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5. Offering New Agility to Clinical Trials

Andy Dwyer

 

Head of Clinical Packaging Operations at GSK

Leader, Clinical Supply Chain Platform

 

From the start we recognised that the way we operate the supply to clinical trials has not been ideal. We wanted to create different capabilities that would serve the customer better. It soon became clear to us that offering something that was much more responsive and quicker for the customer had a lot of value, both in terms of running trials and saving money. Our solution has been to design and, I hope before too long, build the capability to completely transform the way we supply medicines to the clinicians.

 

We have developed a clear understanding of value, which is really important, and an understanding from the customer’s point of view through various analyses and engaging in a discussion of what the best models might look like. That allowed us to create a hypothesis and a value statement for a direction travel that we believe is worth pursuing – an automated ‘just-in-time’ pharmacy dispensing operation.

 

We have developed an integration of robotic automation that handles product with control systems and data management that ultimately allows us to produce products far more frequently and at much lower volumes per turn of production than is currently achievable with our currently system of paper batch records and people-operated production lines. So, instead of being constrained on the number of batches that we produce, this equipment offers the option of being able to flow material through the supply chain much more quickly. Where I might only get the chance run the production line for my produce a few times a year, the automated approach would allow me to do it every week if needed.

 

So we have created and tested an engineering design model that we are confident is feasible to build, and are now able to offer is manual on how to build it. Our ambition now is to build it.

 

I believe it will be a game-changer, dramatically reducing waste and coping with the uncertainty that we have by supplying to meet the need now rather than over-supplying and over-stocking as a hedge against scenarios that never actually occur, which means multiples of tens of millions of pounds for every major pharmaceutical company lost to waste.

 

The other impact is on time. Time is a very important factor when you are developing new medicines and so much of it is spent waiting for supplies. We are predicting that our approach could take between three and 10 months out of the timeline from the point of decision to the material being available – bringing clinical trials forward and, ultimately, being able to launch a new medicine sooner