A digital revolution for the pharma industry

Adents, specialists in unit serialisation and traceability solutions, organised its first educational conference in Paris on serialisation and innovation, 5-6 April

Attended by more than 200 people, the event brought together Adents partners Microsoft and Siemens as well as a variety of experts and professionals in healthcare and related fields.

For Adents, the event’s goal was connecting key industry players and offering advanced, comprehensive thought leadership for all those concerned with pending pharmaceutical supply chain regulations – including Industry 4.0 solutions that promise ROI and added value far beyond compliance.

In his opening remarks, Christophe Devins, CEO and co-founder of Adents, asked the following question: "What happens when technology does not follow the needs of the market?"

His answer was clear: "Traditional cellular phones held 90% of market share in 2009; by 2012, that figure was close to 0%. In just 3 years, they all but completely disappeared."

Devins drew a parallel between this example of new technologies and the new traceability and serialisation technologies that will be deployed in the pharmaceutical supply chain to fight counterfeit medicines.

"The latter will have to seamlessly and securely connect all key stakeholder involved, including brand owners, CMOs, wholesalers, distributors, hospitals, pharmacies and, ultimately, patients."

By advocating this "Marketplace" approach, Devins highlighted opportunities for exploiting "big data" to create value and make the pharmaceutical industry more efficient.

A flexible and scalable approach

Today’s life science industry faces real challenges. The proliferation of chronic diseases; patients who do not take their treatment (thus inducing significant health expenditure for various countries); the exponential cost of developing new drugs; and the scourge of counterfeit drugs all have become public health issues worldwide, as Laurent Curny, CEO of Microsoft Services, reminded us in his speech.

For one, falsified medicines are up 15% each year and cause far too many deaths. "It has become essential to secure the pharmaceutical supply chain by reducing the risks that can arise at all points in the chain, from the sourcing of raw materials through the production of the product, its storage, transport, distribution and sale," said Curny.

Microsoft can already address some of these challenges thanks to its new technologies, including Triages bots, interactions generated by artificial intelligence (AI). To address the challenge of drug serialisation, Microsoft decided to partner with Adents to combine the two entities’ expertise. To realise the digital transformation needed by the global pharmaceutical industry, high-level collaborations such as this will be crucial.

The collaboration between Adents and Microsoft can be seen as a firm handshake: on one hand, an expert in unitary product identification and traceability; on the other hand, a powerful and proven technology partner through its Microsoft Azure platform - a set of cloud services enabling pharma manufacturers to create, deploy and manage applications through its global network of data centers.

"We believe that Microsoft has the best approach to foster trust in the Cloud through the four pillars that underline our platform: transparency, privacy and control, compliance and security," said Curny.

The issue of serialisation implementation is by no means anecdotal: no less than 20,000 pharmaceutical packaging lines – about 10,000 each for the US and Europe – must be outfitted and operational by early 2019. Further, an examination of regulation mandates on both sides of the Atlantic Ocean shows that each region has issued special requests, which means that the platform implemented by Microsoft and Adents (Adents Prodigi) needs to be particularly adaptable, scalable and enable data recovery – both for traceability purposes and for future valorization projects.

Digitisation of the pharmaceutical process

Is the pharmaceutical industry technologically ready to take this leap towards digitising its production? A clearer picture is drawn by Siemens, which in addition to partnering with Adents to implement serialisation solutions, also provides high-level technology for the organisation of industrial processes.

Nicolas Teissié, Industry Software Product Manager at Siemens, argues that 80% of production sites are not equipped with proper manufacturing execution systems (MES), which enable production data to be collected in real time.

This information echoed a previous presentation from his colleague, Andrew Whytock, Head of Digitalization and Innovation, Pharmaceutical Business at Siemens. Considering that the fourth revolution (Industry 4.0) is in progress, after the industrial revolution of the 19th century, followed by that of electricity and automation, the digitalisation revolution should transform the innovation and the manufacturing process.

According to him, it is necessary to integrate and digitise the entire value chain and not just the automation of production. It is this holistic approach to digitisation that is advocated – one that integrates product design, production planning, production, production execution and services to the customer.

Under this approach to process digitalisation, the masterbatch record (MBR) - a recording model of the production of a pharmaceutical batch that ensures that every detail is recorded - becomes an eBR (electronic Batch Record), its digital twin. By linking the serialisation technologies to the eBR, "we offer full visibility on the traceability of the batch, from the first stages of creation to the last stages of the supply chain," explained Teissié.

The integration of the Adents Seriza and Adents Prodigi (Cloud) serialisation solutions with the MES solutions dedicated to the paperless and fully electronic pharmaceutical industry, Simatic IT eBR from Siemens, enables the sharing and updating of production information, as well as distribution of serialisation information.

Blockchain, activity apps, marketplace

Faced with these issues of data sharing and interactivity between the various players in the pharmaceutical supply chain, it was interesting to ponder the relevance of blockchain technology to serialisation. If Adents and Microsoft advocate for a blockchain based on traceability to increase the trust and transparency of the pharmaceutical supply chain, it is defined based on different principles.

