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Wednesday, June 18
 

1:45pm EDT

Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Discuss PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Describe the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speaker

Industry Perspective
Sumati Nambiar, DrMed, MPH

Panelist
Teppei KIUCHI, MD, PhD, MPH


Speakers
avatar for Edward Ian

Edward Ian

Head of Integrated Innovation Service Center, Mediscience Planning Inc., Japan
Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →
avatar for Teppei KIUCHI

Teppei KIUCHI

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Teppei Kiuchi, M.D., MPH, PhD, is an associate executive director in the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In this role, Kiuchi is in charge of the review of regenerative medical products, Bio-CMC, vaccine and blood products. In his career Kiuchi has been... Read More →
SN

Sumati Nambiar

Senior Director, Johnson and Johnson, United States
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session
 
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    00: Plenary
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    01: ClinSafety-PV
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    02: ClinTrials-Ops
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    08: RD-Quality-Compliance
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    10: RegCMC-Product Quality
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    11: Statistics-Data Science
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    12: ProfDevelopment
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    13: Spotlight
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    14: DIAmond
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    15: Content-Hubs
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    16: Community-Rounds
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    17: Posters
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    18: InnovationTheaters
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    20: Short-Courses
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  • Level
    Advanced
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  • Keyword
    Advanced Analytics
    Artificial Intelligence (AI)
    Bioethics
    Biomarkers
    Cell and Gene Therapy
    Clinical Trial Design
    Diagnostics
    Digital Technology
    Global Perspectives
    Non-CE
    Patient Experience
    Payers
    Pediatrics
    Rare Disease
    Real-World Data (RWD) / Real-World Evidence (RWE)
    Regulator Perspectives
    Regulatory Collaboration
    Regulatory Convergence and Harmonization
    Regulatory Reliance
    Student Programming
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EH
TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming