Use of Emerging Digital Health Technologies for Combination Products

Digital health technologies (DHT) are increasingly deployed by combination product and medicine manufacturers for a range of uses in clinical programs and medicine development. Areas such as remote patient monitoring, digital endpoints, and use of artificial intelligence and machine learning (AI/ML) in medicine discovery and development are helping to provide patients with new technologies faster and with less burden both in clinical and commercial phases. In recent years, health authorities have begun to establish early frameworks for how they will oversee and assess these technologies. We will cover recent health authority guidance for digital health technologies and explore applicability to combination product and medicine development.

Moderators

• Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
• Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie

Speakers

• Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie
• MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA
• Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA
• Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
• Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA