Innovation

Index

Our goals and ambitions

We strive for innovations in our existing products and care services as well as the development of new therapeutic approaches in the healthcare services and healthcare products market segments. In this way, we give patients access to innovative treatments.

In our daily dealings with patients and healthcare professionals, we are confronted with questions that arise from the use of products and devices or therapies. Successful clinical studies are the basis of our products and services because they guarantee safety and effectiveness. They drive development and implementation of innovative technologies and treatment concepts and can help us to find solutions to many challenges in the healthcare sector, adding value for customers and patients. The success of an innovation in medicine is measured by whether it prevails over the existing standard of care.

The Fresenius Group focuses its activities on expanding its competencies and develop new business areas to offer solutions, including digital ones, to the ever-new challenges faced by the healthcare sector. Many of our stakeholders, especially our patients and our employees, are directly affected by the changes resulting from the advance of digitalization. For more information see the Digital transformation chapter. Our R & D activities are closely linked to digitalization and are an integral part of our growth strategy. Our aim here is to develop innovative therapies and integrated healthcare services. However, we do not conduct fundamental research. Further information on our strategy can be found in the Group Management Report.

Our approach

To drive innovation at Fresenius and simultaneously take into account each specific market’s situation, we take different approaches in our business segments – from independent R & D strategies to active innovation management, as described in the Research and development chapter of our Group Management Report. In this context, we also involve external partners such as research institutions and start-ups. One of our priorities is developing innovative products that meet stringent requirements regarding both quality and affordability. In doing so, we are responding to the growing global demand for high-quality yet cost-effective products and outcome-based services. In the care of critically ill patients, there is increasing demand to provide transparency on treatment quality. We will also face rising demand for effective therapies alongside intelligent applications and medical engineering devices. Our product innovations are described in more detail in the Group Management Report 2023. Risks that derive from product innovations or of not conducting innovation, are described in the Opportunities and Risk Report.

Our products and therapies are designed to help promote human health. Benefits and risks must be carefully evaluated. Whether in registration studies or in clinical research projects, the Fresenius Group strives to create opportunities to improve the quality of treatments, especially in the area of acute illnesses and chronic diseases.

All new or improved products and services are subject to internal quality requirements as well as external regulations and legal requirements. In the case of digital developments, we pay particular attention to the requirements of the European Union’s General Data Protection Regulation (EU-GDPR); for more information see the Data protection section. We also observe European directives for the medical technology sector such as the EU Medical Devices Regulation (MDR). We address potential risks such as hacker attacks on sensitive data and systems by implementing comprehensive cybersecurity concepts, as described in the Cybersecurity chapter.

Organization and responsibilities

Within the Group Management Board, the chairperson is responsible for the Group’s strategy. The Chief Executive Officers (CEOs) of the business segments are responsible for operational management. The segments’ respective Management Board committees design their respective management approaches and manage responsibilities for innovation and R & D, e. g., via business allocation plans. Within the Group function Corporate Development, the Technology & Innovation division is responsible for the strategic framework in which innovation takes place globally. Corporate Development reports to the chairperson on a daily basis and informs the Group Management Board via various internal committees. Those responsible for Corporate Development and the responsible business segments’ managers align if required or on specific topics. In the context of Management Board meetings, the entire Group Management Board is informed monthly about relevant developments from the business segments, or receives resolutions for approval.

Interdepartmental committees take responsibility for Group-wide innovation projects. The Innovation Council, for example, develops and steers a joint innovation roadmap on the topic of Connected Hospitals. Representatives of Fresenius Kabi, Fresenius Helios, and Group Technology & Innovation work on integrating new digital possibilities into medical treatment concepts, further optimizing patient care in the process.

Product innovation

In the healthcare products market segment, we are continuously working on expanding our product portfolio, e. g., in the field of biopharmaceuticals, clinical nutrition, and MedTech, as well as IV (intravenous) generics. Innovation is defined as new substances, devices, software, containers, or services, to be introduced on the market, reformulations of existing substances for a new market, or the registration and launch of established products in new countries.

In 2023, an agreement was signed with Virginia Oncology Associates (VOA) to further develop the innovative Ivenix Infusion System. VOA is an oncology and hematology practice group with multiple locations across the United States with more than 35 years of experience. VOA is part of the U.S. Oncology Network, a network of more than 1,200 independent physicians and more than 500 cancer treatment centers in the United States. This collaboration looks to integrate the Ivenix Infusion System into VOA’s Electronic Medical Record (EMR). In the field of oncology, there is high demand for reminder functions related to safety checks and standards of care at the treatment site. Nurses are supported in their daily routine, e. g., by means of the interactive medication library system. This way, treatment risks can be reduced.

In 2023, Fresenius Kabi launched Tyenne^®, the first approved tocilizumab biosimilar in the European Union. It is available in Europe for both subcutaneous and intravenous administration and designed for the treatment of various inflammatory and immune diseases.

In its core business of generic IV drugs and IV fluids, Fresenius Kabi has entered additional segments of its global addressable market, expanding its product portfolio in areas such as complex formulations, differentiated generics, contrast agents, and prefilled syringes, among others.

