April 2023 • PharmaTimes Magazine • 28-29

// DIGITAL HEALTH //


Evolution energised

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In an ever-complex regulatory environment – and a rapidly evolving digital landscape –adopting an effective digital transformation strategy is pivotal

Pharmaceutical companies know they need to digitally innovate. According to a GlobalData survey, 40% of pharmaceutical industry professionals in Europe and North America believe that the COVID-19 pandemic accelerated digital transformation by more than five years.

The industry is duly responding to the transformation requirement and is expected to invest $4.5 billion on digital evolution by 2030.

At the same time, pharma companies face a host of regulatory challenges that demand sophisticated data management and security capabilities.

From compliance and cyber security to data reliability and platform stability, pharma companies are operating within a complex and constantly shifting terrain.  Additionally, complex data ecosystems across drug formulation, clinical operations, enterprise testing and patient privacy are creating further challenges for companies.

In fact, regulatory non-compliance could be so disastrous, not only is the company’s reputation affected, it could also impact its finances and its customers in a profound way.

Due to this, a holistic approach to digital transformation is needed, an approach that limits business disruption, while ensuring a process that achieves transformation with speed, consistency and scale.

Digitalisation offers pharmaceuticals incredible potential and those who adapt successfully will have a major competitive advantage. Done right, it should enhance processes to help improve decision-making and make everything from back-end administration to patient-facing services smoother.

Risks avoidance

Despite many pharma companies clearly being aware that digital transformation is needed in order to stay ahead of the competition, it is understandable that concerns around cost and business disruption remain huge concerns.

This is particularly so when ultimately patient safety and meeting regulatory requirements are paramount despite any digital changes that are made.

There are a number of reasons why digital transformation programmes can fail or fall short of their intended aims. These include:

  • Lacking a single source of truth
  • Absence of a business-led approach focused on outcomes
  • Lack of a cloud-based digital business platform (DBP)
  • Pursuing transformation with a big bang approach rather than an incremental one
  • Failing to adopt an agile digital culture.

Successful digital transformation is centred on a more agile and pragmatic approach that focuses on bite-sized outcomes that are essential to accelerating business growth – we call this our Digital Business Methodology.

As part of this, it is important to offer a cloud-native application development platform, which we call a digital business platform (DBP), that offers a simplified end-to-end collaborative environment that is independent from the existing complex, siloed environments.

The DBP should establish and apply end-to-end industry best practices in relation to security, compliance (audibility and traceability), quality, reliability and observability. It should create a service catalogue providing reusable playbooks, components and assets with governance for higher productivity.

The biggest risk digital transformation poses is the temptation to implement everything in one go, at one point in time. Consider this scenario – a company knows what the outcome is that it wants to achieve, gets the funding in place and then sets off on the long and arduous journey to reach its end goal.

The problem with this is that by the time the company reaches this goal (if it ever does), the world has moved on; customers’ needs have changed, technology has evolved and the outcome is no longer relevant or even desirable.

Big bang vs bite-sized

We call an approach like this a ‘big bang’. Big bang approaches to digital transformation almost always fail and certainly fall short of the mark. Their long-term nature means the business sees no short- or mid-term benefits to the transformation and the whole exercise becomes very monolithic.

A preferable way of tackling digital transformation is to take a ‘bite-sized approach’. This method involves taking incremental steps and achieving short- and mid-term goals along the way. The business sees the visible benefits of each step and the transformation can be reviewed, retuned and recalibrated if necessary, depending on how the market is changing.

Course correction, if it is needed, is much easier to achieve, and trust is built and maintained by customers and stakeholders being able to see for themselves how operations and services are improving as the transformation unfolds.

User experience can be incrementally tested and, at any point, potential new digital deployments can be assessed for new risk windows, such as cybersecurity or compliance to regulation, before they are fully adopted.

The more gradual the approach, the greater your control of risk.

What makes pharmaceuticals different?

Entering any digital transformation with a ‘bite-sized is best’ mindset will bring substantial rewards to companies in any industry, but it is particularly beneficial to pharmaceuticals. Few other industries are as heavily regulated, and implementing small changes at a time means companies can assess their regulatory compliance every step of the way, all without disrupting operations.

The complexities of drug development, clinical trials and lengthy approval processes mean that the last thing a pharmaceutical company needs is disruption, which would only lead to more complications and further delays.

Successful outcomes need agility and people-support. The pharmaceutical industry relies heavily on an ecosystem of partnerships, contract research organisations, external businesses and regulatory bodies.

In the pharma environment with high-risk areas, such as trial design and drug safety, an agile approach empowers companies to test the effectiveness of new systems and processes before upscaling them.

We must also remember the reason we need change. For pharmaceuticals, digital transformation is about achieving better outcomes for patients. Implementing new technologies will mean that you can knock down barriers and reach a wider, more diverse market.

It means that new therapies and treatments can be delivered more effectively, meeting patient needs and helping them to better monitor and manage their conditions. There are monetary benefits to be had too. Successful digital transformations make companies more cost-efficient and transparent, accelerating their growth.

The final analysis

Pharmaceutical companies who grasp the opportunity to achieve digital transformation and use an incremental approach to get there are giving themselves a serious competitive advantage. They will benefit from cost and operational efficiencies, risk control, stakeholder engagement and, most importantly, being able to provide better for their customers.

The concept of digital twins, for instance, is being used by some pharmaceutical companies to optimise the drug development process.

Those who don’t shift their perspective may get left behind.


Bheem Adavikolanu is Chief Transformation Officer at Altimetrik.
Go to altimetrik.com