On May 15, 2020, the Federal Government announced Operation Warp Speed, a public-private initiative that aims to develop and deploy at least 300 million doses of a SARS-CoV-2 vaccine by the first half of 2021, according to a New England Journal of Medicine perspective article. (To date, the fastest vaccine ever to make it to market was for mumps, which took four years.)
Operation Warp Speed partners, hailing from the Department of Health and Human Services, the Department of Defense and the private sector, selected eight vaccine candidates based on criteria demonstrating their safety, efficacy, scalability and other key quality attributes. Six of those candidates are currently in clinical trials; in total, there are 48 coronavirus vaccines in human trials and at least 89 under preclinical evaluation, according to The New York Times.
Those are just the vaccines. Dozens of new and existing drugs are being tested to treat COVID-19, and the U.S. Food & Drug Administration’s (FDA’s) Coronavirus Treatment Acceleration Program (CTAP) promises to bring new therapies to COVID-19 patients as quickly and safely as possible.
Innovating from Adversity
Drug discovery and development is notoriously one of the most complex, costliest and highest-risk endeavors in modern science, taking an average of 12 years and $2.6 billion to complete. Statistically, only a small percentage of drug candidates make it from concept to market; of the few compounds that reach clinical trials, just 14% are eventually granted FDA approval, according to a study from the MIT Sloan School of Management.
Amid the emergence of the coronavirus and the race to find a treatment, we have seen a level of cross-sector collaboration and efficiency that could fundamentally alter the future of drug development for the better. At the same time, the pandemic has brought equally unprecedented challenges to the larger clinical research ecosystem — challenges that, if navigated successfully, could serve to eliminate barriers to pharmaceutical innovation.
Decentralizing Clinical Trials
With investigator sites and research laboratories forced to close during the height of the pandemic — and doctors and researchers heavily focused on the coronavirus — many clinical trials were derailed, including multiple studies for non-COVID-19 indications. According to data from ClinicalTrials.gov cited in a Nature Reviews Drug Discovery study, April 2020 saw an approximate 80% decrease in the number of new patients enrolling in clinical trials per site as compared to April 2019. As trials began to resume, the same study found that 57% of patient interactions and 79% of sponsor/contract research organization interactions took place remotely.
In general, the pharmaceutical industry has been slow to fully embrace decentralized clinical trials — “those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial,” as defined by the Clinical Trials Transformation Initiative (CTTI). These trials are inherently more patient-centric than the traditional model, as they often involve the direct delivery of supplies to — and retrieval of samples from — the participant’s home or other location outside of the conventional clinical setting. Additionally, study sponsors and physicians can connect with, monitor and collect data from patients remotely through wearables and other personal health technologies.
Decentralized trials have the potential to eliminate many barriers to patient recruitment and retention, which CTTI notes is particularly promising for the study of rare diseases, for which patient populations are often small and located in geographically remote regions. Recent events have shown that we are technologically equipped to mobilize clinical trials; continuing on this trajectory post-pandemic could allow sponsors to greatly expand the reach of their trials to include those who may not otherwise be able to participate.
Strengthening the Pharmaceutical Supply Chain
The COVID-19 crisis has brought many supply chain vulnerabilities to the surface — namely, the U.S.’ reliance on drug products and active pharmaceutical ingredients (APIs) manufactured overseas. According to STAT News, nearly one-third of the manufacturing sites that produce APIs for the U.S. are located in India and China, which presented an acute threat as Chinese factories shut down and Indian exports were restricted early on in the pandemic.
Though these incidental barriers have since been lifted, the risks associated with having a limited supply chain network go beyond the realm of the pandemic. Mitigating these risks is vital to ensuring continuity of pharmaceutical supply through the current pandemic — including the distribution of a coronavirus vaccine — as well as other national and global emergencies.
Shaping the Future
If a COVID-19 vaccine is in fact developed, deployed and distributed within the aggressive timeframe outlined in Operation Warp Speed — or even close to it — it will set a new precedent for pharmaceutical development. This wouldn’t just be evidenced by achieving record-breaking speed to market, but by the means it took to get there — specifically, the breaking down of silos between industries, sectors, stakeholders and even competitors to advance science for the greater good of public health. If there is one positive outcome of this devastating pandemic, it is hopeful that the efforts taken to overcome today’s challenges will give way to a more sustainable future for drug development and healthcare as a whole.
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