U.S. Department of Health and Human Services | Assistant Secretary for Preparedness and Response 

Biomedical Advanced Research and Development Authority 
Inside front cover
 

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BARDA Strategic Plan 2011-2016
 

Contents 

Message from the Director .............................................................................................................3
 

Introduction ...................................................................................................................................4
 

Vision, Mission and Values .............................................................................................................7
 

Guiding Principles...........................................................................................................................8
 

Goals and Strategies...................................................................................................................... 11
 

Goal 1: An advanced development pipeline replete with medical countermeasures and 


platforms to address unmet public health needs, emphasizing innovation, flexibility, multipurpose and broad spectrum application, and long-term sustainability ..............................11
 

Goal 2: A capability base to provide enabling core services to medical 


countermeasure innovators ...............................................................................................12
 

Goal 3: Agile, robust and sustainable U.S. manufacturing infrastructure capable 


of rapidly producing vaccines and other biologics against pandemic influenza 


and other emerging threats ...............................................................................................13
 

Goal 4: Responsive and nimble programs and capabilities to address novel and 


emerging threats ...............................................................................................................14
 

Goal 5: A ready capability to develop, manufacture and facilitate distribution of 


medical countermeasures during public health emergencies..............................................15
 
2 BARDA Strategic Plan 2011-2016 
Message from the BARDA Director
 

Dear Colleagues, 

The nation has endeavored over the past ten years to become better prepared for the medical consequences of 

catastrophic events such as bioterrorist events and pandemic influenza. During that time period Project BioShield, 

The National Strategy for Pandemic Influenza, and the Biomedical Advanced Research and Development 

Authority have emerged to support the development and acquisition of medical countermeasures (MCMs) and 

the domestic manufacturing capacity to prepare for and respond to an emergency. Where very limited medical 

countermeasures were available in 2001, there are now vaccines, therapeutic drugs, and diagnostic devices 

for anthrax, smallpox, botulism, and pandemic influenza and a robust pipeline of products in development 

for these and other threats. While only one manufacturing site existed in the U.S. during the influenza vaccine 

shortage of 2004, now there are three with more on the way. Yet there is much more work to be done, and a 

clear path is needed to guide the way. 

Thus I am pleased to provide an update of the BARDA Strategic Plan for 2011-2016. The Plan describes our 

strategic goals and vision to accomplish BARDA’s mission over the next five years and beyond to develop and 

provide medical countermeasures for Chemical, Biological, Radiological, and Nuclear threats, pandemic influenza, and emerging infectious diseases. The implementation measures to achieve these strategic goals include 

support of product advanced development, stockpile acquisition, manufacturing surge capacity infrastructure 

building, and product innovation. These medical countermeasures include vaccines, biological and small molecule therapeutics, antiviral drugs and antibiotics, diagnostics, respiratory devices, and other medical supplies. 

As BARDA completes its fifth year of existence, the results of our advanced development support are becoming 

evident with a robust product development pipeline for nearly all threats. Many of these products in the development pipeline will become mature enough for acquisition and regulatory review over the next five years. 

Initiatives recommended by the 2010 Public Health Emergency Medical Countermeasure Enterprise Review 

are expected to enable more of the MCM products to become available as FDA-licensed approved or cleared 

products. BARDA will lead several of these initiatives including the establishment of Centers for Innovation 

in Advanced Development and Manufacturing and the Medical Countermeasures Strategic Investor. Greater 

emphasis on multi-purpose MCMs and more flexible and innovative manufacturing technologies will make improved and greater quantities of MCMs available sooner. MCMs and manufacturing capabilities that afford the 

nation the ability to respond immediately to known and unknown threats will be high priorities. 

The BARDA Strategic Plan is a dynamic process with the steadfast aim to enhance national MCM preparedness 

and the flexibility to adopt better technologies, meet unforeseen challenges, and avoid unnecessary risks. MCM 

preparedness and response and this Plan are the results of the dedicated professionals at BARDA, ASPR, and 

across federal, State, local, and industry sectors. I wish to thank them for their tireless efforts to ensure that ours 

is “a nation prepared.” 

Respectfully, 

Robin A. Robinson, Ph.D., Director 

BARDA Strategic Plan 2011-2016 3 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Introduction
 

WITHIN THE LAST TEN YEARS, THE UNITED STATES HAS 

experienced an intentional attack with a biological 

agent in the form of the anthrax letters as well as naturally emerging outbreaks of high-consequence infectious diseases, including pandemic influenza and SARS. 

These events represented national security threats and 

public health emergencies. The past decade has also 

witnessed the dramatic spread of antimicrobial resistance and community outbreaks of multidrug-resistant 

bacteria that had previously been confined to hospitals. 

Concerns persist about the potential use of chemical, 

biological, radiological and nuclear agents by terrorists. 

