Biomedical Advanced Research and Development Authority (BARDA)
The ORISE Research Participation Program has announced new fellowship opportunities at the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS).
The ORISE BARDA program is a training and succession planning mechanism designed to provide graduate students, postgraduates, and university faculty opportunities to participate in animal model and medical countermeasure (MCM) research and development. Since BARDA is engaged in program management; there will be no bench or wet lab research associated with these fellowship positions.
The ORISE BARDA program is an educational and developmental program formed in partnership with Oak Ridge Associated Universities (ORAU) and the U.S. Department of Energy (DOE) through an Interagency Agreement. BARDA ORISE participants do not perform work in place of federal employees, nor are they considered to be BARDA or US Government employees.
The BARDA ORISE program is considered a valuable human capital tool which provides educational experiences and training in public health as a means to introduce highly motivated participants to public health as a viable career field.
The guidelines provide a system and framework of information that ensures applicable policies, regulations, laws, and agreements related to ORISE are observed; effective stewardship of government resources through the adoption of effective, consistent, and efficient business practices; and development of successful mentoring relationships which encourage education, and support the national defense and public health mission of BARDA.
- Post-Graduates can apply at https://www.zintellect.com/Opportunity/Details/HHS-BARDA-2023-01
Post Graduate Appointments
Graduates: One year appointment which may be renewed, for a maximum of five years, upon recommendation of BARDA and is contingent on the availability of funds. Participants must have received a bachelor's, master's or doctoral degree in one of the relevant fields within the last five years.
Below are specific opportunities for Graduates available at BARDA.
Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Countermeasures Vaccine Branch
With the recent outbreaks of emerging infectious diseases such as Ebola, Zika, and now COVID-19, BARDA is playing more of a role as a response agency, helping to address public health needs by advancing the development of MCMs. Leveraging BARDA’s recent experience in helping to push the Ebola vaccine, ERVEBO®, to licensure, we are working hard to help address the current COVID-19 pandemic. However, there are still CBRN threats for which we do not have licensed vaccines. The fellowship within the Vaccine Branch will primarily support vaccine development efforts within the CBRN Vaccine Branch by coordinating activities related to market research into vaccine candidate pipelines for emerging viral threats. The fellow will conduct literature searches and market research, as well as participate in communications with interagency partners. Other opportunities will include providing technical support for current CBRN Vaccine programs for smallpox, anthrax, and viral hemorrhagic fever viruses. This will include technical assessments to support the CBRN Vaccine program mission.
Antivirals and Antitoxins Branch
The Antivirals and Antitoxins Branch is focused on the development of therapeutic medical countermeasures that can be used to respond to public health emergencies caused by Anthrax, Botulinum, Smallpox, and selected filoviruses, including Ebola, Marburg, and Sudan viruses. The selected fellow will join a group of experienced scientists tasked with managing a portfolio of complex advanced research and development initiatives to augment and improve on existing capabilities and fulfill unmet needs across the Branch’s threat space. Current active areas of interest in the Branch include small molecule antivirals with efficacy against filoviruses and, ideally, other RNA viruses.
A selected fellow’s activities will align closely with those of existing government personnel to provide the fellow with a clear understanding of AVAT efforts. The fellow will gain experience in medical countermeasure development, including manufacturing, nonclinical, clinical, and regulatory components. Primary activities will include literature reviews, meeting or workshop coordination, market research, portfolio evaluation, communication with interagency and industry partners, manuscript development, and program management, each of which will be tailored to the selected fellow’s experience level while remaining true to the intent of the opportunity and allowing for growth.
Radiological/Nuclear Countermeasures Branch
The Radiological/Nuclear Medical Countermeasure (MCM) program at BARDA is focused on identifying MCMs that can be used in radiological/nuclear mass casualty events and the development of nonclinical models to support the advanced development of MCMs. Areas of interest include the impact of radiation on vascular injury, coagulopathy, multi-organ failure, and dysregulation of the hematopoietic system as well as sex differences to radiation exposure. The Radiological/Nuclear MCM program has supported natural history studies of radiation injury in novel nonclinical models and evaluating MCMs. This fellowship will focus on collaborating with the nonclinical model team to refine the model, analyze data, and use the information to identify new MCM targets. Additionally, there is ample market research that needs to be completed for the numerous pathophysiologies associated with acute radiation injury. Another area of interest for fellowship activity would be in our blood products portfolio and assisting the project officers of those programs.
