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Applying machine learning to increase clinical trial efficiency: a regulatory journey

In March 2022, Unlearn reached an historic milestone with the European Medicines Agency (EMA) releasing a draft qualification opinion on their 3-step PROCOVA™ procedure for Phase 2 and 3 trials. In light of this achievement, Charles Fisher, founder and CEO of Unlearn, reflects on the origin and evolution of ideas that shaped Unlearn’s groundbreaking TwinRCT™ solution—delivering on the promises methods like synthetic control arms had failed to keep of making clinical trials smaller, faster, and suitable for supporting regulatory decisions. Hear from Charles about the many twists and turns along the way as his team iterated on using digital twins in clinical trials and the journey towards their recent draft qualification opinion—proving success is never a straight line.

  • Recounting the origin and evolution of ideas that shaped Unlearn’s technology from its founding through today
  • Discussing some of the early experiments that led to the development of the TwinRCT solution and PROCOVA
  • Reviewing Unlearn’s recent draft qualification opinion from the EMA
  • Academia, biotech, and pharma
  • Biostatisticians
  • Chief Medical Officers/Medical Directors
  • Chief Innovation Officers/Head of Innovation
  • Data Science
  • Clinical Operations
  • Regulatory Affairs
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Charles Fisher

Charles Fisher

Founder & CEO, Unlearn.AI

Charles is a scientist with interests at the intersection of physics, machine learning, and computational biology. Previously, Charles worked as a machine learning engineer at Leap Motion and a computational biologist at Pfizer. He was a Philippe Meyer Fellow in theoretical physics at École Normale Supérieure in Paris, France, and a postdoctoral scientist in biophysics at Boston University. Charles holds a Ph.D. in biophysics from Harvard University and a B.S. in biophysics from the University of Michigan.

Arsalan Arif

Arsalan Arif

Founder & publisher, endpoints news

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.