Effective medical countermeasures such as vaccines, 

antimicrobials, therapeutics, and diagnostics have the 

potential to reduce the impact of such threats and are 

a bulwark of our national defense and public health 

emergency preparedness. 

The mission of the Biomedical Advanced Research 

and Development Authority (BARDA) is to develop 

and procure medical countermeasures that address the 

public health and medical consequences of chemical, 

biological, radiological, and nuclear (CBRN) accidents, 

incidents and attacks, pandemic influenza, and emerging infectious diseases. 

Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other 

products that are considered priorities for national 

health security. BARDA funding bridges the “valley of 

death” characterizing the late stages of product development. BARDA’s support ensures continuity of funding at a critical point for medical countermeasures 

developed by industry or emerging from the basic 

research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of 

the Centers for Disease Control and Prevention (CDC) 

to organize an effective response. 

BARDA is a core component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) 

and as such contributes to the broader ASPR mission to 

“Lead the country in preparing for, responding to, and 

recovering from the adverse health effects of emergencies and disasters by supporting our communities’ 

ability to withstand adversity, strengthening our health 

and response systems, and enhancing national health 

security.”1 

The first BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

(Draft) was published in July 2007. The specific goals 

of the 2007 Plan included aligning and coordinating 

BARDA goals and programs with key pandemic influenza and CBRN strategy documents; developing an 

HHS Public Health Emergency Medical Countermeasure Enterprise CBRN implementation plan; and establishing programs that promote innovation in MCM 

development. 

The 2011 BARDA Strategic Plan builds on BARDA’s 

successes in achieving those goals, defines BARDA’s 

vision, and lays out a series of capability goals over 

the next five years (2011-2016). This Plan reflects the 

dynamic evolution of BARDA’s mission and responsibilities, since its establishment in early 2007 and is 

informed by the National Health Security Strategy 

(NHSS; December 2009)2

, The Public Health Emergency Medical Countermeasures Enterprise Review: 

Transforming the Enterprise to Meet Long-Range National Needs (PHEMCE Review; August 2010)3

, and the 

many lessons learned from the 2009 H1N1 pandemic 

influenza response. 

1 HHS Assistant Secretary for Preparedness and Response Strategic 

Plan 2011-2015. http://www.phe.gov/about/aspr/strategic-plan/ 

Pages/default.aspx 

2 National Health Security Strategy of the United States of America. 

U.S. Department of Health and Human Services. 2009. http:// 

www.phe.gov/Preparedness/planning/authority/nhss/strategy/ 

Documents/nhss-final.pdf 

3

The Public Health Emergency Medical Countermeasures Enterprise 

Review: Transforming the Enterprise to Meet Long-Range National 

Needs. U.S. Department of Health and Human Services. 2010. 

https://www.medicalcountermeasures.gov/documents/ 

MCMReviewFinalcover-508.pdf 

4 BARDA Strategic Plan 2011-2016 
 

 

Who We Are And WhAt We do 

The Biomedical Advanced Research and Development Authority is the component of the Public Health 

Emergency Medical Countermeasures Enterprise that 

focuses on the advanced development, manufacturing 

and acquisition of medical countermeasures against 

chemical, biological, radiological and nuclear (CBRN) 

threats, pandemic influenza, and emerging infectious 

diseases. BARDA’s staff includes experts in the fields of 

physical, chemical and biological sciences, engineering, clinical medicine, public health, product development, regulatory affairs, and program management. 

The Pandemic and All-Hazards Preparedness Act 

(PAHPA) established BARDA in December 2006. 

BARDA oversees the Project BioShield program and 

Special Reserve Fund and is charged by statute with 

(1) promoting collaboration and communication between the U.S. Government and interested parties in 

the advanced development and licensure of needed 

medical countermeasures; (2) directing and coordinating the countermeasure and product advanced 

research and development activities of the U.S. Department of Health and Human Services (HHS); (3) 

facilitating medical countermeasure development by 

providing advice or directing interested parties to the 

relevant Centers of the U.S. Food and Drug Administration (FDA); and (4) supporting innovation through 

strategic initiatives and investment in technologies 

and research tools that facilitate countermeasure development. 

PAHPA established a dual mandate for BARDA. BARDA is charged with coordinating the development of, 

and bridging the “valley of death” for, MCMs determined to be critical to the Nation’s health security. 

It is important to note that many such MCMs lack 

meaningful commercial markets and without U.S. 

Government support would be unlikely candidates 

for development. In supporting their development, 

BARDA fills the gap between NIH, which supports 

basic and preclinical research, and CDC, which develops utilization plans and deploys MCMs during 

public health emergencies. BARDA fulfills its mission 

by supporting advanced research and development 

of needed medical countermeasures; working in collaboration with manufacturers, the NIH, the CDC, 

the FDA, and the Departments of Defense (DoD) and 

Homeland Security (DHS); supporting technology innovation through strategic initiatives; and overseeing 

Project BioShield acquisitions. 

