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HEALWELL's DARWEN(TM) AI Platform Demonstrates One of the World's First Examples of Using AI to Generate Regulatory-Grade Real-World Data (RWD) for Supporting Patient Access and Advancing the Pharmaceutical Industry

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Executive Summary
- HEALWELL AI announced that its DARWEN™ AI platform generated regulatory‑grade real‑world data (RWD) showing that vedolizumab dose escalation (8 weeks → 4 weeks) improves remission outcomes in ulcerative colitis and Crohn’s disease.
- The results were presented at United European Gastroenterology (UEG) Week in Berlin on October 6, 2025 in collaboration with Takeda Pharmaceutical.
- HEALWELL was named a finalist for Newsweek’s inaugural AI Impact Awards 2025, highlighting its leadership in healthcare AI.
Key Details
- Collaboration: HEALWELL AI + Takeda Pharmaceutical (top‑20 global pharma).
- Presentation Venue & Date: United European Gastroenterology (UEG) Week, Berlin – October 6, 2025.
- AI Platform: DARWEN™ AI platform generated the RWD/RWE.
- Therapeutic Focus: Vedolizumab dose escalation for ulcerative colitis and Crohn’s disease.
- Clinical Insight: Switching dosing from every 8 weeks to every 4 weeks produced improved remission outcomes, supporting potential label advancement and broader patient access.
- Disease Burden Context: Inflammatory bowel disease affects ~2.39 million people in the U.S. and ~400,000 in Canada (cited sources).
- Scientific Validation: DARWEN™ AI platform has >40 peer‑reviewed manuscripts validating its capability for clinical data abstraction and RWD/RWE generation.
- Recognition: Finalist in Newsweek’s 2025 AI Impact Awards for advancing validated, ethical AI with measurable clinical/commercial impact.
Notable Quotes
“Our collaboration with Takeda demonstrates how our DARWEN™ AI platform can unlock clinically meaningful insights from the wealth of data buried and not effectively used within electronic health records and documents,” – Dr. Christopher Pettengell, Chief Medical Officer, HEALWELL AI.
“AI is reshaping our world, and the organizations receiving this award are at the forefront of that transformation,” – Jennifer H. Cunningham, Editor‑in‑Chief, Newsweek.
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