Wolfgang M. Roßberg

Consultancy in non-clinical drug safety and development aspects

• Design, out-sourcing and monitoring of tailored safety evaluation programs
• Assessment and compilation of data for milestone decisions and licensing
• Preparation and review of documents for global regulatory submissions

Certified toxicologist (ERT, DABT)

Consultancy for small and international life-science companies (since 2012).

Profound experience gained over 30+ years as toxicologist in major multinational life-science company:

• Safety aspects of drugs for various indications - oncology (focus area), cardiovascular diseases, infectious diseases, diabetes, obesity, hormonal contraception, diagnostic imaging
• Processes - core member of global drug discovery and development teams
• Design of tailored safety evaluation programs for drug candidates
• Review and compilation of non-clinical data summaries for internal milestone decisions and global regulatory submissions (NDA/MAA, IND/IMPD, PSUR, IB)
• Assessment and compilation of non-clinical safety data for in-/out-licensing candidates, due diligence investigations

Toxicologist ERT (European Registered Toxicologist), D.A.B.T. (Diplomate of the American Board of Toxicology)
Dr.rer.nat. (PhD, Chemistry)

Education:

Learning on the job (risk assessment, methods in toxicology, mechanisms of toxicity for small molecules and biologicals, investigative toxicology, regulatory toxicology, safety pharmacology, pharmacology, pharmacokinetics, drug metabolism, medicinal chemistry, galenic formulations)
Training and certification in biomedicine and toxicology
Studies in Chemistry

Experience:

Consultancy in drug development and drug safety aspects

Senior Expert in Toxicology, Project Manager (Bayer HealthCare AG, Germany)
Executive Director, Project Manager (Bayer HealthCare Pharmaceuticals Inc., USA)
Assistent Professor (Universität Karlsruhe, Germany)

Areas of Expertise:

Medical Writing, Preclinical Development, R&D Strategies