The PHEMCE MCM Review (2010) recommended that PHEMCE partners provide not only financial help to medical countermeasure developers but also technical and regulatory assistance. BARDA’s Strategic Plan (2011) set a goal to provide assistance to developers through core assistance programs in critical areas including animal and clinical studies to obtain safety and efficacy data and manufacturing optimization, validation, and scale-up for clinical studies and commercial launch.
In 2011 BARDA established the Non-clinical Studies Network comprised of 17 laboratories in the U.S. and UK that have perform studies supporting the natural history of chemical, biological, radiological, and nuclear events in multiple animal models and the safety and efficacy afforded by different medical countermeasures supportive of FDA Approval. The Centers for Innovation in Advanced Development and Manufacturing (CIADM) were established in 2012. The three Centers are located in the U.S. and are comprised of industry, academic, and Sate government entities partnered with BARDA. BARDA established in 2013 a Fill Finish Manufacturing Network (FFMN) to assist medical countermeasure developers with final drug product manufacturing (e.g., aseptic syringe and vial filling, lyophilization), support national pandemic influenza vaccine manufacturing efforts and other public health emergencies. The FFMN is comprised of four domestic manufacturers with a broad set of capabilities to address every day and emergency needs Lastly BARDA established a Clinical Studies Network (CSN) in 2014 to provide clinical study services from designing clinical protocols to managing clinical trial sites. The five domestic Clinical Research Organizations in the Clinical Studies Network will provide these services to medical countermeasure developer partnered with BARDA and backfill NIH’s clinical study capabilities in a public emergency as requested.
Together the four existing BARDA core service assistance programs form a comprehensive aid package to mitigate many inherent risks associated with medical countermeasure development and manufacturing.
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