Vol 5 Issue 6

CELL AND GENE THERAPY INSIGHTS

June 2019 Issue

Vol 5 Issue 6

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Featuring

Issue Spotlight: Global Regulatory Update
Data Management & Integration 2019
Other articles
Webinars

SPOTLIGHT

Global Regulatory Update
Christiane Niederlaender
Guest Editor:
Christiane Niederlaender, Vice President Technical at Parexel

Editorial

European developments in ATMP Regulation

European developments in ATMP Regulation

Christiane Niederlaender
24 June 2019
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Perspective

EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA

Oliver Ball, Sarah Robinson, Christopher Bravery
25 June 2019
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Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Neil WA McGowan, John DM Campbell
25 June 2019
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Gene therapy success: how to keep its promises and improve – a regulatory perspective

Gene therapy success: how to keep its promises and improve – a regulatory perspective

Filomena Nappi, Francesca Capone, Maria Cristina Galli
24 June 2019
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The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B

The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B

A Kuta, E Sawyer, M Cantor et al.
24 June 2019
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Interview

Korea’s evolving regulatory landscape for cell & gene therapies

Korea’s evolving regulatory landscape for cell & gene therapies

Jaeseung Lim
24 June 2019
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US FDA goals and priorities for cell & gene therapy regulation

US FDA goals and priorities for cell & gene therapy regulation

Peter Marks
24 June 2019
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Update on the regulatory environment for ATMPs in Israel

Update on the regulatory environment for ATMPs in Israel

Ofra Axelrod
24 June 2019
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Regulatory Insight

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Y Maruyama, M Kasai, Y Fujiwara et al.
24 June 2019
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Supply Chain FOCUS

Data Management & Integration 2019

Interview

Supply chain data management and integration: process development and manufacturing

Supply chain data management and integration: process development and manufacturing

Jordan Croteau
24 July 2019
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From the get-go: how to ensure your organization is built with harnessing data in mind

From the get-go: how to ensure your organization is built with harnessing data in mind

Darshan Patel, Jarrod Lefton, Hubert Sun
24 July 2019
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Keys to successful supply chain data management for T-cell immunotherapy

Keys to successful supply chain data management for T-cell immunotherapy

Charles Wilfong, Dan Lowther
24 July 2019
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Journal articles

Expert Roundtable Video

AAV vector process development: achieving high purity & high yield – experiences from the frontline

AAV vector process development: achieving high purity & high yield – experiences from the frontline

M Bakhshayeshi, M Mercaldi, M Hebben et al.
4 June 2019
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Expert Roundtable

AAV vector process development: achieving high purity and high yield – experiences from the frontline

AAV vector process development: achieving high purity and high yield – experiences from the frontline

M Bakhshayeshi, M Mercaldi, M Hebben et al.
6 June 2019
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Interview

Optimizing cell-based product consistency through automation

Optimizing cell-based product consistency through automation

Nadine Mockel-Tenbrinck
2 November 2019
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Maximising data standardisation and reproducability from flow cytometry

Maximising data standardisation and reproducability from flow cytometry

Andrée Salz
29 September 2019
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Progress and challenges in the development of bi-specific CAR-T cell therapies

Progress and challenges in the development of bi-specific CAR-T cell therapies

Bryon Johnson, Nirav Shah
14 September 2019
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Webinars