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Succeed faster to get early-phase studies through milestones quicker

Succeed faster to get early-phase studies through milestones quicker

We’ve posted elsewhere about the many data challenges involved in early-phase clinical trial approval, and how we at Eramol adopt a pragmatic and proportionate approach to help you overcome them. But we understand that your challenges don’t stop there. The route from proof of concept all the way to commercialisation passes through numerous milestones and funding rounds.  Most likely, you could use some help navigating these.

How, though, do you accelerate a process that is complex, exacting, and often unpredictable? How do you succeed faster in these early stages to get to first patient, first dose quicker?

For us, this is about being flexible enough to smoothly manage and overcome the sometimes difficult initial stages of Investigational Medicinal Product (IMP) manufacture, in order to expedite the timeline of the study startup without compromising in any way on quality.

So, how do we make that work?

The three Ps: proportional, pragmatic, phase-appropriate

Once again, as with the trial application submission process, providing a pragmatic and proportionate response that is specifically suited to the phase of the process in question is key to delivering the best outcomes for the trial Sponsors.

One thing that is often constant in early phase studies is that there are changes to the requirement of IMPs. The complexities and demands of setting up IMP manufacture for these studies are therefore different to latter-phase and larger-scale projects. 

A good example is the repeated IMP manufacturing changes and experimental dose adjustments that often occur as part of a Dose Escalation Study (DES).

At Eramol, we are experienced in the manufacture of IMPs for Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.  We have created a purpose-built Quality Management System (QMS) that gives us the flexibility to support these types of studies to respond to dose escalation under a challenging timeline.  In doing so, we have optimised the overall trial timeline.

Another example of where we have looked at the way our Sponsors have to work, and built the processes around them, is where IMPs used in early-phase trials have a limited shelf life.  At Eramol, we’re no stranger to the manufacturing and handling of short shelf-life IMPs, and based on the requirements of the clinical study concerned, we design a process flow to suit.  Even with IMPs that have just a 72-hour shelf life, agility in our QMS and manufacturing process enable us to meet the logistical challenges.

In addition to producing and managing IMPs with limited shelf life, at Eramol we also have established processes in place to deal with products with complex legal requirements.  For example, we have specific processes for the handling, import and export of controlled substances including psychedelics and other categories of drug.

All under one roof

One thing that is often constant for early phase studies is the frequent changes to IMP requirements.  As a result, these complex and sometimes bitty early-phase IMP manufacturing processes are best managed by one cohesive and competent team in one place – and this is exactly what Eramol delivers.

Our QMS of course maintains compliance with UK and European regulatory requirements and GMP (Good Manufacturing Practice), but building on the QMS, we also have a dedicated team of specialists in formulation, manufacturing, and Quality Control, as well as Qualified Persons (QPs) who understand and realise the priorities of these studies. 

These are professionals with detailed knowledge of all the different steps it takes to manufacture the final clinical trial product, enabling quality to be maintained across people and departments.

Quality processes for quality outcomes

By accelerating the early-phase process in this way, but also ensuring quality is “baked in” from the start and enforced throughout, potentially successful IMPs face fewer chronological - and therefore fewer financial – hurdles.

In addition, the early-phase work can effectively be scaled up to expedite later phases where required, because approaches have been tested and validated.

Succeed early, hit funding milestones punctually, get to first dose, first patient quicker. It sounds like a big ask, but we make it work for clients and Sponsors every day.

 

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