The former principal deputy commissioner outlined what she sees as the future data requirements for real world evidence and why cell and gene therapy will lead the way.

Research shows bringing trials to community oncology centers remains a daunting task, but Verily and OneOncology aim to help with new clinical trial management software. In other trial news, MindBio’s LSD goes into Phase II; Erasca starts tumor agnostic program; the Project to Accelerate New Treatments for Tuberculosis launched an international study investigating new combinations; and more.

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.