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Wednesday, June 29 • 4:00pm - 5:15pm
#364: Cell and Gene Therapies: Current Global Landscape

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session aims to cover the current global regulatory landscape for products belonging to gene therapy, cell therapy, and regenerative medicine, a rapidly emerging class of medicinal products with huge potential for managing many unmet medical needs and contribute substantially to patient care. The complexity of the products and the regulatory development and expectations across different regions, both established and emerging, will be covered.

Learning Objectives

Identify and understand the challenges unique to the regulatory review of global clinical trials with gene therapies; Discuss the development of regenerative medicine after new pharmaceuticals and medical devices law was implemented in Japan; Describe the regulatory development of cell therapy in Taiwan, including comparison of regulatory development of cell therapy among selected Asia countries and future prospects.


Linda F. Bowen


Examining the Global Regulatory Environment and Scientific Landscape for Gene Therapy Clinical Trials
Victoria Rocchi

Regulation of Cell Therapy Products in Asia
Chao-Yi Joyce WANG, MSc

New Approach to Development of Regenerative Medicines in Japan
Noriaki Murao, MS

avatar for Gopalan Narayanan

Gopalan Narayanan

Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for... Read More →

avatar for Linda Bowen

Linda Bowen

Senior Director, Global Regulatory Science and Policy, Sanofi
Linda is Senior Director, Global Regulatory Science and Policy at Sanofi, and has held senior positions at Bayer and Block Drug/GSK, with global regulatory responsibilities for submissions, LCM and due diligence. She is an adjunct professor in the Temple University RA/QA Program... Read More →
avatar for Noriaki Murao

Noriaki Murao

Representative, NM Consulting
Noriaki received BS and MS degrees in pharmacy from Fukuoka University and Kyushu University. He spent his professional career for new drug development in pharmaceutical industries for four decades. He is currently running an independent regulatory consultancy business. He contributed... Read More →
avatar for Victoria Rocchi

Victoria Rocchi

Senior Regulatory Affairs Specialist, AnGes, Inc.
Victoria Rocchi is a Senior Specialist in Global Regulatory Affairs at AnGes, Inc. Ms. Rocchi has extensive experience in communications, project management and is a certified teacher. She began her career in the pharmaceutical industry at Merck Sharp and Dohme in Regulatory Operations... Read More →
avatar for Chao-Yi Wang

Chao-Yi Wang

Director, Division of Medicinal Products, Ministry of Health and Welfare, TFDA, Chinese Taipei
Ms. Chao-Yi (Joyce) Wang was appointed as the Director of Division of Medicinal Products, TFDA, Chinese Taipei, Ministry of Health and Welfare on January 7, 2016. She is responsible for management of pharmaceutical policies and regulations, including premarket approval of medicinal... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session