Dr. Toru Suzuki

 Prioritize activities for launch in new markets of pan Asian region  Search epidemiological data to forecast the potential market  Search the health system with reimbursement  Quality assurance for regulatory and clinical documents  Review and appraise clinical data to evaluate risk benefit balance of the product  Review for marketing materials in line with regional promotional codes  Quality control of documents; technical file, SOPs, quality manuals

 Analyse key factors for anti-psychosis drug development by reviewing articles  Search regulations regarding drug pricing in target regions and simulate new drug price for new chemical entity in Gabather AB

 Lead the regulatory team to file a new drug application in Japan, South Korea, Taiwan and China based on the data of Pan Asian study.  Lead the team to meet the stretch goal  Complete a CTD preparation and pre-NDA formal consultation during the review period for the new chemical entity  Plan the strategic interaction with the health authority  Early communication with the health authority to obtain the broadest indication of the world

 Manage and enhance subject enrollment to achieve a top enrollment number  Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial  Ensure site activities in line with milestones (i.e. startup, recruitment, monitoring, closeout, etc)

Health economic evaluation (cost benefit analysis)

Bone metabolism, Angiogenesis, Hematopoietic stem cell

Orthopedics surgery, knee research, Mechanical stress, Meniscus and articular cartilage