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Publications

1155. Coadministration of Intranasal M2SR (M2-deficient Single Replication) Investigational Influenza Vaccine with Fluzone High Dose Induces Superior Immune Responses to Fluzone High Dose Alone in 65-85 Year Old Adults

Open Forum Infect Dis

Published December 2023 by Dr Bryan Murray

Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial

Journal of Patient-Reported Outcomes

Published October 2023 by Prof Alan Boyd

Long-term administration of intravenous Trappsol® Cyclo™ (HP-β-CD) results in clinical benefits and stabilization or slowing of disease progression in patients with Niemann-Pick disease type C1: Results of an international 48-week Phase I/II trial

Molecular Genetics and Metabolism Reports

Published September 2023 by Dr Bryan Murray and Dr Bryan Hurst

Immunotherapy with CD25/CD71-allodepleted T cells to improve T-cell reconstitution after matched unrelated donor hematopoietic stem cell transplant: a randomized trial

Published January 2023 by Kim Champion

Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial

The Lancet Oncology

Published November 2022 by Prof Alan Boyd

A novel maturity index for assessing medical device startups

Journal of Clinical and Translational Science

Published August 2022 by Katy Rudnick

Prevention of Respiratory Syncytial Virus Infection in Healthy Adults by a Single Immunization of Ad26.RSV.preF in a Human Challenge Study

The Journal of Infectious Diseases

Published August 2022 by Dr Bryan Murray

Safety and Antiviral Effects of Nebulized PC786 in a Respiratory Syncytial Virus Challenge Study

The Journal of Infectious Diseases

Published June 2022 by Dr Bryan Murray

Antiadenovirus Antibodies Predict Response Durability to Nadofaragene Firadenovec Therapy in BCG-unresponsive Non-muscle-invasive Bladder Cancer: Secondary Analysis of a Phase 3 Clinical Trial

European Urology 

Published March 2022 by Prof Alan Boyd

EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge

The New England Journal of Medicine

Published February 2022 by Dr Bryan Murray

PD09-02 ANTI-ADENOVIRAL ANTIBODY LEVELS PREDICT NADOFARAGENE FIRADENOVEC RESPONSE IN BCG-UNRESPONSIVE NMIBC: RESULTS FROM A PHASE 3 TRIAL

The Journal of Urology

Published September 2021 by Prof Alan Boyd

Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP

NPJ Regenerative Medicine

Published May 2021 by Monica Pianella

Commentary on “Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model”

British Journal of Clinical Pharmacology

Published March 2021 by Prof Alan Boyd

Update on phase I study to evaluate the single- and multiple-dose pharmacokinetics of intravenous hydroxypropyl betacyclodextrin (HPβCD) in patients with Niemann-Pick disease type C (NPC-1) and the effects of dosing upon biomarkers of NPC disease

Molecular Genetics and Metabolism

Published February 2021 by Prof Alan Boyd

Update on safety and efficacy results for phase I/II trial of hydroxypropyl betacyclodextrin (HPâCD) administered intravenously in patients with Niemann-Pick disease type C1

Molecular Genetics and Metabolism

Published February 2021 by Prof Alan Boyd

The Global Alliance for iPSC Therapies (GAiT)

Stem Cell Research

Published December 2020 by Dr Patrick Ginty

Regulatory Readiness Level: a Tool to Enhance Early Regulatory Adoption in Academic Discover

A Technological University Dublin Journal of Research and Innovation

Published December 2020 by Eamonn McGowran

Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial

The Lancet Oncology

Published November 2020 by Prof Alan Boyd

Advanced therapy regulation in the UK: what might the future hold post-Brexit?

