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Embassy Suites Old Town Alexandria

Nov 06, 2013 7:30 AM - Nov 06, 2013 5:30 PM

1900 Diagonal Road, , Alexandria, VA 22314 , USA

DIA Meeting on Personalized Medicines and Companion Diagnostics

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New Developments in CDER/CDRH Working Framework

Session Chair(s)

Azin Shahzamani

Azin Shahzamani

Senior Director, Regulatory Affairs

Genentech, A Member of the Roche Group, United States

Over the last year, with the introduction of the breakthrough development path, the need for coordinated administrative processes and management commitment for development of co-diagnostics at FDA and in industry has been highlighted. In this session the panelists will provide their perspectives and experiences on CDER/CDRH working framework.

Speaker(s)

Jeff Allen, PhD

Speakers

Jeff Allen, PhD

Friends of Cancer Research, United States

President and Chief Executive Officer

Pamela Bradley

Speakers

Pamela Bradley

FDA, United States

Staff Fellow, Office of In Vitro Diagnostics & Radiological Health, CDRH

Christopher Leptak, MD, PhD

Speakers

Christopher Leptak, MD, PhD

Greenleaf Health, Inc., United States

Executive Vice President, Drug and Biological Products

Mya Thomae, RAC

Speakers

Mya Thomae, RAC

Myraqa, United States

Founder and Chief Executive Officer

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