DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

July 5, 2007 

1

U.S. Department of Health and Human Services 

Public Health Emergency Medical Countermeasures Enterprise 

Biomedical Advanced Research And Development Authority (BARDA) 

DRAFT BARDA STRATEGIC PLAN 

for Medical Countermeasure 

 Research, Development, and Procurement 

INTRODUCTION 

On December 19, 2006, President George W. Bush signed into law the Pandemic and AllHazards Preparedness Act (Public Law 109-417), referred to as PAHPA.1

 Title IV of PAHPA 

established the Biomedical Advanced Research and Development Authority (BARDA) within 

the Department of Health and Human Services (HHS) to facilitate the research, development, 

and acquisition of medical countermeasures for chemical, biological, radiological, and nuclear 

(CBRN) agents and emerging infectious diseases, including pandemic influenza.2 BARDA 

establishes systems that encourage and facilitate the development and acquisition of medical 

countermeasures such as vaccines, therapeutics, and diagnostics, as well as innovative 

approaches to meet the threat of CBRN agents and emerging infectious diseases, including 

pandemic influenza, in support of the mission and priorities of the HHS Public Health 

Emergency Medical Countermeasures Enterprise3 (HHS PHEMCE). 

BARDA has worked with HHS partners to create this Draft BARDA Strategic Plan for Medical 

Countermeasure Research, Development, and Procurement (Draft BARDA Strategic Plan) to 

guide and facilitate research, development, innovation, and procurement of medical 

countermeasures, in fulfillment of Section 401(b) of PAHPA. ASPR is in the midst of a search 

process for a BARDA Director. This Draft BARDA Strategic Plan represents current thinking 

within BARDA. A Final BARDA Strategic Plan will be updated, finalized, and made public 

after the appointment of the BARDA Director. 

 

1 Available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ417.109.pdf 2

 Medical countermeasures for which this document discusses BARDA’s strategy for promoting development 

include those drugs, biological products, and devices that meet the definitions of qualified countermeasure and 

qualified pandemic or epidemic product found in sections 319F-1 and 391F-3 of the Public Health Service Act. See 

42 USC § 247d-7e. 

3 Federal Register, Vol. 71, No. 129, Thursday, July 6, 2006, Notices. The HHS Public Health Emergency Medical 

Countermeasures Enterprise leads the mission to develop and acquire medical countermeasures that will improve 

public health emergency preparedness as well as prevent and mitigate the adverse health consequences associated 

with chemical, biological, radiological, and nuclear threats and emerging infectious diseases, including pandemic 

influenza. HHS PHEMCE is a coordinated, intra-agency effort led by the Assistant Secretary for Preparedness and 

Response and includes three HHS internal agencies: the Centers for Disease Control and Prevention, the Food and 

Drug Administration, and the National Institutes of Health. Additionally, HHS PHEMCE collaborates with its ex 

officio members: the Department of Defense, the Department of Homeland Security, the Department of Veterans 

Affairs, and other interagency stakeholders as appropriate.
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

July 5, 2007 

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In April 2007, HHS announced intentions to establish BARDA under the Office of the Assistant 

Secretary for Preparedness and Response (ASPR) to encourage, facilitate, and streamline the 

development and acquisition of medical countermeasures.4

 The BARDA office is intended to 

incorporate all of the programs, mission responsibilities, and organizational functions previously 

managed by the HHS Office of Public Health Emergency Medical Countermeasures 

(OPHEMC), primary of which is the coordination, support, and execution of the goals and 

objectives of the HHS PHEMCE and the medical countermeasure goals of the HHS Pandemic 

Influenza Plan5. BARDA will work with other Federal Departments and agencies in the 

preparation and implementation of plans to manage and transport medical countermeasures and 

associated materials to and from manufacturers to designated sites, including the Strategic 

National Stockpile (SNS) and States, as appropriate, to support delivery platforms for the 

efficient deployment and utilization of medical countermeasures. 

