Digitization is fundamentally changing the healthcare industry, and that includes the pharmaceutical supply chain. New technologies and innovations are enabling pharma companies to improve drug design and development, manufacturing and distribution. Here, we take a top-line look at some of these areas that might soon – if not already – be affecting you.

Digital pills

Described as “perhaps the boldest use of digital technology in healthcare”, in 2017 the US Food and Drug Administration (FDA) approved a pill integrated with an ingestible sensor that transmits information to a mobile app. The transmitted data allow patients and physicians to track medication intake.

Much of the discussion relating to this digital pill has circled around the clinical and economic benefits of treatment compliance but, if we stretch our imaginations, there is potential for much more. To give just one example, could sensors be designed to detect parameters that might enable more targeted treatment delivery/active ingredient release? Surely this is just the start of a very exciting evolution in medication technology – enabled, of course, by digitization.

Personalized medicine

From genomic sequences and cell types, to individuals, populations and our environments, we know more about the human condition than ever before. This is enabling a new model for healthcare – one of ‘personalized medicine’ – in which patients receive the diagnoses and treatments best suited to them, as individuals.

While genome sequencing and data analysis are essential components of personalized medicine, it is digitization that has invited genome sequencing and other digital advances – wearable sensors and digital health, for example – into everyday clinical practice. The ability to manage and analyze bio-data from millions of people helps researchers to study patterns, make new discoveries and better understand how to prevent, treat and manage different diseases.

Biomarkers are already becoming an important part of prospective drug development, with biomarker-based approaches being integrated in more than 40% of new programmes. This has the potential to markedly increase success rates for new drug approvals, as higher response rates in specific populations can be achieved.

Data analytics

The ability to manage and analyse ‘big data’ from millions of people is a significant contribution to the personalized medicine movement. It allows researchers to identify biomarkers, risk factors, patient subgroups and responders, all leading to the application of those data to finding exactly the right treatment for every individual.

In addition, data analytics is changing the way in which we manufacture our drugs. Most manufacturing plant equipment collects data, and real-time analysis of those data (alone and in factor analyses with other data) can enable data-driven decision making and global early warning systems. These proactive approaches can improve the quality and consistency of product under manufacture, advance equipment maintenance, reduce downtime and improve plant safety. Such goals can be achieved because potential problems are detected and fixed before they have a material impact. Many pharma giants like healthcare supply companies have already embraced this so-called fourth industrial revolution, broadly referred to as Industrie 4.0 – the age of digitization in manufacturing.

Serialization

We have previously discussed the requirement in the US and Europe for the serialization to every saleable unit of prescription drugs. As each serialized code, unique to every individual package, must be accounted for, highly complex systems are required to confirm the presence of the code, verify, capture, interpret and store it, in a form that can be shared with downstream partners. This simply would not have been possible before the availability of digital technologies.

Blockchain

Not too distant from serialization, blockchain technology provides a means of tracking goods through the supply chain, with the goal of combatting the counterfeiting of products via sophisticated track-and-trace capabilities. Offering decentralization, security and transparency, blockchain can alleviate frictions in procurement, transportation management, customs collaboration and trade finance. The European Association of Chemical Distributors (Fecc) has even described blockchain as a ‘game changer’, seeing it as a way of enabling more automated, error-free, cost-saving processes to meet, for example, regulatory requirements relating to the supply of information concerning pharmaceutical substances in their long and complex supply chains.

Conclusion

Digitization is enabling some of the most exciting revolutions in 21st century healthcare. New models of healthcare, and better ways of developing, manufacturing, distributing and prescribing drugs are all emerging as more organizations and enterprises embrace the digital age.

Author biography

Sarah Harding, PhD, Independent Science Writer

Sarah Harding, PhD, worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and is currently providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

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