Biomedical Advanced Research and Development Authority (BARDA) Market Research Report

Background

Overview

The Biomedical Advanced Research and Development Authority (BARDA) is a component of the U.S. Department of Health and Human Services (HHS), operating under the Office of the Assistant Secretary for Preparedness and Response (ASPR). Established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA), BARDA is dedicated to the advanced development and procurement of medical countermeasures (MCMs) to address public health emergencies. These emergencies include chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases.

Mission and Vision

BARDA's mission is to develop and procure vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products that mitigate the public health and medical consequences of CBRN incidents, pandemic influenza, and emerging infectious diseases. Its vision is to enhance national health security by ensuring the availability of effective medical countermeasures during public health emergencies.

Primary Area of Focus

BARDA focuses on the advanced development and procurement of medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical products, to protect the nation from a wide range of health security threats.

Industry Significance

As a pivotal entity within the U.S. federal government, BARDA plays a critical role in bridging the gap between early-stage research and the availability of medical countermeasures during public health emergencies. Its collaborations with the biomedical industry and other federal agencies are essential for the rapid development and deployment of life-saving interventions.

Key Strategic Focus

Core Objectives

Advanced Development: Support the transition of promising medical countermeasures from early research through advanced development stages.

Procurement and Stockpiling: Acquire and maintain stockpiles of essential medical countermeasures for rapid deployment during emergencies.

Public-Private Partnerships: Foster collaborations with industry partners to accelerate the development and availability of medical countermeasures.

Specific Areas of Specialization

Chemical, Biological, Radiological, and Nuclear (CBRN) Threats: Develop countermeasures to address potential CBRN incidents.

Pandemic Influenza: Advance the development of vaccines and therapeutics for influenza strains with pandemic potential.

Emerging Infectious Diseases: Respond to new and re-emerging infectious diseases through rapid development of diagnostics, treatments, and vaccines.

Key Technologies Utilized

Recombinant Protein Expression: Utilized in the development of vaccines and therapeutics.

Cell-Based Manufacturing Platforms: Employed for the production of vaccines and biologics.

Diagnostic Assays: Developed for rapid detection of infectious agents.

Primary Markets or Conditions Targeted

Public Health Emergencies: Addressing threats such as bioterrorism, pandemics, and emerging infectious diseases.

National Stockpiles: Ensuring the availability of medical countermeasures for the Strategic National Stockpile (SNS).

Financials and Funding

Funding History

In fiscal year 2020, BARDA's budget was approximately $1.6 billion, which included $512 million for medical countermeasures, $192 million for combating antibiotic-resistant bacteria, and $260 million for advanced research and development.

Recent Funding Rounds

During the COVID-19 pandemic, BARDA received additional funding to support the rapid development and procurement of vaccines, therapeutics, and diagnostics. This included significant investments in Operation Warp Speed to expedite vaccine development.

Notable Investors

As a government agency, BARDA's funding is provided by the U.S. federal government through appropriations from Congress.

Intended Utilization of Capital

The capital is utilized for:

Advanced Research and Development: Funding the late-stage development of medical countermeasures.

Procurement and Stockpiling: Acquiring and maintaining stockpiles of essential medical countermeasures.

Infrastructure Development: Building and enhancing manufacturing capabilities for medical countermeasures.

Pipeline Development

Key Pipeline Candidates

BARDA supports a diverse portfolio of medical countermeasures, including:

Vaccines: For influenza, anthrax, smallpox, and other infectious diseases.

Therapeutics: Antibiotics, antivirals, and other treatments for infectious diseases.

Diagnostics: Rapid diagnostic tests for infectious agents.

Stages of Clinical Trials or Product Development

BARDA's supported products are at various stages, from preclinical development to late-stage clinical trials and FDA approval.

Target Conditions

Infectious Diseases: Including influenza, anthrax, smallpox, and emerging infectious diseases.

Bioterrorism Threats: Countermeasures for potential CBRN incidents.

Relevant Timelines for Anticipated Milestones

Timelines vary by product and threat, with BARDA aiming to expedite development to ensure rapid availability during public health emergencies.

Technological Platform and Innovation

Proprietary Technologies

Pfēnex Expression Technology™: A recombinant protein expression system used in vaccine development.

Cell-Based Manufacturing Platforms: For scalable production of biologics.

Significant Scientific Methods

Recombinant DNA Technology: For the development of vaccines and therapeutics.

High-Throughput Screening: To identify potential therapeutic candidates.

AI-Driven Capabilities

While specific AI-driven capabilities are not detailed, BARDA collaborates with industry partners to incorporate advanced technologies into the development of medical countermeasures.

Leadership Team

Key Executive Profiles

Dr. Gary Disbrow: Acting Director of BARDA. Dr. Disbrow has extensive experience in public health and emergency response, having previously served as Director of the Medical Countermeasures program and Director of the CBRN division at BARDA.

Ashim Subedee, Ph.D.: Acting Director of the Division of Research, Innovation, and Ventures (DRIVe). Dr. Subedee leads efforts to foster health security innovation through public-private partnerships and has a background in biomedical entrepreneurship and product development.

Mike Angelastro: Director of the Pharmaceutical Countermeasures Infrastructure Division (PCI). Mr. Angelastro oversees strategic investments to strengthen the nation's medical countermeasure manufacturing industrial base and has over 15 years of experience at BARDA.

Competitor Profile

Market Insights and Dynamics

The market for medical countermeasures is characterized by the need for rapid development and deployment during public health emergencies. Key drivers include the emergence of new infectious diseases, bioterrorism threats, and the necessity for national preparedness.

Competitor Analysis

As a government agency, BARDA does not have direct competitors. However, it collaborates with various private sector entities, including pharmaceutical companies, biotechnology firms, and contract research organizations, to develop and procure medical countermeasures.

Strategic Collaborations and Partnerships

Significant Collaborations

Public-Private Partnerships: BARDA collaborates with industry partners to accelerate the development of medical countermeasures.

Centers for Innovation in Advanced Development and Manufacturing (CIADMs): BARDA has established CIADMs to enhance domestic manufacturing capabilities for medical countermeasures.

Operational Insights

Strategic Considerations

BARDA's strategic focus includes:

Enhancing Manufacturing Infrastructure: Building and expanding facilities to support the rapid production of medical countermeasures.

Fostering Innovation: Encouraging the development of novel technologies and approaches to address emerging health threats.

Competitive Advantages

BARDA's unique position within the federal government allows it to coordinate resources and expertise across agencies, facilitating a comprehensive response to public health emergencies.