For so long, drug development has been moving at the same slow and increasing pace that some fear that speeding it up would mean taking shortcuts and sacrificing patient safety or the accuracy of the data collected.
Then came the Covid-19 pandemic. He upped the stakes and challenged global health and research communities to transform the traditional timeframe of development. The results saved lives, exceeded expectations and, importantly, provided guidance that can be applied not only to future pandemics, but also to the devastating diseases that affect people on a daily basis. Life-threatening and debilitating diseases like cancer and neurodegenerative diseases can greatly benefit from these kinds of disruptions.
Learning quickly can be good learning when life is at stake. The concept of Rapid Learning is based on the convergence of several basic elements: innovative technologies, novel clinical trial models, strategic partnerships and improved regulatory procedures. When these elements are coordinated and responsibly managed, they lead to medical breakthroughs and reduce the time from conception to commercialization, leading to improved individual health, better access to life-saving therapies for patients, and lower research costs. Indeed, learning fast is a way of preserving the fundamentals of drug manufacturing – finding new therapies for unmet needs – while adopting new technologies to advance science in a more responsible and inclusive manner.
As the biopharmaceutical industry is currently at an exciting crossroads in drug development, it must embrace this new mindset or risk being left behind.
Fast science calls for increased collaboration
Consider how scientists, pharmacy, clinical research organizations, healthcare professionals, and governments around the world came together to develop vaccines against Covid-19. To see also : Executive Constantine, Mayor Harrell appoints an experienced leader as Director of Public Health.
Collaboration was the name of the game from the very beginning. Chinese scientists made the SARS-CoV-2 genetic sequence publicly available in early January 2020, just weeks after ‘mysterious pneumonia’ began killing people in Wuhan, China. Companies like Pfizer and BioNTech have joined forces to use this information to develop a vaccine, like many others. Importantly, there was government support to accelerate development and distribution. This included collaboration between Moderna scientists and the National Institutes of Health that served as the basis for the biotech vaccine, as well as federal funding and investment in clinical research and manufacturing to minimize risk to other pharmaceutical companies involved in the vaccine effort.
Although the approved schedule for vaccine development is typically around a decade, it was only 11 months from the publication of the SARS-CoV-2 sequence to the first FDA emergency approval for a Covid-19 vaccine.
It has been a truly remarkable success for the biotechnology industry and the research community, public health and regulators, highlighting what can happen through strategic collaboration.
Rapid learning not only speeds up the process of scientific discovery, but opens the door to new partnership opportunities. For example, an increasing number of pharmaceutical and biotechnology companies are now working with disease promotion organizations in the drug development process, giving those who defend patients a more visible voice and a seat at the table.
When the entire healthcare ecosystem is combined with urgency and focus, breakthrough therapies can move from preclinical to delivering to patients much faster than before.
Fast science demands innovative infrastructure
In a recent post on GatesNotes, Bill Gates discussed the key investments that have enabled healthcare systems around the world to fight infectious diseases. He described global efforts such as “training health professionals, building laboratory oversight and capacity, building efficient supply chains and accelerating innovation”, while developing equity and tools to help prevent, detect and respond to disease. He explained that creating infrastructures for global health and pandemic prevention would be a “critical security issue” in the future.
New systems to support research will also be needed as they move from single observational studies to large-scale statistical analyzes, creating a need for innovative tools to strengthen collaboration between scientists, researchers, biopharmaceutical companies and regulators, and to develop and implement new technologies to help monitor patients more effectively. To see also : RWJBarnabas Health new program to promote NJ minority owned businesses.
Artificial Intelligence will be a key element in supporting this new job. Incorporating what we have learned over decades of drug development into algorithms can provide fresh insight that will aid in selecting new drug candidates and recruiting study participants, while helping scientists predict the success or failure of experimental agents.
Rapid Learning also challenges the industry to optimize clinical trial design. While interest in virtual clinical trials has grown steadily over the past decade, demand has reached a record high. Just as the Coronavirus Acceleration Program has provided a faster path to approval of Veklury (remdesivir) for treating people with Covid-19 by accelerating the time to completion of the study, the Food and Drug Administration is exploring ways to speed up drug approval and biologics that could fight other serious diseases unmet needs. Moderna, for example, is using its experience with mRNA as a vaccine platform against Covid-19 to enter the field of HIV vaccines, potentially paving the way for new approaches to a disease that currently affects nearly 40 million people worldwide.
While it may have taken a long time to reach this turning point, there’s no reason to slow down now that tools and science exist.
Fast science cuts costs and streamlines efficiencies
As drug development costs and timelines increase, the likelihood of success continues to decline. For example, about 90% of drug candidates fail in clinical trials and cost an average of nearly $ 2. On the same subject : FACT SHEET: Health Department leaders join Biden Administration’s commitment to reduce greenhouse gas emissions by 50% by 2030.6 billion to develop. In this context, the principles of rapid learning can provide an attractive and cost-effective solution. Drug makers who make a concerted effort to leverage innovation and collaboration can transform development and potentially get through the regulatory process faster than those who take a more traditional approach.
Recognizing the need to accelerate the development schedule, the FDA is also investing in new ways to gather more comprehensive information and data, eliminate some regulatory red tape, and speed up the drug approval process. For example, when the 21st Century Cures Act eased the requirements for drug manufacturers willing to change their labels to treat wider populations, the FDA issued a mandate to facilitate new clinical trial designs for this specific purpose.
Fast science is the future of health care
As patients wait for new and better therapeutic approaches, the biopharmaceutical industry must champion urgent change. People in the field must act quickly, maintaining the highest standards of safety, efficiency and accountability at every stage of the process. The best way to do this is by adopting the basic elements of rapid learning.
Ron Peck, hematologist / oncologist, is the medical director of Arvinas, a clinical biopharmaceutical company focused on developing new drugs for cancer, neurodegenerative diseases, and other difficult-to-treat diseases.
