Since 1995, The DoD has used TTI on 

the cartons of MRE to link the quality 

of the ration to the time and temperature 

since packaging. Boxes of rations are 

often stored for long periods of time in 

hot storage facilities, waiting for shipment to troops around the world. TTI 

have provided a cost effective tool to 

assist in managing the quality of rations. 

The CBMS-MITS is bringing the 

same TTI technology used on WHO 

vaccines and DoD MRE to Warfighter 

carried CBRN MCM. These types of 

TTI use a heat sensitive polymer-based 

CBMS Pharmaceutical Managers, Dr. Renae Malek (left) and Mr. Tim Belski (right) discuss the inherent advantages of TTI with Major 

Nizamettin Gul.
12 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

ink that irreversibly darkens over time 

due to temperature exposure. The rate 

of chemical reaction, or polymerization, 

can be predicted by the Arrhenius equation. This equation defines the combined 

effects of time and temperature which 

cause a gradual, predictable, cumulative 

and irreversible color change from clear 

to dark. The rate of polymerization of the 

TTI can be tailored to closely follow the 

temperature profile of a CBRN MCM. 

In selecting TTI for CBRN MCM, 

CBMS-MITS is following ASTM F 1416-

96 Standard Guide for Selection of TimeTemperature Indicators. This guide states 

that visually readable indicators should 

reach end point before the product shelf 

life at all temperatures within the reasonable and abusive storage ranges. CBMSMITS’ challenge is to select TTI for each 

CBRN MCM that signals product failure 

before actual product failure, but not too 

soon as to cause an excessive amount of 

product to be unnecessarily discarded. 

TTI will assist supply chain management of CBRN MCM by providing information on product quality at the 

basis of issue level. This information can be used for more efficient medical logistics management.

Warfighter inspects Soman Nerve Agent Pyridostigmine Bromide Tablets to determine when to order more CBRN MCM.
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JPEO-CBD

13

Operational life guidance for products 

with a TTI will be based on validation 

testing that determines CBRN MCM condition at different stages of TTI darkening. 

Each TTI consists of an outer reference 

ring and an inner circle. The inner circle 

darkens with time, and darkens more 

quickly as the temperature increases. 

When the inner circle matches the outer 

ring, this indicates that the CBRN MCM is 

approaching the end of its usable life and 

a new product must be ordered. When the 

inner circle is darker than the outer ring, 

the CBRN MCM must not be used. 

Mr. Tim Belski, Pharmaceutical Manager with CBMS-MITS, is collaborating 

with Mr. Rudy Olszyk, the Joint Project 

Manager-Decontamination and his team 

to field a TTI on the Reactive Skin Decontamination Lotion (RSDL). This Evolutionary Acquisition Incremental effort, in the 

form of a Preplanned Product Improvement 

(P3I), resulted in the selection of a TTI 

from available commercial systems with 

sound chemical kinetic data for further validation. A field test at Camp Bullis, Texas to 

assess the ruggedness and durability of the 

attached TTI to the RSDL packet began in 

March 2009 and and was completed in June 

2009. The selected TTI will be validated 

against the RSDL stability specifications 

and will be incorporated into the product 

packaging by the RSDL manufacturer by 

the third quarter of fiscal year 2010.

The CBMS-MITS shall apply the lessons 

learned from the RSDL TTI effort to other 

CBRN MCM in advanced development. 

The Advanced Anticonvulsant System 

(AAS) program is in the Post Milestone B 

Engineering and Manufacturing Development phase and is planning the product 

stability studies necessary to select an 

appropriate TTI. Other CBMS-MITS 

programs, the Improved Nerve Agent Treatment System (INATS), Medical Radiation 

Countermeasure (MRC), and Bioscavenger, 

are in the Technology Development phase 

and will also include TTI in their acquisition plans. CBMS-MITS is also investigating the use of TTI on legacy products 

such as Soman Nerve Agent Pretreatment 

Pyridostigmine (SNAPP) and the Antidote Treatment Nerve Agent Autoinjector 

(ATNAA) countermeasure. 

 The use of TTI will result in significant cost savings to the DoD by retaining 

product exposed to unknown environmental conditions that would otherwise 

be discarded. WHO estimates the use 

of TTI on vaccines has saved the global 

health community $5 million (US) every 

year. More importantly, TTI will identify 

products that are no longer effective as 

the result of exposure to extreme environmental conditions and alert the Warfighter of the need for a replacement. The 

TTI will provide to Warfighters the assurance that their lifesaving CBRN MCM 

are safe and effective when needed.

REFERENCES:

HealthTech Historical Profile: Vaccine 

Vial Monitors June 2005 www.path.org/

files/TS_htiv_vvms.pdf 

“Bull’s Eye” Time Temperature Indicator Labels: A Cost Effective Approach 

to Monitoring the Quality of Rations 

www.ssc.army.mil/about/pao/pubs/warrior/96/mar/labels.htm 

ASTM Designation: F 1416 – 96 

(Reapproved 2008) Standard Guide 

for Selection of Time-Temperature 

Indicators.

TTI increases the Warfighter confidence that their CBRN MCM are effective and ready to use when needed.
14 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

A True CBMS Ace

A Discussion 

with

 Dr. Ronald 
www.jpeocbd.osd.mil

JPEO-CBD

15

By Cicely Levingston, Executive Special Assistant / Legislative Specialist, CBMS

 Clawson...

