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Causal Inference in Drug Development: Why, When, How?
August 21 @ 8:30 - 16:00
08:30 – 9:00 Registration
09:00 – 9:10 Welcome from the organizing committee
9:10-10:40 Causal Inference in Drug Development – Why or why not
(Session chair: N.N.)
What you need to know (Miguel Hernan, Harvard)
Relation to ICH E9 (Christine Fletcher, Amgen)
A regulator’s perspective (Frank Pétavy, EMA)
10:40 – 11:10 Coffee break
11:10 – 12:30 Case studies 1 (Session chair: Giusi Moffa, University of Basel) Adverse reactions confounded by prior medication: (how) can causal inference solve the problem? (Valentine Jehl, Novartis)
Treatment sequencing and effectiveness: challenges and considerations (Thibaut Sanglier, Roche)
12:30 – 13:20 Lunch
13:20 – 14:40 Case studies 2 (Session chair: N.N.)
Principal stratification techniques in the context of regulatory decision making (Nikolaos Sfikas, Novartis)
Estimating treatment effects in the pharmaceutical arena using instrumental variable methods: from “academic” causal inference to the Estimand Framework via the CANTOS study (Jack Bowden, University of Bristol)
14:40 – 15:00 Coffee break
15:00 – 16:00 Panel discussion: Where do we go from here?
Session chairs: Sigrid Behr, Novartis and N.N. Including all Speakers
16:00 Closure of the meeting