Digitization of healthcare is a major driver of precision medicine, but the generation and usage of health data is a complex task. Pharma, biotech and medtech players from Northern Germany find their way through the challenge and explore new ways of cross-sectoral collaboration.

How important is health data for digitalisation?

For Jens Nieland, health data is the most important currency in health care: “Anyone who wants to practice personalized medicine depends on the necessary data. For this reason, all stakeholders involved in a defined patient path need to develop common interfaces and standards to provide the best possible medical outcome for the individual patient and the health system in general.”

In his role as Medical Advisor Medical Devices DACH at Johnson & Johnson he is among the drivers of promoting further digitization, steadily discussing challenges and potentials as well as exploring new ways of collaboration. Topics such as connected data, interoperability, standardization and cross-sectoral exchange are on his daily agenda. His goal is to help establish a truly digital ecosystem – internally within J&J, but also in cooperation with external partners.

We are moving away from purely device or product-focused sales towards patient path models that are accompanied by digital solutions.

Jens Nieland,
Medical advisor Medical devices DACH, Johnson & Johnson

Do pharmaceutical and medical companies now have to work together?

According to him past months and years demonstrated quite clearly that, “the sector boundaries between pharmaceuticals and medical technology are becoming increasingly blurred.” Pharma and biotech companies are developing more targeted therapies based on new molecular insights and tools. The medical device industry is increasingly including data- and IT-driven approaches.

At the same time, several legal framework conditions on the national level in Germany – be it in the reimbursement scheme for digital health solutions or the Federal funding of digitization of hospitals through the Krankenhauszukunftsgesetz (KHZG, Hospital Future Act) – are pushing forward ambitious plans for increased usage of digital health applications, although data privacy and data security laws are still among the strictest in Europe.

How are we preparing for the change?

Given these circumstances, the big question is how healthcare stakeholders can adapt to this situation in the near future. For this reason, the Life Science Nord Cluster established the P.I.L.O.T. project aimed at addressing these challenges across the

• pharma,
• medtech
• and biotech sectors.

Nieland belongs to the active experts within this network and argues that a holistic access to health data is imperative for everything related to personalized or precise medicine. As a result, strategies will shift towards analyzing single therapies or specific medical products within their context of usage. „If we take precision medicine seriously, we will move away from purely device or product-focused sales towards patient path models that are accompanied by digital solutions,“ he says.

Revolution in medicine through health data

Also other large companies are taking the road towards new digital applications by using data-driven innovation. “Health data hold the potential to revolutionize healthcare and enable dynamic, learning, and sustainable health systems,” emphasizes Alexander Unger. He heads the Data Insights & Business Intelligence team at AstraZeneca GmbH at its German headquarters in Wedel near Hamburg.

How do health data and AI work together?

“Our mission is to leverage the power of health data and AI to enable a future of individualized healthcare, driven and informed by science and data, and aimed at substantially improving outcomes for patients and healthcare systems worldwide”, he says. Among the top issues he deals with is using (new) data sources and technology to develop evidence capabilities that ensure more patient insights are considered, enabling real world evidence generation and new value-based reimbursement strategies.

With the Digital Healthcare Act digital health applications are getting a boost in Germany, Unger explains. “What is very interesting for us as an innovation-driven biopharma company is how digital healthcare solutions can help to create integrated ‘healthcare ecosystems’ beyond the medicine that bring benefits and support for the whole of the patient experience from prevention, diagnosis and treatment to recovery and wellness.”

Digital tools and technologies can not only improve patient outcomes and bring better care along the treatment pathway, Unger lines out. “On the other side, they help to transform our clinical trials and make data generation more patient-oriented and efficient.” Thus, they accelerate the development and approval of new therapy approaches, he points out. “They help to ensure more patient insights from the real world are considered and these generate real world evidence,” Unger underlines.

AstraZeneca establishes the “Helios” digital patient registry

In Germany, AstraZeneca is exploring different ways of data innovation. Together with Germany’s largest hospital operator Helios, AstraZeneca is establishing a largely digital patient registry for heart failure – The Helios Heart Registry (H2 registry). The H2 registry is scientifically independent.

How is health data obtained?

