BioInsights - Vol 4 Issue 6

CELL & GENE THERAPY INSIGHTS

Vol 4 Issue 6

Cell & Gene Therapy Vol 4 Issue 6

Featuring

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

Global Update on the Cell & Gene Therapy Regulatory Landscape

Guest Editor:

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

Expert Insight

Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective

Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective

Yaron Ramati

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

X Wang, W Bryan, L Xu

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

S Bishop, S Flight, N Thomas

Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products

Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products

Y Maruyama, M Kasai, K Oyama et al.

Proposed Solutions to Further Improve the Regulatory Landscape for ATMPs in Europe

Proposed Solutions to Further Improve the Regulatory Landscape for ATMPs in Europe

A Hubert, J Barry, C Vieira et al.

Journal articles

Commercial Insights

Cell & Gene Therapy Commercial Insight – June 2018

Cell & Gene Therapy Commercial Insight – June 2018

Mark Curtis, Richard Philipson