Chem-Bio Defense Quarterly - hsdl.org

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)

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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 McCormickUSA

Col. Brett BarracloughUSA

Mr. Will HartzellUSMC

Mr. Scott WhiteUSN

Col. David WilliamsUSA

Mr. Rudolf OlszykUSMC

Mr. Michael AbaieUSN

Col. Alan BurketUSAF



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 WilliamsJoint 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

[email protected]

Editor, Chem-Bio Defense Magazine

Mr. Julius L. Evans [email protected]

Contractor Support Provided by Kalman & Co., Inc. and Camber Corporation

Mr. Steven Lusher Senior Graphic Designer

[email protected]

Contractor Support Provided by Goldbelt Raven, LLC

Ms.Cicely Levingston Guest Editor

[email protected]

Ms. Lisa Calloway Senior Graphic Designer

[email protected]

Mr. Scott Brown Senior Graphic Designer

[email protected]

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: [email protected]

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

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The Joint Project Management Office (JPMO) Chemical Bio-logical Medical Systems (CBMS)

rapidly provides the Warfighter with safe, robust, and affordable medical countermeasures (MCM) against a broad spectrum of Chemical, Biological, Radio-logical, 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 com-posed of two subordinate organizations: the Joint Vaccine Acquisition Program (CBMS-JVAP) and the Medical Identifi-cation and Treatment Systems (CBMS-MITS) Product Management Offices. Together, these product offices deliver CBRN MCM spanning the continuum of

medical care from prevention and diagno-sis to treatment.

The advanced development of CBRN vaccines and drugs starts with the iden-tification of Warfighter requirements and capability gaps identified through the use of the needs-driven Joint Capabili-ties Integration and Development System (JCIDS). Based on the capability gaps identified by JCIDS, the Joint Require-ments Office (JRO) documents these requirements. This includes identifying promising technologies within the DoD’s Joint Science and Technology Office, academia, industry and other federal agen-cies. 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 developmen-tal 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 Manufac-turing Readiness Levels as well. This

Cicely Levingston, Executive Special Assistant/ Legislative Specialist, CBMSCol. 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 FDA-approved CBRN MCM.



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 associ-ated with medical product development and the challenges unique to the develop-ment and manufacturing of vaccines and drugs. Despite these challenges, CBMS exceeds industry standard metrics by exploring ways to shorten our develop-ment 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 gov-ernments, 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. Addi-tionally, CBMS has been able to structure itself so that all supporting functional areas are collocated. CBMS enjoys full-time, on-site support from a team of con-tracting 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 FDA-licensed 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. CBMS-JVAP, 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.

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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 exper-tise in animal model and assay develop-ment 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 vac-cines, the ability to sustain combat power would rely solely on physical protection, detection of agents, a long medical logis-tics 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. Lever-aging these practices accelerates sched-ules and minimizes risk. Additionally, CBMS-JVAP partners with other U.S. agencies and allied governments in prod-uct 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 sys-tems of FDA approved drugs and devices to protect Warfighters and the nation from CBRN threats. In so doing, three individ-ual 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 technolo-gies in its 8-year history.



U.S. Army Medical Materiel Devel-opment Activity (USAMMDA) of the U.S. Army Medical Research and Materiel Command (USAMRMC)

• The Joint Biological Agent Identifica-tion 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 chal-lenge in rapidly providing the Warfighter and the nation with robust, affordable, FDA-approved, life-saving CBRN MCM drug and diagnostic system capabili-ties. 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 FDA-approved fielded CBRN MCM products to include:

• Joint Biological Agent Identification and Diagnostic System (JBAIDS)

integrated system for detection, rapid identification, and diagnostic confirma-tion of biological agents

• Convulsant Antidote for Nerve Agents (CANA) for the treatment of nerve agent-induced seizures

• Antidote Treatment Nerve Agent Auto-injector (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 treat-ments. 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 pro-phylactic 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 develop-mental effort conducted in partnership with HHS, is anticipated to replace the currently fielded CANA. The INATS, which will protect against a broad spec-trum 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 al-lied governments. Here, Brigadier General Jess Scarbrough (Center), Joint Program Executive Officer for Chemical and Biologi-cal Defense, and members of CBMS visit a vaccine manufacturing facility in Frederick, MD.

