Introduction
In the relentless innovation race waged by pharmaceutical companies, the clinical trials stage is absolutely crucial. Not only must the drug be shown to work, it must also be shown to be more effective than treatments already on the market - and of course, to operate without causing other illnesses, too many side effects, or other risks that outweigh its benefits.
The first company to demonstrate this gains a decisive advantage over its competitors, forcing them to repeat the whole trials process, but this time, taking this newly approved drug into account. For the runners up, there's no consolation prize; all the money and years invested in R&D are irretrievably lost as they start over. So, it's not enough to develop the right molecule; you must also be the first to prove it.
To provide the necessary proof, a worldwide panel of patients is set up, part of whom receive the candidate drug and the other an existing treatment (or a placebo when there is no equivalent). This process is particularly complex from a regulatory and methodological point of view - all the more so for increasingly tailor-made treatments, like gene therapy, immunology and oncology (in which the treatment type and dosage are adapted to the patient’s body weight and/or other physical parameters). The process is also a logistical headache - from both a scientific and ethical point of view. For example, we must be able to guarantee each patient receives the planned dose, at the planned time, wherever in the world they are.
To prevent shortages that could delay or invalidate a clinical study, laboratories often build up substantial safety stocks at every stage of the process, starting from initial manufacturing to storage in the pharmacies of participating hospitals. But, in addition to its cost, this strategy results in significant wastage (in extreme case as much as 70% of products go unused), as well as the significant environmental impacts from drug manufacturing, transport and storage (particularly for refrigerated or frozen drugs, which are more carbon-intensive). Not to mention the ethical issues raised by such a practice: in a world where some people can’t get the treatments they need, it seems unfair to stockpile drugs, only to destroy those that have expired before they can be used in the studies for which they were intended.
For all these reasons, it is more important than ever to change our approach. To ensure the robust and rapid supply of products to a clinical trial, while reducing their cost and environmental impact, we must optimize the use of our products and critical processes from end to end, and mobilize all available expertise and technological solutions.
So, what will this take? That is what you will discover in this point of view.