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Careful Innovation

Yesterday’s "Early Adopters" has made some waves in our little pond, and brought up two fundamental questions.

So let’s roll our sleeves and answer the first one today:

How does the industry overcome potential barriers to adoption, such as regulatory challenges and the integration of new technologies into existing manufacturing processes?

This is THE biggest question, and the AMT Designation FDA introduced is one such way to lower the barrier.

Innovation is not a simple decision- especially for a drug that is already in the market (as implied by the question), but also during development.

Any change that is significant enough to improve the process, might also result in changes to the product itself (especially with the more advanced therapies).

Such changes warrant comparability studies (on top of the development efforts), and the results are almost always NOT black and white.

If the product is approved- the question is whether the "improved" product is as safe and effective as before. If the product is still in development- the question is whether the previous clinical data is still supportive of the next phase of development.

Companies with an approved product are reluctant to go forward and start new discussions with the regulator(s) if things are not broken.

Each such interaction might open a can of worms concerning the existing process and might result in unintended consequences.

If the product is marketed globally, multiply that by the number of regulatory authorities now being approached for the change.

That’s a risk.

But sometimes things break, and drug shortages are a real thing.

On top of that, drug costs are very high- oftentimes due to existing inefficiencies.

High costs and drug shortages are real public health issues, and regulators are trying to encourage the industry to implement innovation in ways that reduce the regulatory risk I mentioned above.

The biggest effort in recent years was the introduction of ICH Q12- which tries to create some predictability in the implementation of changes post-approval.

Softer ways, such as the AMT Designation introduced yesterday, are reducing the risks by opening lines of communication that are available BEFORE formal submissions, and the nice thing with the AMT is that it allows discussing technologies not directly related to an existing drug.

This allows companies and regulators run an open discussion and go back and forth without jeopardizing an existing product.

By the way- this approach (regulatory de-risking by communication, BEFORE formal submission) is not new and is the exact purpose behind different interaction meetings through drug development- from INTERACT and pre-IND, to End of Phase 2 meetings and pre-NDA, etc.

Very short answer for a very big question.

If you wish to dive deeper into post-approval changes, the place to start is ICH Q12,

I also recommend a recent comparability guideline for Cell and Gene therapies. There are a few others but this one presents the case for changes of the most complex processes:

Tomorrow, we will touch upon the second question which was:

With the increasing emphasis on personalized medicine and complex therapies, what role do you see advanced manufacturing technologies playing in shaping the future of pharmaceutical production?

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