Ep 207 [11 March 2026]: Nicolle Gatto PhD – Never too early! (To think about RWD)

Ep 207 [11 March 2026]: Nicolle Gatto PhD, Chief Science Officer, Life Sciences at Datavant – We discussed Nicolle's unique background and discussed the impact of RWD on early drug development decisions and strategy. Building on her published paper (reference below), Nicolle explored how systematic use of RWD informs critical decisions in early clinical development, shaping smarter clinical & regulatory strategy from the start (& why it has been hard to adopt). Reference: Gatto NM, Campbell UB. Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development Decisions. Ther Innov Regul Sci. 2025 Nov;59(6):1288-1293. doi: 10.1007/s43441-025-00822-x. Epub 2025 Jul 18. PMID: 40679790; PMCID: PMC12579674. > https://link.springer.com/article/10.1007/s43441-025-00822-x (https://pubmed.ncbi.nlm.nih.gov/40679790/) Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.club Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.