Broad Agency Announcement for the Advanced Research and Development of Medical Countermeasures

Broad Agency Announcement for the Advanced Research and Development of Medical Countermeasures is sponsored by Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), HHS. BARDA solicits proposals for the advanced research and development of medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases, including therapeutics for Ebolavirus and Marburgvirus.

Medical Countermeasures | About BARDA (Biomedical Advanced Research and Development Authority) only on official, secure websites The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop 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.

Celebrating 115 FDA Approvals, Licensures, and Clearances For BARDA-Supported Products Medical Countermeasures Programs Director Meet BARDA's Division Leadership Kimberly Armstrong, Ph. D. , MT (ASCP) Christopher Houchens, Ph.

D. Bill G. Kapogiannis, M.

D. , FIDSA Management Operations Director MCM Preparedness and Response Director Gary L. Disbrow, Ph.

D. | BARDA Director Gary L. Disbrow, Ph.

D. is the Director of the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Dr. Disbrow joined BARDA in January of 2007 and has held a variety of positions related to the advanced development and procurement of medical countermeasures against an array of threats to national security and public health. Prior to becoming the Acting BARDA Director, Dr. Disbrow served as Deputy Assistant Secretary (ASPR) and the Medical Countermeasures Program Director.

In October 2013, Dr. Disbrow was named Acting Director of the Chemical, Biological, Radiological and Nuclear (CBRN) Division and was subsequently named the Director of the Division in December of 2014. During that time, the CBRN Division built a robust pipeline of candidate products under advanced research and development.

In 2014 and 2015, Dr. Disbrow was identified as the Ebola Incident Coordinator for BARDA and worked closely with the BARDA Director on funding needs, development of candidate products, and was the primary liaison for BARDA across the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). These efforts led to the first licensed Ebola vaccine, ERVEBO licensed in December 2019.

Prior to joining BARDA, Dr. Disbrow was an Assistant Professor of Oncology and Pathology at Georgetown Medical Center where he worked on human papillomavirus (HPV) vaccines and therapeutics. Dr. Disbrow has previously worked at W. R.

Grace, Kodak, and Genecor. April Brys, Ph. D.

| Acting MCPSS Director April Brys, Ph. D. | Acting MCPSS Director April Brys, Ph.

D. is the Acting Deputy Director and Director of Medical Countermeasures Program Support Services (MCPSS) for the Biomedical Advanced Research and Development Authority (BARDA) and directs BARDA's Nonclinical Division (NCD), Division of Clinical Development (DCD), and its Regulatory and Quality Affairs Division (RQA).

Collectively, these divisions, their networks, programs, and subject-matter experts, support the advanced development of life-saving drugs, vaccines, therapeutics, diagnostics, and medical devices to mitigate chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza and emerging infectious diseases through collaborations with industry partners and colleagues across the U.S. government.

Dr. Brys also oversees BARDA's internal operations including all workforce related areas such as recruitment and non-recruitment actions, recognition awards, training, and travel. Dr. Brys joined BARDA in 2020 as the Director of the Division of Nonclinical Development leading the coordination, oversight, and execution of the critical path nonclinical efforts supporting BARDA's medical countermeasure enterprise.

Prior to joining BARDA, Dr. Brys held various positions focused on advancing development of medical countermeasures including as the Vice President of the Drug Development Division at Southern Research and the Director of the Clinical and Nonclinical Business Unit for Battelle. Robert Johnson, Ph. D.

| Medical Countermeasures Programs Director Robert Johnson, Ph. D. is the Director of Medical Countermeasures Programs (MCMP) for the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

As the MCMP Director, Dr. Johnson overseas the MCM development efforts across BARDA. In this role, Dr. Johnson has a focus on incorporating new technologies that can provide a faster pandemic response across multiple threat areas, as well as new partnerships and approaches to ensure sustainment of current and future capabilities.

Dr. Johnson joined BARDA in November of 2017 as Director of the Influenza & Emerging Infectious Diseases Division (IEIDD). In this position, Dr. Johnson led efforts focused on advanced development and manufacturing capacity of medical countermeasures against pandemic influenza and emerging infectious diseases. Joffrey Benford, MBA | Contract, Management and Acquisition Director Joffrey Benford oversees the execution of approximately $1.

