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Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies

Human gene therapy, 2022-11, Vol.33 (21-22), p.1126

2022

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Preclinical Safety Evaluation of AAV2-sFLT01— A Gene Therapy for Age-related Macular Degeneration

Molecular therapy, 2011-02, Vol.19 (2), p.326-334

2011

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The Bespoke Gene Therapy Consortium: facilitating development of AAV gene therapies for rare diseases

Nature reviews. Drug discovery, 2024-03, Vol.23 (3), p.157-158

2024

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Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules – A survey of industry 2008–2019

Regulatory toxicology and pharmacology, 2021-04, Vol.121, p.104872, Article 104872

2021

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Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies

Regulatory toxicology and pharmacology, 2021-02, Vol.119, p.104825, Article 104825

2021

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Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use

mAbs, 2017-07, Vol.9 (5), p.742-755

2017

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Inhibition of Choroidal Neovascularization in a Nonhuman Primate Model by Intravitreal Administration of an AAV2 Vector Expressing a Novel Anti-VEGF Molecule

Molecular therapy, 2011-02, Vol.19 (2), p.260-265

2011

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Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics

Regulatory toxicology and pharmacology, 2017-06, Vol.86, p.221-230

2017

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Apoptotic Threshold is Lowered by p53 Transactivation of Caspase-6

Proceedings of the National Academy of Sciences - PNAS, 2002-07, Vol.99 (14), p.9492-9497

2002

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In Vino, Curationis?

Cancer biology & therapy, 2008-08, Vol.7 (8), p.1313-1314

MacLachlan, Timothy

2008

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Nonclinical Safety Evaluation of scAAV8- RLBP1 for Treatment of RLBP1 Retinitis Pigmentosa

Molecular therapy. Methods & clinical development, 2018-03, Vol.8 (C), p.105-120

2018

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BRCA1 Directs a Selective p53-Dependent Transcriptional Response towards Growth Arrest and DNA Repair Targets

Molecular and Cellular Biology, 2002-06, Vol.22 (12), p.4280-4292

2002

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Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial

Nature reviews. Immunology, 2012-10, Vol.12 (10), p.740; author reply 740-740

2012

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Nonclinical Evaluation of GMA161-An Antihuman CD16 (FcγRIII) Monoclonal Antibody for Treatment of Autoimmune Disorders in CD16 Transgenic Mice

Toxicological sciences, 2012, Vol.125 (1), p.299-309

2012

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Nonclinical Studies that Support Viral Vector-Delivered Gene Therapies: An EFPIA Gene Therapy Working Group Perspective

Molecular therapy. Methods & clinical development, 2020-12, Vol.19, p.89-98

2020

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Corrigendum to “Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics” [Regul. Toxicol. Pharmacol. (2017) 221–230]

Regulatory toxicology and pharmacology, 2017-08, Vol.88, p.364-364

2017

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Insulin-like growth factor factor binding protein-2 is a novel mediator of p53 inhibition of insulin-like growth factor signaling

Cancer biology & therapy, 2006-10, Vol.5 (10), p.1408-1414

2006

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BRCA1 Transcriptionally Regulates Damaged DNA Binding Protein (DDB2) In the DNA Repair Response Following UV-Irradiation

Cancer biology & therapy, 2002-03, Vol.1 (2), p.177-186

2002

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BRCA1 Effects on the Cell Cycle and the DNA Damage Response Are Linked to Altered Gene Expression

The Journal of biological chemistry, 2000-01, Vol.275 (4), p.2777-2785

2000

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Not reinventing the wheel: applying the 3Rs concepts to viral vector gene therapy biodistribution studies

Human gene therapy. Clinical development, 2013-03, Vol.24 (1), p.1-4

2013

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Marine-derived cancer therapeutics making a splash

Cancer biology & therapy, 2005-08, Vol.4 (8), p.883-884

2005

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Insights into differential endostatin activity

Cancer biology & therapy, 2004-11, Vol.3 (11), p.1167-1168

2004

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BRCA1 signals ARF-dependent stabilization and coactivation of p53

Oncogene, 1999-11, Vol.18 (47), p.6605-6614

1999

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Chromosomal mapping of members of the cdc2 family of protein kinases, cdk3, cdk6, PISSLRE, and PITALRE, and a cdk inhibitor, p27Kip1, to regions involved in human cancer

Cancer research (Chicago, Ill.), 1995-03, Vol.55 (6), p.1199-1205

1995

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Repression of BRCA1 through a Feedback Loop Involving p53

The Journal of biological chemistry, 2000-10, Vol.275 (41), p.31869-31875

2000

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Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies

Preclinical Safety Evaluation of AAV2-sFLT01— A Gene Therapy for Age-related Macular Degeneration

The Bespoke Gene Therapy Consortium: facilitating development of AAV gene therapies for rare diseases

Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules – A survey of industry 2008–2019

Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies

Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use

Inhibition of Choroidal Neovascularization in a Nonhuman Primate Model by Intravitreal Administration of an AAV2 Vector Expressing a Novel Anti-VEGF Molecule

Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics

Apoptotic Threshold is Lowered by p53 Transactivation of Caspase-6

In Vino, Curationis?

Nonclinical Safety Evaluation of scAAV8- RLBP1 for Treatment of RLBP1 Retinitis Pigmentosa

BRCA1 Directs a Selective p53-Dependent Transcriptional Response towards Growth Arrest and DNA Repair Targets

Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial

Nonclinical Evaluation of GMA161-An Antihuman CD16 (FcγRIII) Monoclonal Antibody for Treatment of Autoimmune Disorders in CD16 Transgenic Mice

Nonclinical Studies that Support Viral Vector-Delivered Gene Therapies: An EFPIA Gene Therapy Working Group Perspective

Corrigendum to “Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics” [Regul. Toxicol. Pharmacol. (2017) 221–230]

Insulin-like growth factor factor binding protein-2 is a novel mediator of p53 inhibition of insulin-like growth factor signaling

BRCA1 Transcriptionally Regulates Damaged DNA Binding Protein (DDB2) In the DNA Repair Response Following UV-Irradiation

BRCA1 Effects on the Cell Cycle and the DNA Damage Response Are Linked to Altered Gene Expression

Not reinventing the wheel: applying the 3Rs concepts to viral vector gene therapy biodistribution studies

Marine-derived cancer therapeutics making a splash

Insights into differential endostatin activity

BRCA1 signals ARF-dependent stabilization and coactivation of p53

Chromosomal mapping of members of the cdc2 family of protein kinases, cdk3, cdk6, PISSLRE, and PITALRE, and a cdk inhibitor, p27Kip1, to regions involved in human cancer

Repression of BRCA1 through a Feedback Loop Involving p53

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