Podcast on Real-World Evidence in Regulatory Contexts Launched with Episode on Rare Disease Drug Development with Managing Principal James Signorovitch

September 21, 2026

The use of real-world evidence (RWE) in regulatory and transactional contexts continues to expand, particularly in rare disease drug development, where limited patient populations often preclude traditional randomized controlled trials.

Analysis Group Managing Principal James Signorovitch participated in the first installment of a podcast series on the use of RWE in those contexts. He was joined by Bethany Hills (Partner, White & Case) and Dilesh Doshi (Vice President, Acadia Pharmaceuticals) in a focused discussion on considerations for rare disease treatments.

Participants examined the role that external controls may play in drug program planning, evidence preparation for regulatory submissions – including to the US Food and Drug Administration (FDA) – and how rigorous RWE can inform valuation of emerging therapies.

Analysis Group is proud to sponsor FDA Watch’s “The Rise of Real-World Evidence in Regulatory Strategy” series.  

Listen to Part I: Real-World Evidence in Rare Disease Drug Development