ISPE Releases Report on its Work Supporting the Establishment of the European Health Emergency Preparedness and Response Authority (HERA)
08 June, 2023
ISPE was engaged by McKinsey & Company to provide technical and regulatory expertise and advice in the areas of antimicrobial resistance and flexible manufacturing countermeasures.
ISPE is excited to release a new report summarizing its 2022 work that helped lay the groundwork for the establishment of the European Health Emergency Preparedness and Response Authority (HERA). ISPE worked with McKinsey & Company on two workstreams for the project, commissioned by the European Health and Digital Executive Agency (HaDEA).
HERA was launched as a new European Commission Directorate-General with a mission to prevent, detect, and rapidly respond to health emergencies. As part of the preparation for this new Authority, (HaDEA) selected McKinsey & Company to lead two assessments and studies. McKinsey & Company then engaged ISPE to provide technical and regulatory expertise and advice on chemistry, manufacturing, and control (CMC) aspects of manufacture and supply in two workstreams: stockpiling of antimicrobial resistance medical countermeasures and flexible manufacturing and innovation.
ISPE put together a multidisciplinary team that included experts from Roche, Novartis, Merck, Merck Darmstadt, Gilead, and others, to take on the project. We are very glad to apply our expertise for these particular workstreams by providing much-needed input and raising the right questions to ensure a diversity of perspectives.
The objective of the stockpiling workstream was to develop a feasibility assessment on stockpiling of countermeasures in antimicrobial resistance (AMR). For this workstream, in May and July 2022, ISPE contributed subject matter experts for two virtual workshops with some follow-up, one-to-one discussions. The workshops covered options for stockpiling, needs and availability in the EU, as well as regulatory issues, appropriate funding mechanisms, and operational deployment issues.
For the flexible manufacturing workstream, in July 2022 ISPE conducted an anonymous response survey of its members and other industry professionals to better understand opportunities for flexible manufacturing of therapeutic API’s and associated drug products, to assist with alleviating drug shortages.
Ultimately, the ISPE team provided a substantial amount of technical and regulatory insight to McKinsey & Company for consideration in their discussions with DG HERA related to the two workstreams. The newly released report details inputs and outputs from the workshops as well as the results from the survey. The "Report on ISPE Work to Support Establishment of the European Health Emergency Preparedness and Response Authority (HERA)" is available for download as a bundle with the ISPE report "Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients" published December 2020 at the ISPE website.
This engagement highlights the technical leadership and bench strengths of ISPE that is built on our 22,000+ members’ knowledge and commitment to assure reliable delivery of quality medicines to patients worldwide. We remain committed to providing support for major regulatory initiatives with development, manufacturing, and supply chain knowledge.
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