In addition to scientists gaining an understanding of SARS-CoV-2 transmission, pharmaceutical companies also jumped into action to develop inhaled and nasal products for the treatment and prevention of COVID-19. Commercial clients quickly approached us with projects centered on antibodies, antivirals, therapeutics, and prophylactics against SARS-C0V-2, and similar efforts are going on across the industry. In addition to novel products, a number of companies looked to repurpose drugs such as remdesivir and niclosamide, reformulating them as inhaled therapies for the treatment of COVID-19. And numerous companies began development of intranasal vaccines against SARS-CoV-2, including Altimmune, AuraVax, Bharat Bio, BlueWillow Biologics, Codagenix, and Meissa.
Of course, the pandemic has made development of all OINDPs much more difficult. Pre-clinical work has been slowed due to a shortage of non-human primates, especially the African green monkeys that provide a particularly good model for SARS-CoV-2. Clinical trial work has been slowed by safety concerns, not only the possibility of transmission between subjects and researchers, but also questions of how to handle blood samples when apparently healthy subjects could have asymptomatic infections. Travel restrictions mean that we have had to find a way to conduct audits remotely. CROs and CDMOs with expertise in respiratory and infectious diseases are struggling with staffing and may not have the capacity for projects, particularly for products that are not intended for the treatment or prevention of COVID-19.
Scientific exchange within the OINDP community has also been hindered, with meetings like RDD and DDL forced to go virtual. We can no longer have conversations over a cup of coffee during a meeting break, and it’s much more difficult to facilitate introductions to people who should be working together. Scientists who are new to inhaled and nasal drug delivery and those who work for small companies now have very limited opportunities to make connections within the industry.
Despite the challenges, scientists are forging ahead. We’ve bought a lot of cameras in the past year, learned how to use Zoom, and found ways to share data confidentially. We have come up with new protocols and new suppliers where necessary. Phone calls, virtual meetings, and webinars have provided a forum for the exchange of scientific knowledge. Even regulators quickly adjusted to deal with the pandemic, and the FDA has done a nice job of balancing risk versus reward, including by allowing drugs with known toxicology profiles to get an IND with fewer studies before going into trials for COVID-19 when presented with well put together scientific arguments.
Some of our work in the past year may be discarded eventually; other work, like our new understanding of how aerosolized viruses are generated, new treatments for acute respiratory distress, and new methods of producing vaccines, may be the foundation for years of work to come. Whatever the long term effect, as our work and home lives changed over the past year the world turned to us to lead the way, and aerosol medicine specialists stepped up and responded.
Philip Kuehl is Senior Scientist and Director of Scientific Core Laboratories at Lovelace Biomedical
Jacob McDonald is Vice President of Applied Sciences at Lovelace Biomedical
