Ariel Dora Stern posted on LinkedIn
Ariel Dora Stern
Ariel Dora Stern posted images on LinkedIn
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Thank you #Nobel Prize Laureate Jean Tirole & Pierre Dubois for a thought-provoking Health Economics Conference at Toulouse School of Economics last week! Shout-out to Ariel Dora Stern for her enlightening keynote 🎤 showing that there can be innovation in regulatory policy itself. In particular: 1️⃣ "BreakThrough Designation (BTD) launched by FDA in 2012 does not shorten regulatory approval periods BUT… shortens clinical development time, in particular the length of late-stage trials, by ~5 months. 2 main comments about mechanism of action: ✔ It benefits more to “low experience” firms ✔ Trial characteristics are less complex than average 👉 Interestingly, one can get to a similar conclusion by asking precisely the humans who made the regulatory judgment of interest! 2️⃣ Digital Health: success of German #DiGA ✔ 50+ Apps today available (after 3 yrs of policy), covering various use cases (diagnosis, monitoring, support, …), with same HTA & pricing mechanisms as for drugs. ⁉ // & differences to FDA #PreCert program, which abruptly stopped in Sept 22 were discussed 🎤 We also had a stimulating panel on the use of Health Data, Platforms & Digital Technologies for Innovation chaired by Jean Tirole, with Edwin Morley-Fletcher & Ariel Dora Stern 👉 I was happy to present Dassault Systèmes' ambition in #LifeSciences & #Healthcare, and how #VirtualTwin can accelerate therapeutic innovation and improve medical practice. Among examples shared, I mentioned #SCA (synthetic control arms), #MediTwin, our partnership with FDA for in silico clinical trials. 🌩 Key challenges include: 1️⃣ Access to data, which itself requires a solid business model, data standardization, trusted Cloud 2️⃣ Reimbursement & adoption in physicians workflow -> change management will be key 🙏 Thanks a lot to all participants for exciting discussions!