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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 prod-ucts to treat the acute radiation syndrome resulting from radiological or nuclear events. CBMS-MITS bases its system of systems approach on three pillars: preven-tion, 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 tech-nology integration and cost in the develop-ment 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 environ-mental 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, front-line 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 MCMCBMS 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-of-effort” 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 continu-ously 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 temper-ature sensitive product units that experi-ence 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 inclu-sion 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 temperature-

controlled supply chain, requirements; thereby, resulting in decreased logisti-cal 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 deliv-ery technologies that will provide alter-natives 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 emerg-ing 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.



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, radiologi-cal 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 pos-

session 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 opera-tional use guidance for these products, resulting in the disposal of CBRN MCM that were still safe and effective. For example, the Soman Nerve Agent Pretreat-ment 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 indi-vidual 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 Organi-zation (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-dam-aged 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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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 qual-ity at the basis of issue level. This infor-mation 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 technol-ogy 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, mini-mizing logistics and increasing outreach capabilities

• Better manage vaccine stocks by determining which vials have expe-rienced 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 ship-ment 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.



ink that irreversibly darkens over time due to temperature exposure. The rate of chemical reaction, or polymerization, can be predicted by the Arrhenius equa-tion. 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 Time-Temperature Indicators. This guide states that visually readable indicators should

reach end point before the product shelf life at all temperatures within the reason-able and abusive storage ranges. CBMS-MITS’ 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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Operational life guidance for products with a TTI will be based on validation testing that determines CBRN MCM con-dition 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 Man-ager 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 Decon-tamination Lotion (RSDL). This Evolution-ary 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 vali-dation. 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 Develop-ment phase and is planning the product stability studies necessary to select an appropriate TTI. Other CBMS-MITS programs, the Improved Nerve Agent Treat-ment System (INATS), Medical Radiation Countermeasure (MRC), and Bioscavenger, are in the Technology Development phase and will also include TTI in their acquisi-tion plans. CBMS-MITS is also investi-gating the use of TTI on legacy products such as Soman Nerve Agent Pretreatment Pyridostigmine (SNAPP) and the Anti-dote Treatment Nerve Agent Autoinjector (ATNAA) countermeasure.

The use of TTI will result in signifi-cant cost savings to the DoD by retaining

product exposed to unknown environ-mental 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 envi-ronmental conditions and alert the Warf-ighter of the need for a replacement. The TTI will provide to Warfighters the assur-ance 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 Indi-cator Labels: A Cost Effective Approach to Monitoring the Quality of Rations www.ssc.army.mil/about/pao/pubs/war-rior/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.



A True CBMS Ace

A Discussion

with

Dr. Ronald Clawson…

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

A Discussion

with

Dr. Ronald Clawson…

Dr. Ronald Clawson served as the Deputy Joint Project Manager for the Chemical Biological Medical

Systems (CBMS) Joint Project Manage-ment Office located in Frederick, Mary-land. 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 Bio-logical Radiological and Nuclear (CBRN) Defense systems. Dr. Clawson collaborated with joint service, interagency, international teams of scientists and acquisition profes-sionals in the development, acquisition and fielding of Food and Drug Administration-approved 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 Univer-

sity 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 Pharma-ceutical 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 USAM-MDA, Dr. Clawson led the charge to obtain

FDA approval for seven products.Following his 19-year career at USAM-

RMC, 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 develop-ment. 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.



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 Warf-ighters 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 comple-tion of my undergraduate degree, I didn’t quite know exactly how I wanted to apply my education. Fortunately, I completed ROTC and was commis-sioned as a second lieutenant and com-pleted 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. Addition-ally, 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 fasci-nated 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 experi-ence 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.

