Precision Medicine Using Companion Diagnostics, AI/ML Modeling, and Digital Health Technology? Buzzwords or Reality?

Description: Precision Medicine, also referred to as personalized medicine, is an innovative approach to tailoring disease prevention and treatment to target the right treatments to the right patients at the right time.

A companion diagnostic (CDx) device is in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Since the FDA first approved trastuzumab and the Hercep Test in 1998, the FDA has cleared or approved over 150 CDx primarily for oncology treatments. The application of CDx is now being explored in other indications such as neurological disorders, cardiovascular diseases, infectious diseases, and mental health in clinical studies.

Digital Health Technology (DHT) such as wearables and mobile apps is revolutionizing the way clinical studies are conducted. DHT allows collection of continuous data remotely with patient’s active involvement. DHT may allow detection of clinically meaningful changes that were not measurable with traditional clinical assessments, particularly in patients with early disease.

Artificial intelligence (AI)/machine learning (ML) has recently been applied rapidly throughout the drug development life cycle from drug discovery to post market safety surveillance.

Is precision medicine possible with the use of CDx/ DHT/AI/ML? This session will cover case studies of drug development using CDx/AI/ML/DHT and conclude with the next steps on engagement and collaboration.