Driven by Data A roadmap to biopharma’s digital future

DRIVEN BY DATA

A ROADMAP TO BIOPHARMA’S DIGITAL FUTURE

Biopharma’s efforts to digitally transform operations are proving more important than ever to drive improvements in process efficiency and deliver essential treatments to patients. However, the industry’s attempts are returning mixed results and the digital transformations of many enterprises remain in early-phase development. As with any business initiative, a lack of clear goals and strategies keeps some biopharma programs from being successful. As a result, these shortfalls may be further preventing many companies from moving toward the more data-driven future the industry needs to deliver reliable access to better performing, more affordable medicines. It is clear biopharma needs a shared vision and a strategic roadmap to achieve digital transformation. Samsung Biologics’ technology strategist James Choi proposes an instrumental strategy that could drive the digital transformation of biopharma organisations and prepare themselves and the industry for the road ahead.

James Choi, Executive Vice President and Chief Information & Marketing Officer and head of Global Public Relations and Process Improvement, Samsung Biologics Despite great effort and expense implementing data-driven business models and processes, the biopharma industry’s attempts to digitally transform operations are returning mixed results. Those in the industry understand the competitive and pertinent imperatives, especially post COVID-19, but recent polling indicates that for many enterprises, their digital transformations remain in early-phase development.

As with any business initiative, lack of standards, vision, and strategy are hindering digitalisation programs from success. This is preventing biopharma from moving toward the more data-driven future which the industry needs to offer reliable accessibility to better performing and more affordable medicines.

It is clear that biopharma needs a shared vision and a clear strategic roadmap to achieve digital transformation. Samsung Biologics’ Executive Vice President and Chief Information & Marketing Officer

and head of Global Public Relations and Process Improvement, James Choi offers fresh thinking and a vision biopharma’s leaders need to drive digital transformation in their organisations and prepare themselves and the industry for the road ahead.

Accelerating biopharma’s digital transformation

The rise of globalisation and business expansion has led to more and more companies undergoing mergers and acquisitions and as a result, siloed approaches, digital infrastructure compromised of dated legacy systems, and poor data integrity have become increasingly common.

Despite the biopharma industry being heavily focused on accelerating change, polling has revealed that there is still some hesitancy to accelerate the pace of adopting data-driven digital business models1.

The lack of consistency in the uptake of innovative methods to implement digitalised solutions is proving to be unsustainable. Addressing this problem and accelerating progress will require the adoption of industry-developed standards to ensure improvement of efficiency and maintenance of data integrity.

The need to alleviate manufacturing complexity

Innovative technical advancements and discoveries have allowed us to enter into an era in development where drugs have become increasingly personalised. This has been highlighted by the rising popularity of cell and gene therapies. However, as biologics become progressively more complicated, the complexity of their manufacturing process rises in parallel. Their production can also necessitate more convoluted supply chains or special logistics and handling requirements than traditional small molecule drug products.

It is essential that the quality of the biologic is maintained despite rising intricacies, but as the complexity of a process increases, so does the probability of error. This is further compounded by manual processes that add to the likelihood of mistakes being made. As a result, biologic production could face an increase in cost, a reduction in product quality, and ultimately, the potential to impact patient safety.

Manufacturers will need to carefully consider methods to prevent increasing production complexities from affecting the quality of the biologic while improving efficiency. This can be achieved by correctly implementing digital tools, data-driven business models, and operational models while having a thorough understanding of their potentials and limitations.

Set goals strategically from the start

True digital transformation should be focused on reducing complexity as well as transforming and easing the experience employees have managing it. Before embarking on a digital transformation journey, the organisation must clearly outline the goals it hopes to achieve. These goals should be centered around implementing digital transformations in a way that is client-focused while optimising business or operational processes by applying process improvement principles.

The major regulations currently governing electronic records and DI controls are 21 CFR (Code of Federal Regulations) Part 11 published by the FDA and its European equivalent EudraLex (the collection of rules and regulations governing medicinal products in the EU) Vol.4, Annex 11.

Go digital, not paperless

Digital transformation initiatives can often result in false starts and inefficiencies if goals and objectives are not well thought through. A common mistake that is made in digitalisation efforts is the focus on ‘going paperless,’ with the primary performance metric being the elimination of paper alone.

When digital technologies are implemented correctly, they have the potential to minimise human error throughout the creation, recording, management, storage, and archival of data. As a result, the use of digitised solutions in previously paper-based processes is often mistakenly equated with improvement and enhanced data integrity.

Example: Digital logbooks for tracking assets

Converting paper entries into electronic logs via a digital logbook can make assets and any changes made to them easier to track. However, from an end-user perspective, switching from manual entry to a keyboard and screen may only be marginally more convenient. Although a paperless environment can be achieved with digitalisation efforts, it should not be the sole indicator of success nor the initial objective. Identifying and converting paper-based forms and procedures to electronic means requires broader, strategic reasoning as opposed to merely forgoing manual processes and can jeopardize potential productivity gains. A more optimal approach in this example would be to analyse the actual information that is needed from the source (asset) and eliminate the need to manually collect it in the first place. By connecting the asset (a lab instrument or equipment) to a centralised system instead, information that would have been entered into the logbook can be collected automatically, obviating the need for a logbook – paper or electronic – to begin with.