ASPR leads the nation in preventing, preparing for, and responding to the adverse health effects 

of public health emergencies and disasters. Acting under the leadership of the ASPR, BARDA is 

the focal point for the advanced development and acquisition of medical countermeasures for 

CBRN threats and emerging infectious diseases, including pandemic influenza, for the U.S. 

civilian population. BARDA will work with industry, academia, public health organizations, 

other government agencies, and stakeholders to foster innovation and promote strategic 

initiatives, such as the development of rapid diagnostics, broad spectrum antimicrobials, and 

next-generation vaccine manufacturing technologies. Using its advanced research and 

development authority, BARDA will strengthen HHS efforts to bridge the valley of death6

funding gap that exists between the early stages of product development and the acquisition of 

approved or approvable medical countermeasures for the SNS.7 As a result, BARDA aims to 

enhance the availability of medical countermeasures to address public health emergencies arising 

from CBRN threats or pandemic and epidemic diseases. 

 

STRATEGIC GOALS 

The Draft BARDA Strategic Plan is built upon the framework established in national 

strategies for CBRN and pandemic influenza medical countermeasures, specifically the 

National Strategy for Pandemic Influenza8 and the National Strategy for Medical 

Countermeasures against Weapons of Mass Destruction (Homeland Security Presidential 

Directive-18)9

. BARDA has four specific goals: 

Goal 1. BARDA will align with and coordinate the execution of the 

medical countermeasure goals articulated in the HHS Pandemic 

Influenza Plan. 

 

4

 Announcement available at www.hhs.gov/news/press/2007pres/04/pr20070426d.html 

5

 Available at www.hhs.gov/pandemicflu/plan/ 

6 HHS testimony before the House Homeland Security Committee, Subcommittee on Emerging Threats, 

Cybersecurity, and Science and Technology, April 18, 2007. 

7

 For purposes of this document, the term approval includes approval or clearance under sections 505, 510(k), and 

515 of the Federal Food, Drug, and Cosmetic Act and licensure under section 351 of the Public Health Service Act. 

8

 Available at www.whitehouse.gov/homeland/pandemic-influenza.html 

9

 Available at www.whitehouse.gov/news/releases/2007/02/20070207-2.html 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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Goal 2. BARDA will align with and coordinate the execution of the 

medical countermeasure goals articulated in the HHS Public 

Health Emergency Medical Countermeasures Enterprise Strategy 

for Chemical, Biological, Radiological and Nuclear Threats (HHS 

PHEMCE Strategy for CBRN Threats).10 

Goal 3. BARDA, in concert with federal partners, will create a road map 

for execution of the HHS Public Health Emergency Medical 

Countermeasures Enterprise Implementation Plan for Chemical, 

Biological, Radiological and Nuclear Threats (HHS PHEMCE 

Implementation Plan).11

Goal 4. BARDA, in concert with federal partners, will establish programs 

that promote innovation in medical countermeasure development. 

As described specifically in the HHS PHEMCE Implementation Plan and the HHS Pandemic 

Influenza Plan, the United States Government (USG) has prioritized medical countermeasure 

research, development, and procurement programs. Such prioritization is critical because the 

development and acquisition of medical countermeasures for all potential threats to the U.S. 

civilian population would far exceed available resources. The overall goal is to provide the USG 

with an increased level of public health emergency preparedness to respond to a wide range of 

potential challenges, including traditional as well as novel agents that are highly communicable, 

associated with a high rate of morbidity or mortality, and/or without known medical 

countermeasure. 

To implement this Draft BARDA Strategic Plan, BARDA will employ proven and successful 

approaches for the advanced development of medical countermeasures, an example of which is 

the HHS Pandemic Influenza Medical Countermeasures Program that supports the advanced 

development of multiple medical countermeasure candidates in order to reduce risk, maximize 

the odds of success, and inform sound acquisition decisions. Specifically, the HHS Pandemic 

Influenza Medical Countermeasures Program utilizes milestone-driven contracts and incremental 

funding to support multiple medical countermeasure candidates in the advanced stages of 

product development. As products near Food and Drug Administration (FDA) approval, 

increased consideration for their inclusion into national pandemic stockpiles stimulates 

competitive pricing and further development of new and better pandemic products by these and 

other manufacturers. Funding incentives for influenza vaccine manufacturing facility design, 

construction, and validation also stimulate product development and serve to expand domestic 

vaccine manufacturing surge capacity. BARDA awards contracts and provides technical 

guidance to manufacturers on the development of pandemic influenza medical countermeasures. 

