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Strategic recommendations from the STARS project to foster academic drug development

Improved understanding of regulatory requirements by academic researchers can accelerate the translation of new medical interventions to the clinic. Here, we highlight the recommendations of the ‘Strengthening Training of Academia in Regulatory Science’ (STARS) project to improve the interaction and knowledge exchange between academics and regulators, and thereby advance academic drug development.
  1. Viktoriia Starokozhko

    1. Dutch Medicines Evaluation Board (MEB), Utrecht, The Netherlands; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

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  2. Anne Heß

    1. Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.

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  3. Wiebke Löbker

    1. Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.

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  4. Wolfgang Ballensiefen

    1. German Aerospace Center (DLR), Project Management Agency, Health, Innovation for Disease Related Research and Personalised Medicine, Bonn, Germany.

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  5. Eleonora Agricola

    1. Italian Medicines Agency (AIFA), Rome, Italy.

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  6. Bettina Ziegele

    1. Paul Ehrlich Institute (PEI), Federal Institute for Vaccines and Biomedicines, Langen, Germany.

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  7. Marko J. Kallio

    1. Finnish Medicines Agency (FIMEA), Helsinki, Finland.

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  8. Laurence O’Dwyer

    1. Health Products Regulatory Authority (HPRA), Dublin, Ireland.

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  9. Yoana Nuevo

    1. Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.

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  10. Peter G. M. Mol

    1. Dutch Medicines Evaluation Board (MEB), Utrecht, The Netherlands; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; European Medicines Agency (EMA), Amsterdam, The Netherlands.

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  11. Anna M. G. Pasmooij

    1. Dutch Medicines Evaluation Board (MEB), Utrecht, The Netherlands.

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Academia plays a key role in drug discovery and development, especially for innovative medicines and technologies1,2. However, progressing projects into clinical development is often challenging for academic drug researchers3, in part owing to a lack of knowledge regarding regulatory requirements and skills for navigating the regulatory system4.

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doi: https://doi.org/10.1038/d41573-023-00021-z

Acknowledgements

The STARS project was funded by Horizon 2020 (grant number 825881). We would like to acknowledge the support that we received from other STARS members while preparing the STARS Common Strategy, including the recommendations.

References

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Supplementary Information

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Competing Interests

The authors declare no competing interests.

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