7 billion in spends annually and the facilitation of a contract portfolio valued at over $60 Billion as the Director of BARDA's Division of Contracts Management and Acquisitions (CMA), which is responsible for providing executive advice and contracting management of all BARDA acquisitions.

Before starting his career in federal service, Mr. Benford spent close to five years in the financial services industry with various multinational organizations. He joined the U.S. Department of Health & Human Services (HHS) in 2013 as a contracting officer and later matriculating into a branch chief, where he managed Advanced Development and Manufacturing contracts valued at over $1. 5 billion including options.

He also served as the Contracting Officer responsible for administering BARDA's Embryonated Egg Supply contract with a net value well over $42 million. As a Branch Chief, he provided support to numerous commercial and U.S. government clients in developing vaccines against and therapeutics for pandemic and seasonal influenza and emerging infectious diseases.

Rodney Wallace | Detection, Diagnostics, and Device Infrastructure Director Rodney Wallace joined BARDA in 2009 as part of the newly formed diagnostics function within the Chemical Biological Radiological and Nuclear Division (CBRN). Development of diagnostic and device countermeasures were combined into a focused division in 2014.

DDDI leads the development of diagnostic and device countermeasures for CBRN, Pandemic Influenza, and Emerging Infectious Disease. Mr. Wallace led BARDA's diagnostic response during multiple public health emergencies including Ebola, Zika, and COVID-19. BARDA funded partners have received 32 FDA clearances or approvals and 41 EUAs for countermeasures developed under his leadership.

Mr. Wallace and team are recipients of three HHS Secretary's Awards for medical countermeasure development. Prior to joining BARDA, Mr. Wallace held executive positions with companies that develop and manufacture clinical diagnostic and microarray platforms including Digene, which is now part of Qiagen, and NimbleGen Systems, now part of Roche.

He worked for nine years in the diagnostics division of Abbott Laboratories developing large clinical diagnostics systems. He has experience developing electro-optical equipment for industrial, transportation, aviation, and military applications. Mr. Wallace holds a bachelor's degree in electrical engineering from Texas A&M University.

Christopher Houchens, Ph. D. Christopher Houchens, Ph.

D. | Chemical, Biological, Radiological and Nuclear Countermeasures Division Director Chris Houchens, Ph. D.

is the Director of the Division of Chemical, Biological, Radiological and Nuclear Countermeasures (CBRN). His primary role is building and managing a diverse product portfolio focused on the advanced research, development, and procurement of novel vaccines, prophylactics, therapeutics, diagnostics and devices as medical countermeasures against chemical, biological, radiological and nuclear threats.

In this role, Dr. Houchens conducts outreach with industry to identify new partnership opportunities and participates on numerous interagency working groups across the U.S. government with the goal of strengthening the ability and capacity of the U.S. to rapidly respond to naturally occurring and intentionally engineered threats to public health. David Simon, Ph. D.

| Medical Countermeasures Preparedness and Response Director David Simon, Ph. D. is the inaugural Medical Countermeasures Preparedness and Response Director within the Office of Medical Countermeasures Program.

In this role, Dr. Simon leads BARDA response efforts and is responsible for improving BARDA's future response posture, in part by informing medical countermeasure development through the lens of national response needs.

Dr. Simon's responsibilities also include Deputy Director of Project NextGen, a joint BARDA and NIAID initiative aimed at accelerating the development of next-generation vaccines, therapeutics, and technologies through public-private collaborations.

Dr. Simon's role as Medical Countermeasures Preparedness and Response Director is a key component of BARDA's work within the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), contributing to the nation's preparedness and enhancing the nation's ability to respond to known and unknown threats.

Dr. Simon has served within BARDA for nearly a decade, working in multiple branches in the Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasures (CBRN) and leading multiple COVID-19 vaccine development activities as part of the COVID-19 public health emergency response, including the USG PCT lead for both the Pfizer and AstraZeneca vaccine development efforts.

