07.05.24 -- Cell & Gene Best Of June

FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

Genome editing holds immense promise for treating genetic diseases, but off-target effects remain a significant concern resulting in the development of various strategies to reduce those risks.

Examine the similarities and differences between how the FDA and EMA approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

Although cell and gene therapies are potentially transformative, their effectiveness is undermined by difficulties with patient access and support, high costs, and a complex pathway to treatment.

Take a deeper look into innovative solutions for researchers facing challenges throughout the development of novel cell and gene therapeutics.