Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap

STARS consortium; Viktoriia Starokozhko; Marko Kallio; Åsa Kumlin Howell; Anna Mäkinen Salmi; Gunilla Andrew-Nielsen; M Goldammer; Manja Burggraf; Wiebke Löbker; Anne Böhmer; Eleonora Agricola; Corinne S de Vries; Anna M G Pasmooij; Peter G M Mol

doi:10.1016/j.drudis.2020.10.017

Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap

STARS consortium, Viktoriia Starokozhko, Marko Kallio, Åsa Kumlin Howell, Anna Mäkinen Salmi, Gunilla Andrew-Nielsen, M Goldammer, Manja Burggraf, Wiebke Löbker, Anne Böhmer, Eleonora Agricola, Corinne S de Vries, Anna M G Pasmooij, Peter G M Mol^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.

Original language	English
Pages (from-to)	283-288
Number of pages	6
Journal	Drug Discovery Today
Volume	26
Issue number	2
Early online date	2020
DOIs	https://doi.org/10.1016/j.drudis.2020.10.017
Publication status	Published - Feb-2021

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STARS consortium, Starokozhko, V., Kallio, M., Kumlin Howell, Å., Mäkinen Salmi, A., Andrew-Nielsen, G., Goldammer, M., Burggraf, M., Löbker, W., Böhmer, A., Agricola, E., de Vries, C. S., Pasmooij, A. M. G., & Mol, P. G. M. (2021). Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap. Drug Discovery Today, 26(2), 283-288. https://doi.org/10.1016/j.drudis.2020.10.017

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title = "Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap",

abstract = "Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.",

author = "{STARS consortium} and Viktoriia Starokozhko and Marko Kallio and {Kumlin Howell}, {\AA}sa and {M{\"a}kinen Salmi}, Anna and Gunilla Andrew-Nielsen and M Goldammer and Manja Burggraf and Wiebke L{\"o}bker and Anne B{\"o}hmer and Eleonora Agricola and {de Vries}, {Corinne S} and Pasmooij, {Anna M G} and Mol, {Peter G M}",

year = "2021",

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doi = "10.1016/j.drudis.2020.10.017",

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STARS consortium, Starokozhko, V, Kallio, M, Kumlin Howell, Å, Mäkinen Salmi, A, Andrew-Nielsen, G, Goldammer, M, Burggraf, M, Löbker, W, Böhmer, A, Agricola, E, de Vries, CS, Pasmooij, AMG & Mol, PGM 2021, 'Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap', Drug Discovery Today, vol. 26, no. 2, pp. 283-288. https://doi.org/10.1016/j.drudis.2020.10.017

TY - JOUR

T1 - Strengthening regulatory science in academia

T2 - STARS, an EU initiative to bridge the translational gap

AU - STARS consortium

AU - Starokozhko, Viktoriia

AU - Kallio, Marko

AU - Kumlin Howell, Åsa

AU - Mäkinen Salmi, Anna

AU - Andrew-Nielsen, Gunilla

AU - Goldammer, M

AU - Burggraf, Manja

AU - Löbker, Wiebke

AU - Böhmer, Anne

AU - Agricola, Eleonora

AU - de Vries, Corinne S

AU - Pasmooij, Anna M G

AU - Mol, Peter G M

PY - 2021/2

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N2 - Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.

AB - Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.

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DO - 10.1016/j.drudis.2020.10.017

M3 - Article

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SP - 283

EP - 288

JO - Drug Discovery Today

JF - Drug Discovery Today

IS - 2

ER -

Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap

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