Dr. Ronald Clawson served as the 

Deputy Joint Project Manager for 

the Chemical Biological Medical 

Systems (CBMS) Joint Project Management Office located in Frederick, Maryland. In this role, he was responsible for 

the daily management of the Department 

of Defense’s (DoD) organization chartered 

with the centralized research, development, 

acquisition management and joint service 

integration for all medical Chemical Biological Radiological and Nuclear (CBRN) 

Defense systems. Dr. Clawson collaborated 

with joint service, interagency, international 

teams of scientists and acquisition professionals in the development, acquisition and 

fielding of Food and Drug Administrationapproved CBRN medical countermeasures 

(MCM) and diagnostics. 

Born into an Army family and spending 

much of his early years moving from one 

post to another, Dr. Clawson received his 

doctorate degree in pharmacology from the 

University of Maryland at Baltimore. He 

spent 10 years in research at the University of Maryland Cancer Center studying 

the basic pharmacology of new anticancer 

candidate drugs. After that, he joined the 

U.S. Army Medical Research and Materiel 

Command (USAMRMC) as a government 

schedule (GS) civilian.

Dr. Clawson’s first role within the 

USAMRMC was that of consultant in the 

area of pharmacology to the Director of 

the Medical Chemical Defense Research 

Program. Later, he transferred to the U.S. 

Army Medical Materiel Development 

Activity (USAMMDA - the Army’s agency 

for the advanced development of drugs, 

vaccines and medical devices). His service 

at USAMMDA ultimately resulted in 

his selection as the Project Manager and 

Division Chief of USAMMDA’s Pharmaceutical Systems Division. In this role, he 

was responsible for the development of 

products used to protect, treat and diagnose 

infectious diseases as well as chemical and 

biological warfare agents and treat combat 

casualties. During his tenure at USAMMDA, Dr. Clawson led the charge to obtain 

FDA approval for seven products.

Following his 19-year career at USAMRMC, Dr. Clawson joined the CBMS team 

in 2002 and assumed his most recent role 

as Deputy Joint Project Manager. After 29 

years of dedicated service to the Federal 

government, Dr. Clawson retired in January 

2010.

Dr. Clawson is a world-renowned expert 

in the field of CBRN MCM development. He has several publications to 

his credit and has received a myriad of 

accolades throughout his career. Those 

awards include: Secretary of the Army’s 

Award for Outstanding Achievement in 

Materiel Acquisition, the David Packard 

Award for Acquisition Excellence, The 

Commander’s Award for Civilian Service, 

The Department of the Army Meritorious 

Civilian Service Award, the Army Medical 

Department’s Order of Military Medical 

Merit and the Chemical Corps Order of 

the Dragon.

Dr. Clawson and his wife, Jeanne Marie, 

live in Martinsburg, West Virginia.

Dr. Clawson, shown here with his wife (Jeanne Marie) 

and daughter (Anne Marie) retired in January 2010 with 

over 29 years of Government service.
16 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

A true CBMS ace, Dr. Clawson entered 

retirement in January with fond memories 

of his career and time with the CBMS. His 

expertise and leadership throughout the 

years were key in helping shape CBMS 

into the superb organization it is today. Dr. 

Clawson’s service to our country has made 

a lasting impression on CBMS, our Warfighters and the world. He recently took 

some time to share his accomplishments, 

thoughts and memories with us.

1. When did you first take an interest in 

science?

I have fond memories of my 10th grade 

biology teacher, Mr. Rose. He made the 

overall concept of science and biology 

exciting and interesting. I also knew 

that an education in science would 

prove to be a good career choice. 

2. Was there anyone in your life who 

served as a catalyst for your interest 

in science? If so, who and how did 

they promote your interest?

In addition to Mr. Rose, Dr. Jean 

Kerschner, my college faculty advisor, 

played a key role in peaking my interest 

in the world of science. Dr. Kerschner 

pointed me in the right directions and 

placed me on a track for a career in the 

biological life sciences. Upon completion of my undergraduate degree, I 

didn’t quite know exactly how I wanted 

to apply my education. Fortunately, I 

completed ROTC and was commissioned as a second lieutenant and completed two years of military service in 

the field artillery, allowing me to delay 

my decision as to what science career 

track I would take. 

3. What hobbies and interests do you 

enjoy outside of work?

Away from CBMS, one of my key 

passions is the game of bridge. I am a 

dedicated tournament player. Additionally, I love contra dancing and skiing. 

I am also a globe trotter with the most 

interesting places I’ve visited being 

Italy (Pompei was magnificent) and 

Edinburgh in the United Kingdom. I am 

a lover of history and was truly fascinated with the relatively modern history 

found in Edinburgh. It is truly amazing 

to make note of how much technology 

was lost over the centuries. 

4. What is a “little known fact” that 

JPEO/CBMS employees would be 

surprised to know about you?

Contrary to popular belief, I do own jeans!

5. What is your most memorable experience while working for the government?

During mid-1990 to early 1991, I 

feverishly supported the Warfighter by 

providing investigational products for 

their protection and use during Operation 

Desert Storm. One of these products was 

a nerve agent countermeasure known as 

Pyridostigmine Bromide. In order to get 

this product to the field, Food and Drug 

Administration approval was required. 

Accomplishing this monumental task 

required interfacing with Warfighters in 

Iraq, military leadership in the Pentagon 

and officials within the FDA. This made 

for lots of hard work and very long 

nights. But once approval was granted, 

I felt a true sense of accomplishment 

and contribution to my country and our 

service members. Additionally, these 

efforts were the genesis of the current 

FDA “Animal Rule” allowing DoD to 

work in the CBRN arena and obtain 

FDA approval when testing on humans is 

not feasible or ethical.

