Publications by authors named "Helen Booler"

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Beyond Eye Changes in Ocular Toxicity Studies: Practical Considerations for Sampling and Evaluation of Extraocular Visual Pathways, and Common Findings.
Typhaine Lejeune, Helen Booler, Joan Wicks

Toxicol Pathol· December 2025

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Pathology Findings and In-Life Correlates in the Nonclinical Development of Adeno-Associated Virus (AAV)-Based Retinal Gene Therapies.
Helen S Booler, Typhaine Lejeune, Oliver Turner, Chandra Saravanan, Joshua T Bartoe

Toxicol Pathol· December 2024

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Discovery of TRPA1 Antagonist : Derisking Preclinical Toxicity and Aldehyde Oxidase Metabolism with a Potential First-in-Class Therapy for Respiratory Disease.
Jack A Terrett, Justin Q Ly, Paula Katavolos, Catrin Hasselgren, Steven Laing, Helen Booler

J Med Chem· March 2024

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Intravitreal RTH258 (brolucizumab) demonstrates no effect on pregnancy, parturition, embryofetal or postnatal development in cynomolgus monkeys.
Helen Booler, Anthony M DeLise, Erik Nimz, Diana Shefchek, C Marc Luetjens

Reprod Toxicol· October 2023

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CSL-Tox: an open-source analytical framework for the comparison of short-term and long-term toxicity end points and assessing the need of chronic studies in drug development.
Doha Naga, Smaragda Dimitrakopoulou, Sonia Roberts, Elisabeth Husar, Susanne Mohr, Helen Booler

Sci Rep· September 2023

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International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs.
Ingrid M Pruimboom-Brees, Swati Gupta, Nagendra Chemuturi, Helen S Booler, Erik Nimz

Clin Transl Sci· May 2023

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Scientific and Regulatory Policy Committee Points to Consider: Fixation, Trimming, and Sectioning of Nonrodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies.
Helen S Booler, Typhaine Lejeune, Steven Sorden, Margarita M Gruebbel, Kenneth A Schafer

Toxicol Pathol· February 2022

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Uncovering of intraspecies macular heterogeneity in cynomolgus monkeys using hybrid machine learning optical coherence tomography image segmentation.
Peter M Maloca, Christine Seeger, Helen Booler, Philippe Valmaggia, Ken Kawamoto

Sci Rep· October 2021

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Antibody semorinemab reduces tau pathology in a transgenic mouse model and engages tau in patients with Alzheimer's disease.
Gai Ayalon, Seung-Hye Lee, Oskar Adolfsson, Corinne Foo-Atkins, Jasvinder K Atwal, Helen Booler

Sci Transl Med· May 2021

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Inflammation of a Posterior Ciliary Artery in a Naive Cynomolgus Macaque.
Steven T Laing, Marie M Bockenstedt, Helen S Booler

Toxicol Pathol· April 2021

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Foreign Body Reaction, Retinal Degeneration, and Epiretinal Membranes Associated With Intravitreal Administration of PLGA Rods.
Helen Booler, Thomas Larsen, Amy Shelton, Vladimir Bansteev, Mayur S Mitra

Toxicol Pathol· April 2021

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Nonclinical Toxicology and Biocompatibility Program Supporting Clinical Development and Registration of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration.
Vladimir Bantseev, Joshua Horvath, Giulio Barteselli, Shrirang Ranade, Mauricio Maia, Helen S Booler

Toxicol Pathol· April 2021

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Intravitreal Administration of Acetyl Triethyl Citrate and Benzyl Benzoate Is Retinotoxic in Rabbits but Not in Cynomolgus Monkeys.
Roxanne Andaya, Helen Booler, Denise de Almeida Nagata, Chris Lawson, Jennifer Vogt

Toxicol Pathol· April 2021

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Nonclinical Safety Assessment of FHTR2163, An Antigen-Binding Fragment Against HTRA1 for the Treatment of Geographic Atrophy.
Edward Dere, Susan Crowell, Mauricio Maia, Chris Schuetz, Phillip Lai, Helen Booler

Toxicol Pathol· April 2021

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An Anti-CD22--CBI-Dimer Antibody-Drug Conjugate (ADC) for the Treatment of Non-Hodgkin Lymphoma That Provides a Longer Duration of Response than Auristatin-Based ADCs in Preclinical Models.
Shang-Fan Yu, Donna W Lee, Bing Zheng, Geoffrey Del Rosario, Douglas Leipold, Helen Booler

Mol Cancer Ther· February 2021

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EVALUATION OF SURGICAL FACTORS AFFECTING VITREOUS HEMORRHAGE FOLLOWING PORT DELIVERY SYSTEM WITH RANIBIZUMAB IMPLANT INSERTION IN A MINIPIG MODEL.
Vladimir Bantseev, Chris Schuetz, Helen S Booler, Joshua Horvath, Kristof Hovaten

Retina· August 2020

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Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.
Helen Prior, Paul Baldrick, Sonja Beken, Helen Booler, Nancy Bower

Regul Toxicol Pharmacol· June 2020

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Retinal Features in Cynomolgus Macaques () Assessed by Using Scanning Laser Ophthalmoscopy and Spectral Domain Optical Coherence Tomography.
Nora Denk, Peter M Maloca, Guido Steiner, Helen Booler, Christian Freichel

Comp Med· April 2020

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Identification and characterization of an octameric PEG-protein conjugate system for intravitreal long-acting delivery to the back of the eye.
Whitney Shatz, Philip E Hass, Nikhil Peer, Maciej T Paluch, Craig Blanchette, Helen Booler

PLoS One· February 2020

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Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics.
Vladimir Bantseev, Rebecca Erickson, Douglas Leipold, Caroline Amaya, Paul E Miller, Helen Booler

J Ocul Pharmacol Ther· October 2019

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Rapid Development of Glaucoma Via ITV Nonselective ANGPT 1/2 Antibody: A Potential Role for ANGPT/TIE2 Signaling in Primate Aqueous Humor Outflow.
Evan A Thackaberry, Yi Zhou, Christina L Zuch de Zafra, Germaine Fuh, Chingwei V Lee, Helen Booler

Invest Ophthalmol Vis Sci· October 2019

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Determination of a No Observable Effect Level for Endotoxin Following a Single Intravitreal Administration to Cynomolgus Monkeys.
Vladimir Bantseev, Paul E Miller, T Michael Nork, Carol A Rasmussen, Aija McKenzie, Helen Booler

J Ocul Pharmacol Ther· May 2019

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Determination of a No-Observable Effect Level for Endotoxin Following a Single Intravitreal Administration to Dutch Belted Rabbits.
Vladimir Bantseev, Paul E Miller, Ellison Bentley, Chris Schuetz, Tim M Streit, Helen Booler

Invest Ophthalmol Vis Sci· March 2017

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Degree of Cajal-Retzius Cell Mislocalization Correlates with the Severity of Structural Brain Defects in Mouse Models of Dystroglycanopathy.
Helen S Booler, Josie L Williams, Mark Hopkinson, Susan C Brown

Brain Pathol· July 2016

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The transgenic expression of LARGE exacerbates the muscle phenotype of dystroglycanopathy mice.
Charlotte Whitmore, Marta Fernandez-Fuente, Helen Booler, Callum Parr, Manoli Kavishwar

Hum Mol Genet· April 2014

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