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
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