When I just joined in the Pharma industry, they told me we are very conservative with new technologies because we are a highly regulated industry.
That remains true.
But then, comes technology, and audaciously advances without us.
So we look around and see other industries celebrating AI, IoT, and whatnot, while we at Pharma do the same ol’ tried and true.
Why?
Because new things are risky, and we don’t like risk in Pharma.
And it's so easy to have someone else to blame (The Regulator, in our case).
But time and again, the regulators, with FDA running at the front, are literally BEGGING us to come forward and innovate.
They open more and more lines for communication and expedited programs, and COVID pushed these even further.
So here is the latest such call- published just yesterday: AMT Designation (Advanced Manufacturing Technologies).
It basically calls for anyone in the drug manufacturing business (even if not directly related to a specific drug, e.g. CDMOs and equipment makers) to apply for this designation and get an expedited review of their technology- which can later be applied in any one or several different drugs in development.
This is a HUGE selling point as it reduces the regulatory risk by a lot, especially since it can be considered standalone and not be tied to a specific drug.
If you are on the cutting edge of a manufacturing technology, from either side- you should definitely consider this.
Technologies at early development have other tracks, of course, but the overarching message here is similar: Don’t take novelty as an automatic “no-go” risk. Consult with the authorities early on, de-risk your idea, at least regulatory-wise, and stop making excuses!
Eventually- staying behind with technology is a risk in of itself because someone else will do things better, safer, or faster than you.
The FDA acknowledges this- now it's your turn!
Want to dive a little deeper? Here is FDA’s AMT Designation draft guideline, straight from the oven: