George Stephen did the impossible. He managed the team that rapidly developed remdesivir, the world's first approved treatment for hospitalized COVID-19 patients. The story behind its creation is a fascinating tale of quick decision-making and tireless work during one of the most intense global health crises in modern history.
From Scientific Research to Pandemic Response
George Stephen began his career in the pharmaceutical industry as a scientist on a mission to cure cancer. However, he quickly realized that accelerating drug research and getting life-saving treatments to patients faster was his true passion.
During the COVID-19 pandemic, the biopharmaceutical company Gilead tasked Stephen with managing the new antiviral treatment, remdesivir (Veklury).
"We already had some pre-clinical data available from the 2014 Ebola outbreak that suggested remdesivir could work against SARS-COV-2 due to its broad spectrum antiviral activity," Stephen said. "But we needed to confirm if it could be used as a viable treatment for COVID-19."
At that point, the company realized the urgency. "Lives were being lost, and we had to act fast," recalls Stephen. "Remdesivir had emerged as a potential treatment for COVID-19, but proving its efficacy and safety in patients was paramount. The clock was ticking—we needed to move quickly through clinical trials and get it to patients as soon as possible."
Fast-Tracking the Development Process
What followed was an incredible journey, one that would normally take years to complete but was fast-tracked due to the unprecedented nature of the crisis.
"It's normally an eight to twelve-year process to bring a new drug to market, but during the pandemic, the FDA was looking for ways to accelerate the drug development with potential candidates," said Stephen. "We had a 50/50 chance of success. We didn't know for sure if it would work until we had data, but the urgency made everyone move quickly."
Gilead began supporting multiple clinical trials, including the ACTT-1 (Adaptive COVID-19 Treatment Trial), and worked closely with various regulatory organizations around the world, including the FDA, to ensure the regulatory pathway was clear.
In no time, Stephen and his team were coordinating clinical trials across the globe. Their efforts were focused on gathering the right data quickly.
"The CEO was deeply involved, and I was managing the program, ensuring that senior management had the right data to make informed decisions quickly," Stephen explained. "We weren't drowning in unnecessary details—our focus was on what mattered."
Lessons Learned: Making Quick, Data-Driven Decisions
From the start, the team had no illusions about the challenges. They were unsure of whether remdesivir would be a silver bullet, but early results from the ACTT-1 trial were promising.
"When ACTT-1 was unblinded and the data was analyzed, we saw remdesivir showed promising results and was making a difference," Stephen said. "It was reducing recovery time for hospitalized patients and helping to prevent severe disease progression."
With a success rate of around 80%, remdesivir showed that it could reduce the severity of the disease. The positive data fueled further investment in the program, and by May 2020, remdesivir was approved for emergency use.
"We were constantly under pressure, but with the CEO's backing and clear communication, we were able to stay focused. We worked tirelessly cutting the drug manufacturing time by 50% and receiving full FDA approval in October 2020. That's unheard of in drug development," Stephen added.
The Second Step: Oral Treatment Research
While the injectable remdesivir treatment was proving effective, Stephen's team knew that a more accessible, easy-to-administer solution would be crucial for broader patient reach.
"We already had the groundwork laid out with remdesivir, so we shifted gears and began working on an oral version. Normally, it would have taken a decade to complete drug development from scratch, but we completed it in two years applying the lessons from development of remdesivir and interactions with FDA," he shared.
The rapid vaccine rollout was vital in addressing the pandemic, but it was remdesivir that set the stage for future breakthroughs. "We learned how to work faster, how to make smarter decisions, and how to stay efficient under pressure."
Building the Blueprint for Future Pandemics
One of the most critical lessons that Stephen and his team learned was the importance of creating an efficient, scalable approach to dealing with public health emergencies.
"We now have a blueprint for rapid response to future pandemics," Stephen explained. "We are working with various U.S. organizations and academic researchers to create processes where we can go from identifying a drug for a new virus to having a drug in much faster time unlike the pandemic."
This blueprint is informed by the experiences of developing remdesivir, and the lessons learned will help future teams move faster, more efficiently, and with clearer decision-making paths.
"It's not just about reacting to the next crisis; it's about being prepared, having the systems and strategies in place that can save lives when the next pandemic hits," Stephen said.
The Global Impact: From COVID to Marburg
The story of remdesivir doesn't end with COVID-19. George's team has continued to apply their rapid-response strategies in other global health emergencies, such as the Sudan ebolavirus outbreak in Uganda in 2022 and the Marburg virus outbreak in Rwanda in 2024.
"We knew from our research that remdesivir could work for Marburg, a deadly disease with no approved treatment," Stephen explained. "Partnering with the Ministries of Health of those countries, we were able to donate drugs under the Emergency Use Authorization (EUA) in no time, that helped to control the spread. We were able to stop those outbreaks because of Gilead's research team's proactiveness in generating pre-clinical data on various diseases."
The world may have moved past the COVID-19 pandemic, but for George Stephen and his team at Gilead, the work is far from over. The next big challenge isn't just COVID—it's anticipating how respiratory diseases will evolve over the next decade and ensuring the pharma industry is ready.
"We're looking at the bigger picture," Stephen explains. "This means understanding diseases of the future that will disproportionately impact older populations, the influence of climate change on respiratory health, and tackling the vast unmet needs that still exist."
With pandemics no longer a once-in-a-century event but a recurring global threat, preparing for the future demands innovation, collaboration, and an unyielding commitment to public health. And for Stephen, that mission is deeply personal.
"In the end, it's about making a difference," he says. "It's about saving lives. That's what drives me, and that's what drives the team at Gilead every single day."
