12 MONTHS TO DEVELOP A DRUG—PULL THE OTHER ONE, IT'S GOT BELLS ON

Big pharma's been pull our legs...

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).

Data relating to production must be carefully recorded and collected, including but not limited to, manufacturing processes and procedures, suppliers, service providers, contract manufacturers, material specifications, development protocols, and analytical methods.

These data must be included in Module 3 (chemistry, manufacturing & controls) section of the regulatory filing. Similarly, all data applicable to Module 4 (safety) must be included in the filing.

Regulatory (FDA/EMA/MHRA) evaluation and approval to conduct clinical trials in humans ‘should’ have been based on these data.

The average timescale for this initial stage is 2 to 3 years.

The jury was out four years ago, as to whether any preclinical safety testing was carried out on the SARS-CoV-2 injections. All the evidence now (2025) points to no safety testing being carried out prior to administration to humans.

How evil is that?

TESTING OF MEDICINES IN HUMANS

For the next stage in the development lifecycle, studies in humans, GMP is mandated for production of all of test material. The batch size will still be small given the relative low number of subjects receiving drug product. Further safety data must be generated for each batch, to confirm there has been no change to the character of the final molecule. At this stage, Module 5 (clinical) data from the studies in humans is added to the regulatory filing.

It is essential that the phases of clinical trials are carried out sequentially (not in parallel) as explained below.

Phase 1 production used in humans must be proven safe before moving to a larger scale for phase 2 studies within the broader patient population. Ditto for phase 3 studies if scale up is required.   There is a regulatory limit to scale up set at a factor of 2.5X the existing batch.

When phase 3 studies are complete, all data pertinent to the three Modules of the eCTD must be submitted electronically to yourselves at EMA.

This stage of clinical development typically takes 5 to 8 years.

THEN THERE IS THE REGULATORY REVIEW AND EVALUATION TIMELINE

The amount of data to be reviewed is humongous. In the olden days, it used to be pallet loads of files and paperwork. Today, it is the digital equivalent.

The regulator ALWAYS compiles a long list of questions for the applicant to answer in detail. Sometimes, answers do not stack up, and the applicant has to do more work, taking months, sometimes years, to finish and re-submit.

12 - 18 months is the typical timeframe, never less.

SO, WHAT DO WE CONCLUDE?

It takes 8 - 12.5 years to develop and gain approval for any drug (medicine) especially a gene therapy never before produced, still at an experimental stage.

Forget all this talk about rolling reviews and clever mRNA technology—it was all smoke and a shed load of mirrors…

…time the truth came out!