How to prepare your TGA Clinical Trial Application for first in human cell and gene therapies in Aus

ABOUT THE WEBINAR

Join the ISCT ANZ Regional Executive Committee for an informative and practical webinar focused on navigating the regulatory landscape for early-phase clinical trials of cell and gene therapies in Australia. Whether you're part of an academic team or a biotech company, this session will equip you with the knowledge to successfully prepare your Clinical Trial Application (CTA) for the Therapeutic Goods Administration (TGA). 

This is your opportunity to pose questions on barriers you may be facing in your regulatory workflows, and to get a step-by-step overview on the preparation of a CTA from start to finish.

KEY LEARNING OBJECTIVES

  • Identify the purpose of a CTA?
  • Explore how a CTA differs from a TGA manufacturing or product licence
  • Learn what information needs to be included in your CTA dossier
  • Discover how to plan your preclinical and manufacturing activities to support a CTA submission
  • Discover how to proceed if your candidate already has an IND in another jurisdiction
  • Discuss what makes Australia an attractive environment for early clinical testing of advanced therapies
 WEBINAR CO-CHAIRS

Emily Blyth, FRACP, FRCPA, PhD
Clinical Lead, Immune Effector Cell Service, Westmead Hospital
Principal Research Fellow, University of Sydney
Westmead Hospital and University of Sydney
Australia 

Associate Professor Blyth is a haematologist, bone marrow transplant physician and the clinical lead for the Immune Effector Cell Service at Westmead Hospital in Sydney, Australia. She is a Principal Research Fellow at the Westmead Institute for Medical Research, University of Sydney. She is the ANZ Regional Vice President-elect for ISCT.

As a member of the Westmead Cell Therapies Group she has 18 years’ experience in bringing cell and gene therapy technologies to patients in clinical trials. This encompasses the development of novel cellular therapies that are manufactured at the Westmead Human Applications Laboratory, designing trial protocols, treating patients on trials and assessing the biological effect of cellular therapies using multiparameter analysis tools.

Siok Tey, MBBS (Hons I), PhD, FRACP, FRCPA
Senior Staff Specialist Haematologist
Research Group Leader
Royal Brisbane and Women’s Hospital, Brisbane
QIMR Berghofer Medical Research Institute
Australia

Dr Siok Tey is a Group Leader at QIMR Berghofer Medical Research Institute and a Senior Staff Specialist in Haematology and Bone Marrow Transplantation at the Royal Brisbane and Women’s Hospital. She also serves as Medical Director for the Good Manufacturing Practice Facility at QIMR Berghofer and Clinical Director for Genetically Modified Cell Therapies at RBWH. Siok received her medical training at the University of Queensland and her research training at the Center for Cell and Gene Therapy, Baylor College of Medicine (USA), followed by a PhD in immunology at QIMR Berghofer.  Her research interests are the immunobiology of bone marrow transplantation and the development of novel immunotherapeutics using cell and gene technology. She currently leads a phase I clinical trial using place-of-care generated Chimeric Antigen Receptor (CAR) T cells.

 WEBINAR SPEAKERS

Jane Oliaro, PhD
Chief Scientist and Group Leader
Peter MacCallum Cancer Center
Australia


A/Prof Jane Oliaro is the Chief Scientist for the Centre of Excellence in Cellular Immunotherapy and a Group Leader in the Cancer Immunology Program at the Peter MacCallum Cancer Centre. Jane’s research program uses immunological assays, genetic screening and preclinical models to understand tumour immune evasion and resistance to immunotherapies such as checkpoint blockade and CAR-T cell therapy. She has a particular interest in novel immunotherapeutic approaches for the treatment of lymphoma and multiple myeloma and is a Theme Leader for the Barrie Dalgleish Centre for Myeloma Research and Related Blood Disorders. Jane also leads a translational program focused on the development of novel cell-based immunotherapies through the Centre of Excellence in Cellular Immunotherapy Development Program. In this role, Jane works closely with Peter Mac clinicians and onsite manufacturing company, Cell Therapies Pty Ltd, to translate novel cellular immunotherapies into proof-of-concept clinical trials in partnership with Australian researchers and biotech. 

Ken Micklethwaite, MBBS, FRACP, FRCPA, PhD
Medical Director of the Blood Transplant and Cell Therapies Laboratory
Clinical Haematologist, Immune Effector Cell Service, Westmead Hospital
Westmead Hospital and NSW Health Pathology

AustraliaA/Prof Micklethwaite is a physician scientist working in the fields of bone marrow transplant and cell and gene therapy. He is the Medical Director of the Blood Transplant and Cell Therapies Laboratory, NSW Health Pathology ICPMR Westmead and a chimeric antigen receptor (CAR) T-cell clinician at Westmead Hospital.
His research interests are in developing new cell and gene therapies, he has been an investigator on multiple cell therapy trials for treatment of infection and haematological malignancies including first in-man CAR T-cell trials treating leukaemia and lymphoma. He is the recipient of multiple competitive grants from the Australian National Health and Medical Research Council and other funding bodies. He has been a member and chair of the Australian Therapeutic Goods Administration Advisory Committee on Biologicals for the last 10 years and has served as co-chair of the International Society for Cell and Gene Therapy Immuno-Gene Therapy Committee. He is a clinical associate professor at the University of Sydney.

Mat Adams, PhD
Australian Therapeutic Goods Administration (TGA)
Australia

Mat received his PhD in Virology from the Australian National University in 2004 on myxoma virus vaccine development. He then did a postdoctoral fellowship at the University of Florida in poxvirus research (basic virology, animal models of smallpox, vaccine and antiviral development). A brief stop in the private research sector for two years (Johnson and Johnson Research in Sydney in novel nucleic acid technologies) was followed by four years at CSIRO Animal Health Labs in Geelong, working on emerging arbovirus infections.

Mat joined the Therapeutic Goods Administration in 2013 as the Biologicals framework (covering human cell and tissue products) was implemented. He has worked on quality (CMC) evaluations for biological medicines, human tissue products, cell and gene therapies, both in the commercial registration and clinical trials pathways, as well as providing advice to Sponsors and other stakeholders in the cell therapy space, and contributed to projects to update and modify the biologicals framework.