Meet Our Experts

Please select a topic:

                     
                    Chemistry, Manufacturing and Control
                  
        Audit
Biopharmaceuticals
Cell Lines
CMO & CRO Selection and Management
Due Diligence
Formulation Development
GMP
Interim Management
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IVD
Life-cycle Management
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Qualified Person
Quality Control and Assurance
R&D Strategies
Radiopharmaceuticals
Regulatory CMC
Risk Management
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                    Non-clinical Research and Development
                  
        Contract Research Service
Disease Models
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Due Diligence
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Interim Management
Oncology
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Pharmacokinetics
Pharmacology
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REACH
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Toxicology

                    Clinical Development
                  
        Biomarkers
Biostatistics
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Clinical Development Phase II-III
Clinical Operations
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Drug Safety
Due Diligence
In Vitro Diagnostics
IVD
Health Economics and Market Access
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PK-PD
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Translational Medicine
Vendor management
Vendor selection

                    Regulatory Affairs and Compliance
                  
        Conformity Assessment
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Submissions

                    Business Strategy & Development, Intellectual Property and Corporate Design
                  
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Experts for: Translational Medicine

Katja WosikowskiExpert 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
 
Astrid SchottExpert for Clinical Research & Development
Clinical Development planning, Phase I-III
Interim management
Due Diligence, licensing
Daniel SehrtExpert for Early Clinical Research & Development
Scientific concept & design of Phase I-IIa trials
Clinical pharmacology (PK/PD and pharmacogenomics)
Clinical trial applications
Jörg TäubelExpert for cardiac safety in drug development
Sabine PilariExpert 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
Frank S. ZollmannExpert for Pre-/ Clinical Drug Development
Safety pharmacology, toxicology, pharmacogenomics
Integrated preclinical & clinical development up to PoC
Clinical pharmacology