BARDA Division of Research, Innovation, and Ventures (DRIVe)

DRIVe’s Next-Generation Sequencing (NGS) Technologies Initiative

DRIVe is starting with an NGS-based diagnostic that will cover all known and unknown respiratory RNA viruses. Partners will optimize their in-house NGS capabilities for commercial clinical use by:

Lowering the sample-to-result time to under 24 hours
Reducing interference from host RNA
Performing analytical and clinical validation of their platform using both contrived and clinical respiratory samples

Learn more about DRIVe’s NGS-based diagnostic program

11.11.2022

It's all in a day's work. BARDA supports a diverse portfolio of medical countermeasures through public-private initiatives.

BARDA is celebrating 63 FDA approvals, licensures, and clearances for medical countermeasures, supported by BARDA under novel public-private partnerships. Find out more about these FDA approvals.

08.29.2022

Bench to BARDA: How to Take Your Technology from the Lab Bench to BARDA Funding and Beyond

Health-security innovators, biotech early-stagers, checkout this comprehensive program: it's a new, FREE & virtual series of informational discussions - Bench to BARDA: How to Take Your Technology from the Lab Bench to BARDA Funding and Beyond.

It's a FREE series of 6 panel discussions with industry and government partners, focused on providing guidance and insight into how innovators can take their solution from their lab benchtop to BARDA. Attend this series if you are an early-stage startup who would benefit from expert insight and knowledge about the resources available to you throughout your commercialization journey.

Read about all 6 events, and register for the Bench to BARDA - Accelerator Collaborative Series here

Remember to register for all 6 events

Bench to BARDA's series is collaborative offered from the following BARDA accelerators and incubators:

06.01.2022

BARDA's Five-Year Strategic Plan

This strategic plan is built on four goals to fortify and strengthen the nation’s health security:

Enhancing PREPAREDNESS by investing in development of a robust pipeline of innovative medical countermeasures
Embracing our role as an agile RESPONSE organization
Expanding and sustaining public-private PARTNERSHIPS
Continuing to invest in the organization’s WORKFORCE

Each goal is supported by objectives that are critical to achieving BARDA’s mission. Each objective identifies new activities and associated milestones to achieve by 2026. Each one is ambitious and may be challenging to achieve. But when they are interwoven, BARDA will be able to continually provide a solid foundation that protects our nation’s health security. Read the plan to learn how BARDA will leverage our world-class workforce and diverse public-private partnerships to strengthen the nation’s preparedness and response.

05.24.2022

Read the plan

BARDA - DRIVe Launches Phase II Mask Innovation Challenge

Learn more and to enter: https://www.challenge.gov/?challenge=mask-innovation-challenge-phase2

12.17.2021

BARDA is seeking feedback from the biopharmaceutical industry to expand domestic capacity for mRNA-based vaccines, to support domestic and global response, and to better prepare for future pandemics.

They have posted a new Request for Information (RFI) seeking feedback by December 13, 2021 from the biopharmaceutical industry in increasing mRNA vaccine manufacturing capacity by at least one billion doses annually.

The “Bolstering U.S.-based Vaccine Manufacturing Capabilities that Utilize messenger Ribonucleic Acid [mRNA] Technology” RFI is looking for mRNA vaccine manufacturing capabilities.

Information collected from this RFI will serve as continued market research for the development of a possible program where BARDA would partner with industry to achieve the pandemic preparedness goals set forth by the U.S. Government.

Visit their website here to learn more.

11.18.2021

BARDA and its HHS partners have launched a data challenge competition to develop algorithms that could help healthcare providers predict which among their pediatric patients with COVID-19 are likely to develop severe COVID-19 complications.

The challenge is sponsored by BARDA DRIVe, and includes partnerships with two National Institutes of Health institutes (National Center for Advancing Translational Sciences (NCATS) and National Institute of Child Health and Human Development (NICHD)), and the Health Resources & Services Administration (HRSA) Maternal & Child Health Bureau (MCHB).

The total cash prize purse is $200,000, split among up to three winners. Winners may also be eligible to apply for follow-on support from BARDA for further technology development and clinical evaluation.

If you are an innovator interested in developing computational models to help determine which pediatric COVID-19 patients are likely to develop severe illness and complications, such as multi-system inflammatory syndrome in children (MIS-C), check out this new challenge competition: https://www.challenge.gov/challenge/pediatric-covid19-data-challenge/ Note that due to the sensitive nature of the data we are working with, part of the registration requires the completion of training modules (60-90 mins) if not previously completed.

Registration details are above, but note participants should be registered for the Challenge within the N3C Data Enclave by September 15

8.26.2021

BARDA in Partnership with NCATS Seeks Submissions for the Development of Advanced Microphysiological Immune Tissue Platforms Through its New DRIVe ImmuneChip+ Program

BARDA's Division of Research, Innovation, and Ventures (DRIVe) opened a new area of interest (AOI) under the EZ Broad Agency Announcement (EZ-BAA) solicitation, in partnership with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, for the development of advanced microphysiological systems (MPS) that can replicate components of vital human tissues and immune system functions and monitor their interactions. MPS, also called tissue chips, are 3D biophysical platforms comprised of cellular constructs that mimic the structure and function of vital human tissues and organs, such as the lungs, liver, and heart.

Accurately modeling human systems in vitro to test treatment effectiveness is a key step to accelerating the pace of drug discovery and development. However, predicting and testing the effects of therapeutics during early clinical studies is difficult, costly, time-consuming, and can fail to anticipate side effects in people. To safely and quickly evaluate a drug’s effectiveness and toxicity, researchers could utilize MPS in the early stages of studies. MPS may serve as a predictive tool in the drug development process, aid the screening of signaling molecules and drug targets, and help develop precision medicine-based therapies.

Experts at BARDA expect that the use of advanced MPS will create new opportunities for understanding mechanisms of health and disease, and enable more efficient assessment of promising potential biomedical interventions. Recent rapid advances in this field now make the prospect of MPS commercialization and broad usability more realistic.

Under this EZ-BAA AOI, BARDA is seeking applicants with product ideas that focus on enhancing existing, fully-mature MPS that incorporate a human immune system component. These 3D platforms should include in-line sensors for continuous tissue monitoring, and utilize materials suitable for automated manufacturing and assembly of the platforms. Full proposals may be submitted until June 30, 2021. For more details, check out the Special Instructions 013, AOI #7 (PDF - 205KB) of the EZ-BAA (BAA-20-100-SOL-0002).