The HHS Pandemic Influenza Medical Countermeasures Program’s multi-pronged portfolio 

approach stimulates competitive product development, enables flexible and sound product 

acquisition decisions, and mitigates risk. 

 

10 Available at www.hhs.gov/aspr/ophemc/enterprise/strategy/strategy.html 11 Available at www.hhs.gov/aspr/ophemc/enterprise/strategy/phemceimplementationplan.pdf 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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ENHANCING MEDICAL COUNTERMEASURE PRODUCTION 

BARDA was established to provide funding and coordination to address challenges in medical 

countermeasure development. For CBRN threats, for example, the medical countermeasures 

required to address the highest priority threats are generally not supported by a commercial 

market. Large pharmaceutical firms and small biotechnology companies, whose product 

development strategies are driven by market forces, are reluctant to develop medical 

countermeasures for which there is no clearly-defined, robust, sustainable, commercial market. 

In many cases, the anticipated rate of return on development of a new medical countermeasure 

for a specific threat may not justify the required resource allocations. BARDA was created to 

enhance incentives - in conjunction with Project BioShield Act12 authorities - to industry by 

providing greater government transparency. Furthermore, BARDA was created to increase 

funding for advanced research and development and to better coordinate the USG medical 

countermeasure development and acquisition process. 

 

In addition to supporting novel product development, BARDA also may support evaluation and 

licensure of existing medical countermeasures that were developed originally by the private 

sector for commercial indications. These medical countermeasures also may have utility for 

addressing other CBRN threats and emerging infectious diseases. One such example is 

ciprofloxacin, which is available commercially for the treatment of clinical bacterial infections, 

and which is now also a significant component of the USG arsenal for treating anthrax. 

BARDA will facilitate and support the advanced development of new or modernized medical 

countermeasures for pandemic influenza as well as the FDA review of the products for potential 

approval. Such pandemic influenza countermeasures may be produced by existing commercial 

industry. Further, BARDA will support the expansion of the domestic vaccine manufacturing 

infrastructure to support new seasonal influenza vaccines, national pre-pandemic influenza 

vaccine stockpiles, and pandemic influenza vaccines, where an expansion of domestic 

manufacturing surge capacity is desired to provide sufficient quantities of products in a timely 

manner to ameliorate the morbidity and mortality associated with worst case scenarios of an 

influenza pandemic. 

THE MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT PATH: 

TECHNOLOGY READINESS LEVELS AND FUNDING SOURCES 

The development path for biomedical products begins with a comprehensive and robust basic 

research effort that discovers and characterizes scientific concepts. These concepts can be 

exploited by trial and error as the basis for medical intervention. While there are several 

conventions for characterizing the various stages of the product development pathway once a 

candidate product has been identified, the path can be described as including four generic 

stages:13 

 

12 Project BioShield Act of 2004 (Public Law 108-276) available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ276.108.pdf 

13 The specific activities described under each stage of development are most representative of the development of 

pharmaceuticals. Development activities may differ for devices, including diagnostics. 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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• Early-Stage Product Development 

Optimization; pre-clinical evaluation; animal model development; Phase 1 clinical 

trial (safety and pharmacology); manufacturing process development; 

formulation; and stability. 

• Mid-Stage Product Development 

Advanced non-clinical toxicology; manufacturing process scale-up; advanced 

formulation and stability programs; animal model testing; and Phase 2 clinical 

trial (dose range and expanded safety, efficacy). 

• Late-Stage Product Development 

Validation of the manufacturing process (e.g., consistency lot manufacturing) and 

all assays; Phase 3 clinical human safety studies; and Phase 3 clinical human 

efficacy studies that may be replaced by animal efficacy studies, provided 

applicable regulatory criteria are met.14

• Licensure and Commercialization

Regulatory review and approval; marketing; post-marketing surveillance; and 

Phase 4 clinical evaluation. 

As demonstrated in Figure 1, these generic stages overlap. Progress from one stage to the next is 

usually not represented by a sharp demarcation; rather, multiple activities occur in parallel. 

