MorphoSys frames its CMP on several key regulations and guidances, where notably we use the Seven Elements of a Compliance Management Program as communicated by the Office of Inspector General (OIG), the updated Guidance 2020 of the U.S. Department of Justice, as well as applicable EU Directives and regulations. In addition, there are Entity Level Controls in the framework of Sarbanes-Oxley Act (SOX) addressing key compliance elements on a regular basis. These indicators are constantly monitored and improved.
Our key priorities for 2022 will be finalizing the integration of Constellation Pharmaceuticals regarding the extension of our global policies as well as building lean and business-friendly processes including the approval process for Constellation Pharmaceuticals activities. Additional priorities in 2022 include compliance with the U.S. Open Payments law (or “Sunshine Act”) and related U.S. state laws on a federal and state level for which MorphoSys has been preparing via successful launch of an aggregate spend tool, continuing to develop relevant compliance training and communication, and continuing a risk-based approach to monitoring our business activities to ensure compliance and continuous improvement.
Bioethics in Preclinical Research
Our research and discovery activities are guided by the highest ethical standards. As European and international legislation requires animal testing to determine the toxicity, pharmacokinetics and pharmacodynamics of drug candidates, we as a biopharmaceutical company cannot forgo this type of testing. Animal testing for our drug candidates at MorphoSys AG is outsourced to contract research organizations (CROs) as we do not have laboratories suitable for this type of research.
As part of our product development activities at MorphoSys AG, we award contracts for animal studies in accordance with the 3Rs principle of animal welfare (Replace, Reduce, Refine) as set out in national, European and international regulations. We aim to improve animal welfare by closely monitoring the adherence to the 3Rs principle. The principle describes the use of methods in research which replace the use of animals where possible, which enable researchers to obtain the same level of information from fewer animals (reduce), and which alleviate or minimize potential pain or distress for the animals (refine).
We have established a quality assurance system with written standard operating procedures (SOPs) at MorphoSys AG that are continuously updated to ensure that we work only with those CROs who comply with local, national and international guidelines and animal welfare regulations.
The institutions we work with also need to ensure that they are complying with the ethical principles and legal requirements involving animal research. In case Good Laboratory Practice (GLP) studies are conducted, as required by applicable the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, these facilities are required to have a GLP quality assurance certificate. These steps are intended to help fulfill our moral obligation to treat animals respectfully as well as our legal obligations. On-site visits are also conducted to check the contract research institutes’ test centers, the training and competence of the staff responsible and animal welfare.
The department is in regular contact with the Head of Research, who reports to the responsible Management Board Member for Research and Development.
Focus in 2021
In the reporting year MorphoSys AG continued to strictly apply the 3Rs principle of animal welfare which is tracked by various metrics. All scientists working in the preclinical research area at MorphoSys AG are instructed in regular meetings to comply with this principle, and 3R newsletters are distributed.
One CRO visit planned for 2021 was conducted by MorphoSys AG and further visits are planned for next year.
Bioethics in Clinical Development
We conduct clinical trials in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice (ICH-GCP), with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki. At MorphoSys, we make it a priority to protect the rights, safety and well-being of all participants involved in clinical trials. Clinical trials are only initiated after the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) and/or regulatory authorities give written approval or a favorable opinion as required. In addition, written informed consent of clinical trial participants must be obtained prior to their participation.
Focus in 2021
The acquisition of Constellation Pharmaceuticals has accelerated the growth of the MorphoSys pipeline with the addition of two compounds in mid- to late-stage clinical development, CPI-0209 and pelabresib respectively.
Focus in 2021 was the integration of Constellation Pharmaceutical’s development activities into MorphoSys, leveraging on the current established infrastructure of MorphoSys and building one global Development Organization.
Despite an improving situation of the global COVID-19 pandemic, restrictions on visits to healthcare facilities, increased demands on healthcare services and changes in the availability of study personnel are still present. MorphoSys continuously monitors the situation and decides on a case-by-case basis to ensure the safety of patients, study personnel and other stakeholders, as well as to safeguard data integrity in the conduct of all ongoing studies of tafasitamab, felzartamab, pelabresib and CPI-0209 programs.