The EZ-BAA was created to provide a streamlined process through which BARDA's Division of Research, Innovation, and Ventures (DRIVe) can review and accept applications for development funding of transformative products and technologies to protect Americans from health security threats. The application process is both business-friendly and easy to follow.

About NCATS: NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS helps shorten the journey from scientific observation to clinical intervention, visit https://ncats.nih.gov.

Read the Full Article

3.16.2021

Sepsis Among Medicare Beneficiaries: The Burdens of Sepsis

In the last of their 3-paper series, BARDA DRIVe and Centers for Medicare & Medicaid Services assemble their findings to inform methods, models, and forecasts of sepsis among Medicare and Medicaid beneficiaries. In the first of a 3-paper series, we identified more than 9.5M sepsis inpatient hospital admissions during 2012–2018. Over this interval, annual admission counts increased more than 65% to nearly 1.7M in 2018; the total 2018 cost of sepsis hospitalizations and skilled nursing facility care for beneficiaries exceeded $41.5B, excluding pre/post-stay care or any professional fees. Interested in learning more: BARDA Research

2.28.2021

DRIVe EZ-BAA - DRIVe has two main solicitations, EZ-BAA for awards less than $749K and BAA Special Instructions for larger projects

The official posting of the BAA (broad agency announcement) is available on beta.sam.gov and can be found here: BAA-20-100-SOL-0002. The announcement as it is posted on beta.sam.gov serves as the official Governmentwide point of entry (GPE).

This list of AOI (areas of interest) is information directly from the GPE and is provided here for ease of reference only. In the event of any conflict or inconsistency between information on the GPE and the below information, the information found on the GPE shall control.

AOI’s Currently Accepting Submissions:

Unless otherwise noted below, open AOI’s are accepting submissions throughout the EZ-BAA open period which ends 03 February 2023, 1700 HRS ET.

BARDA reserves the right to revise the status of submission periods for any of the AOI’s or the EZ-BAA itself. Any change to open periods for submissions will be posted in the form of an amendment / special instruction to the EZ-BAA. For more details: https://drive.hhs.gov/partner.html?id=partneringApproaches

AOI #1: ENACT (Early Notification to Act, Control and Treat) (ENACT@hhs.gov)
AOI #2: Infection Severity & Solving Sepsis (SolvingSepsis@hhs.gov)
AOI #5: ReDIRECT (Repurposing Drugs In Response to Chemical Threats) (chemrepo@hhs.gov)
AOI #6: Beyond the Needle (BeyondTheNeedle@hhs.gov)

1.20.2021

BARDA seeks nonprofit partner for BARDA Ventures: Catalyzing the 21st Century Cures Act and launching a new way to do business with HHS

This will be the first time HHS has utilized VC practices to make investments. As part of the new program, BARDA is soliciting proposals for an existing nonprofit partner to manage an investment fund that will support breakthrough technologies and create entirely new approaches to enhance U.S. preparedness and response to 21st century health security threats, including COVID-19 and future pandemics. For more information and specific details click here.

11.10.2020

_{Special Instructions 012 Issuance for Easy Broad Agency Announcement (EZ-BAA) BAA-20-100-SOL-0002}

Revisions to Research Areas of Interest | October 22, 2020

_{A. OVERVIEW:}

BARDA DRIVe issues these special instructions with the intent to:

Revise and open Area of Interest (AOI) #1 ENACT (Early Notification to Act, Control and Treat).
Revise and open AOI #2: Infection Severity & Solving
Revise and rename “AOI #4.3: Alternative Routes of Administration (AROA) for Vaccines” to “AOI #6: Beyond the ”

B. STATUS UPDATES FOR RESEARCH AREAS OF INTEREST (AOI):

The following areas of interest (AOI)’s have been established through the original EZ-BAA (BAA-20-100-SOL-0002) or through the current and previous amendments / special instructions. Please be sure to read BAA-20-100-SOL-0002 and all subsequent amendments / special instructions prior to proceeding. In the event of any conflicts, these Special Instructions supersede previous guidance issued under BAA-20-100-SOL-0002.

The following statuses are provided regarding open periods for submissions, specific to each AOI established under the EZ-BAA. Unless otherwise noted below, AOI’s are accepting submissions throughout the EZ-BAA open period which, as of the time of this posting, ends 03 February 2023, 1700 HRS ET. BARDA reserves the right to revise the status of submission periods for any of the AOI’s or the EZ-BAA itself. Any change to open periods for submissions will be posted in the form of an amendment / special instruction to the EZ-BAA.

AOI #1: ENACT (Early Notification to Act, Control and Treat) (ENACT@hhs.gov)
AOI #2: Infection Severity & Solving Sepsis (SolvingSepsis@hhs.gov)
AOI #3: [Not Currently Accepting Submissions]
AOI #4: COVID-19 [Accepting submissions until 31 October 2020, 1700 HRS ET]
1. AOI #4.1-A: [CLOSED]
2. AOI #4.1-B: [CLOSED]
3. AOI #4.1-C: [CLOSED]
4. AOI #4.1-D: Remote Patient Monitoring/Remote Diagnostic Tools (COVID19DxEzBAA@hhs.gov)
5. AOI #4.1-E: Pediatric Diagnostic Tools for Severe COVID-19 Disease and MIS-C (COVID19DxEzBAA@hhs.gov)
6. AOI #4.2: [CLOSED]
7. AOI #4.3: Alternative Routes of Administration (AROA) for Vaccines is revised and now AOI#6: Beyond the Needle
8. AOI #4.4: [CLOSED]
AOI #5: ReDIRECT (Repurposing Drugs In Response to Chemical Threats) (chemrepo@hhs.gov) [Accepting submissions through 31 January 2021, 1700 HRS ET)
AOI#6: Beyond the Needle (BeyondTheNeedle@hhs.gov)

C. RESEARCH AREAS OF INTEREST:

Below is a list of AOI’s revised by these special instructions. See relevant dates above for open periods of submissions. As stated in the EZ-BAA itself, scheduling a call with the relevant Program Manager is strongly encouraged prior to any submission to better understand the program objectives for each research area. The points of contact for each open AOI are listed above.

