The Made Smarter Review estimated that the adoption of digital technologies by the medicines industry could be worth £22.4 billion over 10 years.

Digitalization can help remove non-viable drug candidates from the development process much earlier, thus reducing time and costs to the industry.

Additionally, digitalization would enable the transformation from large-volume manufacturing plants to more agile, localized, and smaller production facilities. This would lead to significant productivity improvements, estimated at 30- 35% by 2030. Digitalization will also create closer links with patients and clinics and give rise to better information for manufacturers. It will also speed up the rate at which clinical data are available, increasing its value significantly. Logistics will be improved, and companies will benefit from reduced waste via better inventory management.

More broadly, the global pharmaceutical industry is estimated to be wasting 7-10% of the input materials, and this could be addressed by digitalization. Digitalization will enable continuous monitoring and adjustment, which will be particularly useful in cell and gene therapies where there are fewer starting materials to work from.

What are the opportunities for digital innovation within pharmaceutical manufacturing?

There are lots of opportunities where pharmaceutical manufacturing can embrace digital innovation in their practices. Short-term plans should focus on a shift from ad-hoc collaboration to more streamlined and efficient sharing of assets. Other opportunities include:

There is a need to develop the entrepreneurial framework and ecosystem to support increased connectivity between companies. Policy interventions may be required at a European level to support this change.

A legal framework is required to allow contracts to be rapidly set up between companies specific to manufacturing applications.

There is a need for standardized data formats for interoperability between clients and service providers to facilitate a service based on data transfer.

There is an opportunity to embrace the Factory of the Future (FoF) concept in pharmaceutical manufacturing. Bringing in new technologies around electronics, sensor technologies, robotic technologies. and through-life engineering.

To read more about the BSI’s development of standards to meet these, and other industry innovation needs, download our brochure.

How can adopting standards kickstart your organization’s innovation journey?

Though there are a lot of opportunities for pharmaceutical manufacturers to embrace digital innovation, many companies are not structured to fully take advantage of them.

Standards are a key tool for corporations to successfully manage innovation and survive in a fast-moving, highly complex global economy. They offer clear frameworks to help organizations create the right infrastructure for capturing and implementing ideas, understanding what works and what doesn’t, and maximizing value.

The BS EN ISO 56000 series helps organizations introduce an innovation management system to identify the most important challenges, capture the right ideas, seize the best opportunities and properly manage emerging trends and risks.

BS EN ISO 56002:2021 Innovation management system guidance gives guidance for businesses looking to adopt an innovation management system.

BS EN ISO 56003:2021 Innovation management tools and methods for innovation partnership guidance gives guidance to organizations on the tools and methods for innovation partnership, supporting wider innovation training for staff, and provides guidance on how innovation partnerships are managed so that collaborative efforts become mutually beneficial.

PD CEN ISO/TR 56004:2020 Innovation management assessment provides guidance on how organizations can carry out effective innovation management assessments and why it is important to manage innovation in a systematic manner.

BS EN ISO 56005 Innovation management tools and methods for intellectual property management guidance provide guidelines for supporting the role of intellectual property within innovation management. Efficient management of the intellectual property is key to supporting the process of innovation, is essential for organizations' growth and protection, and is their engine for competitiveness. 

Public document PD CEN/TX 16555 series (parts 2, 3, 4, and 6) should also be adopted by organizations wanting to embrace digital innovation. This technical specification series provides guidance on establishing and maintaining an innovation management system (IMS), including strategic intelligence, innovation thinking, intellectual property management, and creativity management.

Management teams could also use BS EN ISO 44001 to further support collaborative business relationships. This standard offers specific guidance around knowledge sharing and managing joint objectives to build better relationships and improve innovative results.

When preparing your business to adopt new digital technologies, it is also vital that you have a system in place to protect your organization’s information security. Protecting personal records and commercially sensitive information is critical. BS EN ISO/IEC 27001 helps you implement a robust approach to managing information security (infosec) and building resilience.

The BS EN IEC 62443 series also helps organizations to adopt security best practices for industrial automation and control systems.

Prepare your business for the digital innovations of tomorrow by adopting the above standards today.

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