A05. Getting the most out of repurposing medicines
Tracks
Prescription Medicine Regulation
| Wednesday, June 12, 2024 |
| 11:15 AM - 12:15 PM |
| C2.4 |
Chair & Speakers
Adrian Bootes
Principal
CR Consult
Chair: Getting the most out of repurposing medicines
Abstract
The newly implemented Medicines Repurposing Program by the Department of Health and Aged Care aims to improve patient access to medicines by incentivising sponsors to seek TGA approval and PBS subsidy for new therapeutic uses for existing medicines. The Program employs a collaborative approach inviting nominations from stakeholders, including patient advocates and clinician groups as well as sponsors, to identify candidate medicines that have the potential to be repurposed. The session will include an overview of the program, focusing on the process of candidate identification and selection, and an update on current progress.
Biography
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.
Jess Tidemann
Senior Medical Officer, Prescription Medicines Authorisation Branch
TGA
Getting the most out of repurposing medicines
Abstract
The newly implemented Medicines Repurposing Program by the Department of Health and Aged Care aims to improve patient access to medicines by incentivising sponsors to seek TGA approval and PBS subsidy for new therapeutic uses for existing medicines. The Program employs a collaborative approach inviting nominations from stakeholders, including patient advocates and clinician groups as well as sponsors, to identify candidate medicines that have the potential to be repurposed. The session will include an overview of the program, focusing on the process of candidate identification and selection, and an update on current progress.
Biography
Dr Tidemann is a Senior Medical Officer in Prescription Medicines Authorisation Branch (PMAB) at the Therapeutic Goods Administration working across multiple areas including the Medicines Repurposing Program. Dr Tidemann has worked at the TGA since 2018 in various roles in Pharmacovigilance Branch prior to moving to PMAB and also works clinically as a general practitioner.
