
ISCT-Webinar: How to prepare your TGA Clinical Trial Application for first in human cell and gene therapies in Australia
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Understand the regulations governing early phase trials of biologics in Australia
Hear from the panel about their experiences bringing cell and gene therapies to the clinic
Ask questions during our panel discussion
You will learn:
- What is the purpose of a CTA?
- How does it differ from a TGA licence?
- What needs to be covered in the dossier?
- How to plan work up of your candidate in preparation for CTA submission
- What to do if there is an existing IND in another jurisdiction
- What are the opportunities for academic or biotech to test their product in Australia

Emily Blyth
Clinical Lead, Immune Effector Cell Service, Westmead Hospital Principal Research Fellow, University of Sydney
Westmead Hospital and University of Sydney
AssociateProfessor Blyth is a haematologist, bone marrow transplant physician and theclinical lead for the Immune Effector Cell Service at Westmead Hospital inSydney, Australia. She is a Principal Research Fellow at the Westmead Institutefor Medical Research, University of Sydney. She is the ANZ Regional VicePresident-elect for ISCT. As a member ofthe Westmead Cell Therapies Group she has 18 years’ experience in bringing celland gene therapy technologies to patients in clinical trials. This encompassesthe development of novel cellular therapies that are manufactured at theWestmead Human Applications Laboratory, designing trial protocols, treatingpatients on trials and assessing the biological effect of cellular therapiesusing multiparameter analysis tools.

Siok Tey
Senior Staff Specialist Haematologist Research Group Leader
Royal Brisbane and Women’s Hospital, Brisbane QIMR Berghofer Medical Research Institute
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.

Jane Oliaro
Chief Scientist and Group Leader
Peter MacCallum Cancer Centre
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
Medical Director of the Blood Transplant and Cell Therapies Laboratory Clinical Haematologist, Immune Effector Cell Service, Westmead Hospital
Westmead Hospital and NSW Health Pathology
A/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
Australian Therapeutic Goods Administration (TGA)
Therapeutic Goods Administration
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.
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