Attrition of products as they progress through evaluation and development is high; and 

maintaining a viable pipeline requires numerous candidate products entering early-stage 

development. The absolute number of products expected to reach late-stage development is 

small, whereas the costs of late-stage development are high. According to the FDA, the costs of 

bringing a new medicine to market have been estimated to be $800 million to $1.7 billion.15

To communicate and coordinate effectively and to increase transparency for stakeholders about 

medical countermeasure development activities, BARDA will promote and employ a detailed, 

rigorous, criteria-based nomenclature to identify stages of product development and the potential 

USG funding sources that are available at various stages. Through an interagency process, the 

HHS PHEMCE is developing Technology Readiness Level (TRL) criteria to describe the 

progression of medical countermeasures through the research and development pipeline as well 

as to delineate the milestones that are well-recognized by regulatory agencies and industry.16 

Each TRL level encompasses a diverse set of activities, from efficacy studies to manufacturing 

and regulatory milestones, which often occur in parallel and in coordination with multiple 

 

14 Food and Drug Administration. Approval of Biological Products when Human Efficacy Studies are not Ethical or 

Feasible (21 CFR 601 Subpart H and 21 CFR 314 Subpart I for New Drugs). This rule, known simply as the 

Animal Rule, was designed to permit approval or licensing of drugs and biologics that are intended to reduce or 

prevent serious or life-threatening conditions caused by exposure to biological, chemical, radiological, or nuclear 

substances. This rule amends the new drug and biological product regulations to identify the information needed to 

provide substantial evidence of the efficacy of new drug and biological products only when human efficacy studies 

are not ethical and field trials are not feasible. Available at www.fda.gov/cber/rules/humeffic.htm 15 Food and Drug Administration. Challenge and Opportunity on the Critical Path to New Medical Products, March 

2004. Available at www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

16 The preliminary Technology Readiness Level criteria are available at www.hhs.gov/aspr/ophemc/barda/trl.html 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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stakeholders. As shown in Figure 1, the earliest TRL stages include basic research activities; 

subsequent levels progress through advanced development to the approval of safe and effective 

medical countermeasures. 

Early Stage Mid Stage Late Stage

Basic

Research

Prototype

Design or 

Discovery

Preclinical

Development Clinical Development

FDA Filing/

Approval &

Launch

Preparation

Safety

Medical 

Utility

Industrialization

TRL 1 2 3 4 5 6 7 8 9 10 11/12/13

Licensure

Human & Animal

Efficacy

Evaluation

In Vitro &

Computer

Model

Evaluation

In Vitro &

Animal

Models

Manufacturing

Scale-up/

Refined

Specifications

Physical

Design

Characterization

Small-Scale

Production

Mass

Production

Human

& Animal

Testing

Material Selection

Structure

Activity

Relationship

In Vitro &

Animal

Testing

Safety

Follow-up

Early Stage Mid Stage Late Stage

Basic

Research

Prototype

Design or 

Discovery

Preclinical

Development Clinical Development

FDA Filing/

Approval &

Launch

Preparation

Basic

Research

Prototype

Design or 

Discovery

Preclinical

Development Clinical Development

FDA Filing/

Approval &

Launch

Preparation

Safety

Medical 

Utility

Industrialization

TRL 1 2 3 4 5 6 7 8 9 10 11/12/13 11/12/13

Licensure

Human & Animal

Efficacy

Evaluation

In Vitro &

Computer

Model

Evaluation

In Vitro &

Animal

Models

Human & Animal

Efficacy

Evaluation

In Vitro &

Computer

Model

Evaluation

In Vitro &

Animal

Models

Manufacturing

Scale-up/

Refined

Specifications

Physical

Design

Characterization

Small-Scale

Production

Mass

Production

Human

& Animal

Testing

Material Selection

Structure

Activity

Relationship

In Vitro &

Animal

Testing

Safety

Follow-up

Figure 1. Product Development Path for Medical Countermeasures. This figure demonstrates the approximate 

juxtapositions of various conventions used to describe the product development pathway. BARDA will use the 

Technology Readiness Level (TRL) system. Figure adapted from Challenge and Opportunity on the Critical Path 

to New Medical Products.17

The current TRLs are in draft form; and four preliminary sets of TRLs have been released – one 

each for chemical, biological, and radiological/nuclear medical countermeasures (primarily 

focused on pharmaceuticals) and one for diagnostic devices. A TRL for medical countermeasure 

product development tools (PDTs) is under development. The HHS PHEMCE will continue to 

revise these TRLs and consider whether additional TRLs may be needed to accurately describe 

the development cycle for the diverse products that may be eligible for BARDA funding. 

