Rare Insights: Navigating Medical Affairs in Rare Disease Launches with Eva Gallagher, PhD, CNMAP

Rare Insights: Navigating Medical Affairs in ...

Lumanity Medical Affairs ConsultingLumanity Medical Affairs Consulting

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Proactive vs. Reactive: How the SIUU Guidance is Reshaping Medical Affairs Strategy with Josh Bryson

The FDA finalized its guidance on Scientific Information on Unapproved Uses (SIUU) in January 2025, giving pharmaceutical and biotech companies a framework for proactive off-label communication with healthcare providers. Yet many medical affairs organizations are still navigating ...  Show more

 . 48min 13sec
The Launch Starts Now: A CMO's Approach to Early Medical Affairs Strategy in Biotech with Nick Sarlis, MD, PhD, FACP

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick speaks with Nick Sarlis, MD, PhD, FACP, Chief Medical Officer at Clara Biotech, about why successful biotech launches begin years before approval. Drawing on experience across six product launches and nine indicati ...  Show more

 . 51min 21sec

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