OR WAIT 15 SECS
As the coronavirus pandemic unfolds, the bio/pharma industry must practice science over hype.
The coronavirus pandemic is sweeping around the globe at a rapid pace, forcing governments, regulatory authorities, healthcare systems, and the bio/pharma industry to take novel measures to address the crisis. Some public health officials and doctors sounded early alarms about the spread of a novel coronavirus-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-in January 2020; however, many people and governments did not heed the alarms or were slow to respond to the spread of coronavirus disease (COVID-19).
As politicians weigh protecting public health versus the impact on the economy, medical professionals beg for adequate supplies of face masks and ventilators. Meanwhile, many drug companies and research organizations have announced R&D efforts to test approved therapies as treatments to minimize the effects of COVID-19. The research focus of drugs in development have been redirected to target coronavirus symptoms. And, groups around the world have accelerated efforts to develop much-needed vaccines.
Following initial criticism for delays in approving diagnostic testing to detect who had the virus, FDA stepped up its activity, issuing more than a dozen guidance documents in March 2020. Actions included issuing emergency authorizations for diagnostic test and ventilators, easing regulations for remote monitoring of patients and clinical trials, allowing the compounding of hydroxychloroquine sulfate under certain conditions, releasing guidance for the preparation of hand sanitizers, and facilitating access to COVID-19 convalescent plasma for use in patients with life-threatening infections (1).
The immediate goal is to “flatten the curve” of new cases of COVID-19 to reduce strain on the healthcare system. Staying home, avoiding crowds, and washing your hands are simple measures we all owe the medical professionals, first responders, grocery store clerks, delivery services, transportation workers, and others on the front lines of maintaining our basic needs to get through this crisis.
Obviously, these non-pharmaceutical measures are only part of a temporary solution; therapies are desperately needed to treat COVID-19 patients, and vaccines ultimately required for long-term control of the virus. Bio/pharma researchers, development and manufacturing professionals, and companies supporting drug development and manufacturing are essential to these efforts.
At the same time, patients still need effective, affordable therapies to treat chronic diseases, cancers, and other conditions. A reliable drug supply is vital to maintain health and alleviate public concerns.
During the past few weeks, we have learned about many drugs and vaccines as potential cures. The world could use a “magic pill” right now. But drug developers know the challenges of working the science and producing the data to ensure that the therapy is safe and efficacious. One challenge for those in the bio/pharma industry is to avoid using excessive hype about a potential therapy, which can create false hope. Now is the time to lead with the message that science-not hopes or gut feelings-should drive all healthcare decisions.
The BioPharm International team thanks those working to develop new treatments and vaccines and those maintaining the drug supply; we are here to support those efforts. In addition to our normal coverage, we offer added coverage of COVID-19 drug development programs, links to research, industry suppliers, and regulatory updates. You can find the latest news, updates, and access to an archive of previous issues on www.biopharminternational.com.
Stay safe, and we wish you success in your drug development efforts.
1. FDA, Coronavirus Disease 2019 (COVID-19), www.fda.gov, accessed March 26, 2020.
Vol. 33, No. 4
When referring to this article, please cite it as R. Peters, “Biopharma’s Leadership Role in a Pandemic,” BioPharm International 33 (4) 2020.