AstraZeneca provides long-term financial support for the establishment of the registry, while Helios is responsible for its content, implementation and evaluation. The special thing on the H2 registry is that it will provide well-structured data of high quality which are enriched with patient-reported data. “You do no longer have clinical research and care as two separate data streams – they are integrated. That is why you get a deeper wealth of real world data,” Unger says. AstraZeneca hopes from a long-term perspective to establish register-based, randomized, controlled trials in Germany easier and faster. Integrating different data streams is also the goal of J&J.

In bringing together data sets that normally are not connected you generate deeper wealth of real world insights.

Dr Alexander Unger,
Director Data Insights & Business Intelligence, AstraZeneca GmbH

According to Nieland, digital solutions as well as any further innovation will be developed around patient path models and value-based healthcare. Within J&J, this is for instance currently explored for use cases in oncology such as lung cancer. “Relying on surgery and medical therapies at the same time, this indication already exemplifies the interrelation of medtech and pharma interventions as well as the potential of digital support,” he explains.

Does artificial intelligence determine who is operated on?

Together with clinical partners in Germany, J&J is exploring data-driven decision pathways to support medical decision making. “Today, in clinical practice, many interfaces are not working as they should or could. Our goal is to provide smart data-driven treatment options that are able to evaluate when surgical intervention is useful, when drug therapy, but also which patient is suitable for which surgical or drug therapy,” Nieland says.

In another projects, the company seeks to closely work with other stakeholders in the area of wound infections to establish standardized protocols for documentation purposes. “Within the P.I.L.O.T. project we will hopefully find partners in the North to target this clinical challenge in a joint network.” The collaboration with experienced hospitals such as the Medical Center Hamburg-Eppendorf (UKE) in Hamburg that are at the forefront of using digital infrastructures is key in this and other processes, he argues. “We as industry have to admit that we can learn a lot from clinics and their successful implementation strategies.”

Data-driven R&D for precision medicine

Generating, harvesting and sharing data to explore multimodal treatment options – this trend is especially important for innovation drivers such as Hamburg-based biotech company Evotec. “For precision medicine, we have to rethink the way we look at health and disease. That means: turning away from symptoms and towards a solid database. This is the only way to both dramatically improve the early detection of diseases and at the same time developing really effective therapeutic interventions that address the causes rather than the symptoms of a disease,“ explains former CEO Werner Lanthaler.

From his perspective, the most important thing is the integration of various state-of-the art molecular technologies such as gene and cell therapy, artificial intelligence or mRNA on a common platform and its data-driven usage. „Integrating and interconnecting data along the entire value chain of drug discovery and development is a precondition for achieving true multimodality – i.e. an openness to the therapeutic option that is really best suited. The backbone of such a platform is the constant enrichment of the database,“ Lanthaler points out.

Companies like Evotec and AstraZeneca are working together

Evotec sees itself as a platform provider for all those state-of-the-art-technologies needed to research, develop and manufacture the precision medicine of the future. In Hamburg, among others, the internal core R&D center for induced pluripotent stem (iPS) cells has been established. It explores applications in various medical indications from neurodegenerative diseases up to heart-related diseases. For the latter, in 2021, a strategic cooperation with UKE was closed. Lanthaler: “We are pleased to see the excellent environment in our region, but are open to as many partners as possible, regardless of whether they are based in Eppendorf or Boston.“

The importance of new routes of strategic collaborations is gaining momentum across the value chain. AstraZeneca, for instance, plans a so-called Datathon, trying to overcome existing data silos.

“We will bring our own randomized controlled trial data in the together with claims data from a German health insurance association,” says Unger. As a pilot format, the Datathon will be a collaborative event, with mixed teams from payers and AstraZeneca tackling different challenges. Unger admits it’s an unconventional but highly promising way to do research. “The interesting thing is that you bring together diverse data sets and people in a 48 hours ‘marathon-coding’ event that normally are not connected and that may generate deeper insights to relevant medical challenges.”

Jens Nieland from J&J is also convinced that research will pave the way for further implementation of precision medicine. In this context, however, he criticizes the current German legislation of being too restrictive when it comes to the usage of anonymous health data by industry stakeholders. For now, the government only allows hospitals or academic stakeholders to access health data for R&D purposes, in the future bundled via the new to be established national health data research center. Nieland: “If industry will be left out, it denies the important role we play to finally implement data-based treatment strategies in clinical practice.”

Text: Philipp Graf/Sandra Wirsching

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