Pharma’s Almanac

March 8, 2024

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Richard Gliklich, M.D., Chief Executive Officer, OM1, Inc.

One of the most promising paths being applied to accelerate product development and commercialization comes in the form of real-world data/evidence (RWD/RWE) and applied AI. In clinical development, we are using de-identified RWD to identify clinical sites with eligible patients and using RWD to test clinical trial protocols and to identify potential blockers in inclusion/exclusion criteria. More groundbreaking is using RWD/RWE to construct and deliver synthetic control arms, greatly reducing the time it otherwise would take to recruit and randomize patients to have a sufficient control arm. With respect to commercialization, the combination of RWD and AI offers the opportunity to improve time to diagnoses, personalize treatments based on what is predicted to be most effective, and identify patients who are part of the “treatment gap” –– meaning they should be on guidelines-based therapy but are not. At OM1, PhenOM, our AI-based personalized medicine platform, is driving all three use cases in the clinic today and with that advancing commercialization. These include identifying underdiagnosed patients with rare conditions like Fabry disease or more common but fatal conditions like abdominal aortic aneurysms, as well as predicting which patients are more likely to respond to specific therapies in obesity, rheumatoid arthritis, and major depressive disorder and finding undertreated patients with conditions like migraine and hypercholesterolemia. The promise of AI and RWD is proving to be the vehicle for the right drug for the right patient at the right time.