Digital trailblazers

26 July 2018

Industry 4.0 promises great things for the pharmaceutical sector, but reaping the rewards of this new technology comes with a number of challenges. Henk Mollee, senior director of clinical trials materials at Astellas Pharma Europe, talks to Grace Allen about the industry’s advances in digitalisation and the factors delaying innovation.

When it comes to digitalisation, the pharmaceutical industry seems in agreement on two things: the benefits to be gained from embracing the digital revolution and the sector’s foot-dragging in doing so.

A white paper from Siemens estimated a ‘digital productivity bonus’ for the global industry of between $67 billion and $105 billion. Nevertheless, a 2017 report from Econsultancy, a digital market research and training company, stated that only 6% of healthcare and pharma sector companies characterised themselves as ‘digital first’.

Henk Mollee, senior director of clinical trials materials (CTM) at Astellas Pharma Europe, concedes this sluggish pace of adoption ruefully. “The pharmaceutical industry is rather slow when introducing new technologies, if you compare it with other industries,” he says.

The – largely laudable – caution of regulators in approving new technologies and production methods is a major factor in slowing the adoption of digital innovations. When patient safety is the primary concern, it’s vital that each development receives proper scrutiny.

However, the pace of innovation means that regulators can lack the structures or expertise to analyse digital aspects of the pharmaceutical industry efficiently, potentially blocking revolutionary technologies from entering the supply chain and market.

It’s a problem that regulators are well aware of. Dr Scott Gottleib, US FDA commissioner, acknowledged as much in his remarks at AcademyHealth’s 2018 Health Datapalooza in Washington DC. “FDA’s usual approach to medical product regulation is not always well suited to emerging technologies like digital health, or the rapid pace of change in this area,” he said. “If we want American patients to benefit from innovation, FDA itself must be as nimble and innovative as the technologies we’re regulating.”

Regulatory bodies are taking steps to rectify this – Gottleib pointed to the establishment of a ‘digital health incubator’ at FDA, while the European Medicines Agency set up a task force to investigate the use of big data in 2017 – but the slow pace of change remains frustrating for those in the industry. Mollee gives the example of the continuing campaign for electronic labels in clinical trials materials manufacturing, a development that could increase efficiency and patient safety by enabling updated expiry dates and changes in the language on the label. “It is still not allowed, and that process has been ongoing for years,” he says.

Data saturation

Another issue relates to the vast quantity of patient data produced by the digital transformation, which often originates directly from the patient themselves, as wearable health devices and health apps increase in popularity. The sensitivity of this data, and the necessary restrictions upon it, precludes the pharmaceutical industry from making use of it.

Mollee describes this as a catch-22. “You can, of course, get much more data and engagement from the patient; on the other side, in the pharmaceutical industry, we are also not allowed a lot of information on that patient or to have direct contact with them,” he explains, pointing out that preserving the interface between patients and healthcare professionals, rather than pharmaceutical companies is an important part of European legislation.

This distance provides ample opportunity for other industries, and the tech sector in particular, to move into healthcare. Apple’s Health app, for example, allows users to track metrics varying from heart rate to fertility.

“I have seen examples of apps for phones and wearables, where the system will tell you how well you are getting, when your medication is running low and if there is a pharmacy close by,” Mollee adds.

Often, the best answer for pharmaceutical companies trying to keep up is to partner with companies that are more adept in the digital world. AstraZeneca, for instance, launched the Day-by-Day app, which supports patients recovering from a heart attack, with healthtech business Vida Health. In the realm of clinical trials, January saw Sanofi announce its partnership with health technology and data company TriNetX to model clinical trials and identify potential participants.

Clinical trials and the supply chain

Digitalisation also allows the development of ‘patient-centric’ or remote clinical trials. In 2017, Science37 conducted a clinical trial without a physical location, in which participants followed a plan and communicated with organisers through the company’s mobile app, NORA (Network Oriented Research Assistant). It also highlighted the higher than average enrolment of non-white participants. Such advances open the possibility for far greater participation in trials across geographical and language barriers.

Elsewhere, the ingestible sensors manufactured by companies such as Proteus Digital Health can be used to track patient adherence during phase III clinical trials, creating far more reliable data on the effectiveness of a drug by recording if, when and how much was taken.