BARDA is comprised currently of the Office of the Director and seven functional divisions that oversee BARDA’s programmatic activities. These divisions include 

 Division of Chemical, Biological, Radiological 

and Nuclear (CBRN) Countermeasures 

 Division of Influenza 

 Division of Strategic Science and Technology 

 Division of Manufacturing, Facilities and 

Engineering 

 Division of Regulatory and Quality Affairs 

 Division of Clinical Studies 

 Division of Modeling 

Additionally, to address issues relating to countermeasure development that cut across divisional boundaries, BARDA operates collaboratively in “matrix teams” 

in the areas of vaccines, biological therapeutics, small 

molecule therapeutics, and diagnostics. These matrix 

teams help knit the BARDA organization together and 

facilitate sharing of information and best practices. 

BArdA’s Future 

BARDA is committed to improving its workforce, increasing the expertise and skills of BARDA personnel, 

and helping to prepare the pharmaceutical industry 

to meet the challenges of the 21st Century. The investment BARDA makes now in developing needed 

infrastructure, capabilities, processes, and human 

resources will pay off in the long run by enhancing 

national preparedness to meet the public health threats 

of the future. 

Continually looking forward, scanning the horizon for 

new technologies, and striving to develop a fast, flexible 

and efficient armamentarium of medical countermeasure capabilities and products will be key contributing factors to BARDA’s success in addressing medical 

countermeasure requirements for the nation. BARDA 

BARDA Strategic Plan 2011-2016 5 
will address these current and evolving requirements, 

aggressively seek out and support promising technology and platforms, and facilitate collaboration across 

HHS and other Federal Departments and agencies 

participating in medical countermeasure research 

and development while striving continually for greater overall transparency. 

Context oF the BArdA 

strAtegiC PlAn 

The BARDA strategic plan is guided by the priorities of the Administration and of ASPR and BARDA 

leadership, and by other guidance including the U.S. 

Department of Health and Human Services Strategic 

Plan, governing legislation, Presidential Policy Directives, the 2009 NHSS, the 2010 PHEMCE Review, and 

the 2011 HHS Assistant Secretary for Preparedness 

and Response Strategic Plan 2011-2015 (ASPR Strategic Plan). The NHSS establishes a framework for national efforts, to promote health security and encompasses BARDA’s mission. National health security is a 

state in which the nation and its people are prepared 

for, protected from and resilient in the face of health 

threats or incidents with potentially negative health 

consequences. All elements of this strategic plan align 

with and support the BARDA role in contributing to 

national health security under the NHSS and, as specified in PAHPA, the BARDA Strategic Plan is considered to be incorporated as part of the NHSS. 

orgAnizAtion oF this PlAn 

This strategic plan sets the direction for BARDA over 

the next five years. Five strategic goals define the 

highest level aims of BARDA, each one is supported 

by strategies for accomplishing that goal. These goals 

are interrelated and derive from the mission outlined 

in the PHEMCE Review that “Our nation must have 

the nimble, flexible capacity to produce medical 

countermeasures rapidly in the face of any attack or 

threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging 

infectious disease.” 

A number of themes cut across one or more of the 

strategic goals. Cultivating public-private partnerships, 

for example, is a critical element in almost every aspect of BARDA’s work. Developing tools and processes to facilitate systematic portfolio management 

and program and project evaluation is an important 

priority for BARDA, given BARDA’s broad mandate 

and foreseeable budgetary constraints. In pursuing its 

mandate to develop medical countermeasures to protect civilian populations, BARDA must also address 

the needs of vulnerable populations such as children, pregnant women, persons with compromised 

immune systems, and the elderly. These and other 

cross-cutting issues have been considered as each 

one of the five strategic goals was developed and are 

reflected in the guiding principles. 

iMPleMentAtion 

BARDA will implement this strategic plan with full involvement of its leadership and a firm commitment 

to turning strategy into action, tracking progress, and 

correcting course when needed. The strategic plan 

maps out a broad five-year strategic direction. More 

detailed actions for accomplishing the goals and strategies as well performance measures and milestones 

will be developed and annually reviewed by BARDA staff and leadership. All BARDA employees are 

critical to the organization’s success, and should see 

themselves and their work directly in one or more of 

the goals and strategies. BARDA divisions and program teams may develop even more granular action 

plans, and budgets will be formulated and executed 

in line with strategic priorities. 

Like the HHS and ASPR strategic plans, the BARDA 

strategic plan will be published online and updated 

periodically to reflect evolving activities and progress 

toward goals. BARDA’s partners and the public will 

be able to see the latest information on priorities and 

accomplishments, reinforcing the plan’s purpose as 

an evolving, living tool for guiding decision making 

and action. 