SOAO approach: Simplify, Optimise, Automate, Outsource

The ideal digitalisation strategy is counterintuitive. Rather than focusing immediately on the technology solution, the existing manual processes first need to be examined using the SOAO method: Simplify, (then) Optimise, (then) Automate, (then) Outsource (if appropriate). Implementing a SOAO approach can ultimately drive business growth and innovation by offering several advantages: • Business optimisation enabling real scalability • Enhanced employee experience and productivity • Faster access to the right information when needed • Greater returns on digital investments • Improved customer value

Simplification

Implementing digitalisation without process simplification is not advised. The goal of the simplification step is to streamline all parts of the procedures and processes to maximise efficiencies while delivering client value. Achieving this necessitates the thorough evaluation and assessment of each step, ensuring that all are critical and/or add real value, and removing those that do not.

Optimisation

Once non-critical aspects of the chosen process have been eliminated, those remaining should be optimised to the highest degree possible. There are various methodologies that could be applied and adopted, including Lean Six Sigma, DMAIC (define, measure, analyse, improve, and control), and SIPOC (suppliers, inputs, process, outputs, and customer) analysis. By optimising before automating, businesses can avoid proliferating poor processes that can create even more waste and inefficiencies.

Automate

Following optimisation, organisations can begin to introduce automation and computerised systems. These can improve processes in many ways: • Eliminating the need for certain forms or existing procedures entirely (as in the previous logbook example) • Facilitating comprehensive data reporting in real-time • Allowing data to be followed throughout its lifetime with time stamps • Centralising all sources to a single hub or data repository for more efficient and in-depth analysis

Outsource

Finally, companies implementing the SOAO method will need to carefully consider whether outsourcing digital business processes could be a suitable longer-term strategic decision. This decision should ultimately be made with the interest of its clients and shareholders held above all else. Outsourcing certain digital processes to reliable companies can improve both agility and focus. It also provides the ability to leverage cost structure and expand scalability.

The advantages of implementing the SOAO method

Adopting the SOAO approach to a digitalisation strategy can impact and improve many different important areas in manufacturing by alleviating challenges surrounding their complexities.

Data integrity and compliance efficiency

One of the most important factors in regulatory compliance currently is data integrity. The major regulations currently governing electronic records and DI controls are 21 CFR (Code of Federal Regulations) Part 11 published by the FDA and its European equivalent EudraLex (the collection of rules and regulations governing medicinal products in the EU) Vol.4, Annex 11. These regulations have been consistently updated since their introduction and have helped to shape local regulations around the world.

The adoption of digitalised solutions by manufacturers in a “technology-first” approach has led to a considerable increase in breaches of these regulations. In 2018, up to 75 per cent of the FDA’s manufacturing warning letters cited DI as an issue, as compared with 28 per cent in 20142.

By adopting a digitalisation strategy like SOAO, as well as assuring data integrity with ALCOA principles (attributable, legible, contemporaneous, original, accurate, enduring, available, accessible, and complete), companies can avoid non-compliance with regulations. If not, they may risk recalls, delays, and denied drug approvals.

Supply chain integrity and reliability

There are many elements and processes involved in a secure supply chain that are data-driven, and these can present significant challenges: • Raw material supplies require monitoring to avoid potential disruptions • Track and trace and serialisation are needed to meet security compliance • Cold chain capabilities and personalised medicines have additional demands during transport

Digitalised solutions, including blockchain (a shared ledger that can be used to record transactions and track assets) and other technologies, offer potential solutions. Using an approach like SOAO to implement these solutions and alleviate supply chain challenges is necessary to avoid building processes on poorly designed strategies, which could cause more problems in the long run.

Customer and regulator communication and transparency

It is important that clients can access their data throughout the project, as well as their quality information and the status of their products. This can be achieved by leveraging secure cloud technologies, providing an infrastructure that is scalable and accessible to clients, contract partners, and regulators regardless of where they're located. Cloud technologies also act to reduce human errors, thereby ensuring that quality is maintained.

Transparent communication with customers and regulators is essential to build trust and prevent project delays. As well as cloud technologies, there are many solutions and resources available that can further facilitate open communications and foster strong relationships: • Secure portals for document access • Virtual PIP (person in plant) • Live Virtual Tour (Remote audits and inspections)

Time for biopharma to secure its digital future

Biopharma manufacturers may be aware that viable technologies are currently available, but there is a significant delay in their implementation. It is understandable that companies are wary of adopting the wrong strategy in their digitalisation. A “technology-first” approach with an aim to go paperless without a thorough understanding of the process that is being improved can cause more challenges in the future, particularly when considering regulatory compliance.

The digital future of biopharma is still in its formative stages, but the path to digitally-enabled data-driven operations and business practices is becoming well defined. It is therefore important to choose a manufacturing partner that has adopted strategies like the SOAO approach to systematically simplify, optimise, automate, and potentially outsource processes to improve efficiency and quality.

1.https://www.pharmamanufacturing.com/ articles/2021/smart-pharma-survey-resultspharmas-digital-prowess-put-to-the/

2. https://redica.com/pharma-medicaldevices-data-integrity-breaking-downkeywords-and-citation-trends-from-the-fda/

AUTHOR BIO

Prior to joining Samsung Biologics in 2014, James Choi held various technology and operations leadership positions at major global healthcare and informatics corporations. Choi began his career with Philips Healthcare in 1989 as Site Planning Manager and advanced through leadership positions in Customer Service eBusiness and Technology, Operations, and Information Systems for North America. Mr. Choi then transitioned to the Informatics and Security industry and was CIO for a major background investigation, insurance intelligence, and commercial pre-employment screening company.