Digital Pills + Platforms: Interviewing the PDURS Playbook

The FDA’s PDURS framework has unlocked a new era for pharma–digital convergence — one where software can be formally included in a drug’s label when it demonstrates clinical benefit. This seismic shift redefines what it means to launch and commercialize a therapy, requiring alignment across R&D, regulatory, evidence, and commercial functions. For the first time, life sciences organizations can turn companion software from a support tool into a regulated, value-creating product.

This roundtable unpacks what PDURS means for the future of drug development and commercialization. Leaders from pharma, digital health, and consulting will share how they are designing, validating, and launching software-enabled therapies — from architecture and labeling to reimbursement and adoption. The discussion will also explore early case studies demonstrating real-world impact and the operational blueprints that can guide others through this transformation.

Join us to discuss:

• How can pharma and digital health organizations collaborate to design software-enabled drugs under PDURS?

• What regulatory, evidence, and labeling requirements must be met to include software within a therapeutic label?

• How are early adopters navigating commercialization, reimbursement, and adoption for software-integrated therapies?