AOI #1: Early Notification to Act, Control and Treat (ENACT)

The ability to detect illness and injury early is critical to improving health outcomes and decreasing burden on health care providers and facilities. Through ENACT, DRIVe is seeking technologies and methods to a) identify and characterize biological, behavioral, and physiological signatures that can signal infection or injury before the onset of noticeable symptoms and b) technologies that provide early health status information to medical care providers.

Applications may but do not have to focus on COVID-19 as a potential use case.

To be considered responsive under this topic, technologies should prioritize host- based diagnostics and have one or more of the following desired characteristics:

Technologies should provide quantitation of host-based biophysical and biochemical health markers through sensors that can be deployed and used by anyone with minimal training. Wearable, continuously operating sensors and sensor suites that monitor an individuals’ innate and adaptive immunity are preferred;
Wearable sensors or sensor suites in form factors that facilitate human use (e.g. microneedle patches, smart band-aids, smart tattoos, eye and oral sensors) are particularly desired;
Applicants should prioritize sensors or sensor suites that collect and interpret data autonomously, although they can be coupled with cloud- based data reporting and analytics;
For on-demand sensing, non-invasive or minimally invasive sensors (such as those using a finger stick) are required;
Technologies that quantify the composition of passive samples (e.g. saliva, interstitial fluid, sweat, breath etc.) are of special interest;
Technological approaches should include algorithms and smartphone applications for early indication of health status and optimally directing patients and allocating treatment resources in a large-scale health security event;
Proposals should develop algorithmic and automated approaches to link sensor data to early or pre-symptomatic disease and injury.

Respondents should discuss their approach to obtaining regulatory approval for their technology and commercialization. All proposed clinical studies must equitably include multiple racial and ethnic groups and all clinical data analyses must include race / ethnicity and biological sex as subject groups.

The ENACT team has retrospective and prospective wearables data including heart rate, heart rate variability, accelerometer, electrocardiogram, and other health signature data sets that may be made available for data analytics, algorithm development, and data mining. The program will support the development and validation of models from prospective partners and can make de-identified clinical data sets available.

The following areas are considered to be out of scope at this time and may not be reviewed:

Pathogen based detection or technologies – any technologies that are based on the identification of pathogens will not be considered responsive at this time.
Any technology that is not minimally invasive and simple to use. Specifically, for purposes of this AOI, technologies which require sample preparation and would not be available over-the-counter and cleared / approved by FDA for home use, will be considered non-responsive. (with the exception of app-based solutions).

NOTE: All awarded ENACT partners will be required to share de-identified data collected during the period of performance in an effort to advance the field and knowledge. Interested partners are encouraged to commercialize their technology and algorithms but data collected through the use of Government funding will be made available through full Government purpose rights.

AOI #2: Infection Severity & Solving Sepsis

At least 1.7 million Americans develop sepsis each year and nearly 270,000 Americans die annually as a result. Sepsis occurs when an infection leads to a dysregulated host response and organ dysfunction. In addition to the toll on health, sepsis incurs a large economic burden and sepsis survivors also sustain additional chronic illnesses and associated care expenses.

Sepsis can be the endpoint of almost any infection, including SARS-CoV2, and therefore recognition, early detection and mitigation are critical at the first signs of sepsis. We consider sepsis to be a continuum of infection progression that is further complicated by the heterogeneity of the host response and organ dysfunction. Within the program, we are catalyzing the field through a coordinated approach towards development of innovative host-based diagnostics, host-targeted therapeutics, and clinical management approaches that will advance the way we recognize infection severity, combat sepsis, build resiliency in our healthcare system, improve patient outcomes, and ensure that no American life is needlessly cut short by sepsis.

As sepsis can be a complication of any health security threat, as evidenced by the COVID-19 pandemic, in order to fully protect Americans and save lives, the Solving Sepsis program aims to reduce the incidence, morbidity, mortality, and economic burden of sepsis. The program desires to empower both the patient and the healthcare provider with technologies and approaches that are relevant in a number of care settings, including pre-hospital (e.g., home, nursing homes, outpatient), urgent/emergency care (e.g., EMS transport, Emergency Department), inpatient (e.g., ward, ICU) and post-discharge/recovery (e.g., home, skilled nursing facilities). BARDA is interested in technologies and approaches that apply to adults and special populations, such as neonates and pediatric patients, as all populations are at risk of sepsis.

The program is interested in the following focus areas. Please note that due to the current COVID-19 pandemic, COVID-19 may be an appropriate use case:

Host-based diagnostics, monitoring devices and predictive analytics tool:
1. Diagnostics and monitoring devices that identify sepsis, predict infection severity, or prognosticate outcomes in pre-hospital settings, urgent/emergency care, or post-discharge/recovery settings. We are not interested in tools that can be used exclusively for inpatient settings at this time. The diagnostics must be able to distinguish infection or mild disease alone from severe outcomes, including sepsis, or distinguish from Systemic Inflammatory Response Syndrome (SIRS) in the absence of
2. Pediatric technologies that improve early detection and diagnosis and/or inform on clinical management of pediatric/neonatal patient progression to sepsis and other severe outcomes, including multisystem inflammatory syndrome in children (MIS-C).
3. Post-sepsis (or post COVID-19) monitoring technologies (e.g., after hospital discharge) to detect health deterioration or changes in health outcomes, to inform on clinical care. These technologies should not just provide absolute data values but also include approaches to interpret/analyze data and provide actionable information to the healthcare provider or
4. Patient stratification/endotyping/sub-typing technologies to provide a more tailored approach to improve clinical management in certain subpopulations and potentially correlate with individualized targeted treatment responses (See section 2 below).
Host-targeted therapeutics and clinical management approaches:
1. Novel host-based sepsis therapeutic approaches that can modulate the host response to improve patient
2. Novel clinical management strategies that can be tied to patient stratification approaches (see section 1.d above) to improve patient outcomes.

