Digital: Digitalising Processes

How will the mass integration of digital technologies into the pharmaceutical industry benefit the most underserved countries?

Raman Bhatnagar at AspenTech

Despite significant progress in the field of medicine, some communities across the world still lack access to basic healthcare. The coronavirus pandemic, one of the worst public health crises we’ve faced in a century, brought the chronic problem of inequitable access to medicine into sharper focus.

The WHO reports that, to achieve healthcare for all, at least another two billion people will need to access essential health services by 2030 (1). Universal health coverage can only be achieved when there is affordable access to safe, effective, and quality medicines and health products.

The pharmaceutical industry has a unique role to play in this area of global concern and it understands the pressing need to address this issue. In recent times, multinational pharmaceutical companies have taken practical steps to improve access to life-saving medicines: AstraZeneca and Johnson & Johnson priced their coronavirus vaccines at cost during the pandemic, while US pharmaceuticals giant, Pfizer, has offered all its patented drugs on a not-for-profit basis to 45 lower-income countries (2).

The Medicine Foundation’s 2021 Access to Medicine Index shows evidence of advancement more widely (3). The Index cites that it has seen “undeniable progress” in the pharma industry, with numerous companies today taking seriously the access problems faced by people in low- and middle-income countries. Major players like GSK and Novartis are leading the way with integrating access to medicines in business practice, and adopting new processes to ensure all new products are more accessible to the world’s poorest people.

Whilst the signs are encouraging, there is much more that needs to be done to improve access to medicine in the developing world. Continuously finding novel ways to make medicines both accessible and affordable is critical to the expansion of universal health coverage. While there is no one-size-fits-all approach, pharma companies can become the driving force to ensure their products are available to low- and middle-income countries. Implementing digital technologies to improve the production and provision of medicines will have a positive effect on healthcare inequalities.

Over the past 30-40 years, technological advancements have helped improve the impact, reach, and efficiency of modern healthcare. Its improved diagnostic capabilities help monitor patients’ health more easily, and it plays a crucial role in connecting patients to doctors in faraway health facilities. Telehealth alone has the power to improve health outcomes in rural or remote locations, and provide valuable links to the healthcare system.

While there is no way to ‘download’ actual medicine, the link between digitalisation and getting pharmaceuticals to market, and in a more accessible way, is becoming clearer. In the wake of COVID-19, digitalised technology is more important than ever.

Digitalisation in pharma manufacturing can diversify production, reduce costs, and help build a more resilient and flexible supply chain. Crucially, an increase in productivity in the laboratory can subsequently lead to quicker drug development. Digital laboratory solutions have been shown to significantly reduce the complexity and costs of drug development.

For example, electronic batch records use several databases to record data during the production of a batch. They help pharma companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

In another example, predictive and prescriptive maintenance is helping pharma companies fix small problems with their equipment before they escalate. It provides sufficient prior warning that a piece of equipment is degrading and identifies various solutions and outcomes. This data-driven maintenance is helping to mitigate equipment downtime and over-maintenance, and avoid both safety and product delivery risks. The more efficiencies gained, the quicker and more cost-effectively a drug can be commercialised. When production is leaner, there are fewer faulty batches, reduced product costs, and faster time-to-market.

Despite these positive indicators, the access challenge remains complex. One key issue is the lack of consideration of how novel and mass-market drugs will be made available in underserved areas. This factor is not always considered in the initial design of the medicine, which can limit distribution.

A prime example of this was the COVID-19 vaccine, which needed ultracold temperatures to remain effective and safe. With some underdeveloped countries not even having the power grid necessary for running a regular refrigerator, the lack of ultracold-temperature freezers exacerbated the distribution challenge.

Once a drug is approved, it is cumbersome and expensive to re-configure manufacturing processes and subsequent revalidation. This means that the specific distribution needs required for vaccines in remote areas are not always easily accommodated.

Pharmaceutical labs work with data that need to be stored, analysed, shared, and retrieved. Digitising the data through automated workflows empower pharma companies with more control and reduced risk. Integrating structured, unstructured, and reference data into a single system can help them streamline processes, control costs, and deliver real-time and accurate information. For instance, modern Process Analytical Technology (PAT) is a powerful enabler of quality by design principles and process analytics. It’s an algorithm for analysing and controlling the production process, and offers crucial science-based insight into data that are key to stable and efficient production processes.

