With increasingly expensive and globalised trials, a rigorous supply chain that can be run cost-effectively is a key asset for any pharma company. Alex Robertson, who has been senior director of supply chain management at AstraZeneca since 2014, tells us about the challenges involved in organising plans and managing supply, from API raw materials through to the distribution of investigational products to clinical study centres, and all the activities in between.
Clinical Trials Insight: Inefficient trial practices result in huge costs in unused equipment and merchandise. How can the industry rectify this?
Alex Robertson: The key is strong collaboration between the clinical group running the trials and the supplier providing the investigational drugs and associated materials.
This needs to be tied together in a strong project framework that makes the best decisions overall for the business. You need to be able to make potential costs and overage visible, discuss how the clinical design impacts this, and track the real study dynamics, making adjustments in your supply in order to respond to the actual – as opposed to forecast – situation. All of this takes investment in tools to increase visibility, a collaborative culture and a project structure that optimises for the business as a whole.
How would you define waste in clinical supply and in which areas is this issue prevalent?
At AstraZeneca, we define waste as ‘any medicine that was manufactured but not used by a patient’. In a recent analysis, we found that most of it – 25–30% of the total waste – was material available in depots. The next-largest category, accounting for 15–20% of total waste, was material that expired on site. We have not conducted analysis over time to determine whether these trends are changing but, with the data and metrics we are now collecting, that will be a picture we can build.
One thing that is clear, however, is that, concurrent with the trend in studies becoming more complex and with accelerated development, there is an increasing risk of waste.
Multiple standards of care or rescue medications dependant on patients’ specific clinical needs; more combination trials and complex multiarm designs; growing numbers of countries and sites to improve recruitment rates; and more adaptive designs are all factors that make forecasting more difficult and drive up the number of medications required. This increases the need for clinical supply organisations to develop better and more-sophisticated planning and supply practices to play their part in optimising medicine development, in turn, raising the number of potential new medicines that can be investigated without adding to cost and waste.
What strategies can be developed to drive efficiency and reduce waste?
As mentioned previously, we live in a world of more complex trials and faster development, which makes the supply chain more difficult to manage and potentially more wasteful. In terms of development strategies, the key is to optimise for the best strategy across an enterprise organisation and not for medicine supply – or any other aspect of development – in isolation. In some cases, it may be the right decision to take higher drug waste if that enables you to carry a more complex design, answer more crucial scientific questions, and accelerate development and launch to market but, in other cases, you may be able to reach the same end point in a far more ‘drugefficient’ way or through compromising on aspects such as speed if the trial is not a critical path.
The key challenge for the modern clinical supply organisation is to develop the capability to increase visibility of medicine supply aspects, and to use that information in collaboration with clinical and other development groups across the organisation in order to explore options, and optimise for the business overall through the design and execution phases of trials.
What effects do inefficiencies in the supply chain have on the trial in terms of money, time, resources, space, customer service and patient care?
Inefficiencies can impact all of these areas. The most obvious impact is on cost and resources. By improving efficiency, we could push forward more scientific advances and deliver novel treatments, benefiting patients and pharmaceutical businesses. There are other potential impacts, including the amount of storage taken up in study centres and depots, as well as on aspects such as sustainability and wasted transport.
What changes have you seen in this area recently?
The most significant change I have seen is in the business environment and culture around clinical supply. As an industry, we need to be able to support bigger development portfolios to enable a higher number of smaller and targeted launches rather than a few blockbusters – this also needs to be done at increasing speed. This switches the spotlight on optimising drug development, including clinical supply. The winners will be able to drive more new science, more efficiently. This has shifted the culture in clinical supply away from no risk, high stock and high waste to smart risks, and optimised stock and waste as key features in the overall development process.
A great enabler in this has been our ability to handle and interrogate more data from a wider pool across the organisation, and new systems to integrate that data into better planning and execution. Even more important has been investing in our people in the clinical supply organisation in order to develop further professional supply chain capabilities so that we apply our new tools in the smartest way.
Our journey isn’t finished. We still have to invest significant manual input in how we use our data and plan. This will improve as we develop our datahandling capability and the integration of our tools, but it is a step in the right direction. There are other technical areas we are also developing; for example, postponement of study-specific labelling, which will be a key enabler in reducing the amount of waste we see in depots. This is not without challenges; regulation, growing complexity in customs requirements, speed to import and a huge variation between countries means this will likely be a hybrid approach that is possible for some countries but not others.
What would you recommend to those seeking to curb waste?
My recommendation would be to first make the case for change using real project data, recruit leaders committed to change and improvement, and invest in your organisation in terms of tools and professional capabilities of staff. Follow this through with some quick wins; for example, we implemented a standard business process and tool for forecasting as a first step. Finally, it is absolutely critical to think with a broad business mindset, partnering with your key colleagues in clinical and development. Do not suboptimise in a drug supply silo but rather develop the tools to bring options to the business and its partners.
How do you see efficiency in trial supply chains improving over the next few years, particularly in the context of globalised trials involving more countries – some with less than adequate infrastructure and regulations?
This is a huge challenge and it means you need to drive improvement even to maintain efficiency at current levels. If you do not improve, you will find a decrease in efficiency. In terms of the ‘three Vs’ of supply chain – visibility, variability and velocity – variability is increasing in the world we supply, so we need a strong focus on reducing that in our practice, and improving visibility and velocity across the supply chain to make us more agile and able to respond to growing complexities.
Alex Robertson
Alex Robertson is senior director of supply chain management at AstraZeneca, a position he has held since 2014. Prior to that, he was the organisation’s UK head of quality assurance, process and R&D. He trained as a chemist and has 25 years’ experience in the pharmaceutical industry in a wide variety of roles. He holds a BSc in chemistry from the University of Edinburgh.