Dr. Clawson is a valued mentor and leader to both civilian and military professionals such as MAJ Nizamettin Gul, a Pharmaceutical 

Manager within CBMS-MITS.
www.jpeocbd.osd.mil

JPEO-CBD

17

6. What influenced your decision to 

remain in this career field and support the Warfighter? Why did you not 

choose a career track in commercial 

industry?

I have continued to work within CBMS 

and support the Warfighter simply 

because I enjoy the job. Every day 

is different and I leave each evening 

knowing that I am doing something 

valuable and tangible in helping support 

our Warfighters and our world. 

7. What is your most memorable TDY 

and why?

The most memorable temporary duty 

assignment was to Australia. I vividly 

recall that my plane was two and a half 

hours late departing. This resulted in a 

missed connection flight at Los Angeles 

Airport where I had to spend the night. I 

spent the entire next day unsuccessfully 

attempting to get my wife and daughter on a different plane to Australia. 

Luckily, I finally did arrive safely in 

Australia...but my bags followed five 

days later!

8. What is your most memorable experience while working within CBMS?

I have enjoyed seeing the organization grow and be a part of the series 

of events that have pushed us forward 

and made us who we are today: a successful organization providing critical 

CBRN medical countermeasures to the 

Warfighter. The biggest change I have 

noticed in CBMS since arriving is its 

fast and continued growth. CBMS has 

evolved into an organization that is 

able to function independently without 

CBMS senior leadership having to be 

involved in every aspect. The superior 

quality of the CBMS employees has 

allowed for this shift. 

9. What does CBMS offer the Warfighter that no other organization can?

CBMS has the expertise in FDA and 

DoD acquisition regulations and the 

scientific expertise like no other organization within the DoD or the country. 

We are able to come together to provide 

the Warfighter FDA approved medical 

countermeasures for improving survivability and sustainability on the battlefield. 

10. What will you miss the most upon 

retirement?

Definitely the people! I will also miss 

the daily challenges of the job and the 

simple rush I gained from coming into 

our office each day.

11. What will you enjoy the most upon 

retirement? 

There is so much to look forward to! I 

will definitely do more traveling with 

my wife and enjoy the flexibility I will 

have that will enable me to pick up at a 

moment’s notice and travel anywhere in 

the world. And, of course, more bridge 

tournaments!

12. What legacy would you like to leave 

at CBMS?

I’d like the quality professionals within 

CBMS to keep the mission in mind. Our 

job here is to do all we can to make the 

Warfighter safe. When the country is at 

peace, we in the development community need to be on a war standing 

and continue to provide our Warfighters with the protection they will need 

to accomplish their missions. We can’t 

wait until our products are needed to 

start doing our work–we must be prepared before our products are needed. 

I’d like for anyone who has ever 

worked with me to remember me by 

saying, “He had the mission in mind.”

I say to my successor, you have lots 

of good folks working for you. Let 

them do their job and simply make 

yourself available to provide insight 

and guidance.

Dr. Clawson served two years as an officer in the U.S. Army. He received his commission in 1969. Here, Dr. Clawson’s 

mother, Mary, pins on his Second Lieutenant bars.
18 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

There are a myriad of technical, 

programmatic and Food and Drug 

Administration (FDA) regulatory 

challenges associated with developing 

broad spectrum Medical Countermeasures 

(MCM) against Chemical Biological 

Radiological and Nuclear (CBRN) threats. 

For this reason, the Chemical Biological 

Medical Systems (CBMS) Joint Project 

Management Office (JPMO) collaborates 

with U.S. government agencies and allied 

nations to shape Congressional special 

interest studies that are rapidly providing 

the Warfighter and the nation with safe, 

effective and affordable CBRN MCM. 

Partnering Alignment with 

Department of Defense Agencies

CBMS is one pillar of the Department 

of Defense (DoD) medical Triad (mTriad). 

Chartered in 2005, the mTriad works to formalize a process for ensuring requirements, 

technical base and advanced development 

activities for CBRN MCM are coordinated 

to meet Warfighter requirements in a costeffective and timely manner. Additionally, 

CBMS established a CBRN integrated 

advanced development tiger team consisting of the Joint Program Executive 

Office for Chemical Biological Defense 

(JPEO-CBD), CBMS, JRO and the Under 

Secretary of Defense (Health Affairs) 

[USD(HA)] that meets bi-weekly to ensure 

unity of effort in the adjudication and clarification of CBRN MCM requirements.

Using DoD and industry best practices, 

CBMS works hand-in-hand with the Joint 

Science and Technology Office Chemical 

Biological Directorate (JSTO-CBD) to 

rapidly deliver products to the Warfighter. 

JSTO-CBD manages and integrates the 

early development (S&T base), demonstration and timely transition of effective 

chemical and biological defense solutions 

for the DoD. CBMS uses Technology 

Transfer Agreements (TTAs) to efficiently 

work with JSTO-CBD, ensuring a seamless 

transition between CBRN MCM discovery 

and advanced development, establishing a 

clear product development roadmap. 

In addition to performing its integral role 

on the DoD’s mTriad and working with 

JSTO-CBD to transition products from early 

to advanced development, CBMS partners 

and shares expertise with other DoD organizations: 

• United States Army Medical Research 

and Materiel Command (USAMRMC): USAMRMC performs scientific 

discovery and provides CBMS with 

dedicated, on-site regulatory, legal and 

laboratory support for products through 

the development life cycle. 