The fellow will team with project officers on the nonclinical model development team and some acute radiation syndrome MCM projects. Main activities will include contributing to discussions on study design for animal model development of acute radiation syndrome, assisting in data analyses, and participating in drafting manuscripts to report findings from various models. This will require comprehensive literature searches on a variety of topics including but not limited to vascular injury, prospective medical countermeasure targets, market research for certain prospective product classes, and radiation biology. The fellow will be required to report and share their findings with nonclinical model team and assist in development of a spreadsheet for prospective MCMs targets to screen. Other opportunities may include providing support for the inter-agency integrated program team for Radiological Nuclear Countermeasures, assisting in the development of relevant policy documents, taking relevant training, interacting with animal model developers, participation in team communications with FDA, drug developers, CROs, and NIH all to ensure progress on the mission of the Radiological/Nuclear Medical Countermeasure (MCM) program.
Chemical Medical Countermeasures Branch
The Chemical MCM program at BARDA is focused on developing therapeutics and non-pharmaceutical products that enable us to effectively treat the injuries arising from exposure to chemical weapon agents and toxic industrial chemicals. We take a holistic approach, focusing on addressing the effects of the chemical - and their overlap with conditions seen in ‘normal’ clinical practice, rather than trying to develop specific ‘antidotes’ to individual agents. Our portfolio ranges from work to understand the physiological response to various chemicals (including both non-clinical and organ chip efforts) to screening models for repurposed drugs and development of novel drugs, to advanced development and procurement of drug-device combination products including autoinjectors and inhalation delivery devices. Because exposure to toxic chemicals is almost always an emergency, our products must be familiar to, and easy to use by, first responders and emergency medical personnel.
A selected fellow’s activities will align closely with those of existing Chem Team personnel to provide the fellow with a clear understanding of Chem MCM efforts. The fellow will gain experience in all aspects of medical countermeasure development, including manufacturing, nonclinical, clinical, and regulatory efforts. Specific activities will vary according to the fellow’s expertise and interests and could include conducting literature reviews and market research in support of development of realistic microphysiological and non-clinical models to elucidate the natural history of chemical injury or assisting project officers in the management of drug development processes. A newer focus for our program is outreach and collaboration with the users of our products, including fire departments, emergency medical services, emergency managers, and physicians. Work in this area provides opportunities for coordination of workshops and focus groups, preparation of outreach and training materials, and assisting in updating and modernizing the legacy CHEMM website.
Division of Clinical Development
BARDA’s Division of Clinical Development (DCD) supports BARDA Medical Countermeasure (MCM) Divisions and MCM developers by providing expertise to conduct appropriate clinical studies to support FDA approval for products that can be used under EUA and/or licensure. These clinical studies and trials will support BARDA investment decisions in devices, therapeutics, diagnostics, and vaccines. Clinical efforts include proof of concept studies, regulated phase 1, 2, 3, and 4 studies, and product repurposing studies all of which support efforts to continue MCM development. The overall objective of the clinical fellowship program is for the fellow to become proficient in the methodological aspects of conducting clinical studies and trials. The fellow’s mentored activities will include assessment of preclinical work, statistical design, human participant protection, risk/benefit assessment, operational considerations, regulatory considerations, protocol design, pharmacovigilance, and dissemination of results. The fellow will gain experience developing the technical, scientific and program management skills necessary to successfully execute a clinical trial in today’s complex environment. Primary activities will include literature reviews, market research, communication with interagency and industry partners, project oversight, and program management, each of which will be tailored to the selected Fellow’s experience level while remaining true to the intent of the opportunity and allowing for growth. During the clinical fellowship, the fellow will have exposure to all BARDA MCM Division core areas of research. At completion of the fellowship period, the clinical fellow will have a fundamental understanding of multiple facets of clinical development in support of MCM advanced research and development. Come learn how to take the final steps to take scientific ideas and concepts and transform them into products that protect the public’s health. A fellow with expertise in immunology, biology, nursing, mathematics, statistics, computer science or data science is desired.
