BIO 2021 Notebook: A Breakthrough Year For Emerging Companies?
News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, the US FDA's Patrizia Cavazzoni on science vs. emotion at advisory committees and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.
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Emerging biopharma companies developed and launched 40% of all new drugs that hit the market in the US in 2020, a significant increase from five years ago, according to IQVIA.
Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it can use real-world data and evidence for COVID-19 vaccine evaluation.
Agency is going outside its ‘comfort zone’ to leverage different streams of existing real-world data sources to quickly assess the impact of potential treatment approaches, Amy Abernethy says; pandemic experience could lead to a more open embrace of RWE beyond the current public health emergency.