• DTRA(CB)/Transformational Medical 

Technology Initiative (TMTI): CBMS 

participates in Broad Agency Announcement proposal reviews and provides 

programmatic, regulatory, contracting, 

legal and technical support. 

• Global Emerging Infections Surveillance and Response System (GEIS):

CBMS provided–under a GEIS funded 

Memorandum of Agreement–an influenza 

assay for GEIS on a CBMS-developed 

Partnering to Meet 

Warfighter Needs

Sean O’Day, Senior Acquisition Analyst, CBMS

Cicely Levingston, Executive Special Assistant / Legislative Specialist, CBMS

Chip Wynn, Senior Acquisition Analyst, CBMS

Lt. Col. Brian Gentile, Joint Product Manager, MITS, CBMS-MITS

Lt. Col. Philip Smith, Joint Product Manager, JVAP, CBMS-JVAP
www.jpeocbd.osd.mil

JPEO-CBD

19

diagnostic system (Joint Biological Agent 

Identification and Diagnostic System).

• Defense Advanced Research Projects 

Agency (DARPA): CBMS partners with 

DARPA for the development and potential 

use of the Rapid Vaccine Assessment Tool. 

• Space and Missile Defense Command 

(SMDC): Provides CBMS with dedicated, 

on-site contracting support for products 

through the entire acquisition life cycle of a 

product.

Alignment with Other Government 

Agencies

All CBMS products must be FDA approved 

before delivery to the Warfighter. As a result, 

CBMS must use the FDA as its developmental 

and operational test and evaluation authority 

for all CBRN MCM. Through the submission 

of Investigational New Drug (IND) applications to the FDA, CBMS satisfies the DoD 

acquisition regulation for the requirement of a 

Test and Evaluation Master Plan (TEMP). 

CBMS continually works side by side with 

the FDA in support of advanced product 

development. CBMS is a trailblazer and 

has been instrumental in establishing 

innovative and efficient processes with 

the FDA in delivering CBRN MCM to 

the Warfighter in a timely manner. CBMS 

was the first to obtain FDA approval for a 

product (Pyridostigmine Bromide) using 

the FDA’s Animal Rule, which is required 

when human efficacy trials are not feasible 

or ethical. CBMS is currently developing 

five other products that will be licensed 

under the Animal Rule. Additionally, CBMS 

has led the way in leveraging the FDA’s 

Fast Track Designation process to expedite 

product approval.

“Where there is Unity of Purpose, Unity 

of Effort should follow.” This is the CBMS 

motto when forging partnerships with U.S. 

government agencies such as the Department of Health and Human Services (HHS) 

and its subordinate organizations including: 

the National Institute for Allergy and Infectious Diseases (NIAID) part of the National 

Institutes of Health (NIH), the Centers for 

Disease Control and Prevention (CDC) 

and the Biological Advanced Research and 

Development Authority (BARDA). CBMS 

actively engages in HHS MCM efforts and 

seeks partnerships where there is “unity 

of purpose” in requirements (capability), 

such as achieving FDA licensure, leveraging BioShield and Department of Defense 

(DoD) resources, as well as using the 

Economy Act to purchase systems through 

the Strategic National Stockpile.

 CBMS, in coordination with the JPEOCBD, is an active member on several 

HHS Requirements Working Groups and 

Planning Integrated Product Teams (IPT). 

Additionally, the DoD and HHS (through 

CBMS and BARDA, respectively) are key 

participants and stakeholders for the newly 

formed Integrated National Biodefense 

MCM Portfolio (INBDP). The vision of 

the INBDP is U.S. government-wide coordination of the research and development 

of CBRN MCM. CBMS and BARDA 

work closely to ensure the success of this 

initiative.
20 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

In addition to CBMS’ organizational 

level partnerships, its two subordinate Joint 

Product Management Offices, Joint Vaccine 

Acquisition Program (JVAP) and Medical Identification and Treatment Systems 

(MITS), have also forged strong partnerships in support of their respective mission 

areas.

CBMS-JVAP holds a membership on 

multiple HHS teams, including the Biological Working Group and the Overarching 

Product Development Tools IPT. This IPT 

is responsible for determining what tools 

are necessary to support chemical and 

biological MCM development; identifies 

current capabilities (assays, animal models, 

etc.); and makes recommendations to the 

Executive Committee on priorities for 

funding. The additional HHS IPTs on which 

CBMS-JVAP holds an active membership 

include the: Plague, Filovirus, rBV, AVA and 

Smallpox vaccine MCM IPTs. These partnering relationships are essential to ensure 

coordinated acquisition strategies between 

the DoD and HHS to meet both DoD and 

national CBRN MCM requirements.

Additionally, CBMS-JVAP has formal 

Interagency Agreements (IAAs) with the 

CDC/Strategic National Stockpile (SNS) 

for procurement and storage of the Anthrax 

Vaccine Adsorbed and Smallpox vaccine. 

CBMS-JVAP also has agreements in place 

with NIAID, supporting the development of 

a Plague vaccine.

The CBMS-Medical Identification and 

Treatment Systems (MITS) product team 

has active membership on multiple HHS 

IPTs as well including: the Chemical 

Requirements Working Group and IPT and 

the Radiological/Nuclear Working Group 

and IPT. 

