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BARDA Industry Day 2021 Report

BARDA Industry Day 2021 Report

G2G's summary of the breakout sessions and insights shared during this year’s BARDA Industry Days online conference November 3-4, 2021.

Overview

G2G attended the annual BARDA Industry Days on November 3-4 that was held virtually for the second year in a row. The Biomedical Advanced Research and Development Authority (BARDA), the Office of Acquisitions Management, Contracts and Grants (AMCG), and the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) host this event each fall. The purpose is to increase potential partners’ awareness of U.S. government medical countermeasure (MCM) priorities, provide direct interactions with BARDA and ASPR staff, and network with public and private sector colleagues to develop MCMs or platform technologies to combat COVID-19; pandemic influenza or other emerging infectious diseases; and chemical, biological, radiological, or nuclear (CBRN) threats. Below is a summary of the breakout sessions and insights shared during this year’s online conference.

Director's Update

BARDA Director Gary Disbrow opened the event by stating BARDA investments were slightly lower from FY20 to FY21 but were still much higher than in previous years. Funding for vaccines stood at $36.9 billion, therapeutics at $14.1 billion, and diagnostics at $51 million. BARDA provided many early countermeasures in January 2020 to help fund companies during the pandemic but early investments in Ebola and previous diseases paved the way for the federal COVID-19 response success. In 2020, BARDA had 61 FDA approvals, licensures, and clearances, invested in 97 products, and delivered 511 million vaccines. Since 2020, there have been 4,536 CoronaWatch submissions — more than in the past 15 years combined — 676 of the submissions resulted in meetings. BARDA continues to respond to requests for TechWatch meetings.

Disbrow also shared that the BARDA BAA is now accepting proposals for topics not related to COVID-19 for the first time since early 2020. (Note: G2G has reviewed the BAA and prepared an overview that outlines the topics and key considerations in a separate document. Please reach out to Liz Powell at lpowell@G2Gconsulting.com for more details.)

BARDA’s FY21 successes:

  • New funding programs for multi-organ tissues chips and next-generation sequencing
  • Six products procured for the SNS, including the first BARDA procurements of novel antibiotics
  • First four ReDIRECT awards
  • Kick-off of BARDA Ventures

BARDA Division Updates

G2G attended breakout sessions led by leaders of each division. Summaries of each division are below.

CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR (CRBN)
CBRN supported the COVID-19 response by rapidly pivoting their USG Ebola Medical Countermeasure Working Group to a COVID-19 Medical Countermeasure Working Group. They established and managed the COVID-19 Convalescent Plasma Program as well as Product Utilization Sheets to enable rapid MCM deployment to frontline workers. The division gave 80 total awards in FY21 that totaled $903 million. Of these 80 awards, 13 were products used in routine care for the COVID-19 response.

Looking to the future, CBRN is seeking to make investments for work on projects that will:

  • Support intelligent point of care solutions
  • Integrate telemedicine and communications
  • Repurpose drugs to treat the injury not the threat
  • Support all stages of antibacterial development
  • Develop broad spectrum antivirals with efficacy against multiple virus species/families
  • Invest in flexible technologies for vaccine manufacturing
  • Establish a comprehensive burn and blast trauma care portfolio
  • Produce 4 new antibiotics to address multidrug resistant bacteria by 2030

JOINT PROGRAM EXECUTIVE OFFICE FOR CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR DEFENSE (JPEO- CBRN)
JPEO-CBRN is the entity responsible for modernizing biological defense, enabling early warnings, and developing ways to unencumber Warfighters. The division develops, tests, manufactures, and delivers all CBRN protective, sensors, drugs, and diagnostics. Amidst the pandemic, they provided communities, both civilian and military, with diagnostic tests and personal protection equipment. JPEO’s goal is to be threat agnostic as they deliver point of care diagnostics and improve chemical diagnostics.

Looking to the future, CBRN plans to make investments for work on projects that will:

  • Focus on acceleration of antibody development
  • Study monoclonal and polyclonal antibody products and nucleic acid vaccines
  • Integrate early warnings that allow war fighters to see dangers in their path before they encounter them
  • Develop algorithm for decision support tools

INFLUENZA AND EMERGING INFECTIOUS DISEASE (IEID)
IEID was perhaps the busiest of the BARDA divisions for the last 20 months because of COVID-19 but does still focus in other areas (such as the flu) and continues to research how they can use the lessons learned from this pandemic to apply to future pandemics. It is important to remember that previous infectious disease research is what allowed the COVID-19 vaccine to be developed so quickly, as BARDA leveraged those proven technologies to build the vaccines. IEID is still looking at emerging technologies such as faster platforms that allow for a shorter time from sequence identification to shots in the arm. They are also looking for ways to improve distribution through one dose vaccines that protect faster, vaccines with room temperate stability that require little to no special training to administer, as well as expanding the licensed age range to allow more people to become vaccinated.

