This image depicts industrialising pharma manufacturing

In this blog, John Dyson explores the transformative potential of combining process intensification, modularity, and automation in the pharmaceutical industry. Our London HQ recently hosted the 'Accelerate Pharmaceuticals' event, which included representatives from four large pharmaceutical companies: GSK, Sanofi, Roche, and AstraZeneca and provided a platform to discuss these advanced technologies. Building on the collaborative principles discussed in part one, John now explores how these innovations can revolutionise manufacturing processes, enhance sustainability, and accelerate the delivery of small molecule medicines to market.

Accelerating Pharma was the stated purpose of our first venture in bringing people together to help find solutions that would unlock huge potential. Those who joined us came from several leading pharmaceutical companies united, in part by a frustration that the world cannot see an opportunity that to some seems so obvious and enticing: -

The combination of process intensification, modularity and automation could transform the industrialisation, commercialisation, sustainability of, and access to, small molecule medicines.

The potential benefits of deploying these platforms are huge. Modelling deployment over a 10-year period demonstrates the opportunity of billions in improved cashflow from the reduction in capital wastage and the delivery of products more quickly to market. Developing more secure supply chains which can respond with agility to disruption. At a manufacturing level they can deliver more reliable quality with lower complexity and cost, while driving operations significantly closer to net-zero…

However, on the day we consciously parked any “solution mode” and the morning was spent discussing barriers: -

“Why don’t others see what we see?”

These can broadly be clustered as follows:

The perceived immaturity of the state-of-the-art

There is a belief that the technology involved in intensified chemistry is not very mature and therefore carries substantial risk. Some of the small-scale hardware has not been fully industrialised, the developing data collection, process and quality control approaches have not been fully tested with regulatory authorities.

Complicated supply chain

Pharmaceutical manufacturing of a single product through its lifecycle spans multiple functions and sites within each organisation and spans multiple organisations through product acquisitions and contract manufacturing. Thus, the breadth of what needs to be changed to deploy a new platform technology is significant.

Resistance to challenging accepted practice

Regulatory and patient safety risks are always high up the agenda for the pharmaceutical industry. The unfamiliar and the new are assessed as having higher risk than the known.

How manufacturing sits versus perceived value creation in the pharmaceutical companies

In reality, pharmaceutical value creation comes from the development or acquisition of promising NCEs, and their ability to commercialise them. Manufacturing is complicated and costly and may be seen as a necessary inconvenience, rather than a potential strategic advantage.

The locus of power and decision-making in companies

Operational engineering and manufacturing drive the majority of investment plans and proposals. Their expertise, understanding and comfort lie with the plants and systems they work with every day. This creates a natural inertia away from any transformation of technology or approach.

Capital governance processes skew decision-making and inhibit the new.

Significant investment approvals come to senior executives who rightly ask many difficult questions, while they may mistakenly expect and demand certainty. The demands and difficulties in getting through these governance processes drive both a false optimism in justifying product demand and drive the scale of the investment; “this is our one chance, so go with what we know and go big!”

The resources needed for change (above the day-to-day)

Changing platform technology could place additional demands on operations above and beyond those of securing ongoing supply and product transfer.

The compulsion to change seems not yet powerful enough to overcome these barriers or to put it another way, has not yet reached the activation energy threshold. That said, some companies are getting closer.

The compulsions to invest in capacity, whether new or replacement capacity, are clearly there. All the companies have made strong sustainability commitments, all of them have ageing assets which over the next decade require significant investment, all of them have new products which they want to get to the market as quickly as possible. The problem which loomed behind the stated barriers is that continuing with the historical mode of investment will simply not deliver the stated intent and aspirations of the industry and society at large.

So, where do we go next?

The conversation has just started, however there are some clear ways forward: -

Non-competitive sharing between companies enables a combined building of knowledge and confidence about the developing state-of-the-art platform. In fact, this is not a paradigm shift in technology but a shift in perception.

There was agreement to bring in and include contract manufacturers into the conversation as they have an equal stake and influence on the path forward, particularly in the simplification and pragmatism of any solutions.

Other areas were left more open and the conversations continue.

In reflecting on the day, I believe what struck me most was what happened at the end of the timetabled discussion. Attendees stayed on, clustering into smaller groups and over coffee and lunch continued to build relationships, share ideas and challenges. I was left thinking that this is how transformation happens.

John Dyson, Consultant, Bryden Wood, The Dyson Project, GSK, University of Birmingham

Professor John Dyson spent more than 25 years at GlaxoSmithKline, eventually ending his career as VP, Head of Capital Strategy and Design, where he focussed on developing a long-term strategic approach to asset management.
 
While there, he engaged Bryden Wood and together they developed the Front End Factory, a collaborative endeavour to explore how to turn purpose and strategy into the right projects – which paved the way for Design to Value. He is committed to the betterment of lives through individual and collective endeavours.
 
As well as his business and pharmaceutical experience, Dyson is Professor of Human Enterprise at the University of Birmingham, focussing on project management, business strategy and collaboration.
 
Additionally, he is a qualified counsellor with a private practice and looks to bring the understanding of human behaviour into business and projects.
 
To learn more about our Design to Value philosophy, read Design to Value: The architecture of holistic design and creative technology by Professor John Dyson, Mark Bryden, Jaimie Johnston MBE and Martin Wood. Available to purchase at RIBA Books.