CBMS-MITS has agreements in place 

with the NIH Division of Veterinary 

Resources for the purchase of Rhesus 

Macaques (Indian origin monkeys) in 

support of the Advanced Anticonvulsant 

System (AAS) nerve agent MCM, a CBMS 

program of record. CBMS-MITS partners 

with the National Institute of Neurological 

Disorders and Stroke (NINDS) for the cooperative exchange of information and materials in support of a New Drug Application 

(NDA) to the FDA under the AAS development project. NINDS’ is also conducting 

a clinical efficacy study on the active drug 

component in AAS for the treatment of nonnerve agent induced seizures. Additionally, 

the CBMS-MITS AAS program is working 

to establish an agreement with the CDC for 

exchange of information related to DoD’s 

AAS Phase 1 clinical study.

CBMS-MITS and BARDA participate on 

each other’s integrated product teams and 

source selection activities. CBMS-MITS is 

working with BARDA to develop an agreement for joint development efforts on the 

AAS; other nerve agent MCM include Inhalation Atropine, Bioscavenger, Improved 

Nerve Agent Treatment System and MCM 

against non-traditional agents, as well as 

Medical Radiation (MedRad) countermeasures, including radiation biodosimetry and 

treatments. 

International Partnerships

CBMS understands both the strategic and 

mutually beneficial value of leveraging the 

efforts of international partners as an additional resource in MCM development. As a 

result, the Joint Project Manager for CBMS 

serves as the U.S. head of delegation to the 

international Medical Countermeasures 

Working Group (MCWG). The Partnering 

Agreements negotiated under a Chemical, 

Biological and Radiological Memorandum 

of Understanding (MOU) have the potential 

to align technical and financial resources 

CBMS leverages the expertise of Congressional Special Interest Project partners to maintain cutting edge technologies that help to fill 

Warfighter capability gaps.
www.jpeocbd.osd.mil

JPEO-CBD

21

from multiple nations to address specific 

threats. These mutually beneficial Partnering 

Agreements provide opportunities for MCM 

interoperability at a very early stage, with the 

goal of product licensure under the auspices 

of the respective regulatory authorities in 

each country. With increased interest among 

other NATO partners and support from the 

Office of the Secretary of Defense (OSD) 

for the MCWG, other potential partners may 

step forward bringing additional expertise 

and resources to the table providing more 

innovative ideas for materiel development 

and manufacturing of CBRN MCM.

There are efforts under way to harmonize 

pharmaceutical regulatory requirements 

among several countries under the International Committee of Harmonisation (ICH). 

ICH participating countries are in the process of promulgating a universal pharmaceutical approval application format known 

as the Common Technical Document. NonICH countries have reciprocal regulatory 

approval processes which require multiple 

regulatory applications. Partnering Agreements offer an attractive alternative path 

to regulatory harmonization and facilitate 

MCM interoperability.

Congressional Special Interest Projects

In addition to its partnerships with interand intra-DoD organizations and allied 

countries, CBMS capitalizes on Congressional Special Interest Projects (CSIP) that 

support its current mission profile. CSIPs 

are not CBMS programs of record, rather, 

they are projects specially funded by 

Congress for CBRN MCM research and 

development studies. Before these projects 

become a part of the CBMS management 

portfolio via the CBMS Broad Agency 

Announcement, project proposals undergo 

a rigorous assessment process in which 

subject matter experts ensure alignment 

with CBMS’ mission goals resulting in a 

win/win for all involved. Partnerships with 

CSIP recipients allow CBMS to maintain 

a finger on the pulse of emerging technologies while providing mentoring and 

insight into the world of DoD acquisitions 

for the CSIP partners. For CBMS in particular, our benefits are seen through: 

• Leveraging unity of effort between 

CBMS and CSIP recipients 

• A vested mutual interest in seeing projects succeed

• Potential future use of the results of CSIP 

projects in funded programs of record

• Congressional project funding–CBMS 

directly benefits from funded projects 

that might not otherwise be available

• Leveraging and sharing invaluable 

expertise

• CBMS and CSIP recipients forming 

foundations for long-term benefit

• Broadening of the CBRN MCM industrial base

• Opportunities to work with academia.

Partnering activities are an integral part 

of how CBMS effectively and efficiently 

executes its CBRN MCM mission. 

Through the proactive and innovative 

use of partnerships with other DoD and 

U.S. Government Agencies, International partners and Congressional Special 

Interest Projects, CBMS has been able to 

forge strong mutually beneficial relationships with partners sharing a common 

focus–protection of the Warfighter. These 

relationships are “win-win” opportunities 

for all involved parties and help shape and 

support our collective pursuit of outfitting 

our fighting forces and the nation with 

safe, robust, affordable MCM against a 

broad spectrum of CBRN threats. 

CBMS leverages its partnerships with other Federal agencies, such as the Department of 

Health and Human Services, to rapidly provide the Warfighter with safe, robust, and affordable 

MCM against a broad spectrum of CBRN threats.

CBMS partners with other Federal agencies and organizations, academia, industry, and allied 

nations in the advanced development of CBRN MCM. Examples of such partnerships include 

membership on the International Medical Countermeasures Working Group (some pictured 

here) as well as the U.S. Army Institute of Chemical Defense.
22 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

member of the Joint Program 

Executive Office for Chemical 

and Biological Defense 

(JPEO-CBD) recently earned 

a coveted award for his 

contribution to the field of 

military medicine. 

