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Virtual

Dec 08, 2021 9:50 AM - Dec 09, 2021 4:30 PM

(US Eastern Standard Time)

Diagnostics and Personalized Medicine Conference

This event is now offered in a new entirely virtual format.

Session 2: Companion Diagnostics Beyond Oncology

Session Chair(s)

Maria C. M, Orr, PhD

Maria C. M, Orr, PhD

Head of Precision Medicine, Biopharmaceuticals

AstraZeneca, United Kingdom

Tiffany  Levin, MPH

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)

Scott  Patterson, PhD

Speaker

Scott Patterson, PhD

Gilead Sciences, Inc, United States

Vice President, Biomarker Sciences

Elizabeth  Mansfield, PhD

Speaker

Elizabeth Mansfield, PhD

Foundation Medicine, United States

Vice President of Regulatory

Lakshman  Ramamurthy, PhD

Speaker

Lakshman Ramamurthy, PhD

GlaxoSmithKline, United States

Head of Global Regulatory, Precision Medicine and Digital Health

Robert  Schuck, PharmD, PhD

Speaker

Robert Schuck, PharmD, PhD

FDA, United States

Deputy Director, Division of Translational and Precision Medicine, OCP, OTS, CDE

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