6 BARDA Strategic Plan 2011-2016 
 

 

 

 

 

BARDA’S Vision, Mission, and Values
 

BARDA’S OVERARCHING VISION IS OF A NATION WITH 

the capability to respond quickly and effectively to 

deliberate, natural, and emerging threats so as to 

minimize their impact and recover promptly. A critical enabling factor for the realization of this vision 

is the existence of a robust domestic pharmaceutical 

and biotechnology sector that actively collaborates 

with the U.S. Government to address unmet medical 

countermeasure and public health requirements. 

BARDA’s vision for the next five years is to enhance 

the capability of the U.S. Government to respond 

quickly to both known and emerging threats by supporting the development of a comprehensive portfolio of medical countermeasures, needed manufacturing infrastructure, and countermeasure production 

platforms while establishing an affordable and sustainable foundation for the maintenance and future 

operations of the PHEMCE. 

BARDA’s mission is to develop and procure needed 

medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, against a broad array of public health 

threats, whether natural or intentional in origin. BARDA 

was created to address gaps in the U.S. Government 

medical countermeasure development and procurement process and to bridge the “valley of death” that 

separates candidates identified in early research from 

potential FDA licensure/approval by providing funding, technical support and services necessary to advance candidate products through the developmental 

pipeline. 

BARDA supports the ASPR Values Statement and endeavors to embody these values in its efforts to fulfill 

its mission and realize its vision. 

AsPr VAlues 

Diversity 

We are dedicated to creating and maintaining an 

open, inclusive environment that nurtures differing 

world views. 

Excellence 

We demonstrate quality in what we do, set high expectations for ourselves and others, and innovate and 

improve through the introduction of new concepts 

and methods. 

Integrity 

We are honest and reliable, we hold ourselves accountable, and our actions and decisions are guided 

by fairness and transparency. 

Leadership 

We motivate and inspire our colleagues to achieve 

success through shared vision and unity of effort. 

Public Service 

We commit to serve our country, our community, and 

our fellow citizens, and are accountable to the public 

for our actions 

Respect 

We treat people with dignity and consideration and 

listen openly to what others have to say, to benefit 

from varied perspectives and create environments 

that foster trust. 

Teamwork 

We support and motivate each other, achieving more 

together than we can alone. 

BARDA Strategic Plan 2011-2016 7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

BARDA Guiding Principles
 

BARDA WILL PURSUE ITS STRATEGIC GOALS THROUGH 

an approach comprised of the following core 

principles. 

CollABorAting in PuBliCPriVAte PArtnershiPs 

The PHEMCE Review highlighted the critical role of 

public-private partnerships in addressing the challenges that arise throughout the product development 

process and in rapidly adapting to new technologies 

and changing needs. BARDA’s commitment to publicprivate partnerships is deep-rooted and extends across 

its entire portfolio. 

Where vaccine and biological therapeutics manufacturing capacity is concerned, BARDA will continue to 

enter into public-private partnerships with manufacturers to build and/or retrofit medical countermeasure 

production facilities within the U.S., increasing domestic access to medical countermeasures. Internationally, BARDA will maintain its financial and technical support of the WHO Global Action Plan, working 

in concert with the Developing Countries Vaccine 

Manufacturers Network and other partners to expand 

influenza vaccine manufacturing capacity in developing countries. 

BARDA will establish its Centers of Innovation for 

Advanced Development and Manufacturing as partnerships in which the U.S. Government and private 

sector partners share facility construction costs, collaboratively facilitate medical countermeasure product development, and jointly ensure domestic vaccine manufacturing surge capacity. These Centers will 

provide advanced development and manufacturing 

capabilities for medical countermeasures to address 

both national security and public health needs on a 

cost-effective, reliable, and sustainable basis. In order 

to minimize delays in the availability of critical medical countermeasures during public health emergencies, BARDA will establish a network of providers to 

formulate, fill, and finish bulk vaccine product provided by primary manufacturers in the event that the 

primary manufacturers lack sufficient surge capacity 

of their own. 

ProMoting PlAtForM 

teChnologies 

BARDA is supporting the development of novel platform technologies that provide flexible systems for 

the production of medical countermeasures against 

a variety of threats. BARDA will also leverage established programs to maximize the value of current investments in technological innovations. Strategic support for platform technologies will greatly enhance 

the value provided by BARDA investments and position the U.S. Government to respond more effectively 

to the unknown threats of the future. 

As an illustration, adjuvants, which can be used to 

increase the supply of pandemic influenza vaccine, 

may have the potential to enhance the efficacy of vaccines against biological threats or emerging diseases 

and may be essential components of next-generation 

recombinant protein influenza vaccines. By supporting the development and use of adjuvant “platforms” 

to enhance the efficacy of currently licensed vaccines, 

BARDA is also supporting the establishment of a regulatory pathway for other vaccines that exploit adjuvant 

technology – a critical step in speeding the availability 

of new vaccines against a broad array of threats. 