Submissions should be responsive to the following:

Medical countermeasures should address infection via any etiology (i.e., bacterial, viral, other) versus approaches that are limited to sepsis induced by a subset of pathogens. However, due the current COVID-19 pandemic, approaches that use COVID-19 as a use case, are
Provide evidence of planned adoption or implementation strategies in relevant settings to improve clinical utility of the proposed technology (pre- hospital (e.g. Home, nursing homes, outpatient), urgent/emergency care (e.g. EMS transport, Emergency Department) and post-discharge/recovery (e.g. home, nursing homes).
Proposals should include prior demonstration and preliminary data to support use in sepsis or infection severity relevant models (e.g., sepsis patient samples, sepsis [including severe COVID-19] patient clinical data).
Only technologies focused on host-based approaches or clinical management approaches will be considered. BARDA has existing programs for pathogen- targeted approaches outside of this Area of
Research should be considered translational science. There is no interest in early stage or fundamental research projects for this topic at this
Proposals should present a clear FDA regulatory path for approval/clearance (if appropriate) and, if available, evidence of engagement with regulatory authorities.
Proposals should provide evidence of pre-established agreements with proposed partners for relevant clinical studies, if
Proposals should include consideration of commercialization strategy outside the work proposed to this announcement. This may include other ongoing relevant research; establishment of partnerships with appropriate device fabricators/manufacturers; addressing the ability to scale, deploy, and distribute the medical countermeasure; intellectual property; and modeling the cost per unit, reimbursement strategy,
Clinical studies must be equitable in terms of enrollment, including diversity amongst race, ethnicity, and biological
Diagnostic approaches may leverage a number of innovative areas including host biomarkers, artificial intelligence/machine learning algorithms, digital health, EHR integration, data interoperability, remote and self-monitoring devices,

The following are considered out of scope at this time:

Pathogen-based or pathogen targeted approaches, including serology
Physiological monitoring devices that do not distinguish mild disease or infection alone from severe outcomes, including sepsis, or distinguish from SIRS in the absence of infection
Devices or technologies that only address prevention or detection of infection and do not address infection severity or sepsis
Supportive care technologies that do not specifically improve clinical outcomes for sepsis patients
Sepsis diagnostics that are limited to only the intensive care unit hospital setting
Exploratory research with no near-term translational application
Technologies that will require FDA regulatory approval but have not yet engaged or do not have an appropriate regulatory path

AOI #5: ReDIRECT (Repurposing Drugs In Response to Chemical Threats)

The availability of effective medical countermeasures (MCMs) against chemical threats are critical in the treatment of their acute health effects. Necessary attributes of effective MCMs against chemical threats include ease of administration during a mass-casualty situation and rapid efficacy as a post- exposure therapy.

Drug repurposing is a strategy that is used to identify new uses for FDA approved or late-stage investigational therapeutics that are outside of their original clinical indication. The identification of existing compounds for repurposing as MCMs holds the potential to expand current response capabilities to chemical threats, as well as potentially mitigating the costs and risks associated with conventional drug discovery.

BARDA is requesting abstract submissions for projects that repurpose existing therapeutics as MCMs against chemical threats (cyanide, opioids, nerve agents, chlorine, sulfur mustard, etc.). These therapeutics should have a strong mechanistic justification for potential use as MCMs. Ideal candidates for MCMs should have a known safety profile from previous clinical indications or development and be safe and effective for the entire population, including at-risk populations such as pediatrics, geriatrics, pregnant women, and immunocompromised individuals.

MCM candidates should:

Already be approved or in late-stage clinical development for a conventional indication similar to the symptomology associated with exposure to a chemical agent; and
Utilize improved delivery routes or mechanisms that provide ease of administration (including, but not limited to, reformulation of existing products) to large numbers of exposed individuals during mass casualty situations. Priority will be given to products manufactured in the United

Therapeutics that are eligible for drug repurposing may target any of the following:

Pulmonary Agents: Development of MCMs to prevent and treat lung damage (including pulmonary edema, pneumonitis, and fibrosis) resulting from exposure to agents such as chlorine, sulfur mustard and phosgene.

Opioids: Development of MCMs to treat life-threatening respiratory depression caused by opioid overdose. These post-exposure treatments should be quick- acting and effective against a variety of opioids, including synthetic opioids such as Fentanyl. Candidates should have a mechanism of action different from existing opioid receptor antagonists.

Vesicants: Development of MCMs that limit harmful aspects of exposure to vesicating agents such as sulfur mustard and Lewisite. Particular preference is given to drugs with potential to ameliorate the long term effects of exposure including Mustard Gas Keratopathy.

Blood/Metabolic Agents: Development of MCMs to treat acute poisoning from agents such as cyanides. Antidotes should be easily administered by first responders in personal protective equipment. Preference is given to those cyanide antidotes that are also effective against smoke inhalation-related exposure.

Nerve Agents and Organophosphorus (OP) Pesticides: Development of MCMs to treat life-threatening and long-term effects of nerve agents and OP pesticides.

Antidotes should be easily administered by first responders in personal protective equipment.

Computational approaches to identify candidates for drug repurposing: Development of improved methods to rapidly identify FDA approved or late stage candidate compounds that can be repurposed against any of the aforementioned chemical threats.

To be considered responsive under this AOI, respondents should have:

A drug that is a candidate for repurposing as a MCM against pulmonary agents, opioids, vesicants, blood/metabolic agents, nerve agents, or organophosphate pesticides; and
A FDA approved drug, or one that has completed Phase 2 trials as evidenced by a clinical study report; and
A clear rationale as to why the candidate would be efficacious as a chemical MCM.

Priority will be given to MCMs developed in the United States.

AOI #6: Beyond the Needle

The administration of therapeutics, such as vaccines, biologics, or other medications, can be markedly enhanced by utilizing alternative routes of administration that rely less on a needle and syringe approach used in traditional intravenous (IV), intramuscular (IM), or subcutaneous (SC) administrations. These traditional routes via a needle and syringe are often logistically challenging, rely on cold-chain storage that hinders distribution, and almost exclusively require experienced personnel for administration. The DRIVe Beyond the Needle program seeks to develop technologies that (1) utilize alternative routes of administration for administering therapeutics, such as but not limited to: oral, intranasal, transdermal patches, sublingual, and buccal mechanisms of administration, (2) involve simplified logistics that enable easier deployment and uptake, and (3) able to be administered without a trained health-care professional.

