• Jeff Stoll, Leadership |

The speed, reach and impact of the COVID-19 pandemic continues to pose unprecedented challenges to global public health systems and economies. We are starting to see a disproportionate infection and death rate between different countries, states and cities, each of which have their own unique factors from demographics, population density, strengths of public health facilities, to public compliance with social restriction guidance. When we stand back twelve months from now and take stock of what is occurring, we need to examine how several contra-acting megatrends collided. Organizations like the WHO1 have been highlighting for years that the globe has entered into a new normal with more frequent, faster and broader-spreading epidemic events. COVID-19 is just the latest pandemic to provide an opportunity for governments and policy makers to reflect back 12 months from now and develop a better understanding and approach for a rapid response to the next benefits of the massive innovation movement that has happened in life sciences over the last decade. As has been demonstrated over and over again, and COVID-19 is proving to be no exception, the FDA’s leadership to the world is central to unlocking innovation to pursue solutions for COVID-19. In fact, the speed by which the FDA, academia and the companies from the diagnostic, life science tools and biopharma industries have responded to the COVID-19 pandemic is unprecedented in human history. All of the individuals and companies associated with these areas should be proud of what the significant contributions they are making. A few impressive facts:

  • In December 2019, and under 60 days of the first outbreak, the genomic profile of the virus was starting to be fully understood2
  • By February 2020, over 80 SARS-CoV-2 genomes were shared through the Global Initiative to Share All Influenza Data (GISAID) and GenBank, which expedited the epidemiology and transmission routes, and facilitated development of diagnostics and therapeutics3.
  • In February 2020, pharmaceutical company Gilead started the first clinical trial
  • By March 2020, there were over 50 unique therapeuticsin development to treat COVID-19
  • Gilead’s remdesivir and several other Phase III trial results may read out as early as this month
  • Biopharma company Moderna developed a completely novel mRNA vaccine and began its first patient recruitment for a Phase I trials in early March. If Moderna is successful, it will be the fastest a novel vaccine was developed from discovery to commercial approval in the history of medicine. If successful, approval is expected in early 2021.
  • J&J5 has also announced the start of a Phase I vaccine trial in September and through an expedited special protocol that could also see it approved in early 2021. If this program successful it would rival Moderna for speed of development and approval
  • And although diagnostics companies and reference labs had a more difficult start in this epidemic, in the last 2 weeks, numerous faster point of care diagnostics have been approved by the FDA (e.g., Abbott6 launched its point of care COVID-19 test that only requires a 5 to 10 minute turnaround).

This pandemic has shown first-hand why sustaining incentives that allow highly innovative life science companies to flourish should remain a priority across the globe. They are needed to continue to pursue cures for diseases like cancer, but find solutions for each new emerging epidemic. Lives and economies rely on it.

Success Will Likely Come in Iterations and Raise a Tough Question

While the soonest a preventative vaccine could earn approval is at least another 9 months away, there are other major therapeutic milestones coming in the next few weeks and months, that if successful, could have a meaningful impact on how the risk of COVID-19 is viewed. While in the near-term there are no silver bullets several therapies could curb the course of the disease that if they have positive results in April and May could be approved this summer. Some experts have referred to this as “taking the top off”7 of the viral infection, and drugs like Gilead’s remdesivir and Roche’s Actemra represent some promising options that could prevent the course of COVID-19 from entering into severe disease and becoming deadly. The possibility of having a one or more therapeutic options approved by the FDA for curbing the disease course is a real possibility. While early results from several different drug options have been poor, animal studies suggest a sound rationale for remdesivir8 and early case studies out of China suggest the anti-IL6 therapies9 all could be options. While we all hope for a curative vaccine, there is a very real possibility we’ll need to consider the impact of therapies that prevent COVID-19 from progressing to severe lung disease and significantly lowering the likelihood of death. This raises an interesting question. If COVID-19 is not cured, but these early therapies are successful in significantly preventing death, how much certainty is required for a return to normalcy or some semblance of normalcy? We’re likely to get an imperfect answer for COVID-19 in the near-term, what do we need to do to be prepared to optimally take advantage of this opportunity?