James Choi at Samsung Biologics

A data-driven transformation is helping the biopharma industry drive effective decision making, harmonise processes, and improve efficiency. The competitive and patient imperatives of adopting these technologies are well understood, offering the ability to deliver essential drugs to patients faster.

However, many companies are still in the early stages of their digital evolution and are held back by a lack of consistent standards, vision, and strategy. Clear direction and guidance are needed.

A shared vision and strategic roadmap can help achieve digital transformation. By adopting the ‘simplify, optimise, automate, outsource (SOAO)’ method, a strong foundation of succinctly optimised processes can be built to reduce complexity. Then the implementation of digital technologies can begin to increase true productivity.

The 2021 Pharmaceutical Manufacturing Smart Pharma Survey findings revealed a mixed picture of the industry’s digital transformation (1). Despite the industry’s focus on accelerating change, the polling suggested that there was hesitancy to accelerate the pace of adopting data-driven digital business models. It also highlighted a lack of consistency regarding innovation, with 27% of equipment vendors claiming that digitalisation was ‘rarely’ part of the discussion when their pharma customers were upgrading or designing new facilities.

One reason for this variation is that many companies have a variety of digital infrastructures because of past mergers and acquisitions. They rely on a mix of digital technologies, some of which have outdated legacy systems. This complexity is further compounded by siloed approaches and poor data integrity, adding to costs, and doing little to support efficient, datadriven operations. This lack of consistency and lag in addressing an overall digitalisation strategy is not sustainable.

The manufacture of biological drugs involves complicated processes and often multifaceted supply chains that require special logistics or handling. As a result, many areas have the potential for improvement with digital technologies.

Throughout a single biologic manufacturing project, an abundance of essential data is produced that must be managed by an array of computerised systems. Ensuring that these data are complete, consistent, and accurate is of utmost importance as, without integrity, they are not reliable. If unreliable data are used in decision making throughout the drug development and manufacturing process, they could negatively impact patient safety and have further disastrous consequences for the company.

The FDA recognised the importance of ensuring data integrity and, as a result, published 21 CFR (Code of Federal Regulations) Part 11. This, and the European equivalent, EudraLex Vol. 4, Annex 11, provide the regulatory requirements surrounding electronic records and signatures, including data integrity controls and computerised system validation. The FDA also introduced further guidance to assure data integrity with its ALCOA+ principles, which requires data to be attributable, legible, contemporaneous, original, accurate, enduring, available, accessible, and complete.

However, in recent years, the number of observations made regarding data integrity in documentation and record management practices during inspections has increased. The percentage of the FDA’s manufacturing warning letters citing data integrity as an issue increased from 28% in 2014 to 75% in 2018 (2).

As well as data integrity issues, manual processes in development and manufacturing can compound the complexity of biologic production, inherently increasing the probability of human error. Errors arising from complicated manual processes or uncertainty could increase costs and impact product and patient safety.

The potential risks from complex biologic manufacturing processes and the rise in data integrity issues highlight the urgent need for biopharma to embrace digital tools. However, digitalisation alone will not simplify processes, reduce potential errors, and improve data integrity. A robust and widely adopted digitalisation strategy is also required.

It is essential to outline the key goals of the strategy before starting on the journey towards a digital future. Ideally, that strategy should have a digital infrastructure that is:

• Built on strong foundations: It is important that the aims, limitations, and potentials of digitalising a process are well understood beforehand to avoid complications later
• Client-centred: Client value should be at the heart of decisionmaking and when optimising business or operational processes by applying process improvement principles
• Aimed to improve the employee experience: By reducing complexities in use, the likelihood of error and loss of data integrity can be lessened when employees are managing automated and computerised systems

Digital transformation initiatives can result in false starts and inefficiencies if objectives are not well considered or they are built with the wrong aim. A common issue is the focus on adopting technologies to quickly solve a problem. Often, the potential and limitations of the technologies implemented are not fully understood. Likewise, the process itself may have unnecessary complexities that could be further convoluted by poor implementation.

