Digital Technologies: Innovations That Transform the Face of Drug Development

Session Description

Digital Technologies (DT) are emerging new treatment modalities, which include wearable devices, sensors, mobile health, and telemedicine. In recent years, DT gained a lot of traction and motivated sponsors, investigators, and regulators to discuss and implement integrated approaches of employing DT on a wider scale in drug development. To streamline applications of DT, the FDA established a new Digital Health Center of Excellence. DT spurred restructuring, transformation, and disruption of the clinical trials landscape and provided innovative tools to address unmet medical needs, enabled real-time collection of clinical endpoints, accelerated drug development, and improved drug effectiveness (i.e., how a given drug works in the real world). This session will include speakers from industry, a nonprofit organization, and the FDA. The session will highlight challenges and opportunities for development of DT, and to discuss industry and regulatory considerations for clinical endpoint assessments using DT. Inspired by the Annual Meeting Theme, the session will not only discuss how DT are indeed disruptive novel therapeutic modalities but will also highlight successful examples of utilizing DT to support and accelerate drug development. It will provide an overview of interactions between the pharmaceutical industry and the FDA Digital Health Center of Excellence/Clinical divisions. Importantly, it will identify next steps to optimize DT for more efficient drug development through better assessments of clinical endpoints.

Learning Objectives

1. To provide an overview of DT and how they could be utilized for clinical endpoint assessments to accelerate drug development.

2. To discuss industry and regulatory challenges and opportunities for development of DT.

Session Schedule

3:00 PM - 3:03 PM ET
Opening Remarks
Bilal AbuAsal, PhD and Hazem Hassan, PhD, RPh

3:03 PM - 3:16 PM ET
Digital Technologies in Clinical Trials: Hype and Hypothesis
Elena Izmailova, PhD

3:16 PM - 3:27 PM ET
Regulatory Consideration for the Application of Mobile and Wearables in Clinical End Point Assessment
Anindita Saha, PhD

3:27 PM - 3:40 PM ET
Consensus Building to Facilitate the Use of Digital Health Technologies to Support Drug Development
Diane Stephenson, PhD

3:40 PM - 4:00 PM ET
Live Q&A and Closing Remarks
All Speakers