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      Challenges of Funding the Late Phase Clinical Development – Gaining Market Authorization and Access for Repurposed Drugs

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      conference-abstract
      1
      REPO4EU
      RExPO23
      25-26 October 2023
      Repurposing, financing, funding, payers, development
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            Abstract

            Traditional drug discovery and development is a time-consuming, labor-intensive, expensive and risky process.

            Drug repurposing has the potential to reduce the risk of failure in the development phase, shorten time to market and reduce development costs accordingly.

            Although the European Commission facilitates and encourages the repurposing of medicines, e.g. the Horizon grants are not large enough to set up the registration studies required by the European Medicines Agency (EMA), value dossiers required by payers and large-scale production. The potentially clinically and socially valuable repurposed medicines that achieve a PoC may never reach patients, because these consortia lack the expertise and resources to prepare the products for market approval, reimbursement, production, distribution and medical education.

            Pharmaceutical companies typically opt for innovative products with strong patent protection and the potential for high prices.

            The goal of VCs is not to get a product onto the market, which costs tens to hundreds of millions of euros and exceeds the investment capacity of most VCs.

            The major challenge for fully developing repurposed medicines and making them available to patients, is financing them.

            Content

            Author and article information

            Conference
            REPO4EU
            6 October 2023
            Affiliations
            [1 ] Arega Medical Nederland BV, Breda (Netherlands);
            Author information
            https://orcid.org/0009-0009-2320-267X
            Article
            10.58647/REXPO.23024
            ac5eabf9-3bd8-4199-81f3-f22887bf8e83
            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.

            RExPO23
            2
            Stockholm, Sweden
            25-26 October 2023
            History
            Product

            REPO4EU

            Categories

            Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
            Pharmacology & Pharmaceutical medicine
            Repurposing,financing,funding,payers,development

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