In the field of social matters, MorphoSys focuses on the following aspects as identified in the materiality analysis: 1) quality of products, 2) access to medicine, 3) innovation in research and development (R&D) and 4) data protection.
Quality of Products
We have a special responsibility to comply with the utmost in quality standards with all processes. We use a quality management system (QMS) at MorphoSys AG and a QMS at Constellation Pharmaceuticals to ensure the quality of commercial and investigational medicinal products and the integrity and reliability of the data generated. Furthermore, the QMS shall ensure the protection of rights, safety and well-being of clinical trial subjects.
Our integrated QMS complies with the applicable principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GVP), commonly referred to as GxP in aggregate, to control and regulate these processes in our own drug development activities. In doing so, we want to ensure that all development activities follow national and international laws, rules and guidelines. Our independent quality department prepares an annual risk-based audit plan for the objective auditing of contract research organizations, investigational sites, suppliers and contract manufacturers in the GxP area as well as for internal GxP systems and processes.
The Head of Global Quality reports to the Head of Technical Operations with a dotted line to the Chief Executive Officer (CEO). The integration of Constellation Pharmaceuticals has already been initiated, starting with a direct reporting line from the Vice President Quality to the Head of Global Quality and implementation of regular meetings. The central aim of this integration is to establish a fully integrated and aligned organization, governance and quality standards. In addition, GMP/GDP status updates are reported and discussed with relevant members of the operational management team in a quality management review meeting every quarter and an annual review with the operation managers.
Quality Management System at MorphoSys
Focus in 2021
MorphoSys conducted audits in 2021 in the GxP area. Due to COVID-19 pandemic constraints, some of the audits were conducted remotely. There have been no critical audit findings in 2021.
To make our organization more agile and lean, the integration of Constellation Pharmaceuticals has been a key priority in 2021. We are also aiming to roll out an electronic quality system encompassing key quality processes which will proceed throughout 2022 for MorphoSys and Constellation Pharmaceuticals. In addition, we implemented online inspection readiness training as part of our preparation for hosting regular inspections by the U.S. FDA or local authorities for all employees at MorphoSys AG and MorphoSys US Inc.
Access to Medicine
Ensuring access to our medicines is a critical priority for MorphoSys, and we make considerable investments in developing potential medicines for patients in need. MorphoSys does so without a guarantee of clinical and commercial success, as many products in research and development phases do not achieve market authorization. Sustainable revenues from approved and commercially viable medicines allow for future investments into our research and development efforts.
At MorphoSys, our philosophy is to responsibly price our medicines by balancing the value of the outcomes and innovation they bring to patients and the healthcare system. There are patients who do not have third-party coverage in several countries of the world. For this reason, access to medicine also involves a social, charitable commitment to help patients without insurance coverage. MorphoSys is dedicated to supporting patients throughout their treatment journeys, and we are working together to help remove patient access barriers.
The responsible department consists of a global team responsible for setting the strategic direction for value, access and policy across all markets and of a respective team to execute tactics in the U.S. The reporting line structure is directly to the General Manager of MorphoSys US Inc. with regular updates to the Management Board. The integration of Constellation Pharmaceuticals is currently ongoing.
As part of MorphoSysʼ and Incyteʼs commitment to supporting patients, the ›› My MISSION Support program was launched in 2020. My MISSION Support is a robust patient support program offering financial assistance, ongoing education and other resources to eligible patients who are prescribed Monjuvi® in the U.S. The My MISSION Support program has been able to support patients in initiating treatment with Monjuvi® since FDA approval, by helping them understand their insurance benefits and offering financial assistance to those who qualify.
In addition to My MISSION Support, the non-profit MorphoSys Foundation (“the Foundation”) was established in the previous year in the U.S. Its purpose is to help patients access appropriate and necessary care by administering Free Drug Patient Assistant Program (PAP). All patients must meet certain eligibility requirements, and are either uninsured, have insurance that does not cover Monjuvi®, or cannot afford the cost-sharing for the drug under policies set by their insurance. Furthermore, the Foundation provides charitable donations to independent charitable organizations that provide financial or other assistance to patients undergoing treatment for particular disease.
Focus in 2021
Patients receiving cancer treatments during the COVID-19 pandemic were isolated from their caregivers during their treatment and in many instances hesitant to go to their doctors offices to receive treatment. The burden of the pandemic was high for these patients. In response to this need, we offered a Patient Appointment Kit for those patients enrolled in the My MISSION Support program, which included hand sanitizer, gloves and masks. We also implemented several digital tools to support our patients and their providers in enrolling in the My MISSION Support program, since many patients had limited access to financial counselors within the practice. In 2021 the MorphoSys Foundation helped fund programs to support patients affected by the COVID-19 pandemic.
