Large pharmaceutical organisations are focussing on business development for sustainability, skills, and digitalisation to speed up the transition to the Pharma 4.0 era, a new Global Benchmark report by Ireland’s Unispace Life Sciences found.
The ‘Forefront’ report surveyed over 180 life science industry leaders globally – many based in Ireland – and found that 29% of companies are in the early stages of implementing Pharma 4.0 initiatives.
Based on in-depth interviews with blue-chip pharma companies, the report found that despite positive digital growth and development in the industry, companies are struggling with capturing the right amount and type of data, and data overload is also creating a real threat.
Aisling Crowley, Unispace Life Sciences’ director of sales & strategy, told Euractiv:
“On digital, we were surprised at how immature the industry as a whole is. At the same time, with the ambition and acceleration being placed on Pharma 4.0, we found the majority are confident that within the next five years, they will be fully connected, or even Smart in terms of maturity.”
Asked if this prioritisation of digitalisation and sustainability is driven solely by commercial needs or by European Union legislation, Crowley said, “Both! There is no doubt that legislation is the driving force on what is being implemented and prioritised for compliance requirements.”
For example, the “serialisation, track and trace in digital, or EU requirements for a sustainable reduction in emissions.”
‘Forefront’ confirms sustainability is a high priority for the pharmaceutical sector, with 56% of companies formalising their sustainability goals and 25% adding a sustainability role at the corporate and site level.
This ties in with the European Commission’s proposed revision of the EU’s pharmaceutical legislation, announced in April. It will require Ireland’s pharmaceutical sector “to address the environmental impact of medicine production in line with the objectives of the European Green Deal”.
Skills development
Despite Sustainable Development Goal progress, a significant skills gap remains in the pharmaceutical sector.
The Forefront report highlights that 85% of respondents currently need to upskill their workforce.
Unispace found the sector thinks key skills for the future of pharma include MES engineering (60%), Data Science (57%), and Data Management (57%), with an increased focus on machine learning, AI, and deep learning skills.
As AI advances, data integrity is a significant concern for pharmaceutical companies, while cybersecurity is another critical focus area, with over 80% of formal programs putting responsibility on IT departments rather than engineering teams.
Twin transition
Sinead Keogh, director of BioPharamChem Ireland (BPCI), said: “The two most significant challenges facing Europe over the next decade are the transition towards a climate-neutral society and the retention of our industrial competitiveness.”
“Our recent Ibec research has indicated that by far the main reason that companies are introducing sustainability measures is to reduce the impact on the environment, followed by customer expectations, and finally, to reduce costs, are companies are using digital technologies to increase efficiency and allow continuous improvement.”
“Industry 5.0 can help drive this twin transition, and it involves the interpretation of Industry 4.0 Technologies through a human-centric lens. It broadens the focus from solely shareholder value to value for all stakeholders in society and indeed greater resilience, particularly of supply chains and the manufacture of strategically important goods.”
Achieving Pharma 4.0
Unispace reported that in the next five years, real-time analytics, data analytics, and AI/machine learning are expected to see the most investment.
Automation is also an important development, with 60% of respondents having already invested in automating data flows, while 85% plan on beginning investments in this area within five years.
Key to securing these gains will be the implementation of ‘Pharma 4.0’ – a strategic approach used to describe the application of Industry 4.0 principles to the pharmaceutical industry.
Essentially, Pharma 4.0 is about leveraging digital technologies to improve processes, outcomes, and compliance in the pharmaceutical industry and includes integrating intelligent digital technologies into the manufacturing and industrial processes.
The Forefront report found that 59% of respondents described their Pharma 4.0 initiatives as either “emerging or in infancy”, and 54% do not currently have a Pharma 4.0 roadmap.
Factory 5.0
In a similar vein, Keogh said: “BPCI and IDA Ireland are collaborating on a Factory 5.0 “Lighthouse Project” with the aim of digitising the sector, as well as driving sustainability in the industry.
Advancements in automation, artificial intelligence (AI) and machine learning in recent years have improved the success rate in the structural design of small molecules.”
“Active Pharmaceutical Ingredients companies [traditionally the core of the sector] are adding more sustainable manufacturing processes in line with stated aims to achieve zero carbon emissions from global operations by the mid-2020s onwards.”
Keogh added that this “consortium is developing a roadmap to bring the small molecule API sector towards the principles that underpin Factory 5.0.”
[By Brian Maguire – Edited by Vasiliki Angouridi | Euractiv.com]
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