Bridging the gap between chemistry, manufacturing, and control (CMC) data and the regulator, for right first time trial approval | Eramol
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Bridging the gap between chemistry, manufacturing, and control (CMC) data and the regulator, for right first time trial approval

Bridging the gap between chemistry, manufacturing, and control (CMC) data and the regulator, for right first time trial approval

The quicker your clinical trial can be approved by the regulator, the quicker you can progress your study and proceed with the next phase of trials.  And most importantly of all, the quicker you’ll achieve the critical milestones set by the funder to enable you to secure further funding.

But providing Chemistry, Manufacturing, and Control (CMC) data is often a stumbling block – and at Eramol, we’ve developed innovative ways to surmount the challenge, and save you time and money in the process.

The challenge occurs because an adequate CMC data package around the Investigational Medicinal Product (IMP) in question is essential in obtaining the regulator’s approval for any clinical trial. A robust CMC data package will provide the regulator with confidence that the safety of the trial subjects has been ensured. But the question is: how do you put together a CMC data package that is proportionate to the stage of clinical trial in order to optimise development timeline?

This is particularly true of early-phase trials, where there is limited knowledge of the IMP’s formulation and the risks are therefore comparatively higher. It’s something of a catch 22 that can result in huge delays (providing an over-extensive CMC data package) or indeed failure (providing insufficient data) in gaining the regulator’s approval for the trial.

But even in later-phase trials, there is often still a difficult balance to be struck between what the regulator wants to see to be able to complete their process, and what is arguably necessary to ensure safety.

So, how do we at Eramol address this to give Sponsors a clearer way forward to trial approval?

A proportionate take on data

The answer to this question is that we take each trial application on a case-by-case basis, applying a proportionate and pragmatic approach based on how much (or indeed how little) CMC data is most likely required for that specific and particular stage of the project’s clinical development, and actively arguing the case to the regulator to support it.

This is a much more streamlined, targeted, and strategic approach than shoe-horning a commercial-stage CMC data package into all phases of a clinical trial, and it makes for more rapid, more favourable outcomes, at lower cost. We focus on the CMC data package that is decisive for that particular application, not on applying a blanket approach that covers unnecessary bases.

By way of example, in one recent early-phase case where very little CMC data was available, we secured the approval of the trial by engaging with the regulator and justifying in detail why the data was absent at that point in time, and explaining what the likely overall risks of that absence were and weren’t. 

Similarly, we were able to accelerate another client’s trial application for a Drug Product (DP) by leveraging available data on the Drug Substance (DS) within the product. The end result was that we removed the need to generate new DP stability data as part of the submission package. 

In terms of DP stability, where applicable, we would also explore the option of providing to the regulator a commitment of ongoing stability with a well-defined expiry extension plan as part of the submission package.  This removes the need to generate stability data prior to submission, and the additional time associated with it. 

Furthermore, the approved expiry extension would mitigate the time required for re-assessment by the regulator as and when further stability data is available.

First-hand IMP knowledge

Critically, what makes us able to argue these cases to the regulator so effectively is not just that we get involved at the very earliest stages of the trial application to advise the client and prepare and submit the dossier on their behalf, but that we manufacture and produce the IMPs in question ourselves.

This puts us in a unique position to generate the data required, and build the body of evidence to satisfy the regulator. 

The added benefit is that as the manufacturer of the IMPs, we are in control of the whole process, so we can execute on the advice we provide to ensure continuity and alignment of interpretation from application to first patient, first dose. 

Pragmatism, not reinventing the wheel

Our pragmatic approach to data has helped to accelerate many clinical trials that use existing approved treatments for new purposes, too.

Again, by arguing the case to the regulator that pre-existing approval of a particular drug or treatment necessarily demonstrates that sufficient data for that substance is already available, we ensure the trial can commence quicker and roll out more readily.

But we also incorporate measures to mitigate the increasingly volatile pharmaceutical supply chain and help ensure trials run uninterrupted and cost-efficiently, now and in the future.  

By not committing to any commercial brand of existing drug or treatment, for example, we can switch between suppliers to safeguard availability, yet still guarantee each product’s equivalence for the purposes of the trial.

And by committing to later trials with the regulator upfront, we can also secure permission in advance for extensions to expiry dates for new IMPs, prolonging their shelf-life and giving the trial flexibility to run longer if need be.

Getting the gatekeeper on side

The regulator is the ultimate gatekeeper when it comes to approving clinical trials applications, so engaging with them effectively is crucial.

But what we at Eramol have found is that when that engagement is targeted, focused, and skilfully adapted to suit every case’s specific circumstances and context, it delivers faster and better results.

In short, we bridge the gap between data and regulator – and that’s where every Sponsor wants to be.

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