Prioritizing MultiPurPose 

ProduCts 

BARDA is committed, where feasible, to developing 

products that demonstrate efficacy against a wide 

range of specified threats and will seek out products 

8 BARDA Strategic Plan 2011-2016 
 

 

 

 

 

 

 

 

 

with such potential through its Strategic Science and 

Technology program. Investing in multi-use products 

such as broad-spectrum therapeutics and diagnostic platforms that can find durable and well-defined 

commercial markets and leverage market forces will 

greatly facilitate the development of medical countermeasures for use in public health emergencies and 

enhance long-term sustainability for the PHEMCE. 

BARDA’s Broad Spectrum Antimicrobial Program was 

established in January 2010 and is focused on developing novel antibacterial and antiviral drugs for the 

treatment or prevention of disease caused by currently defined and future biological threats. Recognizing 

the immediate value of new antimicrobials in addressing the increasingly prevalent public health threat of 

antibiotic resistance, as well as the likelihood that antimicrobial resistance will complicate primary treatment of a wide array of threats, BARDA is supporting 

the development of public-private partnerships for the 

development of novel antimicrobials. Through these 

partnerships, BARDA will support the development of 

candidate antimicrobials for their commercial, clinically prevalent infectious disease indications, as long 

as our private sector partners concomitantly support 

the development of these products for biodefense 

threat agent indications. By adopting this approach, 

BARDA will support the development of new classes 

of antimicrobials, increase the number of antimicrobial drugs in the developmental pipeline, address the 

important and immediate threat of antimicrobial resistance, and prepare the nation for the predictable 

threat of biological terrorism and the unpredictable 

threat of emerging infectious diseases. 

Many other BARDA projects demonstrate the variety 

of ways in which “dual utility” and multi-use value 

can be achieved. For example, next-generation, lowcost, easy-to-use ventilators and improved respiratory 

protective devices all have applications against a wide 

array of threats. BARDA will continue to seek out multipurpose products and support their development in 

order to enhance our Nation’s ability to respond effectively to the broad array of threats we face. 

using CAse MAnAgeMent And 

A MAtrixed orgAnizAtionAl 

struCture 

The PHEMCE Review requested by the Secretary of 

HHS included recommendations to adopt a new, 

more intensive approach (“case management”) to program and project management. Under case management, BARDA leads the effort to ensure that intra- and 

inter-agency stakeholders are kept abreast of product 

development progress and issues in the identified 

programs. BARDA is adopting a rigorous approach to 

project, program, and portfolio management that will 

establish cost and schedule metrics for each phase 

of product development, and allow the identification 

of best practices and earlier interventions in troubled 

programs. In Process Review of program contracts 

occur on a regular basis by a team of experts from 

HHS and PHEMCE partners who provide critical input on key decisions in program development and 

guidance on issues that may arise during product development. 

When challenges with product development arise, 

BARDA employs a case management approach of 

intensive support and guidance to private sector partners, which also entails appropriate input and expertise from relevant federal agencies (BARDA, CDC, 

DoD, FDA, and NIH). Case management of BARDA 

programs is essential to the proper stewardship of the 

funding provided for these endeavors and will ensure 

that all U.S. Government stakeholders are aware of 

products being developed and the long-term budgetary impact those products may have on other agencies through the course of their life cycle. 

BARDA has adopted a matrix-like organizational 

structure that makes the specialized capabilities of 

its different components available to project managers throughout the organization. This matrix-like organizational structure will maximize efficiency and 

collaboration across BARDA, promote a culture of 

continual process improvement, and facilitate the 

ultimate application of case management to all supported programs. 

BARDA Strategic Plan 2011-2016 9 
 

 

ensuring An integrAted 

PortFolio With dod 

In addition to the management of specific programs 

under the effort highlighted above, BARDA, in collaboration with its HHS and DoD partners, has adopted an integrated approach to co-managing the nation’s aggregate portfolio of medical countermeasure 

development programs for CBRN threats. The overall 

goal is to optimize the use of resources to address 

the broad range of common threats and requirements 

with greater efficiency and effectiveness. Although 

DoD and HHS each have certain unique requirements 

due to their different missions and focus, there are 

many areas of convergent requirements for products 

or capabilities where resources and information will 

be appropriately shared to optimize investments and 

preclude unnecessary redundancies. This integrated 

approach will ensure balance and completeness 

across all agencies funding the research, development, and procurement of medical countermeasures 

for CBRN threats. 