Digitalisation has already provided enormous benefits in areas where it has successfully been integrated. This is particularly true for the clinical trials manufacturing supply chain, a process with such complexity in the ordering of medication, stock control and housing that Mollee believes would be impossible without digitalisation. Increased visibility means manufacturers know exactly where their product is in real time – something that was unheard of before digitalisation.

“Ten years ago, I think we were very happy if we could see that the batch or the product arrived at the airport from a courier,” Mollee says. “We only knew what warehouse it was in because it was scanned upon arrival. And the temperature you only knew at the end, when the pharmacist opened the batch and read out the reader.”

Taking temperature readings throughout the supply chain allows manufacturers to know whether a replacement product is required before a shipment reaches its destination; this vital tool increases efficiency, as medication becomes more precisely temperature controlled. In addition, the surge in data about the state of products during the manufacturing process and transportation, plus the ability to combine this information to refine insights, mean that predictions can be made about an item, including the stability of the final pack.

Mollee believes this has the knockon effect of boosting patient safety. He says, “All the data that becomes available during manufacturing, release, shipment and testing can be combined and improve the safety of the patient, I think, because it’s easier to forecast how the product will act.” The senior director also spoke on supply chain efficiency at March’s Clinical Trials Supply Europe conference in Milan, Italy.

All this data creates visibility along the supply chain: weak points can be identified, allowing modifications and refinements to increase efficiency.

“If you only know at the end that the temperature was outside specifications during the shipment, then it doesn’t say anything about where it went out of range,” Mollee says. “[A digitalised supply chain means that] you have much more detailed data to control that.” If a batch regularly exceeds temperature limitations at a specific airport, for instance, extra precautions against this can be deployed or the transportation route altered.

Modernised manufacturing

Mollee also points to the role of digitalisation in reducing human error in the CTM manufacturing sector. For a process that involves two operators – one checking the work of the other – the introduction of a digital solution could make the task of establishing whether a product meets the right specifications, or if machine settings are correct, much smarter.

The digital transformation looks set to revolutionise manufacturing in the pharmaceutical industry further through the incorporation of the internet of things. Smart devices within the manufacturing system can collect and transmit data, enabling real and near-real-time analysis of the process. Information can also be gleaned on the efficacy of equipment and provide alerts if a component needs to be replaced. In addition, the ease of accessing digital information on the manufacturing process makes it far simpler for modifications to be made.

All this extra data is a potential boon for regulation, as the workings of the manufacturing process can be supported by far more evidence than ever before. The portable, continuous, miniature and modular (PCMM) plants developed by Pfizer are a step in this direction. Smart-control systems allow speedy assembly, disassembly and continuous processing, while a reduced carbon footprint means manufacturing locations are far less restricted.

As the industry moves away from blockbuster drugs and towards more personalised solutions, reflecting the higher levels of information available to patients and a correspondingly increased engagement with their treatment, digitalisation promotes the production of smaller quantities of more individualised drugs. This is another benefit provided by modular manufacturing solutions, such as Pfizer’s PCMM approach. Smaller units and increased flexibility enabled by digitalisation mean that reduced quantities of drugs, including new products for clinical trials, can be produced quickly.

Mollee sees the miniaturisation of manufacturing extending further, beyond the physical space occupied by the pharmaceutical industry.

“You could think about a 3D printer at the pharmacy, where the patient comes in and the system will print 3D tablets for that patient,” he suggests, continuing to describe how this could allow medication to be produced that corresponds directly with a patient’s profile, which would contain vital information, such as weight or DNA.

Products made ‘fresh’ and to order at a pharmacy would result in the limited wastage of materials – a revelation in an industry that generally produces too much stock – and the ability to manufacture drugs with a very short shelf life. With the first 3D-printed drug approved by FDA in 2015 (Spritam, otherwise known as levetiracetam, used to treat seizures in epilepsy patients) and the establishment of companies that focus on 3D printing for the pharmaceutical industry, such as FabRx, which was set up by a team of researchers at University College London’s School of Pharmacy, this vision of a digital future is already becoming a reality.

In a recent speech, Dr Scott Gottleib acknowledged that FDA must do more to keep up with the changing digital landscape.

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