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About us

Birgit Glasschroeder, PhD, is the founder of Glasschroeder clinical science services. Since 1999, she has been working in clinical research and development at several pharmaceutical companies such as Genetics Institute/Wyeth Pharma, Morphosys, and MediGene. As a senior clinical scientist and manager of medical affairs, she was responsible for clinical development programs in the fields of oncology as well as autoimmune and infectious diseases. She set up and managed international projects of phase I, II, and III with special focus on targeted therapies and translational medicine. The design and development of target product profiles, clinical development plans, and study protocols were key functions of her responsibilities. For successful implementation of development strategies, the compilation of high-level scientific and regulatory documentation was mandatory, including submissions to FDA, EMA, and national authorities for scientific advice, clinical trials, and marketing authorization.

After a year of studies abroad in Bethesda, Maryland, USA, Birgit Glasschroeder studied sciences of nutrition at the University of Giessen, Germany. She received her PhD in genetics at the University of Bonn, Germany, and held the position of a postdoctoral fellow at the University Medical Center Hamburg-Eppendorf, Germany, before she joined the pharmaceutical industry. She is a member of the European Personalised Medicine Association (EPEMED) and the European Medical Writers Association (EMWA).

Core expertise

  • First-in-human, dose-escalation, PK/ADME, pharmacology, toxicology
  • Mechanism-of-action, proof-of-concept
  • Translational medicine, experimental medicine
  • Oncology, autoimmune diseases, infectious diseases
  • Genetics, molecular biology, immunology
  • Biologics, NCEs & ATMPs

© Glasschroeder, 2018, all rights reserved   Dr. rer. nat. Birgit Glasschröder