
Osamu Sugita
, PhD. Visiting Professor
Hokkaido University
(Hokkaido University Hospital Institute of Health Science Innovation for Medical Care: HELIOS)
(Hokkaido University Hospital Institute of Health Science Innovation for Medical Care: HELIOS)
Research Theme
- Development of Non-clinical Strategies for Drug Candidates
- Establishment and Operation of Investigational Drug Manufacturing Systems
- Strategies to Ensure Reliability in Research and Pharmaceutical Manufacturing
Keyword
- Drug Development Strategy (Drug Metabolism and Formulation Design)
- Quality and Reliability Assurance
- Investigational Medicinal Product (IMP) GMP System Development and Management
Overview of Research
- My area of expertise is biopharmaceutics in pharmaceutical development. I have practical experience in physicochemical characterization and nonclinical development, including pharmacology, safety assessment, drug metabolism, and formulation design. I have also been involved in the development and optimization of pharmaceutical formulations. In addition, I have extensive experience in quality assurance for research and development activities to facilitate the smooth transition of research outcomes to subsequent stages, such as clinical trials and licensing to industry. My experience also includes auditing contract manufacturing organizations responsible for the production of drug substances and products.