INSIDE PHARMA

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INSIDE PHARMA
INSIDE PHARMA
Why mRNA vaccines (biologics) couldn't be developed in 9 years, let alone 9 months...

Why mRNA vaccines (biologics) couldn't be developed in 9 years, let alone 9 months...

...unless, of course, they lied?

Hedley Rees's avatar
Hedley Rees
Jul 20, 2022
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INSIDE PHARMA
INSIDE PHARMA
Why mRNA vaccines (biologics) couldn't be developed in 9 years, let alone 9 months...
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I’ve said this before

In February this year, I posted: 12 MONTHS TO DEVELOP A DRUG—PULL THE OTHER ONE, IT'S GOT BELLS ON

INSIDE PHARMA
12 MONTHS TO DEVELOP A DRUG—PULL THE OTHER ONE, IT'S GOT BELLS ON
PRECLINICAL TESTING OF MEDICINES The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale. Batches are pre-GMP (GMP = Good Manufacturing Practice…
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3 years ago · 3 likes · Hedley Rees

It’s a wee bit wordy, so I thought to do it in pictures. Below is a diagram taken from US Government Accountability Office Report GAO-07-49, titled:

NEW DRUG DEVELOPMENT: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts

The diagram was created by PhRMA, the trade association for the US pharmaceutical industry. That makes it straight from the horse’s mouth.

(Ignore for the minute the horrific attrition statistics showing it takes 250 new molecular entities in development to gain a single FDA approval).

In total, the development time from entry into preclinical assessment (STAGE 2) to successful approval, is c. 11.5 years…

…and remember, mRNA injections are an order of magnitude more difficult to manufacture than the products in the GAO Report.

A more detailed breakdown

The point is that each stage of a clinical trial…

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