Getting your cell therapy product approved in Australia - some Dos and Don'ts

When:  Feb 9, 2024 from 12:00 to 13:00 (AEST)

Contact

Elizabeth Lam

elizabeth@isctglobal.org


Getting your cell therapy product approved in Australia - some Dos and Don'ts

Presented by the ISCT ANZ Regional Executive Committee

 

Unlock the pathway to successful cell therapy approval in Australia with our ISCT exclusive webinar, "Getting Your Cell Therapy Product Approved: Some Dos and Don'ts." Hosted by experts from the Therapeutic Goods Administration (TGA), this event is your guide to navigating the intricacies of regulatory processes.

Learn firsthand the crucial dos and don'ts that can make or break your cell therapy product's approval journey. Our distinguished speakers will delve into the nuanced requirements of the TGA, providing invaluable insights into crafting robust submissions, avoiding common pitfalls, and streamlining your approval process.


Stay ahead of the curve by gaining a comprehensive understanding of Australia's regulatory landscape for cell therapies. Whether you're a seasoned professional or new to the regulatory realm, this webinar equips you with practical knowledge to optimize your strategy and enhance your chances of a successful approval.

Seize this opportunity to engage directly with TGA officials, ask questions, and network with fellow industry professionals. Don't miss out! Register now for a transformative experience in advancing your cell therapy product through the regulatory maze Down Under.
 


Key Learning Objectives: 
  • Understand pathways and provisions for Cell Therapy products in Australia.
  • Learn what are the regulator expectations for compliance with relevant standards.
  • Understand which manufacturing principles apply to cell therapies.
  • Learn the dos and don’ts for cell therapy dossier development.



Chairs:

Zlatibor Velickovic, PhD

ISCT ANZ Regional Vice President

A/Prof, Director, CTTWA, Royal Perth Hospital

Australia

Zlatibor Velickovic is the Facility Director overseeing Cell & Tissue Therapies WA (CTTWA) at Royal Perth Hospital in Western Australia. An Adjunct Associate Professor at the University of Western Australia, Zlatibor holds a BSc in Molecular Biology and Physiology from the University of Belgrade and a PhD in Immunogenetics from the University of Otago in New Zealand. Kicking off his scientific journey in 2001 at the Australian Red Cross Blood Service (ARCBS) in Sydney, Zlatibor managed the TGA-accredited molecular testing laboratory, honing his extensive Good Manufacturing Practice (GMP) expertise. In 2012, he helped setup and validate the GMP facility at Sydney's Royal Prince Alfred Hospital, where he established the Quality System and developed regulatory-compliant production processes for clinical-grade Advanced Therapy Medicinal Products (ATMP). As the current director of the FACT, TGA, and NATA-accredited GMP facility at CTTWA, he manages in-house and industry sponsored ATMP manufacturing activities. In addition, Zlatibor is the Vice President for the Australia and New Zealand region of the International Society for Cell & Gene Therapy (ISCT). 









Jessica Sue, MSc, MHSM

ISCT ANZ Regional ESP Subcommittee Co-Chair

Quality Manager, Sydney Cord Blood Bank,

Australia

Jessica Sue is the Quality Manager at the Sydney Cord Blood Bank, and in this role is responsible for the overall management of the quality system at the facility. She has experience in the regulatory requirements of cellular therapy organisations, particularly in the cord blood banking setting. She has been involved in ISCT as a mentee and currently is a member of the global ISCT ESP Committee. She also holds positions on committees with partner organisations such as FACT.
Speaker:

Mat Adams, PhD

Senior Evaluator, Biological Science Section, Scientific Evaluation Branch

Therapeutic Goods Administration,

Australia

Mat received his Ph.D 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.








 
Panelists:

Glenn Smith, PhD

Director, Biological Science Section, Scientific Evaluation Branch

Therapeutic Goods Administration,

Australia

Glenn holds a degree and PhD in biochemistry from UNSW, Australia and worked as a postdoctoral researcher at Stanford University, USA and Cambridge University, UK.  He returned to Australia to work in a biotechnology company and later moved into medical research at St Vincents Hospital in Sydney.  A project he led there developed, produced and tested a recombinant monoclonal antibody in Phase I/II clinical studies in patients with bowel cancer.  This started his interest in regulation and led to taking up a position at the TGA.  In his current role Glenn leads a section responsible for the regulation of human cells and tissues, blood and the quality of biological medicines.

Tony Gill, MBBS MPH FAFPHM

Director, Blood, Biologicals and Infectious Diseases Unit

Therapeutic Goods Administration,

Australia

Dr Tony Gill is a public health physician who is a Principal Medical Adviser in the Therapeutic Goods Administration (TGA) and heads up the Advanced Biological and Therapies Section in the Prescription Medicines Authorisation Branch. In this role he heads up a section involved in the clinical evaluation and market authorisation decision making for gene therapies and cell therapies as well as being involved in developing policy on emerging advanced therapies.


He commenced work at the TGA in February 2010 following 25 years in the Australian Army and has filled various roles including acting Chief Medical Adviser of the TGA and Senior Medical Adviser roles until before moving to his current position in February 2022.  In the TGA he has been involved in the regulation of unapproved therapeutic goods, the clinical evaluation of medicines, biologicals and medical devices, and the scheduling of medicines. As well Dr Gill was the lead for the introduction of TGA’s medicine shortages section and its medicinal cannabis section.  
Dr Gill is the current President-elect of AFPHM and is the past Chair of both the Faculty Training Committee and the Faculty Education Committee. He is Chair of the Faculty Policy and Advocacy Committee.





Location