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With ATMP innovation on the rise, sponsors see increase in FDA IND holds

18.04.23

By By Dr. Paula Vaccarello and Dr. Jörg Schneider

With more innovator companies targeting cell and gene therapy, it’s not surprising that investigational new

Blog

Understanding diverging expectations between FDA and EMA with cell and gene therapy

4.04.23

By Cori Gorman, Ph.D.

Successfully bringing cell and gene therapies through the regulatory process requires preparation and knowing what

Blog

Planning for CBER and EMA success with cell and gene therapy

28.03.23

By Cori Gorman, Ph.D.

The fields of cell and gene therapy are enormously promising while at the same time

Blog

Insights into issues and developments from Advanced Therapies Week

22.03.23

By Dr. Jörg Schneider

Dr. Jörg Schneider, Director – Principal Consultant at BioPharma Excellence, shares key takeaways from Advanced

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ICH’s viral safety guidelines catch up with the latest biotech innovations

1.02.23

By Sebastian Teitz, Ph.D

More than 25 years after adopting the first version of the guideline on the viral

Blog

The rise of Bayesian statistics in rare disease evidence gathering

16.01.23
Regulators are becoming more open to alternative data sources in the context of rare disease