Colonel David Williams, the Joint Project 

Manager for Chemical Biological Medical 

Systems (CBMS), Frederick, Maryland, was 

awarded the Joel M. Dalrymple Award by the 

Association of Military Surgeons of the United 

States (AMSUS), the Society of the Federal 

Health Agencies on Nov. 18, 2009, during 

the AMSUS annual conference in St. Louis, 

Missouri. 

The Dalrymple Award is given to an individual 

who made a significant contribution in the 

development of modern biological defense 

medical countermeasures. The award is named 

in honor of Dr. Joel M. Dalrymple who was a 

preeminent virologist and molecular biologist 

in the field of modern vaccine development. 

Throughout his career, Dalrymple played a 

major role in the success of multiple vaccine 

projects conducted at the Walter Reed Army 

Institute of Research, Washington, DC, and 

the U.S. Army Medical Institute for Infectious 

Diseases, Fort Detrick, Maryland.

Williams received this prestigious honor 

in recognition of his contributions to the 

Department of Defense (DoD) within the field 

Medical Countermeasures 

Development Nets Williams 

the Dalrymple Award

By Cicely Levingston, Executive Special 

Assistant and Legislative Specialist, CBMS
www.jpeocbd.osd.mil

JPEO-CBD

23

of Chemical, Biological, Radiological, and 

Nuclear Medical Countermeasure (CBRN 

MCM) advanced development.

“It is truly an honor to receive the Dalrymple 

Award,” Williams said. “It serves as a tangible 

symbol of the dedicated professionals, both 

military and civilian, who work hard each day 

to ensure our Soldiers, Sailors, Airmen, and 

Marines receive the best [chemical, biological, 

radiological, nuclear medical] countermeasures 

possible.”

Throughout the past 24 

years of his Army career, 

Williams established 

himself as a DoD leading 

expert in Clinical 

Informatics and DoD 

In its short seven year history, CBMS has 

achieved seven Food and Drug Administration 

(FDA) CBRN MCM approvals, licensures, 

and clearances (including one recent 

Emergency Use Authorization in support of 

H1N1 [swine flu] diagnostics); completed 15 

Investigational New Drug (IND) submissions 

to the FDA (including the first two electronic 

IND submissions by any DoD organization); 

completed 12 drug and safety trials, and 

developed two enabling technologies. Under 

the leadership of Williams, CBMS’ efficiency 

and effectiveness increased as evidenced by the 

development and delivery of over three million 

doses of vaccines and 292 diagnostic devices as 

well as reagents and additional CBRN MCM 

to our Warfighters, eight U.S. agencies, and 

eight foreign governments. The CBMS office 

has obtained unprecedented “win-win” 

agreements among divergent federal 

agencies and foreign governments. Now, 

DoD and the Department of Health and 

Human Services (HHS) work “as one” 

on four major efforts; and four nations 

collaborate more closely on acquisition 

burden sharing, saving millions of 

dollars and many years of effort. The 

CBMS partnerships with HHS and 

other government organizations are in 

direct support of the Integrated National 

Biodefense Medical Countermeasure 

Portfolio Initiative, an endeavor to integrate 

MCM efforts among federal agencies. 

In addition to partnering with other 

government agencies to accomplish their 

mission, COL Williams and his team must 

adhere to strict regulations to 

ensure they develop CBRN 

MCM that are both 

FDA-approved and costeffective.

Williams added, “The 

challenges of CBMS are 

unique within both the 

acquisition and medical 

communities. We must 

conform to DoD Acquisition 

regulations as well as 

FDA guidelines because 

everything we put in the 

field for Warfighters must 

be FDA approved.” 

The professionals within 

CBMS leverage DoD 

and industry best 

practices to uniquely 

tailor the Defense 

Acquisition System in 

support of the FDA’s 

stringent regulatory process. Under 

Williams’ leadership, the CBMS office has 

initiated numerous Lean Six Sigma projects 

for continuous process improvement 

opportunities, lifecycle bioinformatics 

initiatives to develop an enterprise-wide 

automated infrastructure, and a formalized 

Risk Management Process to identify, assess 

and mitigate development risks. Williams 

has promoted an aggressive, forward-leaning 

approach to product development that requires 

CBMS to work with partners worldwide 

and capitalize on the benefits of “unity-ofeffort” when there is “unity-of-purpose.” The 

CBMS has achieved unprecedented success 

under Williams’ leadership and continues 

to overcome the evolving challenges of 

pharmaceutical advanced development.

“The future of CBMS includes the development 

of novel countermeasures to fulfill Warfighter 

requirements as well as innovative ways 

to improve currently fielded products,” 

Williams said. Key future evolutionary 

acquisition increments, in the form of 

product improvements, are well under way 

at CBMS and will decrease program costs 

while increasing product performance, 

accountability, and visibility. 

Williams continues to lead a world class team 

of military, government civilian, and contract 

personnel in the advanced development of a 

diverse product line of CBRN MCM. Through 

the utilization of DoD and commercial best 

practices, CBMS expertly combines FDA 

regulations with DoD acquisition policies 

to rapidly provide CBRN MCM materiel 

solutions to our Warfighters, our nation, 

and the world.

Acquisition as well as a renowned authority 

in the development of CBRN MCM. He was 

selected in 2006 to serve as the Joint Project 

Manager of the CBMS, the DoD’s only CBRN 

MCM advanced development organization. 

One of eight Joint Project Management 

Offices within the JPEO-CBD, CBMS is 

comprised of two subordinate offices: the 

Joint Vaccine Acquisition Program (CBMSJVAP) and the Medical Identification and 

Treatment Systems (CBMS-MITS) Product 

Management Offices. 

The CBMS was established in 2002 and 

chartered in 2003 to provide the Warfighter 

with safe, effective MCM against a broad 

spectrum of CBRN threats. As such, CBMS 

has developed and delivered CBRN MCM 

that span the continuum of medical care from 

prevention and diagnosis to treatment. 
24 CBMS Special Edition 2010

Chem-Bio Defense Quarterly

he Department of the Army Office 

of The Surgeon General received 

notification that the Food and Drug 

Administration (FDA) has granted the 

Chemical Biological Medical Systems 

(CBMS) Joint Project Management 

Office’s request for Emergency Use 

Authorization (EUA) of the CDC swH1N1 

(swine) Influenza Virus Real-time RT-PCR 

Detection Panel on the CBMS developed Joint 

Biological Agent Identification and Diagnostic 

System (JBAIDS). This EUA was submitted 

following discussions between the Centers for 

Disease Control and Prevention (CDC) and the 

Armed Forces Health Surveillance Center Division 

of Global Emerging Infections Surveillance 

and Response System (AFHSC-GEIS). The 

Department of Defense (DoD) received this 

authorization less than 90 Days after testing was 

initiated. 

The EUA was a collaborative 

effort among CBMS, AFHSC/GEIS and several 

other agencies including the U.S. Army Medical 

Research and Materiel Command and its 

subordinate units: the U.S. Army Medical 

Research Institute of Infectious Diseases, the U.S. 

Army Medical Materiel Development Activity; 

the U.S. Army 44th Medical Command and its 

subordinate unit, the 9th Area Medical Laboratory; 

the U.S. Army Medical Department Center and 

School; Tripler Army Medical Center; the Navy 

Medical Research Command and its subordinate 

units: the Naval Health Research Center and the 

Naval Medical Research Unit 3; the CDC; the 

University of Utah; the Utah State Public Health 

Laboratory; and the University of Nebraska 

Medical Center. Each brought their distinctive 

talents and all were instrumental 

in accomplishing a common goal 

of developing a solution to aid in 

the diagnosis of the 2009 H1N1 

influenza virus for service members 

across the globe, especially those in 

deployed settings such as Iraq and 

Afghanistan. This authorization is a 

reflection of the dedication of many 

working together for a common goal 

– protecting the Warfighter and the 

Nation.

The JBAIDS is a dual-use, ruggedized 

system for rapid identification 

of biological threat agents in 

environmental surveillance samples, 

and for diagnostic confirmation of 

biological agent exposure or infection in 

clinical samples. Based on commercial 

polymerase chain reaction technology, 

the JBAIDS is man-portable, reusable, and 

capable of the simultaneous identification 

of multiple Biological Warfare and 

infectious disease agents of operational 

concern. The JBAIDS consists of 

the hardware platform to perform 

sample analysis, a laptop computer 

for readout display, and assay reagent 

test kits. The JBAIDS is the first DoD 

Biological Warfare detection device 

previously-cleared for the detection 

of several biothreat agents by the FDA for 

medical diagnostic use.

An EUA gives authority under a 

declaration of emergency to use 

unapproved medical products or 

unapproved uses of approved medical 

products until the declaration of 

the emergency is terminated or the 

authorization is revoked by the FDA. 

This EUA allows the CBMS, in 

coordination with the CDC and the 

AFHSC/GEIS, to distribute the CDC 

swH1N1 (swine) Influenza Virus Realtime RT-PCR Detection Panel to qualified DoD 

laboratories that have the required equipment and 

the personnel trained on the JBAIDS to perform 

and interpret the results. As a result of the EUA, 

Services’ Medical Specialists are now more able to 

rapidly diagnose the new H1N1 influenza strain, 

and start effective treatments.

The DoD deployed the CDC swH1N1 (swine) 

FDA Authorizes 

Emergency 

Use of the CDC 

swH1N1 Swine

Influenza Virus 

Real-time RT-PCR Detection 

Panel on the Joint Biological 

Agent Identification and 

Diagnostic System

By Jennifer McLaughlin, JBAIDS Systems 

Manager, CBMS

Influenza Virus Real-time RT-PCR Detection 

Panel on the JBAIDS to combat units in the 

Middle East and Navy ships. Initial deliveries 

occured in September 2009. Additionally, 

AFHSC/GEIS is funding CBMS efforts to develop 

a CDC H5N1 Avian influenza diagnostic kit for 

use on the JBAIDS. Submission of this panel to 

the FDA is expected in early 2010.

Detrick, Army Make Plague 

Vaccine with Britain, Canada

“Excerpt from a Frederick News Post article 

by Megan Eckstein” 

group of Fort Detrick researchers 

recently found out their 15-plus 

years of work to combat the 

plague would be the focus of a 

multinational effort to mass produce 

a vaccine.

In 1993, Lt. Col. David Heath, a staff scientist for 

the Military Infectious Disease Research Program 

at Fort Detrick, began researching an innovative 

way of combining the existing vaccine for the 

bubonic plague (an infection in the lymph nodes) 

with a new kind of protection from the pneumonic 

plague, which attacks the lungs.

A group of British scientists were racing with the 

Fort Detrick group to produce a vaccine for the 

pneumonic plague, which many scientists think 

could be used in a bioterrorism attack.
While the British had created two separate 

proteins to put in their vaccine, one for each type 

of plague infection, Heath had the idea to link the 

two proteins together in a single strand of DNA.

