Andy Dwyer leads the REMEDIES Clinical Supply Chain platform, examining the way medicines are developed, manufactured, labelled and delivered to clinical trials around the world. He says there is enormous scope to make the clinical supply chain more agile to match better the needs of researchers:
One of the biggest challenges in the clinical supply chain is the huge variability in the demand that you need to meet. Things change rapidly. It may be something that, on the face of it, sounds simple, like expanding supply into an additional country for example, if the current trial geography hasn’t been able to recruit enough patients within the desired timeframe. This is when the clinical supply chain needs to react and deliver product to a new region or country, a different market with a different set of regulatory approvals, different packaging rules and new languages on the labels and so on. In reality, if this particular scenario had not been prepared for, we quite often end up living with that constraint and not expanding into the new country, as the time it takes the supply chain to bring that new product image “online” can often not meet the requirement.
The way that we have traditionally dealt with uncertainty in the past has always been to produce an overage of stock covering many possible scenarios that we might need – essentially, we contingency plan our way out of likely problems. We try to be as lean as possible but ultimately this uncertainty means that on average, as an industry, clinical trial supplies suffer a relatively high degree of wastage – I would guess, on average, that the industry probably throws away more than 50% of everything it makes – as the impact of not providing a patient with the required medicine is far worse for everybody involved.
This is an important message to remember when we consider future innovations: whatever we do and whatever future solutions we come up with, we will always need to reassure clinicians and colleagues that security of supply is our prime concern and hence will remain at exceptional performance levels, ensuring clinical trial patients will continue to receive their medicine without interruption.
As important as reducing waste, is improving the agility of the supply chain. What we are trying to achieve in REMEDIES truly has the potential to have an industrywide impact. At the moment, if you take some of the early phase development, manufacturing and supply timelines, we are forcing our clinical teams to lock down the doses of investigational interest and hence product quantities etc, 12 to 18 months ahead of when they expect to be using it in the clinic. We essentially constrain the choice of product options that will ultimately be on offer to the clinic, so as to avoid stock-piling an infinite number of contingency supply options.
So, does this “constraining reality” influence the ambition of the clinical study design? I believe that if this constraint could be effectively removed we could afford clinical researchers the freedom to explore a far greater scope in the exploratory stages of clinical development and hence be equipped to respond rapidly to the data being generated in the clinic.
What we are doing in our REMEDIES workstream is looking into novel equipment and automation technology to enable the reduction of our “order to dispatch lead time”. We want, for example, to be able to dose a drug substance into a capsule, count those capsules into a bottle, complete the packaging with the appropriate clinical label, release/certify and dispatch within a 24-hour timeframe – ultimately moving from the current “make to stock” supply model to a rapid “make to order” supply model.
I am really excited by being part of a project that has the potential to disrupt the industry and really bring tangible benefit to patients, clinical investigators and sponsor companies. I hope one day that this type of capability and technology is common place and we don’t think that taking more than 10 years and spending more than £1bn is the expected norm when considering bringing a new medicine to market.