Additionally, he was the Operations Rollout Coordinator for the national 2022 fall COVID-19 booster dose campaign. Dr. Simon has worked as a Senior Director for Project Management within start-up biotech, and before his experiences at BARDA, Dr. Simon held various positions as a Science and Engineering Technical Assistant within the Department of Defense and Defense Advanced Research Projects Agency. April Brys, Ph.

D. | DNCD Director April Brys, Ph. D.

is the Acting Deputy Director and Director of Medical Countermeasures Program Support Services (MCPSS) for the Biomedical Advanced Research and Development Authority (BARDA) and directs BARDA's Nonclinical Division (NCD), Division of Clinical Development (DCD), and its Regulatory and Quality Affairs Division (RQA).

Collectively, these divisions, their networks, programs, and subject-matter experts, support the advanced development of life-saving drugs, vaccines, therapeutics, diagnostics, and medical devices to mitigate chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza and emerging infectious diseases through collaborations with industry partners and colleagues across the U.S. government.

Dr. Brys also oversees BARDA's internal operations including all workforce related areas such as recruitment and non-recruitment actions, recognition awards, training, and travel. Dr. Brys joined BARDA in 2020 as the Director of the Division of Nonclinical Development leading the coordination, oversight, and execution of the critical path nonclinical efforts supporting BARDA's medical countermeasure enterprise.

Prior to joining BARDA, Dr. Brys held various positions focused on advancing development of medical countermeasures including as the Vice President of the Drug Development Division at Southern Research and the Director of the Clinical and Nonclinical Business Unit for Battelle. Bill G. Kapogiannis, M.

D. , FIDSA Bill G. Kapogiannis, M.

D. , FIDSA | Division of Clinical Development Director Bill Kapogiannis, MD is the Director of the Division of Clinical Development (DCD). In this role, Dr. Kapogiannis brings his extensive experience in developing and providing safety oversight for drug treatment studies.

He joined BARDA and DCD in 2023 from the NIH where he led clinical research programs there for more than 18 years.

Most recently he served as: The Acting NIH Associate Director for AIDS Research and the Acting Director of the NIH Office of AIDS Research (OAR) in the NIH Office of the Director, The Scientific Director and Medical Officer for the Adolescent Medicine Trials Network for HIV/AIDS Interventions in the Maternal and Pediatric Infectious Diseases Branch and NIH's National Institute of Child Health and Human Development (NICHD), and The Executive Secretary for and Editor of the Guidelines on the Management of Opportunistic Infections in HIV-Exposed and Infected children for DHHS.

Ashim Subedee, Ph. D. | Acting DRIVe Director Ashim Subedee is the Acting Director of the Division of Research, Innovation, and Ventures (DRIVe) and the Director of the DRIVe Catalyst Office at the Biomedical Research & Development Authority (BARDA), within the U.S. Department of Health & Human Services (HHS).

Ashim leads a team dedicated to fostering health security innovation ecosystem and development and commercialization of next-generation health security technologies through several novel public private partnerships. These include multiple R&D funding programs through BARDA Ventures – a venture capital investment partnership and the BARDA Accelerator Network – partnerships to provide accelerator services and proof of concept funding.

Prior to BARDA, Ashim was at the NIH where he supported biomedical entrepreneurship and product development by both academic and small business innovators at the NCI Small Business Development Center, NIH Small Business Education and Entrepreneurial Development (SEED) Office, and the Rapid Acceleration of Diagnostics (RADx) program.

Ashim joined the federal government as a Presidential Management Fellow and worked at multiple programs across the NIH and at the FDA Center for Drug Evaluation and Research (CDER). He received his PhD in Biological and Biomedical Sciences with a secondary concentration on Science, Technology, and Society from Harvard University.

Mike Angelastro | Pharmaceutical Countermeasures Infrastructure Division Director Mike Angelastro has served at BARDA for more than 15 years and is currently the Director of the Pharmaceutical Countermeasures Infrastructure Division (PCI).

In this role he oversees the Contract Development and Manufacturing Organization Network Branch, the Biopharmaceutical Manufacturing Partnership Branch, and the Pandemic Vaccine Preparedness and Readiness Branch in support of the ASPR/BARDA mission.

