How COVID-19 Is Advancing the Biomedical R&D Process

As the world continues to feel the impact of COVID-19, the biopharmaceutical industry is working around the clock to identify and develop safe and effective vaccines to prevent infection, while also researching and developing new ways to treat those infected with the virus.

To help advance potential treatments and vaccines for COVID-19 as quickly and safely as possible, America’s biopharmaceutical research companies have undertaken monumental efforts to accelerate the R&D process including clinical trials to establish the safety and efficacy of eventual treatments and vaccines. These efforts include the implementation of decentralized clinical trials, expansion of cross-sector partnerships and closer engagement with regulators. Companies are also working proactively and closer engagement with the U.S. Food and Drug Administration (FDA) and global regulators to help ensure the safety of trial participants, maintain compliance with good clinical practice through new and innovative approaches to clinical trials conduct and helping ensure the continuity of ongoing trials for other therapeutic areas during the COVID-19 public health emergency. 

As we consider the long-term impacts COVID-19 could have on society, there are good reasons to hope that some of these changes to the ways we conduct R&D may become permanent improvements.

Here’s How COVID-19 Is Changing Biopharmaceutical R&D: 

Accelerated Start Times: While decoding viruses used to take decades, the genome of the novel coronavirus was unlocked in just a few weeks. With advances in artificial intelligence, machine learning and big data, biopharmaceutical researchers have been able to reduce the time it takes to sequence viruses and develop potential vaccines.

Scientists have also benefited from the deep knowledge gained from decades of industry experience with viruses such as MERS, SARS, influenza, HIV and Hepatitis C. It took 20 months to have a vaccine ready to test in SARS patients a decade ago, and it less than three months to have the first candidates to test against COVID-19.

Decentralized Clinical Trials: Clinical trials have long been a time-consuming part of the biomedical R&D process, due to the increasing complexity of clinical procedures and protocol designs as well as the high standards required to demonstrate the safety and efficacy of a potential treatment. Traditionally, participants in clinical trials are managed on-site at hospitals or clinics, which can create challenges to recruitment due to the need to travel to attend trial site visits for medical procedures and other activities related to their trial participation. 

But with COVID-19 necessitating utilization and innovations in telehealth, some sponsors have adopted digital technologies to facilitate decentralized clinical trials, meaning patients are able to volunteer to participate remotely and are monitored using technology such as computers and cell phones. These tools can remove some of the practical barriers that can slow down recruitment and allow trials to recruit more rapidly. Clinical investigators are also able to use these digital tools to help reach a more diverse group of patients, helping clinical trials to be more reflective of the population that will eventually take their medicine if the trials are successful. 

Expansive Partnerships: The biopharmaceutical ecosystem has long relied on a framework of partnerships among the government, academia and private sector to research and develop new medicines. However, in recent months, these partnerships have advanced to unprecedented levels. Many biopharmaceutical companies have launched partnerships with each other to help speed development timelines in the most efficient way possible. Researchers are sharing early findings in open source platforms, allowing other scientists to develop learnings quickly. Together, these efforts may help shorten the timeline to finding effective vaccines and treatments.

It’s the nature of innovation to constantly evolve toward progress. The impact of lessons learned in recent months will likely extend beyond the field of infectious diseases to further our battle against cancer, heart disease, auto-immune conditions, mental illness and other disease areas. In all cases, the increasing collaboration, innovation, and new ways of advancing clinical development offers hope for patients to receive access to new medicines sooner, as we work to treat and defend against disease in all its forms.

For insight into how America’s biopharmaceutical companies are working to end COVID-19, PhRMA’s activity tracker provides updated numbers of clinical trials, potential therapies and vaccines.