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Blog

Planning for CBER and EMA success with cell and gene therapy

28.03.23

By Cori Gorman, Ph.D.

By Cori Gorman, Ph.D. The fields of cell and gene therapy are enormously promising while
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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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Case Study

Early phase modelling establishes opportunities and feasibility of ATMP for rare genetic disorder

3.02.23
A project consortium was launching an EU-funded clinical trial for a first-in-class advanced therapeutic medicinal
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Blog

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
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White Paper

Science Huddle – SMALL DATA, BIG OUTCOMES

26.01.23
With the reach and impact of biopharma growing exponentially, experts in biotech and the evolving
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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
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