skip to content

Advanced Therapies (Duke-NUS CoRE)

Speaker



Ilisa Bernstein

  • Srinivasan KellathurHead,
    Advanced Therapy Product Unit,
    Health Products Regulation Group,
    Health Sciences Authority (HSA)
    • Day 1 ▶ Opening
      • Overview of workshop

Ilisa Bernstein

  • Katherine TsokasRegulatory Head,
    Regenerative Medicine & Advance Therapy,
    Janssen R&D
    • Day 1 ▶ Session 1
      • Pitfalls and upcoming challenges in development and regulation of Advanced Therapies: An Industry Perspective

Ilisa Bernstein

  • Wilson BryanDirector,
    Office of Tissue and Advanced Therapies,
    US Food and Drug Administration (US FDA)
    • Day 1 ▶ Session 2
      • Update on the US FDA framework

Ilisa Bernstein

  • Ilona ReischlVice-Chair,
    Committee for Advanced Therapies,
    European Medicines Agency (EMA)
    • Day 1 ▶ Session 2
      • Update on the EMA framework
    • Day 2 ▶ Session 3
      • Trials for Advanced Therapies

Ilisa Bernstein

  • Tony MandersonPrincipal Advisor,
    Biological Science, Scientific Evaluation Branch,
    Therapeutic Goods Administration (TGA)
    • Day 1 ▶ Session 2
      • Understanding the Australia’s TGA and Health Canada’s framework for regulating Advanced Therapies

Ilisa Bernstein

  • Kasai MasakiPrincipal Reviewer,
    Pharmaceuticals and Medical Devices Agency (PMDA)
    • Day 1 ▶ Session 2
      • Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Japan

Ilisa Bernstein

  • Jeewon JoungDirector,
    Cell and Gene Therapy Products Division,
    Ministry of Food and Drug Safety (MFDS)
    • Day 1 ▶ Session 2
      • Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Korea

Ilisa Bernstein

  • Azizah Ab GhaniSenior Principal Assistant Director,
    Head of Biologics Section,
    National Pharmaceutical Regulatory Agency (NPRA)
    • Day 1 ▶ Session 2
      • Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Malaysia

Ilisa Bernstein

  • Ong Lee LeeSenior Regulatory Specialist,
    Advanced Therapy Products Unit,
    Health Products Regulation Group,
    Health Sciences Authority (HSA)
    • Day 1 ▶ Session 2
      • Understanding the basis of frameworks and processes in Asia for Advanced Therapies: Update from Singapore

Ilisa Bernstein

  • Lucas ChanDirector,
    GMP Manufacture and Development,
    Stem Med Ltd
    • Day 2 ▶ Session 3
      • Overview of the development of Advanced Therapies

Ilisa Bernstein

  • Antonio LeeCEO & Managing Director,
    Medipost America Inc
    • Day 2 ▶ Session 3
      • Cell Master File - A novel concept

Ilisa Bernstein

  • Marieta ChanLaboratory Director,
    Blood Service Group,
    Health Sciences Authority (HSA)
    • Day 2 ▶ Session 4
      • GMP Requirements for Advanced Therapies: Industry’s perspective

Ilisa Bernstein

  • Goh Choon WeeRegulatory Consultant, Senior GMP Inspector,
    Audit & Licensing Division,
    Health Sciences Authority (HSA)
    • Day 2 ▶ Session 4
      • GMP Requirements for Advanced Therapies: Regulator’s perspective
      • Case Discussion

Ilisa Bernstein

  • Foaud AtoufVice President,
    Global Biologics - Sciences & Standards,
    US Pharmacopeial Convention (USP)
    • Day 2 ▶ Session 4
      • USP standards for Cell and Tissue Therapies

Ilisa Bernstein

  • Tamra LysaghtCentre for Biomedical Ethics,
    Yong Loo Lin School of Medicine,
    National University of Singapore
    • Day 3 ▶ Session 5
      • Ethical considerations in Advanced Therapies
      • Panel Discussion

Ilisa Bernstein

  • Gayatri SharmaExecutive Director,
    Yuki Bioscience Pte Ltd
    • Day 3 ▶ Session 5
      • From Research to Market: An entrepreneur’s perspective on impacting healthcare
      • Panel Discussion

Ilisa Bernstein

  • Toh Han ChongSenior Consultant, Deputy Director
    National Cancer Centre, Singapore
    • Day 3 ▶ Session 5
      • Stakeholders’ Perspective - Practitioners
      • Panel Discussion