“It’s all just one big gene now, where it used to 

be two,” which makes the vaccine easier and 

cheaper to manufacture, said Heath, who at the 

time worked for the U.S. Army Medical Research 

Institute of Infectious Diseases.

In 2000, the United States began working with 

Britain and Canada to share information about 

the plague vaccine. In 2005, the three countries 

agreed to pool their resources to create a vaccine 

to be mass-produced, though they were still 

considering working with the British formula. In 

the latest agreement, the three countries agreed to 

use USAMRIID’s fusion protein as the basis of the 

vaccine.

“We’ve been collaborating at the same time we’ve 

been competing, so for many years we’ve shared 

information, we’ve had joint meetings, because 

we all are after the same goal,” said Patricia 

Worsham, USAMRIID’s chief of bacteriology.

Though the formula is unlikely to change, aside 

from tinkering to find the best human dosage, 

Worsham said it can only help to have three 

countries’ scientists collaborating on vaccine 

production. “Their perspectives are sometimes 

a little different, and I think it gives us a greater 

wealth of information to be able to share 

not only data but ideas between the teams,” 

Worsham said.

Under the agreement, Britain and Canada will 

contribute money and technical expertise 

to the United States, which will act as lead 

developer, said Julius Evans, spokesman 

for the Joint Program Executive Office for 

Chemical and Biological Defense. The end product 

will be a set of instructions for making and 

administering the vaccines, which each country 

will be able to license through its own regulatory 

agency.

Evans said the three countries all have the same 

goal of protecting their armed forces 

against possible biological attacks. 

The U.S. and Canada agreed in 

2002 to work together on a 

smallpox vaccine, he said, and 

other possible partnerships are 

being discussed.

The Army hopes to have the 

vaccine approved by the U.S. 

Food and Drug Administration 

by 2015. Already completed 

early human clinical trials indicate 

the vaccine is safe and does provide 

immunity to the plague bacteria, called 

Yersinia pestis.

The Chemical Biological 

Medical Systems Scores for 

Frederick Community

By Cicely Levingston, Executive Special 

Assistant and Legislative Specialist, 

CBMS

he Chemical Biological 

Medical Systems (CBMS) 

Joint Project Management 

Office partnered with 

the Marine Toys for Tots 

Foundation in support 

of the 2009 Toys for Tots 

Program and local campaign to aid 

children within the Frederick community.

The Toys for Tots Program is a U.S. Marine Corps 

Reserve initiative to collect new, unwrapped 

toys during October, November, and December 

each year and distribute them as holiday gifts 

to less fortunate children. The Toys for Tots 

program began in 1947 and aims to play an active 

role in the development of our nation’s children 

while uniting all members of local communities 

in a common cause and contributing to better 

communities in the future. 

This marks the seventh consecutive year CBMS 

has worked in partnership with the Marine Toys 

for Tots Foundation. Employees of CBMS and 

their families collected over 150 toys this holiday 

season and have collected over 1,100 toys for 

children in the Frederick community since 2002.

Geraldine Morrow, the CBMS 2009 Toys for 

Tots Campaign Coordinator, arranged an array 

of activities within CBMS throughout the three 

month campaign to raise donations in support 

of the worthy cause. “Our group here at CBMS 

has really gotten into the spirit of giving this 

year,” noted Morrow. “With the help of the Staff 

Activities Committee, we have put on several 

theme-based potluck lunches, a Halloween party, 

and even implemented a ‘Toys for Tots Jeans 

Day,’ wherein a donation of a toy or monetary 

contribution was made in exchange for the 

approval to wear jeans to work on designated 

casual Fridays.” 

Morrow also added, “All of these events have 

been on a volunteer basis and designed to 

increase awareness in the Toys for Tots 

Program, while concurrently raising toy and 

monetary donations for this very worthy 

cause. We are thrilled with the results 

we’ve achieved and honored to play a role 

in contributing to the happiness of children 

in need.”

Over the 62 years of the U.S. Marine Corps 

Reserve Toys for Tots Program, Marines have 

distributed more than 400 million toys to over 

200 million less fortunate children. The Toys for 

Tots program is a national effort administered 

locally 

with a key promise 

to the community: the community in 

which toys are collected is the same community in 

which toys are delivered. As such, the success of 

the program in each community relies on volunteer 

support and community involvement.

“The Toys for Tots Foundation is a tremendous 

organization that helps local children and families 

in need,” said Colonel David Williams, Joint Project 

Manager for CBMS. “This organization is part 

of the Frederick community, and we’re proud to 

support the annual toy drive. We also encourage all 

of our Frederick friends and neighbors to purchase 

just one extra gift this holiday season to help a 

family in need. You can make a difference.” 

The CBMS is a Fort Detrick tenant organization 

and one of eight Joint Program Offices within the 

Joint Program Executive Office for Chemical and 

Biological Defense located in Falls Church, Va. 

Established in 2002, CBMS develops and delivers 

safe, effective medical countermeasures against a 

broad spectrum of chemical, biological, radiological, 

and nuclear threats for our nation’s Warfighters.

www.jpeocbd.osd.mil 25

JPEO-CBD
26 CBMS Special Edition 2009

Chem-Bio Defense Quarterly
www.jpeocbd.osd.mil

JPEO-CBD

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28 CBMS Special Edition 2010

Chem-Bio Defense Quarterly