A candidate medical countermeasure’s progression through the stages of development will 

include milestone decision reviews. Developers must successfully achieve milestones before 

moving to the next decision review. BARDA, working through the HHS PHEMCE, will use 

TRLs to identify the development pipeline milestones at which products are eligible to be 

transitioned to new funding mechanisms. The approximate correlations among TRLs and 

 

17 Food and Drug Administration. Challenge and Opportunity on the Critical Path to New Medical Products, March 

2004. Available at www.fda.gov/oc/initiatives/criticalpath/whitepaper.html 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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potential funding sources are displayed in Figure 2. The funding mechanism utilized at each 

TRL is determined on a case-by-case basis, due in part to significant investment differentials 

across the CBRN threat spectrum. If sufficient resources are available, BARDA will fund top 

priority medical countermeasure development programs where funding from other sources is 

unavailable or insufficient. 

TRL 1 2 3 4 5 6 7 8 9 10 11 12/13

Funding 

Sources

BARDA, Private Sector

Academia, NIH, Private Sector, Other USG Entities

Project BioShield,

Pandemic Influenza 

Appropriations, DSNS

BARDA Integrated Program Planning

TRL 1 2 3 4 5 6 7 8 9 10 11 12/13

Funding 

Sources

BARDA, Private Sector

Academia, NIH, Private Sector, Other USG Entities

Project BioShield,

Pandemic Influenza 

Appropriations, DSNS

BARDA Integrated Program Planning

Figure 2. Potential Funding Sources for Medical Countermeasure Product Development (for the U.S. civilian 

population) at Various Technology Readiness Levels (TRL). Once the HHS PHEMCE recognizes the need to 

acquire a particular medical countermeasure for the U.S. civilian population, BARDA supports integrated planning 

across the product development pipeline for top priority medical countermeasures in partnership with USG and 

private sector stakeholders, as appropriate. Medical countermeasure products of potential utility in civilian public 

health preparedness may also be developed elsewhere for other demands. Whenever feasible and appropriate, 

BARDA will procure these medical countermeasures for addition to the Strategic National Stockpile. 

Notes: NIH is the acronym for the National Institutes of Health. DSNS is the acronym for the Centers for Disease 

Control and Prevention Division of Strategic National Stockpile. 

Basic Research and Development18 (Approximately TRL 1 through TRL 8)

The development of medical countermeasures begins with a comprehensive and robust basic 

research effort that characterizes the course of disease following exposure to a particular threat 

agent, along with the evaluation of candidate medical countermeasures using in vitro and in vivo

assays. These initial efforts lead to the identification of products or platforms that could be used 

to address specific medical and public health needs. Within the USG, research and development 

activities at these levels are funded largely through initiatives at the National Institutes of Health 

(NIH) and the Department of Defense (DOD). Once potential candidate medical 

countermeasures have been identified from basic research and development activities, they must 

proceed through the early stages of product development, which may include pre-clinical 

evaluation, Phase 1 clinical safety trials, manufacturing process development, and optimization 

of formulation and product stability. Promising candidates may be eligible for transitioning from 

NIH or other basic research and development programs to advanced product development 

activities supported by BARDA. 

 

18 The approximate TRL ranges correspond to the existing preliminary TRLs for medical countermeasures and may 

differ for diagnostics or in future TRLs. Relevant consideration for funding is based on whether the particular 

product has progressed to the stage of advanced development, as judged for that type of product. 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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Advanced Development (Approximately TRL 7 through TRL 11) 

 ̈ Eligibility generally begins for BARDA support §

As defined in PAHPA [Public Law 109-417, Title IV, Section 401(a)(6)], BARDA will seek to 

provide support for medical countermeasure programs between basic research and development 

activities and product acquisition by specifically supporting advanced research and development. 

