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Clinical development expertise

MorphoSys is committed to developing outstanding treatments for severe diseases. To this end, we have built a highly capable team for the clinical development of our proprietary products. Experts from various fields are working together to design and manage our clinical trials.

Clinical Development

The Clinical Development team develops new therapeutic strategies for the treatment of diseases, especially in indications with a high medical need. The experts of this team understand the importance of clinical investigations for the effective introduction and acceptance of new therapies. They manage and monitor all medical aspects of MorphoSys’s compounds in clinical trials, including the development of study protocols and reports. They also assess the potential development of an area of research.

At the Clinical Operations and Project Management departments, clinical monitoring and project management come together to ensure fast, successful, and scientifically sound project deliverables for MorphoSys’s compounds.

The experts at Clinical Operations strive to maximize the performance, clinical excellence, data integrity and product safety of MorphoSys’s programs. A team of scientists with a medical and pharmaceutical background oversees the development of clinical programs and the implementation of trials. They work in close collaboration with the Clinical Research and Preclinical Development departments on the selection of compound-specific target indications.

Drug Safety and Pharmacovigilance
Dr. Dominika Weinelt, Head of Drug Safety and Pharmacovigilance

The department for Drug Safety and Pharmacovigilance is responsible for the collection, detection, assessment, monitoring and prevention of adverse events in clinical trials which are sponsored by MorphoSys. Adverse events are unwanted effects which may be caused by taking a drug. Drug-related side effects can be mild, such as a stomach ache or drowsiness, and go away after you stop taking the drug. Others can be more serious or even life-threatening. Through a concise and rapid exchange of safety information among all parties, our safety and surveillance experts identify potential hazards associated with pharmaceutical products and minimize the risk for patients when taking part in a clinical trial.

Regulatory Affairs
Dr. Gabriele Elbl, Head of Regulatory Affairs

The Regulatory Affairs team manages all aspects of MorphoSys’s proprietary development programs that are relevant for their admission to clinical trials in the EU and US. They develop the approval strategy for our compounds with a focus on expedited programs and are responsible for its implementation in all proprietary development programs. Furthermore, this team has comprehensive knowledge of the interpretation and implementation of relevant policies and increasingly complex registration requirements.

Quality Assurance
Dr. Armin Weidmann, Head of Compliance and Quality Assurance

The Quality Assurance department is responsible for the implementation, oversight and continuous improvement of a quality management system covering relevant aspects of good clinical practice (GCP), good manufacturing practice (GMP) and good laboratory practice (GLP). Quality Assurance provides advice and support for the quality management system that is in place, ensuring compliance with applicable laws, regulations and guidelines as well as a constant high quality for the whole development process.

Meet us at the following conferences

Mon-Fri
08-12
'18
Jan
Jan

PepTalk

San Diego, CA, USA
Mon-Thu
08-11
'18
Jan
Jan

JP Morgan Healthcare Conference 2018

San Francisco, CA, USA
Mon-Thu
04-07
'18
Jun
Jun

BIO International Convention

Boston, USA
Wed-Tue
28-04
'18
Nov
Dec

ASH 2018 - 60th Annual Meeting

San Diego, USA

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