BioInsights - Vol 5 Issue 11

CELL & GENE THERAPY INSIGHTS

November 2019 Issue

Vol 5 Issue 11

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Featuring

Issue Spotlight: Clinical Trial Designs For Advanced Therapies
Focus: Adherent Culture Methods 2019
Other articles
Webinar

SPOTLIGHT

Clinical Trial Designs For Advanced Therapies
Timothy Miller
Guest Editor:
Timothy Miller, Client Relations & Business Development Manager at Aldevron LLC

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

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

J Gauthier, Y Yuan, P Thall
18 November 2019
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Towards individualized, low toxic conditioning in autologous gene-transduced hematopoietic cell transplantation

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

R Admiraal, S Prockop, J Boelens
18 November 2019
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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
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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
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Interview

Keys to success for foundation: industry clinical development collaborations

Keys to success for foundation: industry clinical development collaborations

Brian Fiske
7 November 2019
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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
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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 Gómez-Platero et al.
8 November 2019
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Vectors FOCUS

Adherent Culture Methods 2019

Innovator Insight

Cost modelling comparison of adherent multi-trays with suspension and fixed-bed bioreactors for the manufacturing of gene therapy products

Cost modelling comparison of adherent multi-trays with suspension and fixed-bed bioreactors for the manufacturing of gene therapy products

E Cameau, C Glover, A Pedregal
20 January 2020
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Expert Insight

Evaluation of AAV vector production from the iCELLis fixed bed bioreactor vessel

Evaluation of AAV vector production from the iCELLis fixed bed bioreactor vessel

S Nass, B Nambiar, M Mattingly et al.
18 December 2019
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Interview

Assessing the future prospects of upstream bioprocessing systems for commercial AAV production

Assessing the future prospects of upstream bioprocessing systems for commercial AAV production

Scott A Jeffers
18 December 2019
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Journal articles

Interview

Enabling cell & gene therapy raw materials standardisation and regulatory compliance

Enabling cell & gene therapy raw materials standardisation and regulatory compliance

Michael Brewer, Kasey Kime
22 November 2019
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Commercial Insights

Cell & Gene Therapy Commercial Insight – October 2019

Cell & Gene Therapy Commercial Insight – October 2019

Mark Curtis, Richard Philipson
26 November 2019
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Webinars