Clinical studies in pharmaceutical approval processes

In the healthcare products market segment, approval processes require support from trials due to official regulations. Depending on the specific requirements, approvals can encompass patient studies or animal trials.

As a producer, Fresenius Kabi conducts clinical studies by commissioning qualified external contract research organizations (CROs), as well as university scientific institutions and physicians. For existing products, further studies are conducted regarding patient safety and to gain new medical-scientific insights or comparative clinical studies with other products available on the market. The clinical studies commissioned by Fresenius Kabi are always carried out in accordance with strict legal requirements, including guidelines from the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), requirements of relevant pharmaceutical regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), as well as the Declaration of HelsinkiDeclaration of HelsinkiDeclaration of the World Medical Association on ethical principles for medical research involving human subjects., and the EU-GDPR. The primary goal is the protection of patients and the quality of the data obtained.

The Chief Medical Officer and the Global Trial Committee, an internal scientific expert committee, review, evaluate, and approve clinical trials before they begin. Responsibility for clinical study management is aligned with Fresenius Kabi’s product groups and is anchored in the Management Board areas. Compliance with applicable regulations and guidelines prior to, during, and after clinical studies is ensured by a risk-based auditing program. Here, study participants’ safety and the validity of study data are considered the most important criteria. No clinical trials are conducted without a positive vote by the responsible ethics committee and approval from the respective competent authority, where required.

Delegated CROs are audited by the Quality Assurance department to ensure that applicable regulations and standards are followed throughout the duration of the clinical studies; internal processes are also reviewed through audits. Each employee involved in clinical research receives regulatory training via online training courses to ensure a uniform understanding of GCP requirements. In addition, employees receive training on the procedures applicable to clinical studies at Fresenius Kabi.

When selecting study participants, Fresenius Kabi also takes diversity into account, e. g., with regard to the population group for which the product in question is intended. Fresenius Kabi does not conduct studies without a prior positive benefit-risk assessment. Furthermore, safety events occurring during a clinical study are constantly monitored and evaluated. Study participants are fully informed prior to the start of the study and are enrolled only with their consent. Internally, clinical studies are documented in a central database and the results are published in accordance with applicable regulations.

Fresenius Kabi’s research and development activities are focused on biosimilarsBiosimilarsA biosimilar is a drug that is “similar” to another biologic drug already approved., clinical nutrition, and generic drugs that are already well-established in markets and consequently need no, less, or limited animal studies. These are conducted if required by national and international laws or regulations. Animal studies are only conducted according to respective animal welfare legislations. The business segment cooperates with professional non-clinical CROs or academic institutions that are accredited according to the standards of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) or a similar standard and follow the 3R principle (Reduce, Replace, Refine) regarding the use of laboratory animals. Moreover, non-clinical CROs are audited by the Fresenius Kabi Quality Assurance department and requalified every three to five years based on the underlying risk.

In 2023, Fresenius Kabi also underwent an inspection by the local regulatory authority. The focus was on a clinical study. In cases of non-compliances identified during these inspections, the business segment initiates or implements appropriate measures.

No critical events with a significant impact on the safety of study participants or compliance with the applicable requirements and standards became known at Fresenius Kabi in the reporting year.

In 2023, we started marketing of various new products, as explained in the Group Management Report. If clinical studies were conducted for the approval of these products, those were designed according to the aforementioned criteria.

Digital healthcare structures

In our Spanish hospitals, the Casiopea project was launched in 2020 with the aim of implementing a system platform through which all processes can be digitally controlled centrally. A high level of digitalization has already been achieved in recent years, which is to be improved by further innovative applications. Potential additional training requirements will be assessed and implemented.

The overarching goals of Casiopea are:

Standardize and digitize processes as comprehensively as possible
Improve patient safety through digitally supported standard procedures
Avoid those measures that do not add value to patients’ well-being and can be replaced by digital alternatives
Ensure comprehensive care for patients before and after hospitalization, supported by digital applications

Full project implementation is planned for the year 2024. Details of the digital processes already implemented can be found in the Digital transformation chapter.

Findings from the Casiopea project that can lead to an improvement in process quality for the German hospital sites are discussed. In the long term, findings can also contribute to the DigitalRadar. Further information can be found here.

Innovative treatment concepts

Innovative treatment concepts are key to our daily work in our clinics. The combination of clinical studies and knowledge gained through daily routines provides information on how established treatment schemes can be changed. These options are discussed with experts both from the medical departments and from care. We focus on oncology and cardiovascular diseases in our acute care hospitals, but health services research is also an important area. Improved treatment concepts can also result in lower mortality ratios, leading to better quality of treatment in our clinics.

We conduct clinical trials at many sites, partly in cooperation with CROs, for example, to determine how effective and safe medicines are and whether medical products are suitable for approval in accordance with internationally applicable ethical and scientific standards. In addition, clinical data is collected, analyzed, and published to evaluate new and already-approved technologies and treatments in everyday care. Based on a clear commitment to evidence-based medicineEvidence-based medicineEvidence-based medicine (EBM) builds on expert knowledge, the experience of those treating patients and their needs, as well as on current scientific findings. The aim is to provide the best possible care for people who are ill., the business segment encourages its employees to engage in scientific and technological research activities. The aim is for them to grow personally and use their insights to improve the well-being of patients.

