Michael Hildebrand

• Evaluation and consultancy in Life Science with special emphasis on biopharmaceutical, pharmacokinetic and CMC (Chemistry, Manufacturing and Control) issues incl. technical transfer assessment
• Project management activities incl. CRO-selection and outsourcing management
• Independent scientific assessment and expert reports
• Scientific and technical support at customer site
• Training, development and educational programs
• QP support
• Organisational development activities
  • efficiency and process analyses
  • design concepts
  • benchmark analyses
  • implementation support
• Change management projects

Recent and actual projects:

• QP for biological API manufacturing
• QP for clinical supplies
• Due diligences for small molecules and biologicals
• Preclinical development support for biological API
• Change Management in R&D reorganisation project incl. implementation follow-up
• R&D strategy for small molecule
• Biopharmaceutical support for formulation development
• IVIVC analyses
• Life cycle management with drug delivery systems
• GXP trainings (GMP, GLP, GCP)

Pharmacist
Expert Pharmacologist “DGPT”
Qualified Person
Professor for Industrial Pharmacy

Education:

Pharmacist

Experience:

International consultancy in Pharma R&D, Production and Administration

Senior VP Global Pharmaceutical Development Schering AG Germany
sites in Germany, France, Finnland, USA and Japan
Dosage forms: IR/MR-tablets, IUDs, patches, solutions, drug delivery devices, semi-solids
Compounds: Small molecules, Biologicals, Radiopharmaceuticals

VP Global Analytical Development (API and DP)
Schering AG Berlin

Qualified Person Global Development
Schering AG Germany

Pharmaceutical Expert
Schering AG Germany

Project Director Global Clinical Development
Schering AG Germany

Department Head Pharmacokinetics and Bioanalytics
Schering AG Berlin

Areas of Expertise:

CMC, Preclinical Development