On 16 June 2021, the BEAM Alliance held a Roundtable event addressing the threat of antimicrobial resistance (AMR) amidst the COVID-19 crisis. The discussion shed light on the content of the Pharmaceutical Strategy for Europe, adopted by the European Commission in November 2020, and foster the necessary transformative changes in European health systems. Speakers included policymakers from the EU institutions, academia, industry, and other global stakeholders. Below are the recordings of each session and their key takeaways.
TAKEAWAYS:
Wolfgang Philipp, Head of the Health Emergency Response and Vaccines unit, DG SANTE, European Commission (video not available)
• Observed shortcomings in responding to the COVID-19 pandemic as a result of insufficient medical countermeasures, which has led to the announcement of the creation of a “European BARDA” named HERA
• Explained HERA could address the aforementioned market failures, the lack of medical countermeasures, the vulnerabilities in research prioritisation and global supply chains, in addition to shortcomings in late-stage development, and overall weak preparedness plans
• Announced some preparatory actions, including technological reviews of the latest AMR medical countermeasures, a needs assessment, and an analysis of AMR-related stockpiling options
• Proposed HERA could act as a pipeline coordinator.
Chris Houchens, Director, Division of CBRN Countermeasures, BARDA
• Introduced the role of BARDA in developing medical countermeasures by forming unique public-private partnerships to drive innovation
• Mentioned that BARDA has invested over $1.5 billion over the past decade and that over the past 17 years, 61 medical countermeasures have been approved
• Described BARDA as a relatively small agency, populated by experts who have spent their entire careers in the drug industry
• Explained BARDA provides support through CARB-X (preclinical and early clinical stages), Advanced Research and Development Program (clinical trials) and the Bioshield project (stockpiling).
Mark E. Jones, BEAM Alliance Secretary, Head of Preclinical Development and Project Management at Basilea Pharmaceutica
• Explained that Basilea is funded by BARDA, and feels the benefits of this in terms of BARDA’s dedicated, experienced, and expert staff, who share a common goal of securing approval
• Highlighted that BARDA offers non-dilutive milestone-based funding on a cost-share basis with shared risk that drives all actors in the same direction. In the BARDA process there is no consortium, and no external stakeholder. It encourages responsible spending, enforced by the requirement for BARDA approval, and also provides oversight via its cross-functional expert team.
