As human beings I think we have evolved (well, most of us) to a state where we have gotten used to (or at least tolerate) many things in our lives.
We have gotten used to the changing seasons – and even embrace them. We tolerate lines at movie theaters, concerts, etc. (at least we did pre-COVID).
We tolerate the “Thanks for calling Dr. XYZ’s office. Can you please hold. Click,” we often get when calling a busy doctor’s office.
So why do we tolerate a 10-year drug development process?
While the COVID-19 pandemic is (hopefully) a once in a lifetime event – it has shown the world that highly effective vaccines can be developed, put through clinical trials, and manufactured in less than a year.
The roll-out of these vaccines took a monumental effort that needed the cooperation of regulatory agencies, technology providers, and pharmaceutical manufacturers.
Will this success be forgotten as time passes?
And let’s take a look at the common 10-year drug development timeline for a minute – the very one we have gotten so used to.
We have taken for granted, and not questioned, this decade long process. We have told ourselves that drug discovery is a slow process, with many failures. Clinical trials are time-consuming, and very expensive. We have gotten used to a slow regulatory review and approval process, and a slow commercial manufacturing scale-up process.
Why?
We say it takes 10 years to make sure new drugs are safe and effective. Really? If this were so, why do we still have (and tolerate) drug recalls, the addition of black-box warning labels, etc.
COVID-19 has forced many pharmaceutical companies to re-think everything about drug development, clinical trials, and manufacturing. It hastened the adoption of new technologies; in many cases years earlier than was expected.
I’m not advocating that every new, promising treatment get pushed through to patients in a year.
What I do think is that, moving forward, we will see the time it takes for drug development, clinical trials, regulatory review and approval, and the manufacturing process shortened considerably.
We can’t go back to the way it was. The health of the world won’t tolerate it.
Mike Auerbach
Editor In Chief
[email protected]
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!