Meeting Preclinical Data Requirements For Cell & Gene Therapies

CELL AND GENE THERAPY INSIGHTS

July 2019

Meeting Preclinical Data Requirements For Cell & Gene Therapies

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Editorial

Need for regulatory compliance in research: what is Good Laboratory Practice and what is a validated assay?

Need for regulatory compliance in research: what is Good Laboratory Practice and what is a validated assay?

Preclinical requirements for cell and gene therapies

Preclinical requirements for cell and gene therapies

Carlos R Plata-Salaman

Expert Insight

Blood–brain barrier models in pre-clinical assessment of CNS-targeting cell and gene therapies

Blood–brain barrier models in pre-clinical assessment of CNS-targeting cell and gene therapies

Danica B Stanimirovic, Anna Jezierski

Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures

Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures

P Salmikangas, P Chamberlain, B Silva Lima et al.

Building a better CAR: emerging high-throughput in vitro tools for CAR selection and optimization

Building a better CAR: emerging high-throughput in vitro tools for CAR selection and optimization

Darin Bloemberg, Scott McComb, Risini Weeratna

Podcast

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Shawna M Jackman, Lauren Black

Perspective

Should cell- and gene-therapy developers engage with regulatory authorities?

Should cell- and gene-therapy developers engage with regulatory authorities?

James W McBlane

Broadly-applicable imaging platforms are necessary for optimizing cell therapies in solid tumors

Broadly-applicable imaging platforms are necessary for optimizing cell therapies in solid tumors

M Srinivas, C Mann, A Andreu et al.

Interview

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Avoiding potential pitfalls in pre-clinical study design for cell and gene therapies

Shawna M Jackman, Lauren Black

1 September 2019

Strategic & regulatory insights for gene therapy preclinical-clinical translation in CNS

Strategic & regulatory insights for gene therapy preclinical-clinical translation in CNS

From NCATS to NASA: the extraordinary potential of tissue chips

From NCATS to NASA: the extraordinary potential of tissue chips

Regulatory Insight

Preclinical considerations for assessment of cellular & gene therapy products: FDA perspective

Preclinical considerations for assessment of cellular & gene therapy products: FDA perspective

Gaya Hettiarachchi, Wei Liang