B02. Update on Establishing the National One Stop Shop for Clinical Trials
Tracks
Clinical Research Landscape
| Thursday, June 13, 2024 |
| 11:15 AM - 12:15 PM |
| Pyrmont Theatre |
Chair & Speakers
Marisa Petersen
Vice President
ARCS BOARD
Chair: Update on Establishing the National One Stop Shop for Clinical Trials
Abstract
The National One Stop Shop is a long awaited solution to streamline the ethical and governance approvals for clinical trials in Australia. Recently, The Hon. Mark Butler, Minister for Health and Aged Care, said when announcing a significant allocation in the 2024/25 Federal budget for this project: “Currently the regulatory framework governing clinical trials is fragmented, differs state to state, increasing the regulatory burden for research organisations, hampering interstate collaboration and leading to postcode lottery for patients”..."Removing the red tape will increase the number of national clinical trials and make it more likely for patients across Australia to get early access to promising treatments developed in the research hubs in Sydney and Melbourne. A National One Stop Shop will help cement Australia’s status as a world-class destination for health and medical research."
In this session Emeritus Professor Ian Chubb, Chair of the Inter Governmental Policy Reform Group charged with implementing this initiative will provide an update on the work of the IGPRG and Dr Bernadette Aliprandi-Costa will take a more detailed look at the next stage of implementation of the OneStop Shop as well as how it will work alongside the National CT Governance Framework and the National CT Front Door.
There will be a panel session, with David Lloyd, General Manager of Southern Star Research joining the speakers to answer your questions.
In this session Emeritus Professor Ian Chubb, Chair of the Inter Governmental Policy Reform Group charged with implementing this initiative will provide an update on the work of the IGPRG and Dr Bernadette Aliprandi-Costa will take a more detailed look at the next stage of implementation of the OneStop Shop as well as how it will work alongside the National CT Governance Framework and the National CT Front Door.
There will be a panel session, with David Lloyd, General Manager of Southern Star Research joining the speakers to answer your questions.
Biography
Marisa retired in 2018 from the position of Chief Executive Officer of George Clinical, a full service, global, Australian headquartered CRO. From 2000 to 2005, Marisa was a Director of ARCS Australia and from 2005 to 2010, was CEO of ARCS – she is a Life Member of the organization with a long held passion for its Mission. Now retired, Marisa has time to once more devote attention to the training, development and mentoring of professionals working to develop new therapeutic goods, and the advancement of their roles with government and healthcare stakeholders – the goals of ARCS Australia.
In her 30 years in clinical trial management and business leadership in the Asia Pacific region Marisa worked with and led several small to medium sized companies and organisations, focusing on strategic leadership with development of achievable medium and long term goals to guide growth and sustainability. This has included leading strategy, growing businesses, ensuring financial sustainability, nurturing stakeholder relationships across healthcare, government and related organisations (Austrade, APPA, ACTA) and actively engaging on Committees such as the Pharmaceuticals Industry Council to advocate for more streamlined processes aimed at making Australia competitive in the global business of therapeutics development.
Marisa chairs the Finance, Risk & Audit Committee.
Ian Chubb
Department of Health and Aged Care
Update on Establishing the National One Stop Shop for Clinical Trials
Biography
Emeritus Professor Chubb (Ian) is the Chair of the IGPRG.
Ian is an Australian neuroscientist and academic, who was Chief Scientist for Australia from 2011 to 2016. Prior to that he was Vice-Chancellor of the Australian National University for ten years and of the Flinders University of South Australia for six years.
In addition to other academic appointments, Ian has served on numerous Boards, and played many other roles related to science, its support, its profile and its place in the public consciousness.
Ian was made an Officer of the Order of Australia in 1999 and then a Companion in the Order of Australia in 2006 for his service to higher education, including research and development policy in the pursuit of advancing the national interest socially, economically, culturally and environmentally; and service towards the facilitation of a knowledge-based global economy.
Bernadette Aliprandi-Costa
Update on Establishing the National One Stop Shop for Clinical Trials
Biography
She is working with the Department to support the delivery of national clinical trials reforms on behalf of all jurisdictions via the Inter-Governmental Policy Reform Goup
These reforms include but are not limited to: the development and implementation of the National Clinical Trials Governance Framework; the National One Stop Shop and the development of a national quality standard and accreditation scheme for human research ethics committees under the National Mutual Acceptance Scheme.
David Lloyd
Southern Star Research
Update on Establishing the National One Stop Shop for Clinical Trials
Biography
Dr David Lloyd, is the Managing Director and founder of the Australian CRO, Southern Star Research. He has over 30 years of research experience working in Academia, Pharmaceutical companies and Contract Research Organisations. Dr Lloyd has provided expert clinical advice and guidance to numerous Biotechnology, Medical Device and Pharmaceutical companies. Dr Lloyd has broad therapeutic area expertise and has worked across all phases of clinical trials, with strong project management and business management skills. He is the former long-term Chair of the Pharmaceutical Industry Council Research & Development Taskforce, and a former member of the Pharmaceutical Industry Council, the Federal Government Clinical Trials Action Group (CTAG) Coordination Group and has served on several National Health and Medical Research Council (NHMRC) committees responsible for clinical trial reform. Dr Lloyd is currently a member of the NSW Health Early Phase Oversight Committee. David holds a Bachelor of Science and a PhD in Veterinary Science from the University of Sydney.
