Meet Our Experts

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Experts for: Biomarkers

Frank S. Zollmann

Frank S. Zollmann

Expert for Pre-/ Clinical Drug Development

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

Jörg Täubel

Expert for cardiac safety in drug development

Daniel Sehrt

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

Wolf-Stefan Richter

Expert for Clinical Development

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

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

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

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

Astrid Schott

Expert for Clinical Research & Development

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