CELL AND GENE THERAPY INSIGHTS

Global regulatory update

July 2022
Global regulatory update
Download PDF

Interview

Inside the UK’s brave new world of ATMP regulatory innovation

Inside the UK’s brave new world of ATMP regulatory innovation

Jacqueline Barry
1 August 2022
Read
Trends in academic ATMP development & manufacture in Europe

Trends in academic ATMP development & manufacture in Europe

Pauline Meij
10 July 2022
Read
Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

David Caulfield
10 July 2022
Read
Regulatory learnings for the next wave of cellular immuno-oncology agents

Regulatory learnings for the next wave of cellular immuno-oncology agents

Robert Pietrusko
26 June 2022
Read
Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Asawari Bapat
24 June 2022
Read

Viewpoint

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Recent gene-editing guidance from FDA – clarifies some gene-editing development questions with room for additional recommendations

Kathleen Candando, Karl Whitney
10 July 2022
Read

Regulatory perspective

A need for a novel regulatory framework for individualized neoantigen-specific therapies

A need for a novel regulatory framework for individualized neoantigen-specific therapies

Amy Hardwick, Kathleen Francissen
29 June 2022
Read

Webinars

International differences in cellular starting material quality and regulatory requirements

International differences in cellular starting material quality and regulatory requirements

B Kuker, P Machalik, S Ahmed et al.
30 August 2022
Watch