DETECTION, DIAGNOSTICS, AND DEVICES INFRASTRUCTURE DIVISION (DDDI)
DDDI addresses diagnostic and medical device needs across BARDA’s portfolio to bring solutions to biothreat and antimicrobial diagnostics, ventilators, respiratory protective devices, and home tests to name a few. For COVID-19, DDDI took a four-pronged approach to the diagnostic development funding. The funding led to 27 total Emergency Use Authorizations (EUAs) — 14 EUAs for molecular diagnostics for acute infection detection, five EUAs for antigen diagnostics for mass screening multiplex with flu, and seven EUAs for antibody diagnostics to shift focus to neutralizing antibody tests. It also has funded capacity expansion for industry partners in collaboration with DoD.

Looking to the future, DDDI is seeking to invest in projects that will:

  • Continue focus on COVID-19 diagnostics and existing flu programs
  • Support COVID-19 programs through 510(K)
  • Execute existing manufacturing capacity expansion programs with DoD
  • Establish rapid contracting mechanisms
  • Design threat agnostic diagnostics and other tools to speed up antigen and protein test development

DIVISION OF RESEARCH, INNOVATION AND VENTURES (DRIVE)
The mission of DRIVe is to help BARDA be prepared for any public health emergency by identifying and de-risking the world’s most promising technologies. They do this by identifying the scientific, technological, regulatory, adoption, and commercial risks of these innovations to improve upon them before a public health emergency arises. DRIVe’s portfolio involves digital medical countermeasures, host-based therapeutics, ReDirect, ImmmueChip+, Beyond the Needle, infection severity diagnostics, lab to home point of care solutions, and sensors. DRIVe also launched BARDA Ventures which uses venture capital practices to accelerate the development of technologies to address global public health emergencies and health security threats. In conjunction with the Global Health Investment Corporation, BARDA Ventures can act with speed and flexibility, help technologies find pathways to commercialization, coinvest, and share cost with the private sector, and work with portfolio companies to enable health security indication and global product access. DRIVE also announced there will be a part two to their Mask Innovation Challenge which seeks to improve the comfort, utility, and protective factor of available face masks that are used by the public. Details for this will be available soon.

Other BARDA Topics

BURN AND BLAST MEDICAL COUNTERMEASURES
Burn and blast medical countermeasures remain a priority for BARDA and is an area of interest in the BAA. BARDA seeks to mitigate bottlenecks in burn and blast injury treatments, development adoptable medical countermeasures that transform the current standard of care and build sustainable national preparedness. They do this by addressing real world challenges in initial and definitive care and partnership with the end-user community. Some topics of interest in the area are advanced imaging, noninvasive vitals and TBI detection, as well as solutions to internal and external hemorrhage and airway access complications. The product development philosophy for this area is to take a holistic approach to address the broader issue of adoption sustainability for every burn and blast project.

ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE (ASPR) FIRESIDE CHAT
In a fireside chat, Dawn O’Connell, the Assistant Secretary for Preparedness and Response, shared the division’s critical role in leading the current response to COVID-19. ASPR awarded $350 million to aid the United States health care system to respond to COVID-19 and led the allocation and distribution for the first three therapeutics approved by the FDA and used during the pandemic. They produced 91 products, 141 diagnostic tests, 4.5 million therapeutics, and delivered over 100 million vaccinations. O’Connell highlighted that MCMs require building stronger collaborations with industry, providing tools and manufacturing support for private partners and upfront understanding of how products work in the real-world. They are still looking for innovations to develop easier to use vaccines, stronger public health preparedness, and more confidence and trust in medical countermeasures.

KEYS TO A SUCCESSFUL WHITE PAPER
BARDA offered tips to submitting a successful white paper. Keeping in mind that they fund products and solutions, not technologies, they offered the following tips:

  • Include critical elements — area of interest, technical explanation, supporting data, market potential, photos of prototype and components
  • List challenges and risks
  • Be mindful of technical readiness — products and solutions should be at least a TRL 4-5
  • Prove you are ready to enter design control
  • Prove capability
  • Remember editing and legibility

Conclusion

The conference reiterated the importance of public-private partnerships and how BARDA continues to make the necessary investments through its vehicles (DRIVe and BARDA Ventures) to support both small and large companies in their research and development efforts. We also noted that for the first time since the pandemic began, BARDA is shifting its focus to other priorities and will fund other MCMs. However, significant focus remains on COVID-19 and new pandemic related technologies. TechWatch meetings remain a valuable resource for addressing conditions ranging from trauma response, sepsis, and infection control to infectious disease to influenza.

G2G always recommends arranging conversations with BARDA staff and reviewing the BAA to understand priorities, obtain feedback, and ensure what offering meets BARDA’s needs before applying for funding opportunities. If we can assist you with this outreach or if you would like the BAA overview document, please let us know.