GRP Workshop


Pre-Conference Workshop
Wednesday, May 3
08:00 - 16:30

The ISCT Global Regulatory Perspectives (GRP) represents the diverse activities and partnerships between international regulatory bodies, industry, clinicians and academia.

The GRP Workshop is an annual one-day program.  Unique to this workshop is the attendance of regulators from North America, Europe, Asia, South & Central America and Australia & New Zealand.  It is a highly interactive program including various hypothetical case studies throughout.



Preliminary Program

Session Topics include:

  • Session I: Genetic Modification
  • Session II: Global Strategy for Development and Supply of Gene-Modified Cell Products
  • Session III: Replication Competent Vector Testing of Gene-Modified Cell Therapy Products
  • Session IV: Clinical Trials – Patient Populations in Developing Regulatory Regions

Detailed program coming soon.

Organizing Committee

Karen Nichols, Esq. – Co-Chair
VP, Regulatory and Quality, NantKwest, USA
Dominic Wall, PhD, FFSc(RCPA) – Co-Chair
Operations Director, Peter MacCallum Cancer Centre, Australia
Christopher Bravery, PhD, Director, Consulting on Advanced Biologicals, United Kingdom
Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, USA
Karen Edward, BSc, MT(ASCP), Vice President, Quality Assurance Operations, Mesoblast, USA
Srinivasan Kellathur, PhD, Head, Advanced Therapy Products Unit, Health Sciences Authority, Singapore
Aisha Khan, ABD, MSc, MBA, Executive Director of Laboratory Operations, Interdisciplinary Stem Cell Institute, USA
Janet Macpherson, PhD, Development Manager, Dept of Cell & Molecular Therapies, Royal Prince Alfred Hospital, Australia
Gustavo Moviglia, MD, PhD, Medical Director, University of Maimonides, Argentina
Paula Salmikangas, PhD, Chair, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA), Finland
ISCT 2017

ISCT 2017