The global pandemic has put a spotlight on the life science industry, and, for the most part, it has stood up to the intensity of that glare.
In less than a year, biopharma and academia went from knowing nothing about SARS-CoV-2 to rolling out a new vaccine using brand-new technology to the world.
But the advent of this pandemic has also raised a lot of questions. Why, before 2020, had vaccines and infectious disease research been left at the back of the cupboard by so many? Meanwhile, rare diseases and cancer, typically much more profitable areas, have been sitting out on the countertop.
Experts had been warning about a major new epidemic or pandemic for years. SARS, Ebola, Zika and H1N1 should have raised their own alarms, but the surges of work to fight those diseases never led to sustained interest in infectious disease R&D.
COVID-19 has left its fingerprints across everything in life sciences, whether directly or indirectly. Biotech IPOs have boomed this year, and not just those for biotechs hunting for COVID-19 drugs; in fact, most of those companies are going after typical oncology and rare disease targets. But as one of the only industries with strong growth amid the pandemic, biotech has seen a major bump in valuations and optimism.
The joint challenges of a pandemic and mounting political pressure from the now-outgoing Trump administration have also opened up questions about the FDA. It was not the first regulator to grant emergency use for a COVID-19 vaccine—that badge went to the U.K.—but it was quick to allow emergency use authorizations for drugs like Gilead Sciences' remdesivir, despite mixed data, and for Regeneron and Eli Lilly’s antibody treatments, one of which was used by Donald Trump when he contracted the virus in October.
Big changes are likely ahead for the FDA: President-elect Joe Biden will have his shot at choosing a new agency commissioner and setting a new, post-pandemic tone for its operations.
Meanwhile, COVID-19 has also reshaped clinical trials: The rise and rise of the virtual model, so necessary during lockdowns to keep R&D moving in all disease areas, has become a present and future bet many pharmas and investors are now making.
The pandemic, coupled with the social justice movement, has fired up new interest in equitable drug research. Recruiting a truly diverse population for any trial has been a longstanding challenge, but COVID-19 brought diversification front and center; when patients of color are disproportionately affected by the disease—with more cases and more deaths—the same communities should be better tested in trials.
Some companies did do so in their COVID-19 trials, although belatedly, but 2021 could be a year of true change.Whatever the pandemic trajectory proves to be in 2021, it's safe to say COVID-19 will have changed biopharma permanently, just as it has the rest of the world.
The rise and rise of the virtual trial model
COVID-19 brings infectious disease R&D out of the wilderness
Hahn heads toward FDA exit after short, dramatic tenure as commissioner
In spite of COVID-19—and partly because of it—biotech IPOs have a record year