The Biodefense Advanced Research and Development Authority (BARDA) released its 2018 BARDA Broad Agency Announcement (BAA), soliciting proposals for advanced research and development of medical countermeasures (MCM). BARDA seeks proposals to detect, contain, and treat chemical, biological, radiological, and nuclear (CBRN) agents; pandemic influenza; and emerging infectious diseases. The BAA highlights areas of interest, which include various technologies, vaccines, therapeutics, diagnostics, and devices to address these threats and to protect U.S. civilian health.

BARDA’s mission “is to develop and procure medical countermeasures that address the public health and medical consequences of CBRN accidents, incidents and attacks; pandemic influenza; and emerging infectious diseases.” BARDA’s priorities and programs closely align with the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategic Plan, as well as the Department of Health and Human Services (HHS) Pandemic Influenza Plan and other interagency efforts to promote and protect the nation’s public health. Per the BAA, interested applicants should be aware of these efforts and agencies’ roles in the national MCM enterprise.

Application Deadline: 

• Stage One (quad charts and white papers) – January 31, April 30, July 31, and October 31, in both 2018 and 2019
• Invited full proposals are due any day during the open period for the BAA (i.e., through October 31, 2019)

Total Funding and Award Size: BARDA anticipates issuing multiple awards of various sizes. Total available funding is subject to change depending on budget and emerging priorities.

Eligibility: The BAA is open to all “single entities or teams from private sector organizations, government laboratories, and academic institutions.” Those interested are encouraged to verify the BAA for full eligibility requirements and award restrictions.

BARDA DRIVe seeks your feedback on a potential new novel public-private partnership that leverages venture capital practices and methods to disrupt the way BARDA invests in health security innovation

BARDA’s DRIVe is pleased to announce the expansion of its market research effort to identify potential partners and capture feedback to support its newest novel public-private partnership, DRIVe Ventures. The release of the DRIVe Ventures request for information (RFI), is a key component of BARDA’s Medical Countermeasure Innovation Partnership (MCIP) enabled in the 21st Century Cures Act. DRIVe Ventures will be responsible for establishing and managing a venture capital fund dedicated to the development of a portfolio of innovative medical countermeasure products and technologies to address systemic healthcare challenges that impact our response to influenza, emerging infectious diseases, and chemical, biological, radiological and nuclear (CBRN) threats. DRIVe Ventures, through a third-party non-profit fund, will provide dilutive investment into promising health security products and technologies to enhance national health security preparedness and response. The MCIP initiative is a key priority of ASPR and BARDA, helping to ensure we fulfill our mission to save lives and protect Americans from 21st century health security threats.

DRIVe Ventures will have the ability to leverage “venture capital practices and methods,” similar to a corporate venture capital model. It will identify, invest in, and promote the development of innovative medical countermeasures and address systemic challenges to ensure medical countermeasures are accessible when and where needed to enhance national health security.

DRIVe Ventures seeks to link innovators and investors, leveraging partnerships and resources to address strategic needs of the federal government. By combining the forces of ASPR and BARDA with the ingenuity and experience of the venture capital community, DRIVe will accelerate the development of critical lifesaving medical countermeasures to increase the preparedness posture of the United States.

BARDA DRIVe wants to hear from the venture capital community, including, but not limited to, venture capital firms, corporate venture capital, impact venture capital funds, and non-profit strategic investors with experience identifying promising innovative products and technologies. If your team has experience leveraging venture capital practices and methods, respond to the RFI by March 4, 2019, 5 p.m. ET.

Submission guidelines:

• Responses must be submitted via email for receipt by 5 p.m. ET on March 4, 2019.
• Responses must be submitted via email to both troy.francis@hhs.gov and matthew.mccord@hhs.gov with the subject line: DRIVe Ventures: Response to RFI.
• It is recommended that submissions are sent at least two hours in advance of the deadline to allow for any server delays.

The Biomedical Advanced Research and Development Authority (BARDA) is leading an interagency group to develop a wearable device to detect, and possibly treat, an opioid overdose.  This group, Technology Innovation to Combat Opioids (TICO) is holding a Deep Dive on Feb 12-13, 2019 to review possible technologies being developed in this area. Specifically, we are looking for wearables or software as a medical device that are no larger than the palm of your hand and measure a physiological response indicative of an opioid overdose. Examples of possible markers that could be incorporated into the device include, but are not limited to, respiratory rate, blood carbon dioxide or oxygen content, brain activity and opioid levels. The device should have the ability to alert potential caretakers nearby that the wearer is in distress and, potentially, have the capability to dispense a treatment for the overdose event. The technologies should be at a maturity level capable of undergoing pivotal clinical trials in 2020.

