Meet Our Experts

Frank S. Zollmann

Expert for Pre-/ Clinical Drug Development

• Safety pharmacology, toxicology, pharmacogenomics
• Integrated preclinical & clinical development up to PoC
• Clinical pharmacology

Jörg Täubel

Expert for cardiac safety in drug development

Daniel Sehrt

Expert for Early Clinical Research & Development

• Scientific concept & design of Phase I-IIa trials
• Clinical pharmacology (PK/PD and pharmacogenomics)
• Clinical trial applications

Wolf-Stefan Richter

Expert for Clinical Development

• Study design and imaging biomarkers
• Medical need assessment
• Medical regulatory strategy

Sabine Pilari

Expert for Pharmacometrics and PK/PD Modeling

• PK and PK/PD analyses, including exposure-response, mechanistic, and PBPK modeling
• Human PK prediction and estimation of efficacious & starting doses
• Pharmacometrics analysis, population PK, and PK/PD modeling
• Guidance on dose selection and dosing regimen optimization for clinical studies

Katja Wosikowski

Expert for Nonclinical Drug Development

• Preclinical pharmacology, safety pharmacology, immunology, toxicology, pharmacokinetics and BA method development
• Translation to early clinical studies including of PK, ADA and Biomarker analysis
• Documents for CTA and IND

Anke Maaßen

Expert for In Vitro Diagnostics (IVDs)

• Regulatory Affairs (EU regulations: IVDD and IVDR)
• Quality Management and Assurance
• Internal and Supplier Audits
• Support for Manufacturing and Control

Astrid Schott

Expert for Clinical Research & Development

• Clinical Development planning, Phase I-III
• Interim management
• Due Diligence, licensing