Debating the future of medicines manufacturing in Glasgow’s Advanced Manufacturing Innovation District at PharmaTech Integrates 2023

“As we explore the future of the pharmaceutical industry, what are the challenges and opportunities, and how can digital innovations help us address these?” asked Maureen Wedderburn, addressing experts from industry, academia, and regulatory governance.

“The industry isn’t homogonous, but one challenge affects us all: how do we cope with the rate of innovation?” asked Ian McCubbin. From an academic perspective, David Littlejohn outlined the challenges accompanying lower concentration APIs and larger molecule modalities: “workforce up-skilling and training is essential to allow us to adopt the new manufacturing technologies to support these trends.”

Adding a regulatory perspective, Ian Rees spoke of capacity and international harmonisation. “Regulators need the capacity to engage with industry and patients to understand what’s required, and international alignment to support manufacture and supply across borders.”

All speakers agreed on the advantages of digital innovation in terms of productivity, pace, and patient benefits: “if we optimally utilise digital solutions, just think of the benefit we could bring to the patient.”

Chris Courtney led a discussion on the opportunities and barriers to building an integrated digital infrastructure. “It’s about saving lives, but doing it in a compliant way, a performant way, a sustainable way, and a financially viable way,” said Jorge Costa, commenting on the advantages technology can bring to pharmaceutical manufacturing, compliance, and quality.

Steven Kenny and Iain Crosley mentioned the advantages technology can bring to workers. “If we get technology right, workers will say ‘you’ve made my job significantly easier, I can’t possibly get it wrong any more,’” said Steven. “It’s about getting people to do the best things they can do by automating the tasks they find boring and repetitive,” agreed Ian.

Discussing barriers, panellists spoke of sustainability and cyber security.

“Chat GPT search uses 7x the energy of Google search. It’s about choosing the appropriate applications to use these high energy technologies,” explained John Mack. Ben Caley presented overcoming cyber-security challenges as an opportunity: “if you can be the company that’s building secure systems, you’ve got a real differentiator to set you apart from other companies. Be proactive.”

Ending the session, each panellists shared the one trend that most excites them, covering AI, horizontal integration, increased processing power, and a reduction in the barriers to adopting new technology:

“you no longer need to build a big data centre with servers and a complex infrastructure. You just need an internet connection and someone who can play with computers,” said Steven.

“How do we use process intensification as a means to achieve targets?” asked Mark Talford, leading a discussion of the strengths, weaknesses, opportunities, and threats of intensification. Commenting on the current state of process intensification, Chris Van Der Walle compared the massive progress in intensification in the biologics sector with the less intensified state of cell and gene therapy, illustrating the varying states of progress across the industry.

The panel debated the factors needed to drive intensification, commenting on outcome-led thinking. “To make a business case for process intensification, we need to start with the business process that will be optimised rather than a new technology that can be applied to a process,” said Jon-Paul Sherlock. “You have to look at the whole process,” agreed Gareth Jenkins, “start out by asking what’s the fastest way to develop a drug – that’s how you halve development times.”

Other key enablers mentioned were integration and culture. “It’s not sufficient to just have a clever widget, you need to integrate the technology with data and you need to get the people on board,” said Dai Hayward MBE. “You need a cultural change in an organisation to successfully adopt a new technology,” said Rolf Hemminga, emphasising the importance of keeping people in mind.

Combining perspectives from industry and academia, Ivan Marziano and Alastair Florence explained their first-hand experiences in the digital transformation of Chemistry, Manufacturing and Controls.

Ivan commented on how the quest for sustainability, resilience, and human centricity is driving change in pharmaceutical manufacturing. He outlined the five key components of the digital domino race: “data sources need to be standardised, we need to store data so it’s accessible, we need to assess the level of data curation needed, we need to visualise relationships between the data, and we need to address the data queries of how we use it to develop and validate models.” Through case studies of effective data structuring and collaboration, Ivan showed how digital transformation allows us to go from product to process more efficiently.

Alastair presented the progress at CMAC, a medicines manufacturing research centre with a focus on delivering and translating research to industry partners: “we look at the entire value stream, from molecular materials through to bulk products, and focus on maximising performance and stability throughout the supply chain.”

He outlined CMAC’s integrated digital toolbox of technologies, capabilities, and ways of workings, which allow industry to traverse the stages of CMC with greater support from advanced technology predictive tools. Alastair highlighted the importance of integration and diversity: “we have a diversity of genders, cultural backgrounds, and scientific disciplines to give us a great team that’s open to collaboration.”

“Where is the digital approach taking the supply chain, how is the supply chain reacting, and how can we drive connectivity?” asked Scott Lawson, leading the ‘Supply Chain Reaction’ session.

“Data is at the heart of better connectivity in supply chains,” said Rob Innes, praising the increased awareness of the value of data over recent years. Rebecca Street agreed: “data is now recognised as an asset that’s worth investing in. Data is as much a part of our product as the physical product itself.” 

 Turning to the integration of data into supply chains, Dave Berry emphasised the importance of standards and structure: “if we don’t bite the bullet and think about the high-level structure of data at the start, it’s always going to be a mushy mess.”  

Kevin Wright agreed, commenting on the importance of ensuring you have the right metrics in place from step-one: “you get what you’ve designed for,” he said.

“There’s a wealth of interesting new technologies, but I’m yet to see them all joined together to produce an end-to-end solution,” said Dave Tudor, finishing the day with a second fireside chat focused on how digital innovation can transform drug development.

“The momentum is there in the pharma sector to talk technology and make a change, but we’re not there with digital transformation yet,” said Rebecca Vangenechten. “67% of all digitalisation projects fail in some way. This doesn’t make us happy as technology providers. We need to make sure our technology is sufficiently interoperable, flexible, modular, and open. But we also need to address the human aspect: are we demystifying and democratising technology enough?”

Panellists noted that a key factor to overcoming this challenge and achieving successful digital integration is collaboration. “We’re at the boundary of our own knowledge and capabilities so collaboration is inherently important,” said Paul Hardy. Chris Kopinski added his experience of collaboration from working with 19 of the top 20 pharmaceutical companies at Amazon Web Services: “there’s complexity in our industry, but we need to come together and decide how we want to move forward as an industry, and work together as an ecosystem to make change happen.”

Speakers shared their hopes for digital transformation in the next 10-20 years, discussing vertical and horizontal integration and the predictive power that comes from combining electronic healthcare data with data from smart devices and wearables. “I hope digitalisation looks like the norm,” said Chris, “we’ll no longer talk about digitalisation, it will just be part of the way we work.”

“In its third year running, we’re so glad to see the continued and growing interest in PharmaTech Integrates,” said Christopher Watt, Executive Director, Life Science Integrates, “it’s been great to hold the event across the two fantastic venues of CPI’s Medicines Manufacturing Innovation Centre and The National Manufacturing Institute Scotland, and we’d like to say a huge thank you to everyone who’s made this possible.”

“Thank you to CPI’s Medicines Manufacturing Innovation Centre for your continued support as official event partner, and thank you to all the sponsors, speakers and attendees who’ve joined us here in Glasgow or online,” added Life Science Integrates Executive Director Samuel Thangiah.