One example of a misguided ‘technology first’ approach is to go ‘paperless’ by converting paper entries into electronic logs via a digital logbook. Although digitalising document management could make assets easier to track and improve data integrity, this may not be the right approach.

From an end-user perspective, switching from manual entry to a keyboard and screen is only marginally more convenient. Instead, connecting the asset (a lab instrument or equipment) to a centralised system could automatically collect information that would have been entered into the logbook. This obviates the need for a logbook – paper or electronic – at all.

A paperless environment could be achieved via a digital logbook or connecting to a centralised system, but it should not be the initial objective. Identifying and converting paperbased forms and procedures to electronic without broader, strategic reasoning merely shifts manual processes and limits true productivity gains.

Therefore, it is essential to build digitalisation efforts on a strong foundation of understanding, both in terms of the process itself and the proposed solution.

Rather than taking a ‘technology first’ approach, the ideal strategy focuses first on existing manual processes. Using the SOAO method as a step-by-step guide, companies can solidify their process foundations before implementing technologies.

1. Simplification
Simplification involves the evaluation and assessment of all processes to ensure that each is critical to quality and adds value. Those that do not meet these criteria should be eliminated, thereby reducing complexity. The goal is to streamline all procedures and processes down to the minimum critical steps that are core to delivering customer value.

2. Optimisation
Once all processes have been streamlined, those remaining are optimised. There are various methodologies that could be adopted to achieve this:

• Lean Six Sigma
• Define, measure, analyse, improve, and control
• Suppliers, inputs, process, outputs, and customer analysis

Optimising processes before automating or implementing computerised systems avoids proliferating bad processes that create and sustain further waste and inefficiencies.

3. Automation
After simplifying and optimising, the next step is to automate processes and realise the potential improvements in productivity and efficiency. Automation can be used to achieve:

• Faster access to information, in real time, for both employees and customers
• Decision making that is both data driven and AI assisted
• An improved user experience for employees
• Harmonised processes that are sustainable and scalable with digital platforms
• Advanced supply chain security and integrity by simplifying disruption monitoring and serialisation
• Transparent communication with clients and regulators through secure portals, virtual tours, and immediate access to data and documents
• Processes that can ensure data integrity is maintained When implemented correctly to enhance processes that have been built on strong foundations using robust strategies, automation can improve customer value and ultimately drive business growth and innovation.

When implemented correctly to enhance processes that have been built on strong foundations using robust strategies, automation can improve customer value and ultimately drive business growth and innovation.

4. Outsource
The final step is to determine whether outsourcing non-core elements of processes is a better long term strategic decision. Outsourcing has the potential to improve agility and focus. It could also allow companies to leverage cost structure and scalability benefits.

It is imperative to evaluate all processes to assess whether each is a core competitive differentiator or adds strategic value before outsourcing. Ultimately, the choice will depend on what is best for customers and shareholders.

Transparent communication with customers is essential to build trust and prevent project delays. An example of outsourcing that could greatly improve the experience of the client is to leverage a secure public cloud. This provides an infrastructure that is scalable and accessible to contract partners and biopharma, regardless of location. This enables clients to access their data, quality information and products’ status, while also potentially reducing human errors and ensuring quality.

There are viable technologies available that can tackle the outdated, siloed, and inconsistent data infrastructure of many biopharma companies and improve data integrity. However, just because they are available does not mean they can be used as a ‘quick fix’. The path to digitally enabled, data driven operations and business practices must be well defined with the right strategies and methodologies first.

Instead of haphazardly taking a ‘technology first’ approach, start at the foundation, using the SOAO method to simplify and optimise a process before investing in, and implementing, technology solutions. With these principles, the biopharma industry can accelerate its digitalisation journey more effectively, collectively improving the lives of patients and enhancing safety.