San Francisco Bay Area Chapter In Person Event: Unlocking the Potential: Drug-Device Combinations/Di

The first session will be a panel discussion on digital health on drug development.

Digital health has revolutionized how we measure physiological and behavioral data. Tools like smartphones, smartwatches, and dedicated medical devices enable remote and continuous monitoring, offering far more frequent and granular data than traditional in-clinic assessments. This shift allows for closer patient monitoring and personalized interventions. A recent breakthrough, the EMA's acceptance of Stride Velocity 95th Centile (SV95C) measured by a wearable device as a primary endpoint in Duchenne Muscular Dystrophy (DMD) trials, underscores the power of digital biomarkers. This is expected to pave the way for the development of other sensitive digital endpoints, transforming clinical trials and patient care.

Furthermore, digital health is being integrated into drug delivery and monitoring for combination products, exemplified by smart inhalers and wearable injectors. The increasing sophistication of artificial intelligence (AI) will further accelerate the analysis of data from diverse sources, enabling the identification of complex patterns and prediction of treatment response. Digital health also holds the promise of decentralized clinical trials, making research more accessible and efficient, and generating valuable real-world evidence for informed decision-making.

Despite this immense potential, significant challenges remain. Establishing clear regulatory pathways for digital health tools in both clinical and commercial settings is crucial. Data privacy, security, and ethical considerations surrounding the collection and use of patient data must be addressed proactively. Moreover, successful implementation hinges on patient engagement and acceptance of these new technologies.

This panel discussion will delve into the industry trends and future of digital health, exploring both the exciting opportunities and the critical challenges.

The second session is to identify the regulatory affairs educational gaps and to help job seekers.

We’re going through unprecedented time as the Trump Administration fired thousands of probationary workers at federal health agencies, including FDA. RAPS community has immediately initiated efforts to support those who may be transitioning to the industry unexpectedly. Industry may also experience hiring freeze, funding issues, or slow down in innovations.

RAPS San Francisco Bay Area Chapter is here to support our community. Please join us to brainstorm how our RAPS community could help you.

This might be a great time to review your regulatory education needs. Finding the right regulatory affairs educational programs or courses virtually or in the Bay Area might be challenging. Join us for a crucial session co-hosted by the RAPS San Francisco Chapter and UCSF. We want to hear directly from you about the educational gaps you're experiencing. Your input will directly shape the development of new programs designed to meet the specific needs of the Bay Area regulatory community.

This is also a fantastic opportunity to expand your professional network with RAPS members and other regulatory and interdisciplinary professionals. This event is open to non-members too.