Drug development has been conducted at the same slow and incremental pace for so long that some have worried that speeding it up would mean cutting corners and sacrificing patient safety or the accuracy of data collected.
Then along came the Covid-19 pandemic. It raised the stakes and challenged the global health care and scientific communities to reimagine traditional development timelines. The results have saved lives, exceeded expectations and, importantly, presented guidance that can be applied not just to future pandemics but also to devastating diseases that affect people every day. Life-threatening and debilitating diseases such as cancer and neurodegenerative diseases could benefit immensely from this type of disruption.
Fast science can be good science when lives are at stake. The concept of fast science relies on the convergence of a few core elements: innovative technologies, novel clinical trial models, strategic partnerships, and enhanced regulatory procedures. When these elements are aligned and conducted responsibly, they drive medical breakthroughs and decrease the time from concept to commercialization, leading to improved individual health, better access to life-saving treatments for patients, and lower research costs. Indeed, fast science is a way to preserve the very foundation of drug making — finding new therapies for unmet needs — while embracing new technologies to advance science more responsibly and inclusively.
With the biopharma industry now at an exciting crossroad in drug development, it must adopt this new mindset or run the risk of falling behind.
Fast science calls for increased collaboration
Consider how scientists, pharma, clinical research organizations, public health workers, and governments worldwide came together to develop Covid-19 vaccines.
Collaboration was the name of the game from the start. Chinese researchers publicly shared the genetic sequence of SARS-CoV-2 in early January 2020, just a few weeks after a “mysterious pneumonia” began killing people in Wuhan, China. Companies like Pfizer and BioNTech teamed up to use that information to develop a vaccine, as did many others. And importantly, there was government support to help accelerate development and distribution. This included the collaboration between Moderna and National Institutes of Health researchers that served as the foundation for the biotech’s vaccine, as well as federal funding and investments in clinical trials and manufacturing to minimize the risk for other pharmaceutical companies involved in vaccine efforts.
While the accepted timeline for vaccine development is typically a decade or so, it took just 11 months from the time the SARS-CoV-2 sequence was published to the FDA’s first emergency use authorization for a Covid-19 vaccine.
That was a truly remarkable success for the biotechnology industry and the scientific, public health, and regulatory communities, underscoring what can happen with strategic collaboration.
Not only does fast science speed up the process of scientific discovery, but it opens the door to new opportunities for partnerships. For example, more pharmaceutical and biotech companies are now collaborating with disease advocacy organizations in the drug development process, giving those who champion patients a more prominent voice and a seat at the table.
When the entire health care ecosystem comes together with urgency and focus, groundbreaking therapies can go from pre-clinical to delivery to patients far faster than before.
Fast science demands innovative infrastructure
In a recent post on GatesNotes, Bill Gates covered the critical investments that have positioned health systems worldwide to tackle infectious diseases. He described global efforts such as “training community health workers, building surveillance and lab capacity, creating efficient supply chains, and accelerating innovation” while advancing equity and tools to help prevent, detect, and respond to diseases. Building out infrastructures for global health and pandemic prevention, he explained, will be “critical security issues” moving forward.
New systems will also be needed to support scientific research as it shifts from single observational studies toward large-scale statistical analyses, creating a demand for innovative tools to enhance collaboration between scientists, researchers, biopharmaceutical companies, and regulatory bodies, as well as for creating and implementing new digital technologies to help monitor patients more effectively.
Artificial intelligence will be a crucial component in supporting this new work. Feeding into algorithms what’s been learned from decades of drug development can yield fresh insights to guide the selection of new drug candidates and recruit trial participants, while helping scientists predict the success or failure of investigational agents.
Fast science is also challenging the industry to optimize clinical trial design. While interest in virtual clinical trials has been growing steadily over the past decade, the demand has reached an all-time high. Just as the Coronavirus Treatment Acceleration Program provided a faster path for the approval of Veklury (remdesivir) for treating people with Covid-19, speeding up the time to trial completion, the Food and Drug Administration is exploring ways to expedite the approval of drugs and biologics that could combat other serious diseases with unmet needs. Moderna, for example, is leveraging its experience with mRNA as a Covid-19 vaccine platform to enter the HIV vaccine field, potentially paving the way for new approaches to a disease that currently affects nearly 40 million people around the world.
While it may have taken a long time to reach this turning point, there is no reason to slow down now that the tools and science exist.
Fast science cuts costs and streamlines efficiencies
As drug development costs and timelines rise, the likelihood of success continues to fall. Approximately 90% of drug candidates, for example, fail during their clinical trials, with the average drug costing companies nearly $2.6 billion to develop. Against this landscape, the principles of fast science can represent an appealing and cost-effective solution. Drug developers who make a concerted effort to leverage innovation and collaboration could transform development and potentially get through the regulatory process faster than those following a more traditional approach.
Recognizing the need to speed up development timelines, the FDA is also investing in new ways to gather more comprehensive information and data, eliminate some of the regulatory red tape, and expedite the drug approval process. For example, when the 21st Century Cures Act eased the requirements for drugmakers wishing to amend their labels to treat wider populations, the FDA issued a mandate to facilitate novel clinical trial designs for this specific purpose.
Fast science is the future of health care
With patients waiting for new and better therapeutic approaches, the biopharmaceutical industry must be an advocate for urgent change. Those in the field must move quickly while maintaining the highest standards of safety, effectiveness, and accountability at every stage of the process. Embracing the core elements of fast science is the best way to get there.
Ron Peck, a hematologist/oncologist, is the chief medical officer of Arvinas, a clinical-stage biopharmaceutical company focused on developing new therapeutics for cancers, neurodegenerative diseases, and other difficult-to-treat diseases.