Matthias Kruse

Matthias is a board-certified Clinical Pharmacologist with diversified experience in the areas of clinical pharmacology, pharmacokinetics and pharmacodynamics, basic and advanced pharmacokinetics, toxicokinetics, biopharmaceutical and bioanalytical methodologies. As a clinical pharmacology lead, he enables bridging from non-clinical, clinical to regulatory services during the drug development process supporting various disciplines with integrated pharmacological and clinical knowledge relevant for the successful registration and approval of drugs. 

Matthias has therapeutic experience as a physician and Principal Investigator in the areas of cardiovascular and respiratory medicine, infectious diseases, endocrinology, dermatology and rheumatology – as well as a proven track record of designing, implementing, conducting, analyzing and reporting of data from clinical studies in these areas.  

He also has 25 years of CRO experience in study conduct, study design, protocol writing, data analysis and reporting focusing on early drug development (Phase I and II). 

With significant expertise in the regulatory framework for EMA and FDA he has supports submissions of Investigational New Drug applications (IND), (Abbreviated) New Drug Applications (A)NDA, Clinical Trial Applications (CTA) and Market Application Authorizations (MAA) submissions as Clinical Pharmacology reviewer or writer, including FDA’s pediatric study plans and diversity plans.