President BidenJoe BidenFox News reporter says Biden called him after 'son of a b----' remark Peloton responds after another TV character has a heart attack on one of its bikes Defense & National Security — Pentagon puts 8,500 troops on high alert MORE has pledged to increase COVID-19 vaccinations to 1.5 million per day during his first 100 days. That’s an ambitious commitment, but bold public health promises are already defining the new administration. Biden also called for an America that “cures diseases like cancer and Alzheimer’s.”
These are welcome words to those of us who have been engaged in the battle against these diseases for decades. Transforming these audacious pledges into the scientific and therapeutic progress needed to achieve them requires that we learn two critical lessons, starting with the race for a pandemic-ending vaccine.
Rapid development of highly effective COVID-19 vaccines forged a new regulatory model that has the potential to bring warp speed — or at least faster — results to our treatment of other deadly diseases. In the urgency of the moment, the Food and Drug Administration (FDA) engaged in continuous dialogue with drugmakers, laying out clear guidance and providing the blueprint, while pharmaceutical companies created the building blocks for effective COVID-19 therapies.
The development and delivery of therapies with FDA oversight ran in a parallel process of design and build. For example, regulators and drugmakers worked together to design late-stage phase three trials even before early phase one and phase two testing were completed. This process worked thanks to real-time information-sharing and communication. Continuous engagement ensured that regulatory requirements and industry efforts were aligned.
The result? Increased confidence on both sides of the regulatory fence. Regulators were assured a vaccine could be developed, tested and launched quickly without sacrificing safety. Drugmakers were encouraged to take risks and ramp-up manufacturing before the final vaccine construct was approved. Together, this made it possible for millions of doses to be shipped instantaneously after the FDA’s go-ahead.
It is vital to emphasize that rapid did not mean reckless. The COVID-19 vaccine approval process was unprecedented not just in its speed but in its transparency and oversight.
There is more work to be done before every person is protected, starting with those 100 million shots in 100 days. But it is not too early to ask a critical question: Will we go back to the old way of doing things once the pandemic is over? Or can regulators take what we have learned from the COVID-19 vaccine and adapt this new way of working with industry to address other equally urgent public health crises?
A second lesson we’ve learned in recent years is that when it comes to treating highly complex diseases like Alzheimer’s or cancer, a first-in-class drug is seldom the best-in-class. Delaying drug approval until a near-100 percent breakthrough occurs not only saps hope from those who desperately need treatments now, but it seriously misunderstands the way innovation works.
In recent decades we have made exceptional progress against certain cancers by building incrementally on small successes that accumulate to significant outcomes. Early chemotherapy drugs approved for testicular and childhood cancers, for example, produced some benefit for only a small percentage of patients, but enabled investigators and clinicians to learn, improve and create the next, better therapy.
That first drug approval stimulates further research. It generates a real-world experience leading to new scientific insights. It draws more resources into the battle, both financial and intellectual. It creates crucial momentum, kicking off a process of incremental innovation that has, for many types of cancer, transformed a diagnosis from a death sentence into a manageable condition.
The successful race for COVID-19 vaccines and progress in oncology has shone a spotlight on how science and technology give us the tools to conquer a global pandemic. It has also taught us a better way for scientists at regulatory agencies and drug manufacturers to work together to save lives and defeat other devastating public health threats.
Our goal now should be to combine cancer’s historical lesson of incremental learning and improvement with the pandemic’s lesson of FDA and industry collaboration. By applying these lessons, we will find better ways to spur new innovations and, together, conquer many more diseases that plague humanity like Alzheimer’s and dementia. In doing so, this will help the Biden administration fulfill its bold promises for more successful treatments.
Dr. Andrew von Eschenbach served as Food and Drug Administration commissioner from 2006-2009 and as director of the National Cancer Institute. He is currently president of Samaritan Health Initiatives and serves on the Board of the FDA’s Reagan Udall Foundation.