CELL AND GENE THERAPY INSIGHTS

Clinical Trial Designs For Advanced Therapies

November 2019
Clinical Trial Designs For Advanced Therapies
Download PDF

Expert Insight

Post-marketing safety and efficacy surveillance of cell and gene therapies in the EU: A critical review

Post-marketing safety and efficacy surveillance of cell and gene therapies in the EU: A critical review

E Fritsche, M Elsallab, M Schaden et al.
18 November 2019
Read
Towards individualized, low toxic conditioning in autologous gene-transduced hematopoietic cell transplantation

Towards individualized, low toxic conditioning in autologous gene-transduced hematopoietic cell transplantation

Rick Admiraal, Susan Prockop, Jaap Jan Boelens
18 November 2019
Read
CRISPR surgery for inherited retinal diseases: landmarks in the 21st century

CRISPR surgery for inherited retinal diseases: landmarks in the 21st century

Stephen H Tsang, Alexander Chai
18 November 2019
Read
Bayesian Phase 1/2 trial designs and cellular immunotherapies: a practical primer

Bayesian Phase 1/2 trial designs and cellular immunotherapies: a practical primer

Jordan Gauthier, Ying Yuan, Peter Thall
18 November 2019
Read
Considerations for patient selection for cell and gene therapy trials using tumor associated antigens as target in early phase development

Considerations for patient selection for cell and gene therapy trials using tumor associated antigens as target in early phase development

Stephanie Traub, David Edwards
4 November 2019
Read
The evolution of adeno-associated virus capsids for CNS gene therapy

The evolution of adeno-associated virus capsids for CNS gene therapy

Steven J Gray
29 October 2019
Read

Interview

Keys to success for foundation: industry clinical development collaborations

Keys to success for foundation: industry clinical development collaborations

Brian Fiske
7 November 2019
Read
Breaking new ground: bringing an iPS cell therapy to the clinic

Breaking new ground: bringing an iPS cell therapy to the clinic

Kapil Bharti
29 October 2019
Read

Regulatory Insight

Clinical trials of advanced therapy investigational medicinal products in Spain: preparing for the European clinical trials regulation

Clinical trials of advanced therapy investigational medicinal products in Spain: preparing for the European clinical trials regulation

J Estevez Alamo, M Timón, C González Gómez-Platero et al.
8 November 2019
Read