Projects funded by public grants focus on the development of new forms of care and process plans (treatment pathways) for medical treatments. In cooperation with manufacturers, the focus is on testing new technologies in clinical application and thus assessing their benefit. Such clinical data on usage in day-to-day patient care is important for evaluating technologies and determining their market price (HTA – health technology assessment). Helios Germany also provides the Robert Koch Institute (RKI) with data on severe acute respiratory infections (ICOSARI) such as influenza virus and COVID-19 incidents.

The Helios Health Institute (HHI) is responsible for the central study audit. The HHI ensures that all regulatory requirements applicable to research activities, including contractual or data protection requirements, are met as part of the study review. This enables clinics to ensure that scientific, ethical, and legal requirements are met and that the project complies with applicable guidelines or quality standards. The respective Group guideline on research (Helios Konzernregelung Forschung) mandatorily provides that every research project, including all necessary documents, must be submitted to the HHI for review in order to protect its patients. With the final legal, regulatory and data protection assessment, a recommendation for the medical research project is made to the applicant and the management of Helios clinic.

HHI maintains a continuously developing quality management system, aiming for certification according to ISO 9001 in 2024, so that it can also operate externally as a CRO.

The Helios Group regulation on research funding further specifies the framework conditions within which Helios specifically promotes research projects that are conducted by its own employees and expected to have a high level of benefit for patients.

Departments or clinics have special certifications, e. g., as certified organ cancer centers or as oncology centers of the German Cancer Society. Certification is based, for example, on the quality of treatments or sufficient participation of patients in clinical trials. If an external sponsor selects a Helios clinic for a study, audits are conducted in accordance with the sponsor’s respective guidelines. Likewise, individual Helios clinics are inspected according to the respective selection procedures for gaining a license as a specialized center of the state authorities.

Conducting clinical studies is subject to strict requirements. These include the internal Group guideline on research as well as numerous external guidelines, national regulatory requirements, the Declaration of Helsinki issued by the World Medical Association, and the requirements of GCP. For both medical and non-medical staff conducting central study reviews, regular GCP training organized by HHI is mandatory.

Monitoring is ensured by audits as well as inspections by state, higher, and regulatory authorities. In case of complaints, appropriate corrective actions are initiated by the respective clinic and reported to the inspecting authority. In 2023, no external inspections and audits took place at HHI.

A prerequisite for any study to begin is a vote or consultation from an independent ethics committee established under state law. In this sense, all clinical studies are reviewed by independent experts who are responsible for each respective German state (Bundesland) or the local state medical association (Landesärztekammer). For research projects of Helios physicians with university affiliation, the ethics committee of the university involved is responsible for the review of a study, depending on each state’s regulations. In experimental studies, investigations can be carried out in the laboratory,for example using tissue samples or blood material; these studies are also reviewed by an ethics committee. All studies using sample material from patients must be evaluated by the ethics committee.

If patients are interested in participating in a clinical trial, they discuss all questions in advance with the responsible investigators. These discussions follow a guideline that includes study-specific, ethics-committee-approved patient information and a declaration of consent. External sponsors are responsible for preparing these documents themselves. Only after evaluation by the ethics committee, and in accordance with the Helios Group guideline on research,may investigators use the documents. The patients’ consent is obtained in writing after sufficient reflection time and the patient information consultations are documented for the protection of patients. The data protection requirements must be complied with.

In 2023, a total of 1,873 studies were conducted or reviewed in Germany and Spain, the majority of which had the goal of improving therapies for patients. In Germany, 300 studies were initiated at 36 German sites, thereof 46 on the initiative of employees of Helios clinics. The focus was on oncology, hematology as well as cardiology.

Initiator	Number
Employees as initiators¹	46
Participation in academically managed studies, publicly funded²	216
Participation in academically managed studies without financing	177
Participation in academically led or publicly funded studies with industry support, trial medication generally provided³	93
Industry-sponsored studies⁴	1,341
Total⁵	1,873
¹ Only Germany, data for Spain not reported separately.
² The majority of these studies are led by universities, mostly with public research funding.
³ The majority of these studies are led by universities / professional societies, but are supported by drug / medical device manufacturers, which usually extends to the provision of the drugs / medical devices.
⁴ The majority of these studies are supported by the pharmaceutical industry, less than 20% are medical device manufacturers.
⁵ Total sum includes studies with employees as initiators at Helios Spain, which were counted in other categories.

In 2023, 36 hospitals in the division Helios Spain were involved in scientific projects in Spain, Colombia, and Peru. 79% of the more than 1,500 studies were industry-sponsored; around 6% of them were publicly funded. 11% were studies without additional funding. The most important area of research has been oncology, with approximately 55% of all clinical trials performed.

In 2023, we received a total of around €6 million in public funding (2022: around €9 million) for our clinical research activities in Spain, Colombia, and Peru.