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Industry has shown it can overcome challenges en route to creating new therapies.
Since 2000, the average time for new drug development is approximately 10 years. New anti-infective vaccine development, from clinical testing to approval, follows a similar timeline, taking anywhere from nine to 13 years. With the onset of COVID-19, however, development time was cut to just 11 months—for not one but three vaccines.
Of course, the circumstances weren’t ordinary. Solving problems without a clear solution has never gone faster. In fact, the only recent comparison would be that of the mumps virus in the 1960s; even then, the time to market was four years. In the past, there wasn’t a burning platform as significant as COVID.
However, some thought should be given to certain aspects of the drug-development process, particularly when it comes to the severity of need and real-world evidence—two factors at play over the past few years. Studies suggest that the faster approval process saved thousands, if not hundreds of thousands, of lives. Evidence outside of the traditional drug trial also appears to have moved the process forward more rapidly.
Naturally, people will look to the FDA approval process for COVID vaccines and ask, “Can we expect the same for other drugs?” While it would be difficult to replicate the process for future vaccine or drug development, the pandemic has allowed FDA and pharmaceutical companies to take a second look at preparedness and exercising emergency use. Pathogens exist that pose a similar risk of causing a future pandemic, and funding research could put the world in a better position to respond to such threats.
Collaboration across drug manufacturers and researchers also holds the endless potential to accelerate the development of new medicines and serves as proof of concept that a patient-focused delivery of new therapies can indeed work when a given disease receives more attention. Beyond that, advances in technology and the involvement of patients in the process’ initial stages have been enabling faster drug development. Time will tell whether any one of these factors will influence the approach to drug development and create better experiences going forward.
While there will always be hurdles to overcome in delivering new therapies, one of the biggest this time around was unexpected by the government and drug manufacturers alike: the supply chain. The past two years have shown us the weaknesses within the network used to produce and distribute almost everything, including medicines. The pharmaceutical industry was quick to respond, coming together and sharing big ideas to deliver vaccines across the world.
But new processes and solutions are still necessary to avoid any interruptions that may impact the distribution and availability of drugs and general medical care in the future. Where those answers can be found is up for debate, but difficult times provide ways to know and understand yourself, others, and the entire ecosystem in a better way. We can learn a lot from both the circumstances and the response. When pharmaceutical companies, suppliers, regulators, and others in the space work together, it’s entirely possible to meet patient needs.
The circumstances and the response also highlight opportunities to streamline areas within the drug-development process to the benefit of patients and manufacturers. While it’s unrealistic that each new drug will take less than a year to reach the market, rethinking the design and execution of clinical trials could shave time off the development process. The same could hold true for how drug companies engage with regulatory agencies or even a manufacturer’s approach to risk investment. Making slight changes in any one of these areas could get life-saving therapies to the public much faster.
About eight years ago, I worked on a project for a manufacturer that would later be approved for one of the COVID vaccines. That project involved one of the phases of the clinical trial process, and its main focus was enabling improved process execution and quicker data submission to improve turnaround times. Little did we know that this project would have a direct impact on getting data to FDA about the COVID vaccine and increase the speed of its approval.
In closing, it’s quite possible to arrive at solutions today that will improve the drug-development process tomorrow. You’ll never find the answers until you start asking the questions.
Marc Helberg is the managing vice president at the Philadelphia office of Pariveda