10 BARDA Strategic Plan 2011-2016 
 

 

 

 

 

 

 

Goals and Strategies
 

goAl 1 

An advanced development pipeline replete with 

medical countermeasures and platforms to address 

unmet public health needs, emphasizing innovation, flexibility, multi-purpose and broad spectrum 

application, and long-term sustainability 

Since its inception, BARDA has prioritized the development and procurement of medical countermeasures 

for the highest risk threats, including pandemic influenza and terrorist use of chemical, biological, radiological, or nuclear materials. The Pandemic and AllHazards Preparedness Act additionally called for the 

public health and medical needs of at-risk individuals to be taken into account in developing a national 

stockpile of medical countermeasures. Consistent with 

statutory requirements, BARDA supports the advanced 

development of medical countermeasures for all populations, with the goal of making them available for use 

as needed during public health emergencies. 

BARDA’s CBRN programs have focused on developing medical countermeasures to meet the requirements determined to be necessary to address the 13 

Material Threats identified by the DHS in accordance 

with Project BioShield. BARDA’s influenza program 

has contributed to pandemic preparedness by supporting the development of improved and/or nextgeneration influenza vaccines, antiviral medications, 

ventilators, and other non-pharmaceutical countermeasures; stockpiles of pre-pandemic vaccines and 

antiviral medications; and increased domestic influenza vaccine manufacturing capacity. More recently, 

BARDA has begun to address the threat of antimicrobial resistance, emerging infectious diseases, and 

other novel threats by initiating programs supporting 

the development of broad-spectrum antimicrobials 

and technologies and platforms with multi-use potential. BARDA will maintain this three-pronged focus 

on CBRN threats, pandemic influenza, and emerging 

infectious diseases, modifying its current portfolio as 

needed to (1) ensure that the medical countermeasure needs of all populations are addressed and (2) 

enhance long-term sustainability of our preparedness 

posture. 

goAl 1 strAtegies 

 Promote development and acquisition of needed 

medical countermeasures by 

 Maintaining and where appropriate expanding the portfolio of medical countermeasures against CBRN threats and pandemic 

influenza 

 Establishing a program to support the development of platforms and countermeasures 

to address the threats of emerging infectious 

diseases and antimicrobial resistance 

 Supporting the development of medical 

countermeasures suitable for use in special populations such as children, pregnant 

women, the elderly, and persons with compromised immune systems, prioritizing and 

supporting projects that provide benefits to 

all populations where possible and exploring focused development projects or studies 

where necessary. 

 Improving processes governing the solicitation, review, and award of medical countermeasure contracts 

 Promote the development of flexible, multiproduct platforms and countermeasures with broadspectrum activity and application by 

 Expanding BARDA’s Broad Spectrum 

Antimicrobials and Innovations programs 

to develop a robust portfolio of countermeasures to address an array of known and 

unknown threats 

BARDA Strategic Plan 2011-2016 11 
 Investing in the development of hostdirected therapeutics, such as small molecule immune modulators, anti-inflammatory 

agents, and regulators of innate immunity 

 Invest more strategically by 

 Supporting the development of robust diagnostic capabilities in order to improve surveillance, facilitate earlier treatment, and 

minimize medical countermeasure wastage 

 Engaging in more proactive outreach, identifying candidate technologies and innovations that promise greater sustainability or 

that BARDA wishes to see advance because 

of portfolio requirements 

 Establishing a medical countermeasures 

Strategic Investor that will pursue the strategic objectives of the PHEMCE while acting 

as, and providing all the services and benefits of, a venture capital firm 

goAl 2 

A capability base to provide enabling core services 

to medical countermeasure innovators 

Considerable expertise and capabilities are required 

to overcome the technical, regulatory, manufacturing, 

commercialization, and business challenges inherent 

in the development of innovative medical countermeasure candidates. Over the past ten years, innovative companies developing CBRN medical countermeasures have encountered many challenges moving 

products along the process development, manufacturing, and regulatory pathways. BARDA already 

provides an array of services to manufacturers and 

innovators of medical countermeasures but has observed that many of these companies would benefit 

from additional support in moving from laboratory to 

commercial scale production and clinical evaluation 

through the regulatory approval process. 

goAl 2 strAtegies 

 Provide core product development services by 

 Establishing the Centers for Innovation in 

Advanced Development and Manufacturing 

(CIADM), which will have the capability to 

support analytical testing, scale-up manufacturing, manufacturing process optimization; 

provide regulatory and quality expertise and 

analytical and process validation support; 

and produce clinical investigational lots, 

engineering lots, process validation lots, and 

commercial-scale lots for stockpiling 

 Developing and qualifying animal models through the new Animal Models 

Development Program 

 Performing GLP efficacy evaluation and testing of CBRN countermeasures in qualified 

animal models 

 Provide biotechnology firms working on medical 

countermeasures access to financial and business services by establishing a medical countermeasures Strategic Investor that will serve as a 

non-profit venture capital firm 

 Reduce regulatory barriers and clarify regulatory 

pathways by 

 Assisting private sector partners in the development of regulatory strategies and design 

and execution of clinical studies for needed 

medical countermeasures 

 Involving FDA experts in providing technical 

assistance on projects supported by CIADM 

 Contributing to the development and implementation of a PHEMCE regulatory science 

agenda 

 Promote the development of a highly trained 

biopharmaceutical workforce by: 