As a consequence to reduce production costs, the medical supply industry has evolved to “just-in-time” supply chain models that involve sourcing and manufacturing raw materials outside the United States. As a result, the domestic availability of needle and syringes is limited and poses as a bottleneck for therapies requiring their use on a large scale. In recent months, the pandemic has highlighted opportunities to strengthen and bolster the United States medical supply chain. The Beyond the Needle program seeks to develop therapeutics that can be administered in a broad range of care settings including within the home and do not rely on skilled medical personnel for administration. A successful alternative technology for administration would reduce the demand placed on qualified personnel, particularly in communities that are underserved and have reduced access to care.

BARDA is seeking abstracts for the development of technology that features an alternative route of administration for any type of payload, including vaccines, drugs (biologics, small molecules, nucleic acids), as well as adjuvants against CBRN threats, Influenza (seasonal/pandemic), coronaviruses (SARS-CoV-2), and other emerging infectious diseases that is of pandemic concern as outlined on www.medicalcountermeasures.gov.

The ideal attributes for therapeutics or adjuvants delivered via alternative routes of administration would be single dose (although additional dosing is acceptable), room temperature-stable without the need for cold-chain storage, and indicated for all populations. Therapeutics delivered via alternate routes of administration should have similar or superior performance characteristics as traditional routes administered via a needle and syringe (i.e. safety and efficacy).

Emphasis will be placed on proposals that focus on the delivery and not on the discovery of payloads.

In some cases, alignment with a proven therapeutic provider might be beneficial, although it is not required for consideration.

All submissions must include:

A proposed technology or platform for administering a therapeutic (can include vaccines, biologics, small molecules, nucleic acids etc.) candidate via an alternative route of administration. Therapeutics may target CBRN threats, Influenza (seasonal/pandemic), SARS-CoV-1 / 2, as seen on (medicalcountermeasures.gov) but are not required.
Plans for IND enabling pre-clinical studies or provide existing supporting data.
Product development plan and a target product profile is
Any regulatory communication with US FDA (pre-IND/IND).
Any pre-clinical or clinical data using this
Potential for use or implementation in underserved

D. Eligible Respondents & Scope Parameters:

These Special Instructions are open to all responsible sources as described in the EZ-BAA and subsequent amendments / special instructions. Abstract submissions that do not conform to those outlined requirements may be considered non- responsive and will not be reviewed. As a reminder, an entity must have an active registration with www.SAM.gov at the time of submission to be reviewed. If not, submissions will not be reviewed and will be rejected. Please do not attempt to submit an abstract if your registration is not active in www.SAM.gov.

E. Application Process:

All submissions will follow the same submission process and review procedures as established under the EZ-BAA as published on. For complete details, please read the EZ-BAA (i.e. BAA-20-100-SOL-0002) document in its entirety, along with all previous amendments / special instructions.

10.23.2020

Office of Biomedical Advanced Research and Development Authority (BARDA)
Division of Research, Innovation & Ventures (DRIVe)

Special Instructions 011 Issuance for Easy Broad Agency Announcement (EZ-BAA)
BAA-20-100-SOL-0002

Adding Area of Interest (AOI) #5:
ReDIRECT
(Repurposing Drugs In Response to Chemical Threats)

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective: Under these Special Instructions 011, BARDA is adding AOI #5 as part of its EZ-BAA (BAA-20-100-SOL-0002). Under this AOI, we are seeking abstract submissions for the following:

AOI #5: ReDIRECT (Repurposing Drugs In Response to Chemical Threats)

The availability of effective medical countermeasures (MCMs) against chemical threats are critical in the treatment of their acute health effects. Necessary attributes of effective MCMs against chemical threats include ease of administration during a mass-casualty situation and rapid efficacy as a post-exposure therapy.

MCM Candidates Should:

Already be approved or in late-stage clinical development for a conventional indication similar to the symptomology associated with exposure to a chemical agent; and
Utilize improved delivery routes or mechanisms that provide ease of administration (including, but not limited to, reformulation of existing products) to large numbers of exposed individuals during mass casualty situations. Priority will be given to products manufactured in the United

Therapeutics that are eligible for drug repurposing may target any of the following:

Pulmonary Agents: Development of MCMs to prevent and treat lung damage (including pulmonary edema, pneumonitis, and fibrosis) resulting from exposure to agents such as chlorine, sulfur mustard and phosgene.
Opioids: Development of MCMs to treat life-threatening respiratory depression caused by opioid overdose. These post-exposure treatments should be quick-acting and effective against a variety of opioids, including synthetic opioids such as Fentanyl. Candidates should have a mechanism of action different from existing opioid receptor antagonists
Vesicants: Development of MCMs that limit harmful aspects of exposure to vesicating agents such as sulfur mustard and Lewisite. Particular preference is given to drugs with potential to ameliorate the long term effects of exposure including Mustard Gas Keratopathy. Blood/Metabolic Agents: Development of MCMs to treat acute poisoning from agents such as cyanides. Antidotes should be easily administered by first responders in personal protective equipment. Preference is given to those cyanide antidotes that are also effective against smoke inhalation-related exposure.
Nerve Agents and Organophosphorus (OP) Pesticides: Development of MCMs to treat life-threatening and long-term effects of nerve agents and OP pesticides. Antidotes should be easily administered by first responders in personal protective equipment.
Computational approaches to identify candidates for drug repurposing: Development of improved methods to rapidly identify FDA approved or late stage candidate compounds that can be repurposed against any of the aforementioned chemical threats.To be considered responsive under this AOI, respondents should have:
- A drug that is a candidate for repurposing as a MCM against pulmonary agents, opioids, vesicants, blood/metabolic agents, nerve agents, or organophosphate pesticides; and
- A FDA approved drug, or one that has completed Phase 2 trials as evidenced by a clinical study report; and
- A clear rationale as to why the candidate would be efficacious as a chemical MCM.
Priority will be given to MCMs developed in the United States.

B. Eligible Respondents & Scope Parameters: These Special Instructions 011 are open to all responsible sources as described in the EZ-BAA. Preliminarily, a call with the relevant Program Manager is strongly encouraged prior to any submission to better understand the program objectives for AOI #5. The point of contact for AOI #5 is chemrepo@hhs.gov.

