CELL & GENE THERAPY INSIGHTS

Jun 2018. Vol 4 Issue 6

Jun 2018

FEATURING

Issue Spotlight: Global Update on the Cell & Gene Therapy Regulatory Landscape
Other articles

Spotlight

Global Update on the Cell & Gene Therapy Regulatory Landscape
Jun 2018
Guest Editor:
Paula Salmikangas
Paula Salmikangas, Director, Biopharmaceuticals & ATMPs at NDA Group
Paula Salmikangas
Paula Salmikangas
Director, Biopharmaceuticals & ATMPs at NDA Group

Editorial

New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?

New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?
Anthony H Davies
14 August 2018
Editorial
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Expert Insight

Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective

Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective
Yaron Ramati
6 August 2018
Expert Insight
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Breakthrough Therapy Designation & Regenerative Medicine Advanced Therapy Designation Programs in Cellular & Gene Therapies

Breakthrough Therapy Designation & Regenerative Medicine Advanced Therapy Designation Programs in Cellular & Gene Therapies
Xiaofei Wang,
Wilson W Bryan,
Lei Xu
30 July 2018
Expert Insight
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The Regulatory Environment for Cell Therapies in Australia – an Opportunity to Expedite Clinical Development

The Regulatory Environment for Cell Therapies in Australia – an Opportunity to Expedite Clinical Development
Simon Bishop,
Simone Flight,
Natalie Thomas
30 July 2018
Expert Insight
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Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products

Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products
Yoshiaki Maruyama,
Masaki Kasai,
Kazunobu Oyama,
Kazuhiko Chikazawa
17 July 2018
Expert Insight
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Proposed Solutions to Further Improve the Regulatory Landscape for ATMPs in Europe

Proposed Solutions to Further Improve the Regulatory Landscape for ATMPs in Europe
Annie Hubert,
Jacqueline Barry,
Carmen Vieira,
Anne-Virginie Eggiman
17 July 2018
Expert Insight
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Other articles

Commercial Insights

Cell & Gene Therapy Commercial Insight – June 2018

Cell & Gene Therapy Commercial Insight – June 2018
Mark Curtis,
Richard Philipson
9 August 2018
Commercial Insights
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