“Blockchain innovation is the sharing of trust and truth," said Marc Gardette, Cloud Strategy Director at Microsoft.

“But this one is above all secure. Each transaction recorded in the database is digitally signed and mathematically guaranteed to be genuine and tamper-proof. From there, the data can be shared and is accessible to everyone in real time.”

What impact can the blockchain have in the digital transformation of healthcare industry?

“It can really revolutionize the approach to care by giving patients, for example, information that helps them understand, control and manage their personal health decisions," Gardette continues.

“It can also help care teams improve their diagnosis and results with real-time access to accurate information."

On production lines, the impact of serialisation can be real. Evren Ozkaya, CEO and founder of Supply Chain Wizard, demonstrated how the decline in Overall Equipment Efficiency (OEE) induced by the implementation of serialisation could be bypassed and turned into an advantage thanks to the introduction of activity and marketplace applications. The example of Par Pharmaceutical, an American producer of generic drugs, is interesting.

“Par Pharmaceutical has seen high losses in the overall efficiency of its equipment after the implementation of serialization solutions on its production lines," said Ozkaya.

“Due to the implementation of an OEE tracker on all packaging lines and its rapid and scalable implementation via the use of IoT sensors, Par Pharmaceutical has improved its efficiency by digitizing the process of collecting data – a task previously performed manually – from the first day of use."

Artificial intelligence and mixed reality

Artificial intelligence also was on full display throughout the summit. Eneric Lopez, Microsoft ‘s Director of Program Management for Innovation, Startups and Developer, presented a case in point.

During the Cochrane transformation project, UCL researchers used artificial intelligence and machine learning to extract thousands of reports and clinical trials for inclusion in a systematic review to improve decisions concerning patient care by physicians. This avoided many weeks of tedious work and results that would have been impossible to achieve until now.

With Microsoft HoloLens, a standalone computer integrated with eyewear, there is no virtual reality, no augmented reality, but instead a mixed reality environment that combines the best of virtual reality and augmented reality, and consists of displaying extremely realistic digital elements and holograms in the actual environment of the user.

Evlampia Thoreau from Microsoft demonstrated on stage that with a simple wave of her hand she could interact with these holograms, shape them or modify them. Translating to the industrial world, the innovation opens real prospects for mobility and real-time interactions of operators throughout the production cycle. As recalled by Christophe Devins in his opening remarks to the summit audienc: "technologies are already available."

The reality of the field

From the perspective of strict adherence to regulatory serialisation compliance, the presentation of Johan Verhaeghe, National Policy Liaison Manager of Medecines for Europe (the EU equivalent to France’s LEEM), provides helpful insight.

“Ten months from the deadline for the implementation of the EU’s Falsified Medicines Directive,” he said, “about 50% of countries appear to be behind the implementation of the European Medicines Verification System (EMVS) to guarantee AMM holders (or their representatives - CMOs) the access to the European Hub to communicate their serial numbers."

On the American side, the 1 year delay granted by the administration to drug manufacturers to comply with the DSCSA regulation (November 2018) shows that things are not simple either. This is essentially what Perry Fri, Executive VP of Industry Relations, Membership & Education and Chief Operating Officer of Healthcare Distribution Alliance (HDA), a group of US drug distributors, explained.

Faced with the problems encountered by the pharmaceutical industry to implement serialisation, HDA has created Origin, a source of product data. Origin was conceived as a "central source of truth" for GTIN drug codes. It serves as a hub to streamline communication between all trading partners and enable product identification. "It's not a router, nor a serial number database, nor a transaction service, nor a catalog of active products," insisted Fri.

For hospital pharmacists, the situation is hardly better. Dr Patrick Mazaud, member of the National Order of Pharmacists, is responsible for deploying regulations relating to the European directive on falsified medicines in hospitals. His first observation: out of 3000 hospitals in France, only 200 are equipped with an IT system.

“Serialization is a huge challenge for hospitals that will force them to reconsider their work organization and logistics,” he said.

This is an opportunity for the digital transformation of hospital pharmacies, but will take longer than the European Union's deadline for implementing the regulation. For Julien Delonca, Director of the Hospital Center of Millau, a 448-bed proximity hospital, the implementation of this regulation is a real headache. The small size of his establishment makes such amounts of investment unthinkable.

As Sophie Molle, GS1's Healthcare Industry Engagement Manager, said: "With more than 65 regulations in place or to come, regulatory compliance is becoming increasingly difficult for pharmaceutical companies."

Even if GS1 is making its contribution to this challenge by developing global standards that allow transparent and efficient exchanges between all stakeholders along the pharmaceutical supply chain, each actor, at each level, is a link in this chain that cannot be cut. These regulations are shaking up the players somewhat, but the demand for transparency for patients, individuals and society in general is such that in the short or long term, all sectors will be affected.

It is therefore a real opportunity for the pharmaceutical chain to be at the forefront of this revolution, which will not only ensure the safety of the patient, but also increase efficiency and uncover new ways of creating value.

The next Adents Serialization Innovation Summit will be held in Philadelphia 20-21 June, 2018 , followed by China in October 2018.

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