AOI #5 will be open for abstract submissions through 31 January 2021, unless otherwise extended. Additionally, award(s) expected to be made under these Special Instructions 011 will be less than $750,000 in total Government funding.

Abstract submissions that do not conform to the requirements outlined in the EZ- BAA may be considered non-responsive and will not be reviewed. To clarify, an entity must have an active registration with https://beta.sam.gov at the time of submission to be reviewed. If not, submissions will not be reviewed and will be rejected. Please do not attempt to submit an abstract if your registration is not active in https://beta.sam.gov.

NOTE: Funding is limited, so we encourage any interested vendors to reach out to chemrepo@hhs.gov as soon as possible before submitting an abstract.

C. Number of Awards: Multiple awards are anticipated and are dependent upon the program priorities, scientific/technical merit of submissions, how well submissions fit within the AOI, and the availability of funding. The program funding is subject to change based on the Government’s discretion.

D. Special Instructions Application Process: These Special Instructions 011 will follow the same submission process and review procedures as those established under the EZ-BAA. For complete details, please read the EZ-BAA solicitation in its entirety.

10.9.2020

Division of Research, Innovation & Ventures' (DRIVe) focus, to accelerate the development and availability of transformative technologies and approaches to protect Americans from health security threats.

DRIVe STRATEGY

Push the boundaries of innovation to tackle the biggest health security challenges. Seek new ideas and new approaches to find solutions that will prevent and protect against health security threats.

Learn more about DRIVe with this short video.

9.28.2020

BARDA Division of Research, Innovation & Ventures (DRIVe) is Extending Closing Date & Revising Topics #4.1-D and #4.3 Under Area of Interest (AOI) #4: COVID-19

I. INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:
Under these Special Instructions 009, BARDA is extending the closing date through 31 October 2020 for its temporary AOI #4: COVID-19 as part of its EZ-BAA (BAA-20-100-SOL-0002). We are only seeking abstract submissions for the following:
AOI #4.1-A: [CLOSED] AOI #4.1-B: [CLOSED] AOI #4.1-C: [CLOSED] AOI #4.1-D: Remote Patient Monitoring/Remote Diagnostic Tools
The development of adjunctive diagnostic technologies with near-term impact that are critical to improving the efficiency and effectiveness of our health infrastructure during the COVID-19 outbreak. These technologies may empower the patient through providing a means of self-monitoring, or empower the healthcare provider through remote monitoring or evaluation and diagnostic capability throughout the care continuum of the patient (i.e. pre-hospital, inpatient, and post-discharge). There is also a need to rapidly assess and diagnose severity of illness in order to triage patients for care or to aid in early recognition of decompensation for improved clinical management of patient.
These technologies may include, but are not limited to, smartphone mobile applications, wearables, or non (or minimally) invasive sensors that can measure/monitor host-signature or diagnose response to infection, telehealth applications, EHR based tools, algorithms that can predict, identify or prognosticate risk trajectories, clinical decision support software, or continuous monitoring devices.
These technologies should be in advanced development and ready for clinical validation. These technologies should be capable of capturing and quantifying a broad range of host biological, immunological, biometric, clinical, laboratory, and/or physiological data. In addition, technologies that incorporate novel informatics approaches to data collection, reporting, and analysis are of interest. Pathogen-targeted and serology diagnostics, as well as bench-top diagnostics, are not of interest for this topic at this time.

To be considered relevant under this topic, respondents should have a need to assess clinical validation through conducting a pilot study that meets the following requirements:
1) Total period of performance should have impact for this current COVID-19 outbreak. After clinical validation, technology should have the ability to be rapidly scaled and deployed under an accelerated timeline of less than 90 days.
2) Software tools should be able to be integrated into EHRs or deployed in less than 30 days.
3) Significant preliminary COVID-19 data to support utility of technology for COVID-19.
4) Requires minimal infrastructure or training to deploy and support.
5) Achieved FDA regulatory clearance/approval or have identified a clear regulatory path for deployment, if applicable to technology.
6) Demonstrates a clear commercialization strategy to expand use.
Priority will be given to products manufactured in the United States.
AOI #4.2: [CLOSED] AOI #4.3: Alternative Routes of Administration (AROA) for Vaccines
Vaccination saves millions of lives per year globally. It is the single most effective public health intervention for preventing infectious diseases. Traditional parenteral vaccinations using needles and syringes are the primary medical intervention for prevention of infections with these viruses. An identified risk during a pandemic response, including SARS-CoV-2, is the availability of needles and syringes used to administer vaccines.
One key risk impacting needle and syringe availability in the United States during a pandemic is limited domestic surge manufacturing. In an effort to reduce production costs, the medical supply industry has evolved to “just-in-time” supply chain models over the past two decades. Industry has also moved sourcing and production of raw materials outside the United States. As a result, domestic availability of needle and syringes would be limited during an infectious disease pandemic.
Another key risk is the limited number of qualified personnel needed to administer vaccine. Personnel trained in the administration of vaccine include physicians, nurses, physician assistants, emergency medical technicians, and pharmacists. In a pandemic where critical care personnel are likely to be in short supply, a successful alternative technology for vaccine administration would reduce the demand qualified personnel to administer vaccine. Enhancing the ease of vaccine administration would logically increase timeliness and vaccine coverage rates, reduce the number of infections, and mitigate mortality and morbidity rates during pandemics compared to current needle and syringe technologies.
Alternative technologies for vaccine administration (oral, transdermal (i.e. micro array patches), and aerosol/inhalation), have the potential to eliminate the need for using the currently available needles and syringes during a pandemic response and hopefully self-administration.
BARDA is seeking abstracts for the development of alternative routes of administration for vaccines (including oral, transdermal (i.e. micro array patches or aerosol/inhalation)) against CBRN threats, Influenza (seasonal/pandemic), SARS-CoV-1 / 2, or MERS-CoV.
Ideal attributes for vaccines delivered via alternative routes of administration would
be single dose, room temperature stable, unadjuvanted and indicated for all populations. Vaccines delivered via alternate routes of administration would have similar or superior performance characteristics as traditional parenterally administered vaccines (i.e. safety and efficacy).
Although the technology for alternate routes of administration of vaccines are not expected to adhere to TRLs, it is expected that the respondent obtains and submits an Investigational New Drug (IND) application upon completion of BARDA DRIVe funding for this project or the respondent shall make the vaccine available for potential toxicology and efficacy assessments under separate USG mechanisms.

