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Session 2: Companion Diagnostics Beyond Oncology
Session Chair(s)
Maria C. M, Orr, PhD
Head of Precision Medicine, Biopharmaceuticals
AstraZeneca, United Kingdom
Tiffany Levin, MPH
President, Association of Medical Diagnostic Manufacturers
Owner/President, 55th Parallel, LLC, United States
Biological understanding of disease and technological advances in diagnostic testing have increased dramatically in recent years making possible huge advances that can drive the targeting of treatments to the patients most likely to benefit. While precision medicine has seen the biggest advances in oncology, these developments will serve to facilitate the uptake of biomarker use and potential companion diagnostic development in disease areas outside oncology. Given this, our industry is faced with the exciting opportunities of advancing these precision medicines while navigating the challenges associated with implementing this in therapeutic indications where biomarker testing for treatment decision making is less well established. In this session, we will look at the advances in precision medicine in some of these key therapeutic indications while discussing the opportunities and challenges we face in making this a reality. Specifically, the session will…
- Outline advances in precision medicine thinking
- Discuss the current and future regulatory landscape for precision medicines in the non-oncology setting
- Discuss the opportunities and challenges of driving precision medicine in these settings
Learning Objective : - Describe the current state of precision medicine in key therapeutic areas
- Define the opportunities and challenges associated with driving precision medicine in disease areas outside of oncology
- Discuss the future regulatory landscape and expectations
Speaker(s)
Speaker
Scott Patterson, PhD
Gilead Sciences, Inc, United States
Vice President, Biomarker Sciences
Speaker
Elizabeth Mansfield, PhD
Foundation Medicine, United States
Vice President of Regulatory
Speaker
Lakshman Ramamurthy, PhD
GlaxoSmithKline, United States
Head of Global Regulatory, Precision Medicine and Digital Health
Speaker
Robert Schuck, PharmD, PhD
FDA, United States
Deputy Director, Division of Translational and Precision Medicine, OCP, OTS, CDE
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