 Incorporating training in biopharmaceutical 

science and other workforce development 

opportunities into the day-to-day functions 

of the CIADM 

12 BARDA Strategic Plan 2011-2016 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

goAl 3	 goAl 3 strAtegies 

Agile, robust and sustainable U.S. manufacturing infrastructure capable of rapidly producing vaccines 

and other biologics against pandemic influenza and 

other emerging threats 

The 2005 National Strategy for Pandemic Influenza established a commitment to making vaccine available 

for all Americans within six months of the emergence 

of a virus with pandemic potential. BARDA has made 

significant progress towards increasing and securing 

domestic manufacturing capacity for pandemic influenza vaccine development. However, the recent response to 2009 H1N1 shows that we are still hampered 

by the limits of current technology. The first domestic 

cases of 2009 H1N1 influenza were identified in April 

and the pandemic peaked about six months later, in 

late October. Despite an intensive effort to develop a 

pandemic vaccine, the 2009 H1N1 vaccine arrived too 

late to have a significant effect on the dynamics of the 

fall disease wave. Influenza vaccines licensed in the 

U.S. use egg-based technology that is more than 50 

years old and a substantial portion of the manufacturing capacity is based overseas. 

Consistent with recommendations from the President’s 

Council of Advisors on Science and Technology in its 

August 2010 Report to the President on Reengineering 

the Influenza Vaccine Production Enterprise to Meet 

the Challenges of Pandemic Influenza BARDA is working with several partners to develop more modern platforms for manufacturing influenza vaccines and this 

investment is beginning to pay off. In 2011, two manufacturers plan to file Biologic License Applications 

(BLAs) for cell-based influenza vaccines, with new vaccines based on recombinant technologies to come in 

following years. Products based on these newer, faster, 

more scalable technologies will move the field forward 

and significantly increase the flexibility, surge capacity, 

and reliability of influenza vaccine production increasing and securing domestic manufacturing capacity for 

pandemic influenza vaccine development. 

 Speed the delivery of pandemic influenza vaccines following the emergence of an influenza 

virus with pandemic potential by 

 Developing improved vaccine seed strains, 

sterility tests, and potency reagents and 

testing 

 Expanding the number of FDA-licensed 

influenza vaccines, to include cell-based 

products 

 Supporting the development of faster, more 

scalable next-generation recombinant influenza vaccines 

 Completing the development and evaluation 

of adjuvanted pandemic influenza vaccines 

 Optimizing the BARDA emergency manufacturing response 

 Increase domestic manufacturing surge capacity 

for pandemic influenza by 

 Supporting the construction or retrofitting of 

influenza vaccine manufacturing facilities 

 Supporting the development of next-generation manufacturing processes 

 Securing the availability of essential vaccine 

supplies and services by enhancing domestic fill finish networks and ensuring a yearround supply of eggs for pandemic vaccine 

surge production 

 Requiring CIADM awardees to maintain a 

capability to manufacture pandemic influenza vaccine 

 As in GOAL 2, promote the development of a 

highly trained biopharmaceutical workforce to 

ensure commercial-scale manufacturing capacity 

by 

 Incorporating training in biopharmaceutical 

science and other workforce development 

opportunities into the day-to-day functions 

of the CIADM 

 Sponsoring academic training programs 

in bio-manufacturing techniques as part of 

a broader initiative to build influenza vaccine manufacturing capacity in developing 

countries 

BARDA Strategic Plan 2011-2016 13 
 

goAl 4 

Responsive and nimble programs and capabilities to 

address novel and emerging threats 

The Pandemic and All-Hazards Preparedness Act 

charges BARDA with the advanced development of 

medical countermeasures for emerging infectious disease threats, which come in many forms. New and 

lethal infectious diseases, such as MRSA, Dengue, 

Ebola, SARS, and Nipah virus, continue to emerge in 

nature. The extensive use of antiviral and antibacterial agents has resulted in the propagation of drug resistant strains of bacteria and viruses and promoted 

the evolution of extensively drug-resistant strains of 

many common pathogens. As has been the case with 

past influenza pandemics where secondary infections 

with resistant organisms accounted for a significant 

proportion of deaths, drug-resistant strains are likely 

to complicate the treatment of CBRN-caused illnesses. Where deliberate threats are concerned, advances 

in genetic engineering and synthetic biology may provide a means for bioterrorists to generate more dangerous pathogens through the insertion of virulence 

factors or drug-resistance genes. 

