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BARDA Industry Day General Report

Friday, November 11, 2016   (0 Comments)
Posted by: Kate Oesterle
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BARDA Industry Day General Report
October 18-20, 2016

This report highlights key takeaways from the annual BARDA Industry Days Conference G2G attended last week in Washington, D.C. It includes an overview on BARDA’s priorities and covers information gathered from our talking with various chiefs and directors and during the one-on-one meetings and general and breakout sessions. Finally, it covers information on how to strategically communicate with program managers to increase your likelihood for success in collaborating with and securing funding from BARDA. Highlights include:

•    BARDA, created as part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) ten years ago, aims to aid in the advanced research and development of products to help prepare for and respond to a vast range of emergencies, including any mass casualty situations that range from Anthrax to influenza and infectious diseases.
•    In FY16, BARDA directed $415 million to Advanced Research and Development, $107 million to Combatting Antimicrobial Resistant Bacteria, $510 million to Project Bioshield, and $117 million towards Ebola efforts. Within the past two years alone, 9 products have come out of BARDA’s Project Bioshield. From FY14-17, BARDA has spent $750 million on 21 Medical Countermeasures and $1.7 billion in the last decade on the national stockpile.
•    The Director of Strategic Science and Technology Division (SSTD) explained how his division is providing strategic/technical support and direction for all of BARDA’s programs and is leading the establishment of BARDA’s new Emerging Infectious Diseases Division focused on naturally occurring infectious threats that are increasing in public health significance.
•    While in the past BARDA has prioritized the stockpile, it wants to pivot towards spending money on commercially available products already employed in medical facilities that can be easily accessed during an emergency.
•    At this year’s conference, unlike last year, BARDA Chiefs and Directors repeatedly asked for submissions and stated their eagerness to fund initiatives. In addition, they welcomed innovative products and shared insights on new initiatives, such as the CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), the Innovative Medicines Initiative, and the Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R). BARDA also highlighted a new focus on Total Lifecycle Management, stating that each proposal must address the business aspect of an innovation’s lifespan to inform the out-year budget, asking submitters to address how their submissions address product and cost sustainability over 10+ years. Overall, BARDA chiefs and directors emphasized the importance of collaboration across industry and academia to make a competitive proposal.

BARDA’s Priority Areas
Chemical, Biological, Radiological, and Nuclear (CBRN) Priority areas:
1.    Improving medical countermeasures against chemical threats
•    BARDA only has one medical countermeasure (MCM) for chemical threats, and that is for nerve agent threats.
•    BARDA lacks treatments for Pulmonary Threat Agents (chlorine), Vesicants (sulfur and mustard), and Cyanide.
•    BARDA’s biggest success in the area of Chemical Threats in decontamination guidance, which is their only broad spectrum MCM.
•    Looking for MCMs that treat the injury, not the agent.
•    Looking to pursue commercially available products to avoid having to store in stockpile.

2.    Addressing the Gaps in Burn Care
•    Looking for new products that will prevent or limit burn conversion.
•    Are very interested in easy to use smart imaging systems for burns.
•    Seeking new allogeneic and biological or small molecules to serve as adjuncts to accelerate healing.
•    Want treatments with high levels of efficacy even with delayed application.
1.    Improving influenza vaccines
•    Looking to create broad spectrum vaccines that work on larger age ranges.
•    Want “one and done” vaccines that can be given once in a person’s life and prevent all strains of influenza infection.
•    Looking to coordinate an approach to improve seasonal flu vaccine selection and flexibility in vaccine production cycle.
•    Launched the BARDA BAA for the Advanced Development of Medical Countermeasures for Pandemic Influenza.

2.    Influenza/ Emerging Infectious Disease Treatment Therapeutics and diagnostics
•    Looking for therapeutics that will fill the gap of treating those who are severely ill and hospitalized from influenza.
•    Funding opportunities in nontraditional therapies such as mAbs, phage, and host-based solutions.
•    Severe MERS CoV also an emerging priority, which BARDA aims to develop alongside influenza therapies to align efforts and find platform technologies that eliminate the “one bug, one drug” paradigm.
•    BARDA is very interested in technology that focuses on diagnostics for viral infections, and encourages anyone with innovative technologies to reach out.
•    The Strategic Science and Technology office in BARDA released a BAA looking for technologies that will result in the production of a vaccine or monoclonal therapy using a platform technology that can be applied to a broad spectrum of diseases. This BAA is called Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases (BAA-16-100-SOL-00003).

Emerging Infectious Disease and Combatting Antimicrobial Resistance (AMR):
•    Since 2010, built a portfolio of antibacterial therapeutics with a total value of about $1.36 billion, providing $548 million in direct funding to 9 companies.
•    There are 6 programs currently in Phase III development with BARDA, with the first FDA approval expected before end of 2016.
•    Launched CARB-X program with NIAID, which offers $250 million in cooperative agreement as a way to accelerate the R&D portfolio of preclinical assets. They look to invest $350 million more in the next three years. BARDA looks to use this incubator accelerator model in future programs as well. The project manager for CARB-X is Boston University. CARB-X partners are also matching over $100 million on these projects. This program looks to fund innovations at TRL 3-6. Some 160 submissions came into the CARB-X program this first round, surpassing their expected number.
•    There are 23,000 deaths annually in the United States from antimicrobial resistance, costing $35 million, and they predict that there will be up to 10 million deaths annually across the globe by 2050 from AMR.
•    Need people to develop novel therapies to treat Gram-negative infections and drug-resistant biodefense pathogens.
•    Expanding the portfolio to include treatment options for C. difficile infections and approaches that can interdict/prevent infection upon entry into healthcare setting.
•    Multi-drug resistant Bacillus anthracis (anthrax) remains a high-priority threat.
•    Innovation Area of Interest—discovery, development, and demonstration of monoclonal antibody platform technologies using immunoprotective proteins from infectious disease pathogens of interest.
•    Introduced a partnership with NIH called the Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test Challenge, which through a three step, multi-year process, aims to produce novel diagnostic tools that can both detect infection, determine resistance, and differentiate between bacterial and viral infections.
•    Looking for diagnostic tools and innovations surrounding Zika and anthrax detection.

Recommendations for Collaborating with BARDA:
1.    When determining if your proposal will be successful, ensure your product meets the following criteria:
•    The product or innovation is addressing an unmet need
•    Your product compares favorably to what exists in the market or is being developed for the market
•    Your innovation is novel
•    You can cost share
•    It fits into BARDA’s portfolio given what BARDA is already funding
•    There is a market beyond the government, ensuring the product is financially sustainable
2.    Avoid the following common mistakes that cause program managers to reject proposals:
•    Insufficient data to back up TRL (Technical Readiness Level)
•    Technology is too early in the R&D process
•    Insufficient demonstration or understanding of the path to licensure
•    Product is not a fit for BARDA
•    IP freedom is not defined
•    Only looking for R&D and not procurement
•    The timeline proposed is inaccurate or not realistic

After submitting a white paper, you should hear back from a program officer within 90 days. It is important, however, to communicate with program officers at all points until submission, as officials at this conference noted that funds may run out or priorities may change. Also, the chiefs and directors are willing to engage and provide counsel until a submission is made, and then will no longer speak with individuals after this point.

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