With this extra insight and acceleration, pharmaceutical production lines can speed up, the number of failed batches is reduced, and product quality can be maintained more consistently. Together, these factors significantly lower the cost of goods sold, and accelerate the delivery of medicines to market to meet patient needs.

Digital technologies like PAT improve drug design and mitigate issues before they arise, also facilitating a better supply of affordable, safe, and quality-assured medicines worldwide. They improve conformity to regulations and can help de-risk distribution variables that add complexity to global medicine access.

There is more visibility and foresight into the entire drug design and manufacturing process, and it enables more informed choices on how to get new drugs, as well as common drugs for chronic conditions like diabetes, into the hands of underserved communities.

Decisions such as where a drug or vaccine will be manufactured, the cost, how it will be shipped, requirements to administer, and local clinic accessibility, no longer need to be made retrospectively.

Pharma companies also have a positive outlook towards the integration of AI within their operation. It can be implemented in every aspect of the pharma industry, from drug discovery and development, to manufacturing and marketing.

AI is helping to identify innovative strategies and opportunities, and develop new drugs that can reach consumers in a faster, cheaper, and more effective way. According to consultancy firm McKinsey, pharma companies demonstrate an estimated 70% improvement in overall equipment effectiveness with the use of artificial intelligence (4).

The FDA Advanced Manufacturing initiative, and the International Society of Pharmaceutical Engineers’ (ISPE) Pharma 4.0 framework have helped lay the foundation for a new, digitalised pharma industry. They are promoting the benefits of digital technology capabilities in the pharma sector, and encouraging the industry to embrace the opportunity.

The IPSE framework provides a roadmap for adapting digital strategies to the unique context of pharmaceutical manufacturing. It conceptualises the digital transformation of the pharma product supply infrastructures, from manufacturing the medicines to dispensing the medicines to patients. The FDA’s initiative highlights new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. Together, they demonstrate an unprecedented opportunity to improve the reliability, quality, and cost efficiency of pharmaceutical product supply when and where patients need it, while also addressing sustainability goals.

Digital transformation can be daunting, but COVID-19 revealed a strong need for innovation and the adoption of digital tools: it successfully demonstrated how quickly the industry can embrace changes when pushed to do so. Achieving universal health coverage requires access to safe, effective, quality, and affordable essential medicines and vaccines. Pharma companies need to start transforming into digital businesses to be competitive in the future.

Technology is helping to yield higher quality pharmaceutical products, more cost-efficient processes, faster time-to-market, and more sustainable production. Many organisations are recognising the way digitalisation has the potential to transform pharma operations. According to a 2021 research study,

Culture Reimagined: How Pharmaceutical Firms Can Use Data and AI with Confidence, 80% of companies say their vaccine manufacturing capacity will be significantly impacted by digital technologies going forward (5).

Digitalisation accelerates various processes in the pharma industry and can guarantee complete transparency throughout the product lifecycle. Predictive and prescriptive maintenance, efficient batch execution, scheduling solutions, and process analytical technologies are all key to this industry-wide digitalisation journey.

Eradicating health inequalities is everyone’s responsibility, and accessible and affordable drugs are essential to the expansion of universal health coverage. Whilst increasing access to medicines and vaccines is a complex issue, pharma companies, as innovators and producers, are key partners on this journey. With innovative and sophisticated use of digital technology, they can help meet the challenge of equitable global access to medicine, and support a more sustainable world.

References

1. Visit: www.who.int/news/item/30-03-2020-new-who- guide-to-help-countries-expand-access-to-essential-medicines
2. Visit: www.bbc.co.uk/news/business-61578956
3. Visit: www.accesstomedicinefoundation.org/publications/2021-access-to-medicine-index
4. Visit: www.mckinsey.com/capabilities/operations/our-insights/operations-can-launch-the-next-blockbuster-in-pharma
5. Visit: www.healthcare-digital.com/medical-devices-and-pharma/pharma-sector-struggling-data-aspentech-survey-finds