Adrian is a long-standing member of ARCS having contributed to our professional organisation for many decades, including as a Board Member for 10 years, CEO for 6 years, interest area member and head, clinical research fellow, speaker, chair and was awarded ARCS life membership in 2009. Adrian has also worked in project and line management for clinical research and regulatory affairs at Roche and served as Head of Prescription Medicines Branch and Senior Executive Service, TGA 2016-21, bringing in many reforms, streamlining, 6 new approval pathways and enacting international regulatory collaborations. During this time his branch brought forward many approvals, including the first Covid-19 medicines and the first gene therapies as well as the first new medicine joint evaluations and approvals. He now teaches, consults and advises for his own company, CR Consult Pty Ltd.

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.

George Lillis is the Head of Regulatory Affairs at Novartis Pharmaceuticals Australia; his responsibilities extend to New Zealand as well. George has over 25 years’ experience in drug regulatory affairs, both locally and internationally, primarily working on the development of innovative medicines. George has also held leadership positionsin Medical Affairs. George studied pharmacy at the University of Sydney where he completed a PhD. George has taught and co-written course material in regulatory affairs for graduate and post-graduate programs at various academic institutions. With Novartis’ entry into the field of cell and gene therapies, he gained familiarity and experience with the regulatory and legal frameworks that govern these ground-breaking products and saw first-hand, some of the issues surrounding these frameworks and where reforms were needed to keep pace with the rapid developments and unique features of these new technologies. George has also been actively worked with regulatory authorities in Australia and in other countries on reforms to the pathways and processes to regulatory approval (including the ACCESS Consortium) and create greater procedural efficiencies and transformative changes to help patients gain access ground-breaking medicines sooner.