Digital Acceleration: Low-Hanging Fruit And Stretch Goals
COVID-19 has pushed the entire health care system to adopt new technologies and new solutions for conducting clinical research and delivering care to patients. An expert panel hosted by the Galien Foundation provided a meditation on what the biopharma industry has learned so far, and how to use the urgency created by COVID-19 to lock-in technological acceleration while maintaining what FDA’s Amy Abernethy called “responsible progress.”
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As the global shut-down caused by the coronavirus pandemic continues, sponsors are rushing to adapt clinical trials that can move to partial or completely remote monitoring, allowing patients to remain in their homes but continue to participate in studies. And the outbreak may have another silver lining for the biopharma industry, a chance to rebuild its reputation.
A potential decline in mRNA vaccine protection against the Delta variant is raising questions about the need for booster shots in the US. Ocugen Inc. and partner Bharat Biotech hope the changing dynamic of COVID-19 in the US will induce the FDA to reconsider additional clinical trial requirements for Covaxin, an inactivated whole virus vaccine authorized for emergency use in 16 countries.
A deeper understanding of rare diseases – how they differ across geographies and ethnicities, or which genes and biomarkers are most useful targets for new treatments – can help to accelerate and de-risk clinical trials. On the commercial front, patient data and insights could mean the difference between a category leader and a failure.