Preparing for the threat of previously unknown emerging diseases, whatever the source, requires a different 

approach than preparing for known threats or pathogens. To address these evolving threats to public 

health, acquisition of broad spectrum antibiotic and 

antiviral medications and new classes of antimicrobials, including host-directed therapeutics and small 

molecule immune modulators, will be a major focus 

of BARDA’s efforts in coming years. 

Over the next five years, building on the experiences 

of the CBRN, Influenza, and Strategic Science and 

Technology Divisions, BARDA will enhance its efforts 

to provide solutions to the growing problem of emerging pathogens and antimicrobial resistance. In the 

near term, BARDA is developing programs to address 

the threat posed by multidrug-resistant pathogens and 

future unknown biological threats. A key element of 

this effort is identifying and supporting the development of broad spectrum antimicrobials. In addition, 

BARDA’s next-generation influenza antiviral drug advanced development program is pursuing new classes 

of drugs and innovative candidate antiviral therapies 

that will be less susceptible to viral resistance. 

goAl 4 strAtegies 

 Develop a formal methodology to identify medical countermeasure projects that are appropriate 

for inclusion in the BARDA Emerging Infectious 

Diseases portfolio 

 Implement a long-term strategy to address previously undefined threats by 

 Expanding BARDA’s Broad Spectrum Antimicrobials and Innovations programs 

 Emphasizing the development of multipurpose and/or broad-spectrum products 

 Investing in capabilities (platforms and facilities) for the rapid development and production of countermeasures 

 Investing in the development of host- directed 

therapeutics, such as small molecule immune 

modulators, anti-inflammatory agents, and 

regulators of innate immunity 

 As in GOAL 1, establishing a medical countermeasures Strategic Investor that will pursue the strategic objectives of the PHEMCE 

while acting as, and providing all the services and benefits of, a venture capital firm 

 Combat the growing problem of antimicrobial 

resistance through development of new antimicrobials and innovative therapeutics by pursuing 

new classes of drugs and innovative antimicrobial therapies that will be less susceptible to drug 

resistance 

14 BARDA Strategic Plan 2011-2016 
goAl 5	 goAl 5 strAtegies 

A ready capability to develop, manufacture and 

facilitate distribution of medical countermeasures 

during public health emergencies 

Ensuring the availability of safe and effective medical 

countermeasures during public health emergencies 

is BARDA’s core mission. Supporting the scientific 

development of vaccines, therapeutics, and diagnostics is only one aspect of BARDA’s role in promoting 

pandemic influenza and public health preparedness. 

The 2009 H1N1 pandemic underscored the critical 

importance of advanced development, manufacturing, and distribution planning. During the pandemic, 

BARDA worked in coordination with the NIH, FDA 

and CDC to procure, test, license and deliver the vaccines and antiviral drugs deployed as part of the U.S. 

Government response. 

Ultimately, 138 million doses of licensed 2009 H1N1 

vaccine were produced and distributed for use by the 

U.S. civilian population, 2.7 million doses for DoD, 

and 16.9 million doses for international assistance. As 

part of a contingency-based public health response, 

BARDA also purchased supplies of adjuvants to be 

used, if necessary, as part of a pandemic vaccine and 

additional supplies of antiviral medications to replenish treatment courses that were distributed from the 

Strategic National Stockpile, focusing on pediatric 

formulations to address critical needs for this population. BARDA’s collaborations with domestic vaccine 

manufacturers and coordination with the response 

activities of CDC and industry partners to ensure 

effective and timely distribution of pandemic countermeasures within regional, state, and tribal jurisdictions were critical enablers of the overall response to 

the pandemic. 

 Refine BARDA planning and readiness capabilities by drawing on the many lessons learned during the pandemic 

 In concert with the ASPR Office of Preparedness 

and Emergency Operations and in close coordination with CDC, FDA, and other U.S. 

Government departments and agencies, develop 

comprehensive plans that will facilitate the 

response to future pandemics, CBRN events, and 

emerging epidemics by 

 Establishing mechanisms for interfacing 

with medical countermeasure manufacturers and distributors during a public health 

emergency 

 Establishing mechanisms for positioning 

BARDA medical countermeasure production subject matter experts in manufacturing 

plants as needed 

 Providing a framework for developing and 

validating emergency funding requests 

 Facilitating the prompt evaluation of investigational products for emergency use authorization as warranted. 

 Exercise these readiness capabilities plans to 

ensure that they are fully consistent with existing ASPR and HHS response plans as well as the 

overarching National Response Framework 

BARDA Strategic Plan 2011-2016 15 
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Inside back cover
 

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U.S. Department of Health and Human Services 

Assistant Secretary for Preparedness and Response
 

200 Independence Avenue S.W.
 

Washington, D.C. 20201
 

www.hhs.gov