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The parent–child IND approach: an interpretation of FDA’s guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The parent–child IND approach: an interpretation of FDA’s guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

Timmothy Taps
03 January 2023
Perspective
 Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014

Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014

N Lambot, J Awigena-Cook, T Reimer et al
29 September 2021
Perspective
 Clinical Update: Breaking New Ground

Clinical Update: Breaking New Ground

Sven Kili
06 February 2020
Perspective
 Complexity be damned: the need to better use biology to achieve more impactful cell therapies

Complexity be damned: the need to better use biology to achieve more impactful cell therapies

Nancy L Parenteau
03 February 2020
Perspective
 Clinical development of ATMPs: hospitals as an exemption?

Clinical development of ATMPs: hospitals as an exemption?

Martin Hildebrandt
29 November 2019
Perspective
 Vision 2020: what could come about in the next decade for biotech?

Vision 2020: what could come about in the next decade for biotech?

Michael Yee
29 November 2019
Perspective
 New frontiers: cellular immunotherapy beyond cancer

New frontiers: cellular immunotherapy beyond cancer

Matthew Brook, Joanna Hester, Fadi Issa
26 November 2019
Perspective
 Health Technology Assessment of Gene Therapies in Europe and the USA: Analysis and Future Considerations

Health Technology Assessment of Gene Therapies in Europe and the USA: Analysis and Future Considerations

T Qiu, E Hanna, M Dabbous et al
04 September 2019
Perspective
 Breakthrough therapies, breakthrough economics in the era of cure

Breakthrough therapies, breakthrough economics in the era of cure

S Farnia, L Mostovoy, C Redding Flamm et al
04 September 2019
Perspective
 Genetic-based therapies: looking ahead to ensuring access to a cure for cystic fibrosis

Genetic-based therapies: looking ahead to ensuring access to a cure for cystic fibrosis

Lisa B Feng, Jacqueline V Erdo, Mary B Dwight
04 September 2019
Perspective
 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
22 July 2019
Perspective
 How biomarkers can be used to optimize the clinical development of dendritic cell vaccines in immuno-oncology

How biomarkers can be used to optimize the clinical development of dendritic cell vaccines in immuno-oncology

Marcelo Bravo
04 July 2019
Perspective
 The advantage of allogenicity when using Inflammatory dendritic cells as antitumor immune primers

The advantage of allogenicity when using Inflammatory dendritic cells as antitumor immune primers

S Longhurst, J Kovacka, E Heimann et al
04 July 2019
Perspective
 Immunotherapy with iPSC-derived dendritic cells brings a new perspective to an old debate: autologous versus allogeneic?

Immunotherapy with iPSC-derived dendritic cells brings a new perspective to an old debate: autologous versus allogeneic?

P J Fairchild, T Davies, C Horton et al
01 July 2019
Perspective
 Toward a scalable and consistent manufacturing process for the production of human MSCs

Toward a scalable and consistent manufacturing process for the production of human MSCs

Qasim Rafiq
21 March 2016
Perspective
 Key considerations in optimizing pluripotent stem cell bioprocessing

Key considerations in optimizing pluripotent stem cell bioprocessing

Iwan Roberts
21 March 2016
Perspective