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      The valley of death – trying to get repurposed drugs registered for new indications: the Australian Experience

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      conference-abstract
        1 , , 2 , 2
      REPO4EU
      RExPO24
      3-5 July 2024
      Registration, Therapeutic Goods Administration, Australia, repurposing, clinical pharmacology
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            Abstract

            The issue of taking drugs from laboratory into clinical trials or clinical practice can be long, expensive and arduous. As seen during the pandemic where there was additional urgency, together with often a lack of funding, little clinical pharmacology input into choice of drug and dose, and potted engagement with multidisciplinary skillsets, Australia spent a lot of funds and human resources on repurposed medicines research and drug and vaccine trials that never provided any therapeutics available for clinical use.

            In addition, both the Australia and New Zealand medicines market are disproportionally affected by supply chains, as their pharmaceutical markets are small on a global scale; and for both countries almost all of their medicines are imported; these facts are a major risk to Australasian health and access to much needed medicines. Recently the Australian government announced a program to support registration of repurposed drugs, the Medicines Repurposing Program. Registration by our regulatory body enables access for doctors to be able to prescribe these therapies. This talk will discuss the new program, the implications of such change in policy, and what it means for clinicians, clinical and non-clinical researchers.

            Content

            Author and article information

            Conference
            REPO4EU
            3 June 2024
            Affiliations
            [1 ] Centre for Human Drug Repurposing and Medicines Research, University of Newcastle, NSW 2305, Australia ( https://ror.org/00eae9z71)
            [2 ] Drug Discovery and Development, Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia ( https://ror.org/01p93h210)
            Author notes
            Author information
            https://orcid.org/0000-0002-8614-0199
            https://orcid.org/0000-0002-1196-0926
            Article
            10.58647/REXPO.24006
            1190afba-c515-4986-8bcc-fb44e63c0b58
            The Authors

            Published under Creative Commons Attribution 4.0 International ( CC BY 4.0). Users are allowed to share (copy and redistribute the material in any medium or format) and adapt (remix, transform, and build upon the material for any purpose, even commercially), as long as the authors and the publisher are explicitly identified and properly acknowledged as the original source.

            RExPO24
            3
            Munich, Germany
            3-5 July 2024
            History
            Product

            REPO4EU

            Categories

            Pharmacology & Pharmaceutical medicine
            Registration,Therapeutic Goods Administration,Australia,repurposing,clinical pharmacology

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