All submissions must include:
1) A vaccine candidate against CBRN threats, Influenza (seasonal/pandemic), SARS-CoV-1 / 2, MERS-CoV, or partnership with an antigen developer to be administered by an alternate route of administration.
2) Plans for IND enabling preclinical studies or provide existing data.
3) Product development plan.
4) Any regulatory communication with US FDA (pre-IND/IND).
5) Any pre-clinical or clinical data using this platform.
Priority will be given to products manufactured in the United States.
AOI #4.4: [CLOSED]

B. Eligible Respondents & Scope Parameters:
These Special Instructions 009 are open to all responsible sources as described in the EZ-BAA. Preliminarily, a call with the relevant Program Manager is strongly encouraged prior to any submission to better understand the program objectives for each topic under AOI #4. The points of contact for each topic under AOI #4 are the following:
AOI #4.1-A: [CLOSED] AOI #4.1-B: [CLOSED] AOI #4.1-C: [CLOSED] AOI #4.1-D: COVID19DxEzBAA@hhs.gov
AOI #4.2: [CLOSED] AOI #4.3: Donna Boston, donna.boston@hhs.gov
AOI #4.4: [CLOSED] The open topics under AOI #4 will be open for abstract submissions through 31 October 2020, unless otherwise extended. Additionally, award(s) expected to be made under these Special Instructions 009 will be less than $750,000 in total government funding.
Abstract submissions that do not conform to the requirements outlined in the EZ-BAA may be considered non-responsive and will not be reviewed. To clarify, an entity must have an active registration with www.SAM.gov at the time of
submission to be reviewed. If not, submissions will not be reviewed and will be rejected. Please do not attempt to submit an abstract if your registration is not active in
www.SAM.gov.

NOTE: Funding is limited, so we encourage any interested vendors to reach out to the appropriate Program Manager listed above before submitting an abstract as soon as possible.

C. Number of Awards:
Multiple awards are anticipated and are dependent upon the program priorities, scientific/technical merit of submissions, how well submissions fit within the AOI, and the availability of funding. The program funding is subject to change based on the government’s discretion.

D. Special Instructions Application Process:
These Special Instructions 009 will follow the same submission process and review procedures as those established under the EZ-BAA. For complete details, please read the EZ-BAA solicitation in its entirety.

For more information: BARDA DRIVe

7.1.2020

BARDA Names First DRIVe Director

BARDA is pleased to announce Sandeep Patel, Ph.D. as the first director of the Division of Research, Innovation and Ventures (DRIVe).

Dr. Patel is committed to advancing high-impact science, building new products, and launching collaborative programs and initiatives with public and private organizations to advance human health and wellness. As the DRIVe Director, Dr. Patel will lead a dynamic team built to tackle complex national health security threats by rapidly developing and deploying innovative technologies and approaches that draw from a broad range of disciplines.

Dr. Patel brings extensive experience in public-private partnerships to DRIVe. Prior to joining the DRIVe team, he served as the HHS Open Innovation Manager. In that role, he focused on advancing innovative policy and funding solutions to complex, long-standing problems in healthcare. During his tenure, he successfully built KidneyX, a public-private partnership to spur development of an artificial kidney, helped design and execute the Advancing American Kidney Health Initiative, designed to catalyze innovation, double the number of organs available for transplant, and shift the paradigm of kidney care to be patient-centric and preventative, and included a Presidential Executive Order signed in July 2019. He also created the largest public-facing open innovation program in the U.S. government with more than 190 competitions and $45 million in awards since 2011.

Prior to his tenure at HHS, Dr. Patel co-founded Omusono Labs, a 3-D printing and prototyping services company based in Kampala, Uganda; served as a scientific analyst with Discovery Logic, (a Thomson Reuters company) a provider of systems, data, and analytics for real-time portfolio management; and was a Mirzayan Science and Technology Policy Fellow at The National Academies of Science, Engineering, and Medicine. He also served as a scientist at a nanotechnology startup, Kava Technology.

He holds a US patent issued in 2005 and has authored over a dozen peer-reviewed articles in areas such as nanotechnology, chemistry, innovation policy, and kidney health. Dr. Patel earned his Ph.D. in physical chemistry from the Georgia Institute of Technology, and has a bachelor’s degree in chemistry from Washington University in St. Louis.

https://drive.hhs.gov/news.html

5.18.2020

BARDA Engages in a Collaboration to Support Mayo Clinic's Expanded Access Program for use of Convalescent Plasma to Hospitalized Patients with COVID-19

Expanded access programs allow access to pre-approved drugs and therapeutic treatments such as convalescent plasma outside of a clinical trial setting. In this way, the expanded access program provides a framework for rapid access to a potential therapy for COVID-19.

Individuals who recover from infections likely developed antibodies as part of their own immune response. These antibodies have the potential to bind the virus and neutralize it. Plasma containing antibodies can be collected from recovered individuals, and transfused into patients with active disease. Because this approach is simpler than developing an entirely new product, plasma can be used in clinical trials or under expanded access programs faster than new therapeutics or vaccines. Read more...

Today's award is now part of BARDA's Rapidly-Expanding COVID-19 Medical Countermeasure Portfolio. Visit our COVID-19 MCM Portfolio page to learn more about all the life saving technologies BARDA is supporting to combat the pandemic.

UEL in partnership with gener8tor is part of the BARDA/DRIVe accelerator network.

5.5.2020

New Updates & Areas of Interest from BARDA/DRIVe &

As you all know the Coronavirus COVID19 pandemic is an extremely fluid situation. As a member of the BARDA/DRIVe accelerator network we are frequently receiving updates - sometimes multiple times in a day. Today's communication is considerable, so rather than sharing it in pieces and perhaps confusing the messages, we have decided to share it in totality. The following is written by BARDA/DRIVe:

Here are some brand new updates regarding BARDA’s response to COVID-19 and new opportunities to partner with BARDA. Specifically -- we have released several new Area of Interest topics related to COVID-19 for both the BARDA BAA and the DRIVe EZ-BAA. (Please note any submissions to either BAA that are other than those in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interests.)

