Report Out on BARDA Industry Day 2015
Tuesday, November 17, 2015
Posted by: Kate Oesterle
The following is a summary compiled by G2G Consulting, a MichBio Preferred Provider, of key presentations and takeaways, agency leaders, and connections at this year’s Biomedical Advanced Research & Development Authority’s industry Day. G2G is always available to schedule introductory call with BARDA staff or if you have questions/interest in a particularly research area.
I. Major Presentations and BARDA Priorities:
The conference was opened with a series of presentations from senior staff at BARDA, the biomedical research and development arm of the U.S. Department of Health and Human Services (HHS). The presenters, some of whom represent the contracting staff at the agency who make award decisions, explained BARDA’s priorities and the series of broad agency announcements (BAAs) it just released the night before the conference. Of note:
- Agency Priorities – BARDA is looking for the following from applicants: innovation, flexibility, multipurpose and broad-spectrum application, long-term sustainability, sustainable manufacturing infrastructure, responsiveness, and the ability to develop new products.
- Cost Savings: Additionally, BARDA staff noted that drug development costs continue to rise ($1.2 - $2.5 billion and 10-15 years per drug) and BARDA only assists businesses at least at the Phase I stage, in efforts to carry them through to licensure. BARDA should not be viewed as a partner capable of funding their entire development pipeline, even if the agency is very interested in the technology.
- Pipeline - BARDA has had 200 different product candidates in their pipeline over the last decade.
- Broad Agency Announcements – New this year will be a review process that designates applications as either acceptable or not acceptable, rather than the scaled review system previously in place. BARDA also now seeks information on the total life cycle cost of a product or technology, and will provide a template on the site for determining these costs in advance of the first round of applications January 2016. The following documents will be distributed along with this report:
- Chemical, Biological, Radiological, and Nuclear (CBRN) (BAA-16-100-SOL-0001) will support development of MCMs (medical countermeasures) for CBRN agents. Burn and trauma are covered under this document.
- Pandemic Influenza (BAA-16-100-SOL-0002) will support MCMs for pandemic influenza. The funding and emphasis applied to this BAA has increased significantly in response to the 2014/15 Ebola outbreaks.
- Infectious Disease (BAA-16-100-SOL-0003) will support innovation through development of platform technologies that enhance capabilities for development and manufacturing of MCMs that are related to infectious disease/pathogen agents/antibody response. In previous years, this “innovations” BAA had been far more broadly defined and accepting of technology from across the R&D spectrum. However, for 2016-17, BARDA is prioritizing delivery methods in the infectious disease space.
- Next Steps – BARDA is looking to invest in products related to emerging infectious diseases and increase the stockpile of drugs related to key diseases. Stockpiling of more MCMs is currently on hold due to Congressional budget negotiations but BARDA wants to expand. BARDA is looking to increase the speed of manufacturing and has started partnering internationally to address this issue. Additionally, BARDA is currently preparing a new comprehensive Strategic Plan for 2017-22, which is expected to include efforts to create a permanent home for the emerging infections disease program.
Ø Takeaway: BARDA is zeroing in on emerging infectious diseases in the 2016-17 timeframe. Additionally, the Innovations Technology BAA is narrower this cycle than it has ever been in previous years, in large part due to funding constraints and the achievement of certain milestones since BARDA BAAs began. Submissions for this funding must include plans to assist BARDA in better developing or manufacturing MCMs that address antibody or pathogen-specific needs.
II. Key Takeaways:
- CBRN (BAA Opportunity) – BARDA is now looking for products that have significant advantages – or increased ROI – as compared to current MCMs in place. CBRN BAA awards will focus on biodosimetry, bio-threat diagnostics, and antimicrobial resistance diagnostics.
- Pandemic Influenza (BAA Opportunity) remains a key concern for BARDA; the agency has stockpiled vaccines for strains of influenza that have proven particularly dangerous in recent years (H1N1, H5N1, H7N9). BARDA awarded 5 contracts in FY15 and a few in FY12-13, all for less than $50 million each. The agency is looking specifically for protective equipment, full-featured continuous ventilators, diagnostic tools, therapies, and vaccines. There is a need for improved respiratory devices for health care workers, as well as for re-usable devices that can function across ages. Therapies should work after 48 hours of infection and there is a need for vaccines that will last for extended durations. All influenza products must meet BARDA’s standards for a TRL-6 designation, described in detail in the relevant BAA.
- Innovations Programs (BAA Opportunity) – This funding opportunity aims to save time and cost in developing MCMs for public health emergencies, but will focus on pathogen-specific MCMs or vaccines that can “plug and play” in response to specific emerging infectious disease threats during this upcoming round of funding.
Emerging Infectious Diseases – Ebola continues to be seen as a threatening disease that can be weaponized, and has changed how we prepare response systems for emerging infectious diseases. BARDA staff is shifting focus from establishing capabilities to enhancing capabilities in response to Ebola and other emerging infectious diseases. The agency seeks to support vaccines resulting in better immunity and fewer, longer-lasting dosages.