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From the onset of the COVID-19 pandemic, the extended medical community launched a broad effort to tackle this public health threat. Building on lessons from prior epidemics, including most recently AIDS, SARS, MERS and Ebola, this ranged from vaccine development to repurposing available therapies. While repurposing drugs with anti-viral properties was obvious, less so was the need for other therapeutics to address the severe manifestations of COVID-19 not thought linked to direct viral effects. That a viral infection could trigger a dysregulated hyper immune process had long been suspected for several viruses including SARS so its identification in CVOID-19 patients was not unexpected. Often described as a cytokine storm, this clinical syndrome can be seen in many conditions and likely has multiple triggers which has made identification of effective therapies in all conditions challenging. Fortunately the last couple of decades has seen an explosion in the development of immunotherapeutics to treat a wide range of immune-mediated diseases. These novel agents are characterized by their “targeted” design which distinguishes them from older agents with more non-specific effects which also carry broader safety concerns. Because these agents were already approved for use, much was known about their pharmacokinetic and pharmacodynamic effects and could be brought to testing in clinical trial with more expediency once recognized as having potential benefit. This presentation will describe the efforts around the selection of Orencia (abatacept) for the treatment of severe COVID-19 among available immunotherapeutics. We will discussed a broad range of issues considered from formulation and dose selection to impact on drug demand in designing and executing this study.
Both the EMA and FDA recognize the vital importance of the Higher Order Structure (HOS) of a protein. It is specifically called out in their guidances and it is their expectation that the latest technology be applied to understand it…