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Tuesday, June 26 • 8:00am - 9:15am
#211: Update on Collaboration and Trends in Global Companion Diagnostics

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-564-L04-P; CME 1.25; IACET 1.25; RN 1.25

Regulatory representatives from Japan, US, and EU will discuss the latest trends and challenges they face in the area of companion diagnostics, and will also discuss potential collaboration opportunities and their value from the scientific and regulatory point of view.

Learning Objectives

Describe the latest trends in regulations related to companion diagnostics; Discuss common challenges and possible global collaboration opportunities.


Karen D. Weiss


PMDA Perspectives on Companion Diagnostics Development in Japan
Mari Shirotani

FDA Perspective
Yun-Fu Hu, PhD

EMA Perspective
Marie-Helene Pinheiro, PharmD


Yun-Fu Hu

Deputy Director, Division of Molecular Genetics and Pathology, CDRH, FDA
Dr. Hu is currently the Deputy Director of the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostics and Radiological Health at FDA. He received his M.S. and Ph.D. degrees from the Ohio State University. He joined FDA in 2009 and was promoted to Associate... Read More →
avatar for Marie-Helene Pinheiro

Marie-Helene Pinheiro

Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency (EMA)
Marie-Helene Pinheiro currently the Industry Stakeholder Liaison within the Corporate Stakeholders Department, at the European Medicines Agency. She is responsible for coordinating the Agency’s interaction with industry stakeholder organisations, for human and veterinary medicines... Read More →

Mari Shirotani

Office of Safety I, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Karen Weiss

Karen Weiss

Vice President, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karen Weiss MD, MPH is the VP for Regulatory Policy and Intelligence for Janssen Pharmaeutical Companies of J&J. She joined J&J in January 2012 after a 22 year career at the US FDA, where she served in a number of postions, within first CBER and then CDER. Before joining FDA, Karen... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum