OTP Director Nicole Verdun acknowledged the agency may need help to determine how to ensure 15 years of patient follow-up is completed despite physician retirements, company closures and other issues that could impact the post-market commitments for gene therapies.

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.