In 2022 we want to ensure patient support programs continue to offer robust support for patients.
Innovation in Research and Development (R&D)
At MorphoSys, our ambition is to redefine how cancer is treated. Our research and development activities address areas of high unmet medical need where people’s lives depend on novel, more effective and differentiated treatment options. We aim to make a real difference in patients’ lives by focusing on therapeutic areas that best fit our expertise and make the best use of our resources. This includes hematological and solid tumor indications as well as autoimmune diseases. At the core, we are aiming to discover, develop, and deliver innovative medicines, and to make them accessible to patients – a commitment for a sustainable contribution to society’s health.
Focus in 2021
Our focus in 2021 was to identify and evaluate suitable licensing or acquisition opportunities to expand our clinical pipeline. In July 2021, we completed the acquisition of Constellation Pharmaceuticals. Both companies, MorphoSys and Constellation Pharmaceuticals, work in the fields of hematology and oncology and with the combination of our research and development portfolio, we are best positioned to discover and develop highly differentiated cancer medicines. Following the closure of the acquisition, there was an extensive period of exchange and alignment between the two companies. Both on the portfolio as well as on the functional level a series of deep dives and review sessions took place to ultimately agree on and execute on a portfolio prioritization strategy and on a fully integrated functional set up. By the end of 2021, the combined Research and Development organization operates in an integrated, global organizational setup. Both, the Head of Research and Head of Development report directly to the Chief Research & Development Officer (CR&DO) ensuring full alignment and close collaboration between the organizations. All divisions from MorphoSys and Constellation Pharmaceuticals are working closely together to advance our combined portfolio and overall R&D activities.
Our cross-functional governance body, the Portfolio Innovation Board (PIB), builds the platform to elevate and advance key strategic questions, to ensure an effective and globally aligned execution of our R&D strategy.
Our laboratory operations continued to run smoothly during the COVID-19 pandemic.
Significant advances were also made to use patient-derived materials and in vitro disease models to minimize the need for animal testing.
Information about ongoing clinical trials with our investigational drugs is available on ›› www.clinicaltrials.gov. Our clinical pipeline can be accessed ›› here.
As a biopharmaceutical company, we constantly work with personal data of patients, employees, partners and other stakeholders. The protection of these data is important. In conjunction with the General Data Protection Regulation of the EU (GDPR) as well as U.S. requirements for the protection and confidential handling of protected health information (PHI), we implemented various procedures to safeguard compliance with these regulations and are continuously working on further enhancements. Our team in the U.S. is offered trainings on compliance with the Healthcare Insurance Portability and Accountability Act (HIPAA) and the appropriate use of PHI.
MorphoSys AG continues to have an external Data Protection Officer (eDPO) in line with the GDPR and the German Data Protection Act. The eDPO summarizes results in a report. A defined reporting process comes into force immediately in case of suspicious incidents.
Focus in 2021
We implemented a data protection e-learning platform to make training accessible also in a remote working area. This training is for all MorphoSys AG employees, and it comprises the principles of GDPR, obligations of employees, data processing, rights of data subjects, the role of our eDPO and legal consequences regarding data protection violations.
We also updated our intercompany data processing agreement to incorporate Constellation Pharmaceuticals and the new Standard Contractual Clauses adopted by the European Commission in June 2021.
There were no reportable data protection incidents at MorphoSys AG in 2021.
Data protection via respective IT security measures continued to be a key topic in the reporting year. The Company utilized an automated penetration testing and validation platform to verify the technical security controls and detect potential weaknesses. No serious weaknesses were identified. Within the scope of special training and phishing simulations, employees learned about their joint responsibility and essential contribution to IT security in our Company. Measures to improve collaboration were selected with a focus on security and additionally secured through integration in Security Information & Event Management (SIEM) and Identity & Access Management System (IAM).
Our internal Computer Emergency Response Team (CERT) has not detected any serious security incidents during the reporting year. Finally, various platforms in the area of Endpoint Detection & Respond (EDR), Cloud Access Security Broker (CASB), Identity & Access Management System (IAM), Security Information & Event Management (SIEM) and Mobile Threat Defense (MTD) were introduced or further developed in order to optimize our cyber defense measures and to ensure data integrity and protection.