{"href":"https://api.simplecast.com/oembed?url=https%3A%2F%2Foperations-utopia.simplecast.com%2Fepisodes%2Fcrystalallard-i3pGl_bc","width":444,"version":"1.0","type":"rich","title":"03 | Rethinking the Fence: Data, Standards, and the New Energy in Regulatory — with Crystal Allard","thumbnail_width":300,"thumbnail_url":"https://image.simplecastcdn.com/images/df950f79-0fa8-4033-ad58-536486f0ec84/b26b99de-b0dc-4c95-b860-ed0ef11d180c/image_7.jpg","thumbnail_height":300,"provider_url":"https://simplecast.com","provider_name":"Simplecast","html":"<iframe src=\"https://player.simplecast.com/51bd6798-4ef4-4248-9393-7d2d37616712\" height=\"200\" width=\"100%\" title=\"03 | Rethinking the Fence: Data, Standards, and the New Energy in Regulatory — with Crystal Allard\" frameborder=\"0\" scrolling=\"no\"></iframe>","height":200,"description":"For the first time in a long while, regulatory innovation in life sciences feels less like stasis and more like movement. In this episode of Operations Utopia, Matt Neal sits down with Crystal Allard — a 15-year veteran of the FDA, now leading government strategy at Veeva Systems — for a wide-ranging conversation about why the last year or two feel genuinely different.\n\nThe throughline is inevitability. External forces — new leadership at standards bodies like CDISC and HL7, the hard lessons of COVID-era rolling reviews, a generation of digitally-native reviewers, and AI itself — are pushing health authorities toward modern, data-centric, API-driven approaches faster than anyone expected. Along the way, Crystal and Matt get into the parts of the system that still don't work: format rules built for review software rather than reviewers, a submission \"fence\" that may need rethinking entirely, and the quiet truth that hard-won regulatory knowledge is now being handed to AI whether the industry is ready or not."}