Division of Research, Innovation and Ventures (DRIVe)
The selected Fellow will join a group of experienced scientists tasked with managing a portfolio of complex advanced research and development initiatives to augment and improve on existing capabilities and fulfill unmet needs across the Branch’s threat space. Activities will align closely with those of existing personnel to provide the Fellow with an in-depth understanding of aspects of medical countermeasure development, primarily in digital health and diagnostic tools. Specifically, programs Lab at Home, ImmuneChip+, NGS-based agnostic diagnostics and Digital MCM offer opportunities for engagement, project management, and programmatic and strategic planning. Primary activities will include literature reviews, market research, portfolio evaluation, communication with interagency and industry partners, project oversight, and program management, each of which will be tailored to the selected Fellow’s experience level while remaining true to the intent of the opportunity and allowing for growth. The Frontiers Office team is especially interested in hosting a Fellow with expertise in next generation sequencing, bioinformatics, data analytics or sensor development, but other areas of expertise will also be considered.
An ORISE Fellow supporting this office would have an opportunity to build and de-risk new strategies for DRIVe, including navigating novel regulatory frameworks for medical countermeasures, and approaches for supporting adoption of such products. The office has two main research programs, Host Based Diagnostics and Host Directed Therapeutics focused on advancing products in clinical development, in addition to an ecosystem program on Healthcare Infrastructure Implementation and Impact (HI-3) which applies the utility of novel health ecosystems, stakeholder collaboration and real world data to maximize clinical impact. The fellow would assist with evaluation of technologies and proposed approaches for medical countermeasure development and pandemic preparedness as well as assist with program management of ongoing contacts. A fellow with expertise in immunology, cell and molecular biology, decentralized healthcare, health data analytics, or clinical utility and adoption studies would be desired.
The Catalyst Office at BARDA DRIVe is a team of innovators, entrepreneurs and commercialization experts and support commercialization of technologies and foster the health security innovation ecosystem with several public private partnership programs including BARDA Ventures, BARDA Accelerator Network and Blue Knight partnership with J&J. The fellow will get in depth understanding of medical countermeasure product development and commercialization. The fellow will have opportunities in the business and commercialization components of life science and technology development, particularly around venture capital practices and methods, product and company incubation as well as product acceleration and providing technical, scientific, and business acumen to scientific problems.
An ORISE Fellow supporting this office will have the opportunity to assist several different efforts led by the DRIVe Alliance team as we collaborate with BARDA divisions, supporting technical and programmatic oversight of programs, as well as participate in the development of CBRN strategic initiatives supporting diagnostics, vaccines and therapeutics. Programs range from needle free technology development to repurposing existing therapeutics for other indications (for AVAT team, CBRN MCM and RAD NUC). Alliance is also starting a program focused on early detection of diseases, starting in the animal population and moving to the human population. ORISE fellows will research new technologies, assist with writing funding requests, reviewing abstracts, managing programs, creating briefings, web announcements, white papers and scientific journal articles. Fellows may also attend conferences, summits, events and performer site visits. Working with the Alliance office is an opportunity to learn about health security activities going on throughout BARDA and other U.S. Government agencies and assist with creating novel technologies to address technology gaps.
Influenza and Emerging Infectious Diseases Division (IEIDD)
IEIDD is focused on developing medical countermeasures for pandemic influenza and emerging infectious diseases, including COVID-19. In addition, IEIDD prepares for the pandemic influenza public health emergency by managing a stockpile of pre-pandemic vaccines and conducting clinical trials to understand the best of the pre-pandemic vaccines in advance of an influenza PHE.
The therapeutics branch is focused on achieving new FDA-approvals of treatments for influenza and emerging infectious diseases. A major focus of the branch is finding treatments for acute respiratory distress syndrome (ARDS) by focusing on threat-agnostic treatments for severe outcomes of infectious disease. In addition, the branch is working to finding pre-exposure prophylaxis options for both seasonal and pandemic influenza.
A fellow joining the branch would work closely with project officers to learn about all aspects of product development including manufacturing development, clinical trial design, critical assessment of nonclinical studies, and creation and editing of regulatory documents of specific products. In addition, the fellow would be tasked with literature reviews, therapeutic landscape development, manuscript writing, workshop coordination, and review of proposals each of which will be tailored to the selected Fellow’s experience level while remaining true to the intent of the opportunity and allowing for growth.