Marc Ellison, our Director of Regulatory Solutions, will be presenting at Phuse Digital’s virtual event!
Join him and other industry experts to discuss Emerging Data Standards Proposals from the Pistoia Alliance for In Vitro Pharmacology, In Vitro NAMs, and In Vivo Laboratory Efficacy Data Standards.
Preclinical drug discovery is hampered by a lack of standardised data formats, hindering data reuse, integration and advanced analytics. The Pistoia Alliance is addressing this through three collaborative initiatives for key pharmacology domains. The In Vitro Pharmacology (IVP) project is developing standardised templates and assay repositories for safety and secondary pharmacology data to streamline regulatory submissions. The In Vitro NAMs initiative is establishing harmonised standards for assay performance, reporting, and metadata provenance to promote the adoption of novel alternative methods (NAMs).
Concurrently, the In Vivo Laboratory Efficacy Data Standards Initiative is defining data elements and piloting a draft data model aligned with CDISC SEND to standardise primary pharmacology (efficacy) study data. These efforts collectively enhance data FAIRness, improve regulatory efficiency, and accelerate the translation of scientific insights into patient benefit.
Day 1, 10 February, 09:35–10:35 (EST) / 14:35–15:35 (GMT) / 15:35–16:35 (CET)
If you are interested in the future of nonclinical data standards and FAIR data, we encourage you to register and attend.
For more information, visit the Event Website
