The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development

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In this first part of our new series in collaboration with A nalysis Group , Wayne chat s with Dr. James Signorovi t ch, Managing Principal at Analysis Group; Bethany Hills, Regulatory Partner at White & Case; and Dr. Dilesh Doshi , Vice President of Global Health Economics & Outcomes Research at Acadia Pharmaceuticals . Together, they discuss FDA's ongoing commitment to rare disease drug development ; defining real-world evidence (RWE) in the context of FDA and rare diseases ; building representative and trustworthy patient registries ; examples of RWE and registries supporting rare disease research and regulatory decision-making; making RWE a more systematic part of drug development and…