Global regulatory update

CELL AND GENE THERAPY INSIGHTS

July 2022

Global regulatory update

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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

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

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

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

Trends in academic ATMP development & manufacture in Europe

Trends in academic ATMP development & manufacture in Europe

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

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

Robert Pietrusko

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

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

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.