New COVID19 Topics in EZ-BAA (BAA-20-100-SOL-0002): AOI #4.1 A, B & C; 4.3; 4.4:

EZ BAA submission deadline has been extended from March 18 to June 30, 2020

For more detailed information please see the attached EZ-BAA Special Instructions #3, and/or visit https://drive.hhs.gov/partner.html#ncov

a. AOI 4.1-A: Molecular Diagnostic Assay for SARS-CoV-2 virus on existing FDA cleared platform (same as former AOI 4.1)

b. AOI 4.1-B: Point-of-Care Diagnostic Assay for detection of SARS-CoV-2 virus

c. AOI 4.1-C: Diagnostic Assay for detection of COVID-19 disease (SARS-CoV-2 infection)

d. AOI 4.3: COVID-19 Vaccine

e. AOI 4.4: Advanced Manufacturing Technologies

NOTE: The EZ-BAA has a limit of $749,000 of government funds and a required 30% project non-federal cost share from the company.

New COVID19 Topics in BARDA BAA (BAA-18-100-SOL-00003):

For more detailed information please see the attached BAA Amendment 14 and/or visit https://medicalcountermeasures.gov/barda/barda-baa/.

a. AOI 7.7.1 Diagnostic Assay for human coronavirus using existing FDA-cleared platforms,

b. AOI 7.7.2 Point-of-Care Diagnostic Assay for detection of SARS-CoV-2 virus

c. AOI 7.7.3 Diagnostic Assay for detection of COVID-19 disease (SARS-CoV-2 infection)

d. AOI 8.3 COVID-19 Vaccine,

e. AOI 9.2 COVID-19 Therapeutics,

f. AOI 9.3 Immunomodulators or therapeutics targeting lung repair, and

g. AOI 9.5 Pre-exposure and Post-exposure Prophylaxis,

h. AOI 10 Respiratory Protective Devices,

i. AOI 11 Ventilators

j. AOI 17 Advanced Manufacturing Technologies

NOTE: The BARDA BAA has a minimum TRL requirement based on the topic area (see BAA for details and TRL definitions) and the application process is much more formalized requiring a 10 page white paper for phase 1 and then, should the company be invited to Phase 2, a detailed full proposal.

3.12.2020

Seeking Additional Information - Coronavirus COVID-19

Through our partnership with BARDA DRIVe, we are seeking additional information on SARS-CoV2, also known as novel coronavirus or COVID-19.

The key areas of interest are:

Market research on a product or technology to support a vaccine, diagnostic, or therapeutic for SARS-CoV2
EZ-BAA (Broad Agency Announcement) seeking information on Molecular Diagnostic Assay for 2019-nCoV / SARS-CoV2
EZ-BAA (Broad Agency Announcement) seeking information on Nonclinical Model Development and Screening for 2019-nCoV / SARS-CoV2

For more information, or to apply for funding, please see the link to the BARDA DRIVe COVID-19 website. For the latest information on SARS-CoV2, please see the following:

Centers for Disease Control and Prevention: COVID-19 Situation Summary

Thanks for your help! please feel free to forward this to others in your network.

2.28.2020

2019-novel Coronavirus Medical Countermeasures Task Force

As part of a multi-pronged response to the coronavirus Covid-19 (2019-NcoV) outbreak, BARDA/DRIVe has set up a website (see link below) to perform market research and keep the government informed about technologies that can be used to develop effective countermeasures against this scourge. A number of you have responded with companies working in this area so we thought to share this link so that your relevant companies have a method to reach out directly to BARDA. Please note that this is only market research and there is no guarantee of any funding based on the information the company may provide—but it is important for us to hear from your relevant stakeholders. https://www.medicalcountermeasures.gov/

2.13.2020

What/Who is BARDA/DRIVe?

The Biomedical Advanced Research and Development Authority (BARDA) operates under the US Department of Health and Human Services (HSS)/Office of the Assistant Secretary for Preparedness and Response. BARDA was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID).

Since it was established in 2006, as part of the Pandemic and All Hazards Preparedness Act, BARDA fine-tuned its’ focus identifying the Division of Research, Innovation, and Ventures (DRIVe) to increase investment and stimulate innovation in the areas of; health security identifications, preventions, treatments and technologies.

DRIVe makes technological and financial resources available to qualified entrepreneurs, innovators and startups whose concepts have the capacity to transform emergency preparedness and timely response.

In the last 12+ years BARDA/DRIVe has facilitated 42 FDA approvals, licensures, and clearances for products addressing a wide range of chemical, biological, radiological, and nuclear threats; pandemic influenza; and emerging infectious diseases.

What Does BARDA/DRIVe have to do with University Enterprise Laboratories?

In October of 2019, UEL partnering with gener8tor, became one of the newest members of the BARDA/DRIVe accelerator network, supporting their effort to utilize promising innovation across the country.

UEL is actively working to identify breakthrough innovators and innovations which may be instrumental in meeting DRIVe’s mission to: Accelerate the development and availability of transformative technologies and approaches to protect Americans from health security threats. UEL's connections with our resident-companies and the great number of Minnesota innovators in healthcare, health technology and health security puts us in a unique position to play a mutually beneficial role for those innovators and DRIVe by identifying, supporting and guiding local entrepreneurs who may become key contributors to our national health security.

Currently there are 2 initiatives open from BARDA/DRIVe:

Invisible Shield QuickFire Challenge– Deadline for applications: February 14, 2020
Request for Information for Next Generation Blood Products– Deadline for submissions: Feb 15, 2020

Impact areas for DRIVe:

Solutions to reduce illness and death from Sepsis
Innovations that provide Early Notification to Act, Control, and Treat (ENACT) infectious diseases
Disruptive solutions that offer treatment or countermeasures to a broad class of pathogens

How to Apply for DRIVe Funding

BARDA/DRIVe collaborates with companies and teams offering solutions to a broad range of national health security threats. DRIVe partnering approaches vary depending on the project. https://drive.hhs.gov/partner.html?id=applyNow 1.9.2020

DRIVe is Decentralizing Innovation Across the Country

The DRIVe Accelerator Network is working with regional accelerators, chosen through a competitive process, to identify promising innovation and provide wraparound technical and business development support services. UEL in partnership with gener8tor is proud to have been selected to be in DRIVe's accelerator network. 12.23.2019