Mr. Angelastro's work centers on engagement with stakeholders and key industry performers to ensure policy and tactical alignment, as well as leading a team of program officials and subject matter experts that oversee a multi-billion dollar portfolio of strategic investments to strengthen the nation's medical countermeasure manufacturing industrial base. John Rigg | Management Operations Director Kimberly Armstrong, Ph. D.

, MT (ASCP) Kimberly Armstrong, Ph. D. , MT (ASCP) | Influenza & Emerging Infectious Diseases Division Director Kimberly Armstrong, Ph.

D. is the Director of the Influenza & Emerging Infectious Diseases Division (IEIDD).

IEIDD primarily focuses on preparing for the next influenza pandemic by modernizing influenza vaccines, developing new therapeutics for the treatment of acute respiratory distress syndrome, advancing the development of pre-exposure prophylaxis options to protect the most vulnerable populations, and managing the National Pre-pandemic Influenza Vaccine Stockpile (NPIVS).

Prior to becoming the Division Director in 2023, Dr. Armstrong was the Chief of the Therapeutics Branch within IEIDD. Her work as Branch Chief focused on testing antivirals for the treatment of hospitalized influenza infections and eventually pivoting the focus of the severe infections program from antivirals to host-directed therapeutics.

In addition, during the COVID-19 pandemic, Dr. Armstrong led the Therapeutics team to achieve Emergency Use Authorizations for 10 therapeutics and to procure millions of treatment courses of COVID-19 antivirals and distribution nationwide.

Before joining BARDA in 2015 as a Project Officer, Dr. Armstrong managed a regulatory science research portfolio for the Office of Counterterrorism and Emerging Threats at the Food and Drug Administration (FDA). Sufficient resources are needed for BARDA to maintain and support portfolio investments to ensure long-term access to licensed medical countermeasures (MCMs) that are vital to the nation's health security.

Strengthening BARDA's agile preparedness and response posture to combat health security threats. Chemical, Biological, Radiological & Nuclear CBRN helps innovators develop promising MCMs from preclinical development to clinical trials and manufacturing scale-up to FDA approval.

Radiological & Nuclear MCMs Providing expert knowledge and support to BARDA’s programs in advanced product development and clinical research, including supporting BARDA clinical studies via the Clinical Studies Network (CSN). Integrated centralized resource: Our focus is BARDA’s success. Contract Management and Acquisition CMA provides flexible and innovative acquisition solutions in support of BARDA’s mission.

CMA strives to enhance the U.S. government’s contracting capabilities to respond quickly to both known and emerging public health threats. Detection, Diagnostics, and Devices Infrastructure DDDI invests in diagnostics and devices across the spectrum of advanced research and development, stockpiling, and domestic manufacturing capacity expansion. DNCD provides nonclinical models, tools, and expertise to advance MCM development.

DNCD provides expertise and laboratory capacity to establish and share nonclinical models, conduct appropriate nonclinical studies to support FDA approval, and evaluate potential MCM candidates prior to BARDA investment. Research, Innovation & Ventures DRIVe works to accelerate the development and availability of transformative technologies and approaches to protect Americans from health security threats.

DRIVe aims to de-risk the most promising technologies and capabilities. Influenza & Emerging Infectious Diseases Influenza & EID invests in advanced research and development, manufacturing capacity, and procurement of MCMs to protect the nation from pandemic influenza and other emerging infectious diseases.

Pandemic Vaccines and Adjuvants Pharmaceutical Countermeasures and Infrastructure PCI provides expertise to strengthen the nation’s ability to manufacture, distribute, administer, and scale production of lifesaving MCMs.

Regulatory & Quality Affairs RQA ensures that BARDA-supported MCMs are safe, effective, and in compliance with relevant and current laws, regulations, and guidelines by providing technical expertise and innovative regulatory and policy approaches. Special Initiatives and Other Programs BARDA invests in innovative projects across our portfolio, including promising technologies, platforms, and programs.

We launch and support efforts designed to accelerate and foster smaller new projects. Radiation Emergency Medical Management (REMM) PRISM: Primary Response Incident Scene Management Chemical Hazard Emergency Medical Management (CHEMM)