Unlocking New Opportunities: Strategies for Pharma and Digital Therapeutics under the FDA's PDURS Guidance
Austin C. Speier, Chief Strategy Officer
Click Therapeutics
3:30 PM - 4:05 PMTue
This session will explore the pivotal role of the FDA's Prescription Drug Use-Related Software (PDURS) Draft Guidance in shaping the future of digital therapeutics (DTx) and pharmaceutical development. During this session, we will delve into the strategic partnerships between PDT developers and pharma, exploring how combination products and pipeline digitization are shaping the future of medicine. We'll discuss the implications of the PDURS Draft Guidance for PDT development and its alignment with AI-enabled combination treatments.
Looking ahead, we'll envision the future of PDTs and predict the transformative impact of software as medicine in tandem with pharmaceuticals. This session will empower attendees to navigate the evolving regulatory landscape, seize new development opportunities, and contribute to the next frontier of patient-centered healthcare.
Key Takeaways/Learning Objectives:
• Understand the significance of the FDA's PDURS Draft Guidance for the future of medicine
• Explore the strategic implications of PDT partnerships with pharmaceutical companies
• Gain insights into the role of combination products to enhance treatment outcomes.
• Learn how to navigate the regulatory pathway for PDTs under the latest FDA guidance, unlocking new opportunities for innovation and patient-centric care.