Regulatory science, Drug development tools (DDTs)

This web app has an overview on Regulatory science and Drug development tools (DDTs), in different stages of their development and based on information made publicly available by the EMA and FDA. Developers of such tools include academia, public-private consortia and for-profit entities. Public information on the stage of research and development of these tools and methodologies serves the broader community of developers and researchers to use the tools for their activities and may lead to investigate expanding their use. The publications listed below further explain the processes, impact and selected cases. The collaborative development of drug development and related tools is also addressed in reports and a guide by the Innovative Health Initiative (IHI), a flagship public-private partnerships of the EU, as well as a previous catalogue of project tools.

Stephenson, Diane, Derek Hill, Jesse M. Cedarbaum, Maria Tome, Spiros Vamvakas, Klaus Romero, Daniela J. Conrado, et al. 2019. “The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease.” Journal of Parkinson’s Disease 9 (3): 553–63. https://doi.org/10.3233/JPD-191648.
Silva, Marcio, Jane Moseley, Thorsten Vetter, Jan Regnstrom, Maria Tome, Stiina Aarum, Francesca Cerreta, Elmer Schabel, and Spiros Vamvakas. 2023. “Patient-Reported, Observer-Reported and Performance Outcomes in Qualification Procedures at the European Medicines Agency (EMA) 2013-2018.” British Journal of Clinical Pharmacology 90 (1): 299–312. https://doi.org/10.1111/bcp.15907.
Laverty, Hugh, and Pierre Meulien. 2019. “The Innovative Medicines Initiative −10 Years of Public-Private Collaboration.” Frontiers in Medicine 6. https://doi.org/10.3389/fmed.2019.00275.


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