TICO invites anyone with an innovative idea in this space to submit a 1-2 page summary of their device that addresses the following items:

1. Provide a high-level device description including how the device detects possible opioid overdose.

2. How does the device notify potential caretakers? Does it notify people nearby?  If so, how?

3. Description of the user population and use environment?

4. What are the performance limitations for the device?

5. How does the device treat an opioid overdose if that is a feature?

6. Do you own the intellectual property for this technology?

TICO will review each submission and invite selected participants to present their technology at the Deep Dive on Feb 12-13, 2019.  Travel funding is not available, however, this meeting will serve as market research for the solicitation that will be issued by BARDA to fund the clinical study.  Accommodations can also be made for a virtual presentation.  Submissions and questions can be sent to Kristen Herring Kristen.herring@hhs.gov and should be received no later than Jan. 22nd.

For more information, contact Emil Runge, erunge@ffvcnc.org, First Flight Venture Center.

Apply now! DRIVe's new EZ-BAA application is streamlined, fast and user-friendly.

The North Carolina Biotechnology Center is pleased to announce the Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation and Ventures (DRIVe) simplified application process, called the EZ BAA, is now open for business. Medical product developers, research teams, and companies offering disruptive solutions to health security threats are invited to submit abstracts beginning today using this simplified EZ BAA process.

BARDA is looking for the most innovative products and technologies to protect Americans from the most serious systemic, natural and intentional health security threats. Our goal is to build a portfolio of products representing disruptive innovative approaches that will transform health security.

Applications accepted through this streamlined process must offer transformative innovation, products and technologies to protect Americans from health security threats. This application process is a business-friendly simple abstract.
 
In-scope priority areas include: products and solutions to reduce illness and death from sepsis as part of DRIVe’s Solving Sepsis initiative; technologies and processes to identify infections and exposures to biological and other health threats, as outlined in the Early Notification to Act, Control, and Treat (ENACT) initiative; and tools and techniques to mitigate the damages and loss of life associated with catastrophic events.

Applying is simple:

• Download the application form from the website.
• Submit a technical abstract no longer than 2,000 words.
• Include a cost proposal of an additional 2,000 words or less.
• Proposed costs should not exceed $749,000.

What happens next:

• Once submitted, DRIVe’s experts will review the application to ensure it is within scope and meets DRIVe criteria.
• As the applicant, you’ll be notified of the review results within 30 days of your submission.

Learn more about the DRIVe EZ-BAA review criteria.

For more information, visit the DRIVe website.

Have questions? Looking for more information? Contact DRIVeContracting@hhs.gov

NC-based resource:
Emil Runge, Program Manager
erunge@ffvcnc.org
Mobile: (404) 668-2136
First Flight Health Security Accelerator
2 Davis Drive, Research Triangle Park, NC

BARDA DRIVe EZ-BAA Reminder

The funding opportunity is up to $749k with roughly 2500 words and money in your pocket in about 30 days. Have multiple ideas? Submit them all! DRIVe is looking for your application to include 30% matching funds. Feel free to talk to the DRIVe team on ways to get the 30% match.
 

• Please let Emil Runge, FFVC know if you have submitted a response for the DRIVe EZ-BAA. The link to the application is on the front page of the DRIVe site (here) and a current link to the application is here. The Pre-Proposal Conference slides can be found here. FAQs are posted on the DRIVe Resources page here.
   

To set up an Area of Interest call before submitting, email the following:

• For Solving Sepsis: 
  • DRIVe@hhs.gov
  • SolvingSepsis@hhs.gov
  • Donna.Boston@hhs.gov
     
• For Early Notification to Act Control and Treat (ENACT) for infectious diseases:
  • DRIVe@hhs.gov
  • SolvingSepsis@hhs.gov
  • Donna.Boston@hhs.gov

Additional BARDA DRIVe info:

• Sign up for the BARDA DRIVe newsletter to get immediate updates: https://cloud.connect.hhs.gov/DRIVe.

BARDA remains committed to engaging industry and government partners to fulfill their mission, saving lives and protecting Americans through the research and development of medical countermeasures against serious health security threats.

The theme of BARDA Industry Day 2018 held October 29-30, 2018 in Washington, DC was "Driving Innovation." Copies of the presentations are now available online for review. 

Presentations from the DRIVe Session on October 30 at 1:00 p.m. are also available below.   

DRIVe: Innovation in the Acquisition Process

ENACT Program Overview

BARDA DRIVe Solving Sepsis Program

The United States Army Medical and Materiel Command's (USAMRMC) mission is to provide solutions to medical problems of importance to the American Service member at home and abroad, as well as to the general public at large. Extramural research and development programs play a vital role in the fulfillment of the objectives established by the USAMRMC.

The FY18-FY22 USAMRMC Broad Agency Announcement (BAA) is intended to solicit extramural research and development ideas. Research and development funded through the BAA are intended and expected to benefit and inform both military and civilian medical practice and knowledge.
Read more information.