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6. What influenced your decision to remain in this career field and sup-port 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 daugh-ter 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 experi-ence while working within CBMS?I have enjoyed seeing the organiza-tion grow and be a part of the series

of events that have pushed us forward and made us who we are today: a suc-cessful 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 War-fighter that no other organization can?CBMS has the expertise in FDA and DoD acquisition regulations and the scientific expertise like no other orga-nization within the DoD or the country. We are able to come together to provide the Warfighter FDA approved medical countermeasures for improving surviv-ability and sustainability on the battle-field.

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 com-munity need to be on a war standing and continue to provide our Warfight-ers 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 pre-pared 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.



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 for-malize a process for ensuring requirements, technical base and advanced development activities for CBRN MCM are coordinated to meet Warfighter requirements in a cost-

effective and timely manner. Additionally, CBMS established a CBRN integrated advanced development tiger team con-sisting 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 clari-fication 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), demon-stration 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 organi-zations:

• United States Army Medical Research and Materiel Command (USAM-RMC): 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 Announce-ment proposal reviews and provides programmatic, regulatory, contracting, legal and technical support.

• Global Emerging Infections Surveil-lance 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, CBMSCicely Levingston, Executive Special Assistant / Legislative Specialist, CBMSChip Wynn, Senior Acquisition Analyst, CBMSLt. Col. Brian Gentile, Joint Product Manager, MITS, CBMS-MITSLt. Col. Philip Smith, Joint Product Manager, JVAP, CBMS-JVAP

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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) applica-tions 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 Depart-ment of Health and Human Services (HHS) and its subordinate organizations including: the National Institute for Allergy and Infec-tious 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, leverag-ing 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 JPEO-CBD, 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 coor-dination of the research and development of CBRN MCM. CBMS and BARDA work closely to ensure the success of this initiative.



In addition to CBMS’ organizational level partnerships, its two subordinate Joint Product Management Offices, Joint Vaccine Acquisition Program (JVAP) and Medi-cal Identification and Treatment Systems (MITS), have also forged strong partner-ships in support of their respective mission areas.

CBMS-JVAP holds a membership on multiple HHS teams, including the Biologi-cal 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 part-nering 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 coop-erative exchange of information and materi-als in support of a New Drug Application (NDA) to the FDA under the AAS develop-ment project. NINDS’ is also conducting a clinical efficacy study on the active drug component in AAS for the treatment of non-nerve 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 agree-ment for joint development efforts on the AAS; other nerve agent MCM include Inha-lation Atropine, Bioscavenger, Improved Nerve Agent Treatment System and MCM against non-traditional agents, as well as Medical Radiation (MedRad) countermea-sures, including radiation biodosimetry and treatments.

International PartnershipsCBMS understands both the strategic and

mutually beneficial value of leveraging the efforts of international partners as an addi-tional 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.

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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 Interna-tional Committee of Harmonisation (ICH). ICH participating countries are in the pro-cess of promulgating a universal pharma-ceutical approval application format known as the Common Technical Document. Non-ICH countries have reciprocal regulatory approval processes which require multiple regulatory applications. Partnering Agree-ments offer an attractive alternative path to regulatory harmonization and facilitate MCM interoperability.

Congressional Special Interest ProjectsIn addition to its partnerships with inter-

and intra-DoD organizations and allied countries, CBMS capitalizes on Congres-sional 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 tech-nologies while providing mentoring and insight into the world of DoD acquisitions for the CSIP partners. For CBMS in par-ticular, our benefits are seen through:

• Leveraging unity of effort between CBMS and CSIP recipients

• A vested mutual interest in seeing proj-ects 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 indus-trial 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, Interna-tional partners and Congressional Special Interest Projects, CBMS has been able to forge strong mutually beneficial relation-ships 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.



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 AwardBy Cicely Levingston, Executive Special Assistant and Legislative Specialist, CBMS

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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 cost-

effective.

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-of-effort” 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 (CBMS-JVAP) 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.



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 Real-time 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 SystemBy 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 CommunityBy 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.

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Documents

Chem-Bio Defense Quarterly - hsdl.org