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Bio/pharma works hard today to change the calendar to tomorrow.
We are now approaching the one-year mark of the year of living distantly, thanks to the public health measures necessitated by the COVID-19 pandemic. In the past 12 months, people have adapted to working from home, buying everything online, and functioning in a bubble.
Like many others, I relate my pandemic experience to the 1993 film Groundhog Day. In the movie, weatherman Phil Connors—the main character—is trapped in time, reliving an unpleasant, monotonous day over and over and over and over again. In the role, actor Bill Murray plays out Phil’s depression, frustration, and anger until he finds a path from his self-adsorbed existence to one of compassion, collegiality, and personal redemption.
Before the pandemic, the bio/pharma industry had a reputation problem. While the rest of the world lived out pandemic-induced isolation and repetitive days, the bio/pharma industry made remarkable progress by innovating and collaborating with colleagues, partners, and competitors.
Recent reports released by FDA show that despite restrictions posed by the pandemic, 2020 was a very good year for drug development. The Center for Drug Evaluation and Research (CDER) approved 53 new therapies in 2020, the second highest number of annual approvals in the past 10 years, including 21 classified drugs as first in class and 31 approved to treat rare or orphan diseases. The approval rate was impressive; 92% of the drugs were approved without a complete response letter, up from the 85% average of the previous eight years. And 75% of the drugs were approved in the United States first, before other countries (1). To read more about FDA’s 2020 performance reports, read the Regulatory Beat column from the March 2021 issue.
FDA had some missteps in 2020, such as the approval, then revocation, of an Emergency Use Authorization (EUA) of chloroquine and hydroxychloroquine, which raised questions of undue political pressure on a scientific process. And progress has been slow on many pandemic-related drugs in development.
Still, the bio/pharma industry had some notable successes, specifically the emergency approval of two novel vaccines in record time—with other vaccine reviews pending—and the rapid approval of remdesivir to treat patients with COVID-19.
When EUAs were issued for the Pfizer-BioNTech and Moderna vaccines in late 2020, it was hailed as the beginning of the end of the pandemic. In reality, it was the beginning of the next phase.
Now, growing concern in public health and medical circles about emerging variants of the SARS-CoV-2 virus and their possible resistance to vaccines and treatments prompted renewed research and regulatory strategies. FDA recently issued a set of guidance documents to address the emergence of variants of SARS-CoV-2, including an update to the October 2020 guidance on EUA for vaccines to prevent COVID-19 and guidance on the impact of the variants on monoclonal antibody (mAb) products and other treatments.
In the cover story for the March 2021 issue, author Cynthia Challener takes an in-depth look at genetic vaccines, challenges associated with manufacturing and distribution, and the potential for rapid reformulation to tackle virus variants .
As the pandemic enters its second year, the pressure is still on bio/pharma companies and FDA, as demand for vaccine production intensifies and any delays—from manufacturing issues or bad weather—contribute to growing public impatience.
I finally see signs that we are emerging from this long winter. The snow that fell in my backyard before Groundhog Day 2021 is finally melting. Daffodils are pushing up from the ground. The pace of vaccinations is accelerating.
However, the virus, like the weather, can be tricky. We must maintain vigilance of social distancing and good manufacturing practices. Today will soon be tomorrow.
1. FDA, Advancing Health through Innovation: New Drug Approvals 2020, Report (January 2021).
Rita Peters is the editorial director of BioPharm International.
Vol. 34, No. 3
When citing this article, please refer to it as R. Peters, "Fighting Through This Slow Season of Change," BioPharm International 34 (3) 2021.