Under this framework, BARDA links initial product development activities (e.g., advanced, nonclinical, toxicology studies; manufacturing process scale-up; advanced formulation and stability 

programs; and Phase 2 clinical trials) with later product development activities (e.g., validation 

of the manufacturing process, such as consistency lot manufacturing and all assays; commercial 

scale manufacturing facility validation; consistency lot manufacturing; and Phase 3 clinical 

human safety and efficacy studies). BARDA will work in close collaboration with other federal 

agencies, private sector developers, and academic collaborators to select and transition medical 

countermeasures that may be considered for acquisition to meet HHS requirements for public 

health emergency preparedness. 

Attrition of products as they proceed through advanced development activities is high. To 

achieve programmatic success, it is therefore essential for BARDA to support a robust pipeline 

of numerous candidate products entering these levels. BARDA will have to support multiple 

products for each top priority medical countermeasure program to increase the likelihood of 

procuring at least one successful medical countermeasure for each priority program. Based on 

typical pharmaceutical industry rates of success, very few candidate products are expected to 

successfully proceed from TRL 1 to TRL 10 and advance to FDA licensure, approval, or 

clearance. According to the FDA, a new medicinal compound entering Phase 1 testing, often 

representing the culmination of approximately a decade of preclinical screening and evaluation, 

is estimated to have only an 8 percent chance of reaching the commercial market.19 

In concert with the changing national need for medical countermeasures to address CBRN and 

emerging infectious disease threats, BARDA will continually monitor the medical 

countermeasure pipeline for candidate countermeasures for top priority public health threats, and 

will assess whether products or technologies are sufficiently robust to be transitioned to latestage development. BARDA will establish clear and transparent principles for these selection 

criteria and for processes to support advanced product development and technology validation. 

Following these principles and making use of well-articulated medical countermeasure 

requirements, such as those delineated in the HHS PHEMCE Implementation Plan, the HHS 

Pandemic Influenza Implementation Plan, and ASPR-issued Requests for Proposals, BARDA 

will provide greater transparency and partnership between the USG and the private sector and 

will provide developers with clear targets for their product development activities. 

BARDA will focus on those promising products that have entered clinical development (TRL 8) 

and that have relevant preliminary safety data. In this manner, BARDA will foster advanced 

development by overcoming the technical hurdles of commercial scale manufacturing and by 

providing assistance in meeting other regulatory requirements needed for eventual product 

approval. To maximize public health emergency preparedness, however, BARDA will maintain 

 

19 Food and Drug Administration. Challenge and Opportunity on the Critical Path to New Medical Products, March 

2004. Available at www.fda.gov/oc/initiatives/criticalpath/whitepaper.html 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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sufficient flexibility to make specific funding decisions on a case-by-case basis. BARDA may 

support advanced research and development of a candidate medical countermeasure across a 

range of TRLs. For example, BARDA’s support of an innovative product could begin at a stage 

before TRL 7 if the product is deemed to be truly innovative as a technology platform. As 

another example, BARDA may support early in the development pathway a novel technology 

that could be applied to improve existing products, resulting in advanced biomedical products 

that could be made more rapidly or less expensively, thereby increasing manufacturing surge 

capacity. Additionally, if sufficient resources are available, BARDA will fund top priority 

medical countermeasure development programs where funding from other sources is unavailable 

or insufficient. 

Transition to Acquisition (Approximately TRL 9 through TRL 12 or 13)

BARDA will support medical countermeasure development as an integrated, end-to-end process, 

including the most risky and expensive later stages of product development. Products that 

successfully emerge from advanced development will have obtained, at a minimum, the 

information and data needed by the FDA to consider use of the unapproved product or 

unapproved use in a declared emergency under Emergency Use Authorization (EUA). Such 

products would be eligible for placement in the SNS under a Project BioShield Special Reserve 

Fund acquisition, or in other national stockpiles. Additionally, medical countermeasures at this 

point may be supported through FDA licensure, approval, or clearance by the Project BioShield 

Special Reserve Fund, the HHS Pandemic Influenza Medical Countermeasures Program, or 

other, non-governmental, funding mechanisms. These final stages of product development 

include regulatory review and approval, post-marketing surveillance, and Phase 4 clinical 

evaluation. 

BARDA will allow products to advance further along the development pipeline before 

acquisition. Moreover, BARDA will ensure that acquisition funds are optimally utilized in 

stockpiling medical countermeasures that are the most appropriate products for use in a public 

health emergency. Other USG funding sources, such as CDC Division of Strategic National 

Stockpile (DSNS) funds and Pandemic Influenza Preparedness appropriations, also could be 

used to procure qualified medical countermeasures. 

