Global Regulatory Perspectives Workshop

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

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

Panel Discussion: 

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

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

Panel Discussion: 

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

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

Panel Discussion: 

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

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