Program

July 18(Wed) Opening remarks, Scientific sessions, Exhibition
July 19(Thu) General assembly, Scientific sessions, Exhibition, Banquet
July 20(Fri) Scientific sessions, Exhibition, Closing remarks
※Morning: Joint symposium with the Japanese Society for Clinical Toxicology

Special Lecture

  • Nonclinical safety evaluation of T-cell based immunotherapies
    Timothy K. MacLachlan (Preclinical Safety, Novartis Institutes for BioMedical Research, USA)
  • Translational safety biomarker strategy applications for innovative therapies
    John Burkhardt (Drug Safety R&D, Pfizer, USA)
(Other 5 sessions)

Educational Lecture

  • Safety review of generic drugs and the regulatory guidelines (Video Session with Teleconference)
    Saryu Goel (US Food and Drug Administration, USA) 
(Other 2 sessions)

Symposium

  • SOT- JSOT Exchange Promotion Program
    –Systems vaccinology for potency and safety–
    • Considerations on the nonclinical safety evaluation of vaccines and adjuvants
      Leigh Ann Burns Naas (Nonclinical Safety & Pathobiology, Gilead Sciences, Inc., USA)
    • Systems vaccinology for evaluating the safety of vaccines and adjuvants in preclinical and lot release tests
      Takuo Mizukami (Department of Safety Research on Blood and Biologicals, National Institute of Infectious Diseases, Japan)
    • Immunopharmacology and immunotoxicology assessment of vaccines and adjuvants
      Jayanthi Wolf (Merck & Co., Inc., USA)
    • Adjuvantome: Adjuvant data base for preclinical evaluation of vaccine and immunotherapy
      Ken J. Ishii (National Institutes of Biomedical Innovation, Health and Nutrition / WPI Immunology Frontier Research Center, Osaka University, Japan)

  • New Phase on the Environmental Risk Assessment of Human Medicine
    • ERA regulation for human medicine in Japan
      Go Yamamoto (Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Japan)
    • Estimation of total prescription weight of active pharmaceutical ingredients (APIs) in human medicines based on the public database in the Internet for ERA in Japan
      Hidenori Watanabe (ERA team, Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, The Japan Pharmaceutical Manufacturers Association, Japan)
    • Detection and kinetics of human medicine in the aquatic environment
      Norihiro Kobayashi (National Institute of Health Sciences, Japan)
    • Development of ecotoxicity assessment method for human pharmaceuticals by in silico approaches
      Takashi Yamada (Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences, Japan)
    • Updates to the EMA’s guideline on the environmental risk assessment for human medicinal products
      Rhys Whomsley (European Medicines Agency, UK)
    • The European pharmaceutical industry’s holistic approach to pharmaceuticals in the environment - Eco-Pharmaco-Stewardship
      Sini M. Eskola (European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium)

  • Nonclinical Safety Assessment of New Modalities and Next Generation Therapeutics
    • Introduction and non-clinical safety evaluation of plasmid DNA vaccine
      Kenji Hoshino (Drug Safety Research Labs, Astellas Pharma Inc., Japan)
    • Considerations for nonclinical safety evaluation of antibody drug conjugates
      Tetsuo Aida (Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd., Japan)
    • Technical aspects for nonclinical toxicology assessments of new modalities and new generation therapeutics
      Thomas S. Vihtelic (Experimental Therapeutics, MPI Research, USA)
    • Oligonucleotide therapeutics and its strategy for nonclinical safety evaluation
      Yoko Hirabayashi (Division of Cellular and Molecular Toxicology, Center for Biological Safety and Research, National Institute of Health Sciences/Working Group for the ICH S6 & Related Issues, Japan)
    • Genome editing gene therapy: Overview and safety assessment strategy
      Eriko Uchida (Division of Molecular Target and Gene Therapy Products, National Institute of Health Sciences, Japan)
(Other 20 sessions)

Workshop

  • Current perspectives on cardiac safety assessment
    • Prediction of heart toxicity of TKIs by using the systems-pharmacological methods
      Hiroshi Suzuki (Department of Pharmacy, The University of Tokyo Hospital, Japan)
    • Advances in the in silico prediction of human proarrhythmic risk
      Taeko Kubo (Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd. / Department of Cardiovascular Medicine, Shiga University of Medical Science, Japan)
    • Development of a new standardized method using human iPS cell-derived cardiomyocytes
      Yasunari Kanda (Division of Pharmacology, National Institute of Health Sciences, Japan)
    • International multisite study of human induced pluripotent stem cell derived cardiomyocytes for drug proarrhythmic potential assessment
      Ksenia Blinova (US Food and Drug Administration, USA)
(Other 8 sessions)

Note: Only English sessions are listed above

  • Invited Lecture
  • Oral Sessions
  • Poster Sessions
  • Commercial Exhibitions

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