About ISCT | Join ISCT | Contact Us | Media
ISCT 2019 Melbourne, Australia
  • HOME
  • Continuing Medical Education
  • Abstracts
  • Program
    • Pre-Conference Workshops
      • MSC Clinical Trial Updates
      • ISCT-CBA Cord Blood Series in Partnership with ASTCT
      • Cell Processing Track
      • Global Regulatory Perspectives Workshop
      • Trending Now
      • ISCT-FACT Cell Therapy Quality Bootcamp
    • Full Program
    • Speakers
      • Plenary Speakers
      • Full Speaker List
    • Corporate Program
    • Pre-Meeting Events (May 28)
      • Pre-Meeting GMP Facility Tours
      • Pre-Meeting Fact Accreditation Workshop
  • Photo Gallery
  • Sponsor & Exhibit

Global Regulatory Perspectives Workshop

Pre-Conference Workshop
Wednesday, May 29, 2019
8:00 – 16:45
Room: 218

Register Now

Supporters

Program Information

Welcome and Regulatory Roundup

Karen Nichols, Esq., VP, Regulatory and Quality, Magenta Therapeutics, United States

Dominic Wall, PhD, FFSc(RCPA), Director Pathology, Operations, Peter MacCallum Cancer Centre, Australia

Speaker: Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, USA

Session I: CMC Considerations (including testing) for Pediatric Treatments

Moderator: 

  • Rebecca Lim, PhD, Associate Professor, Obstetrics & Gynaecology, Monash University, Australia

Confirmed Speakers: 

  • Ieva Ozolins, MD, Medical Advisor, Therapeutic Goods Administration, Australia
  • Yoshiaki Maruyama, PhD, Review Director, PMDA, Japan
  • Mo Heidaran, PhD, VP Technical, PAREXEL, United States

Case Study I

Panel Discussion: 

  • Rebecca Lim, Ieva Ozolins, Yoshiaki Maruyama, Mo Heidaran

Session II: Risk Assessment for Administration of Non-Conforming Products

Moderator:

  • David Ritchie, Deputy Director, Head, Bone Marrow Transplant Service, Australia

Presenters: 

  • Steven Oh, PhD, Deputy Director, Office of Tissues and Advanced Therapies, FDA, United States
  • So-Young Lee, PhD, Scientific Reviewer, Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety (MFDS), Korea
  • Stephan Kadauke, MD, PhD, Assistant Director, Cell and Gene Therapy Lab, CHOP, United States

Case Study II

Panel Discussion: 

  • David Ritchie, Steven Oh, So-Young Lee, Stephan Kadauke

Session III: Clinical Strategies for Treatment of Pediatric Diseases

Moderator:

  • Dominic Wall, PhD, FFSc(RCPA), Director of Pathology Operations, Peter MacCallum Cancer Center, Australia

Presenters:

  • Rachel Witten, MD, Lead Medical Officer, FDA, United States
  • I-Ning Tang, MD, MS, Section Chief of Regulatory Science, Taiwan Center for Drug Evaluation, Taiwan
  • Jaap Jan Boelens, MD, PhD, Pediatric Hematologic Oncologist, Chief of Stem Cell Transplantation and Cell Therapy Service, United States

Case Study III

Panel Discussion: 

  • Dominic Wall, Rachel Witten, I-Ning Tang, Jaap Jan Boelens

Session IV: Regulatory Convergence: Where we are and what we are up to?

Moderator:

  • Karen Nichols, Esq., Regulatory and Quality, Magenta Therapeutics, United States

Presenters:

  • Judith Arcidiacono, MS, Regulatory Scientist, FDA, United States
  • Srinivasan Kellathur, PhD, Head, Advanced Therapy Products Unit, Health Sciences Authority, Singapore
  • Francesco Cicirello, PharmD (GPhC, FOPH), MSc, PIC/S Deputy Chair, Therapeutic Goods Administration, Australia

To view the full meeting program please refer to Program Schedule.

Organizing Committee

Karen Nichols, Esq. – Co-Chair

VP, Regulatory and Quality, Magenta Therapeutics, United States

Dominic Wall, PhD, FFSc(RCPA) – Co-Chair

CSO Cell Therapies Pty Ltd, Peter MacCallum Cancer Centre, Australia

Shirley Bartido, PhD, MBA

Director of Regulatory Affairs, Cellectis, USA

Christopher Bravery, PhD

Director, Consulting on Advanced Biologicals, United Kingdom

Scott Burger, MD

Principal, Advanced Cell & Gene Therapy, United States

Srinivasan Kellathur, PhD

Head, Advanced Therapy Products Unit, Health Sciences Authority, Singapore

Janet Macpherson, PhD

Product Sales Specialist, Cell & Gene Therapy, GE Life Sciences, Australia


Platinum Sponsors

Gold Sponsors

Silver Sponsors

Bronze Sponsors

© 2019 ISCT. All rights reserved.
ISCT, and the ISCT logo are registered service marks of the International Society for Cellular Therapy.
Kangaroo, 2018 © Wendy Rix/Copyright Agency, 2018