BARDA will encourage stakeholders to obtain advice from the FDA on regulatory requirements 

for approval, licensure, or clearance of medical countermeasures. One of the key elements of the 

BARDA contracts for advanced development of medical countermeasures for pandemic 

influenza preparedness and response is the requirement to obtain FDA licensure of these medical 

countermeasures. The FDA will continue to meet with interested persons and publish material to 

provide regulatory and product development guidance on qualified countermeasures and 

qualified pandemic or epidemic products. 

ACQUISITION MANAGEMENT 

HHS will build into BARDA a robust acquisition management system to maximize control, 

transparency, and accountability in all acquisition decisions and in the evaluation of contractor 

performance. This framework will ensure sound stewardship of public dollars through defined 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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10

processes and decision-points to guide procurement decisions and performance management for 

advanced research and development programs. With its acquisition management system, 

BARDA will move from managing component procurement projects to managing a systems 

acquisition program. This evolution will require extensive training in systems acquisition for 

contracting and project management staff. BARDA will systematically identify, analyze, and 

apply lessons learned to support the development of its acquisition management system. 

The BARDA systems acquisition approach will incorporate the following well-established 

concepts for the management of complex development programs: 

• Life cycle aspects of acquisition 

• Analysis tools and techniques 

• Test and evaluation 

• Analysis of alternatives 

• Cost, benefit, and performance metrics 

• Defined milestones and Milestone Decision Authority for appropriate 

development stages 

• Defined plans for test and evaluation, systems engineering, and acquisition 

support. 

INNOVATIVE TECHNOLOGIES 

As identified in the FDA’s Challenge and Opportunity on the Critical Path to New Medical 

Products, innovative technologies will drive advances in medical countermeasure 

development.20 Identifying those areas where investing in innovation will have the highest 

impact is a great challenge. An important partner for BARDA in fostering innovative 

technologies for medical countermeasures is DOD, through the Transformational Medical 

Technologies Initiative and the Defense Sciences Office of the Defense Advanced Research 

Projects Agency (DARPA). To the extent that these DOD candidate products or technologies 

address public health emergency preparedness priorities, BARDA may incorporate them into its 

medical countermeasure programs and initiatives for the U.S. civilian population. 

BARDA will engage the medical product technology community (public and private sectors) to 

identify, encourage, and support the development of innovative broad spectrum approaches. 

While the early proof of concept is likely to be performed by other agencies or private industry, 

BARDA will select technologies to move forward for qualification. A key element for 

evaluating these technologies will be their potential to offer enhanced capabilities with regard to 

existing threats as well as to future and unknown threats. These innovative, flexible, broad 

spectrum products and technologies include: 

 

20 Ibid. 
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• Broad Spectrum Medical Countermeasures 

These products have broad spectrum activity against a range of threat agents and 

are desirable because they have the potential to be active against engineered and 

emerging threats. New classes of broad spectrum antimicrobials or antitoxins 

likely will target novel, but common, pathogen gene products or virulence factors. 

Broad spectrum products also may modulate host responses. Additionally, a 

small number of broad spectrum medical countermeasures (e.g., a universal 

influenza therapy or vaccine) potentially could provide the same coverage as 

dozens of pathogen-specific products, thereby reducing the number of products 

that are required in the SNS. 

• Broad Spectrum Technologies 

This type of medical countermeasure may include technologies that are broadly 

applicable to improved product performance, such as adjuvants; temperature 

stabilization technologies; formulations that improve bioavailability or that allow 

for co-formulation of multi-valent drugs; and immuno-modulators as adjunct 

treatment to traditional anti-infective therapy. 

• Broad Spectrum Platforms 

The application of proven platform technologies to the development of new 

medical countermeasures has the potential to reduce significantly the time and 

cost required to bring products to market. Technologies may include platform 

screening systems, universal expression modules, alternative fermentation, and 

chemical synthesis designs. The potential to rapidly apply such platform 

technologies to new threats will shorten and streamline the process of drug 

discovery and development. 

TECHWATCH AND STAKEHOLDER OUTREACH 

BARDA will maintain a contemporary understanding of public and private sector medical 

countermeasure development and acquisition activities through an endeavor known as 

TechWatch. Areas of TechWatch focus include private sector research and development 

activities and related USG initiatives. TechWatch is an interactive process that provides 

stakeholders the opportunity to directly communicate information on candidate medical 

countermeasures to BARDA through a dedicated portal, to make presentations to BARDA, and 

to respond to Requests for Information and Sources Sought Notices. 

BARDA and the HHS PHEMCE remain committed to reaching out and engaging interested 

parties seeking to develop and manufacture medical countermeasures that meet HHS 

requirements. This outreach enables effective collaboration with public and private sector 

persons in the domestic and international medical product development communities, including 

academia, industry, and federal, state, and local governments. These efforts serve as an 

opportunity to maximize the transparency of HHS priorities, to solicit feedback, and to discuss 

implementation of future medical countermeasure advanced development and acquisition 

programs. 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

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Four specific BARDA outreach efforts are: 

 

• HHS PHEMC Enterprise Stakeholders Workshop 

Annually, the BARDA office will convene a meeting with interested persons to 

communicate HHS priorities for medical countermeasure development and 

acquisition and to receive feedback that can be appropriately incorporated into 

future efforts.21 

• BARDA Industry Day 

Annually, the BARDA office will provide an opportunity for industry 

representatives and other interested parties to demonstrate in an open meeting the 

operation of biodefense technologies relevant to vaccines, diagnostics, 

therapeutics, and non-pharmaceutical medical countermeasures.22 

• Stakeholders Portal 

BARDA will provide ongoing outreach to product developers through the 

stakeholders portal at www.MedicalCountermeasures.gov. With this portal, 

BARDA will centrally manage stakeholder requests for meetings with the USG to 

discuss possible development or acquisition targets and to present medical 

countermeasure product information. The portal will also provide interested 

persons with information on government-sponsored opportunities and events 

related to medical countermeasures. BARDA anticipates that 

www.MedicalCountermeasures.gov will be available for use in Summer 2007. 

• BARDA Dialogues 

BARDA staff will continue their ongoing efforts to engage with stakeholders 

regarding the implementation of the BARDA legislation. In March 2007, for 

example, ASPR and BARDA leadership participated in a roundtable discussion 

with the Center for Biosecurity of the University of Pittsburgh Medical Center.23 

CONCLUSION 

The Pandemic and All-Hazards Preparedness Act established BARDA to promote innovation, to 

increase the potential for success for both medical countermeasure developers and the USG, and 

to invest in medical countermeasure development that will carry products through the crucial 

phases of advanced development to the acquisition of final products. BARDA is the focal point 

within HHS to accelerate, facilitate, and support the development of medical countermeasures 

for the public against the highest priority manmade and natural public health threats facing the 

Nation. Through the leadership of ASPR and the guidance of the HHS PHEMCE, BARDA will 

 

21 Additional information is available at www.hhs.gov/aspr/ophemc/enterprise/bioshield/2007workshop.html 22 Additional information is available at www.hhs.gov/aspr/ophemc/barda/index.html

23 Grovall GK, et al. Meeting Report: Biomedical Advanced Research and Development Authority (BARDA) 

Roundtable. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. 2007. 5(2):1-6. 
DRAFT BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement 

July 5, 2007 

13

communicate and coordinate with stakeholders regarding medical countermeasure and 

technology development priorities and activities. 

With NIH basic research and development programs, the newly established BARDA advanced 

development funding mechanism, the acquisition support available through the Project BioShield 

Special Reserve Fund, DSNS assets, and appropriations for pandemic influenza medical 

countermeasures, HHS now has a comprehensive, end-to-end capability to facilitate the 

successful advanced development, procurement, and availability of medical countermeasures to 

increase public health preparedness for responding to chemical, biological, radiological, and 

nuclear threats and emerging infectious diseases, including pandemic influenza. BARDA will 

select the most promising products and technologies in the pipeline; transition those products and 

technologies to advanced development and qualification; and fund their support to a stage at 

which the products and technologies are appropriate for acquisition. The scope of BARDA’s 

advanced development activities will depend on future funding levels.