Addressing AMR: Regulatory Challenges & Opportunities in Non-Traditional Antimicrobial Development

Antimicrobial resistance (AMR) presents one of the most urgent global public health and development threats we face today. It is a phenomenon that has its origins in nature. Still, modern medical practices have transformed into a global crisis as existing traditional antibiotics have become obsolete in the face of rapid resistance. As we risk running out of effective therapies to fight infection, we look into the new era of “non-traditional” antimicrobials in the development pipeline and summarise the development and regulatory challenges that put the practical application of these promising scientific developments in this field at risk.

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Meet the Author

Victoria Krugersen-Clark, Senior Regulatory Executive, DLRC

Victoria Joined DLRC in 2022 with an academic background in microbiology – an interest that she has brought to her regulatory career. Since joining DLRC, Victoria has worked as a Clinical Trial Regulatory Lead for over 20 clinical trials and has supported a diverse range of regulatory projects, including MAA dossier preparation, clinical trial applications and amendments, post-marketing variations, and preparing agency interactions. This has given her a broad understanding of regulatory processes involved in drug development and regulatory professionals’ key role in the development and lifecycle of medicinal products.

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