Annemarie has been with NDA since 2007 and is an expert in the non-clinical development of new chemical entities, biotech and advanced medicinal products over a broad range of indications.
Key Areas Of Expertise
- Scientific and regulatory strategy of non-clinical development programs (including pharmacology, pharmacokinetics and toxicology in vitro and in vivo studies) to support discovery, early and later stage clinical development for:
- new chemical entities
- biotech products (including biosimilars)
- advanced therapeutic medicinal products
- Risk assessments for first in man and later stages of clinical development
- Due diligences for in-licensing / gap analyses of non-clinical data packages
- Design, monitoring and evaluation of non-clinical studies/reports
- Scientific, regulatory and operational support for interactions with regulatory agencies both in the EU and the US
- Strategic and operational support for the preparation of both EU and US non-clinical regulatory documentation for clinical development (including pediatric development), MAA, BLA and NDA
Before joining NDA, Annemarie worked in the pharmaceutical industry in non-clinical development. Annemarie is a pharmacist with a PhD in Neuroscience and post educational training in pharmacology and toxicology.
Dr Annemarie Ableitner-Kurz