Cell & Gene Therapy Insights

Published September 2020 by Dr Patrick Ginty

Procurement and Distribution of Study Medicines

Principles and Practice of Clinical Trials

Published March 2020 by Dr Eric Hardter

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

Frontiers in Pharmacology

Published March 2020 by Prof Alan Boyd

Evolution of Ethical Principles in the Practice of Pharmaceutical Medicine From a UK Perspective

Frontiers in Pharmacology

Published January 2020 by Prof Alan Boyd

LB6. EDP-938, a Novel RSV N-Inhibitor, Administered Once or Twice Daily Was Safe and Demonstrated Robust Antiviral and Clinical Efficacy in a Healthy Volunteer Challenge Study

Open Forum Infectious Diseases

Published October 2019 by Dr Bryan Murray

902. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of a Single Immunization of Ad26.RSV.preF against RSV Infection in a Viral Challenge Model in Healthy Adults

Open Forum Infectious Diseases

Published October 2019 by Dr Bryan Murray

Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR

Nature Medicine

Published September 2019 by Kim Champion

Preclinical development of an automated injection device for intradermal delivery of a cell-based therapy

Drug Delivery and Translational Research

Published October 2017 by Dr Patrick Ginty

The Faculty of Pharmaceutical Medicine – Foundation, function and future

Journal of Medicines Development Sciences

Published August 2017 by Prof Alan Boyd

Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study

Journal of Clinical Oncology

Published August 2017 by Prof Alan Boyd

Vaccination to improve the persistence of CD19CAR gene-modified T cells in relapsed pediatric acute lymphoblastic leukemia

Original Article

Published January 2017 by Kim Champion

A Tool for Investigating Asthma and COPD Exacerbations: A Newly Manufactured and Well Characterised GMP Wild-Type Human Rhinovirus for Use in the Human Viral Challenge Model

PLOS ONE

Published December 2016 by Dr Bryan Murray

Selection and early clinical evaluation of the brain-penetrant 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitor UE2343 (Xanamem TM ): Clinical evaluation of 11β-HSD1 inhibitor UE2343

British Journal of Pharmacology

Published December 2016 by Prof Alan Boyd

A Novel Second Generation CD19 CAR for Therapy of High Risk/Relapsed Paediatric CD19+ Acute Lymphoblastic Leukaemia and Other Haematological Malignancies: Preliminary Results from the Carpall Study

Published December 2016 by Kim Champion

Global Regulatory Perspective for MSCs

Mesenchymal Stromal Cells: Translational Pathways to Clinical Adoption

Published August 2016 by Dr Patrick Ginty

pH-sensitive pHLIP® coated niosomes

Molecular Membrane Biology

Published August 2016 by Monica Pianella

Cell & Gene Therapy Commercial Insight April 2016

Published July 2016 by Prof Alan Boyd

452. RegenVOX - Translational Exploitation Strategy for Stem Cell-Based Tissue-Engineered Laryngeal Implants Undergoing Phase I/II Clinical Trial

Cell Therapies II

Published May 2016 by Kim Champion

Planning an Academic Clinical Trial

Methods in Molecular Biology

Published May 2015 by Kim Champion

LATE-BREAKING ABSTRACT: Discovering new treatments for asthma and COPD. The use of the human viral challenge model with a newly manufactured and characterised GMP human rhinovirus

European Respiratory Journal

Published August 2015 by Dr Bryan Murray

The design and development of a novel automated intradermal delivery device for cell therapies

Cytotherapy

Published June 2015 by Dr Patrick Ginty

Evaluation of materials of biological origin used in the production of cell-based medicinal products

The British Standards Institution

Published April 2015 by Dr Patrick Ginty

Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products

Regenerative Medicine

Published August 2014 by Dr Patrick Ginty

Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability

Cytotherapy

Published August 2014 by Dr Patrick Ginty

Foscarnet in the management of cytomegalovirus infections in hematopoietic stem cell transplant patients

Expert Review of Anti-infective Therapy

Published November 2012 by Prof Alan Boyd

Standards can help bring cell therapy products to market

BioProcess International

Published April 2012 by Dr Patrick Ginty

Serum CD73 Activity, An Enzyme Involved In Endothelial Barrier Function, Increases Following FP-1201 Treatment Of ALI/ARDS Patients

American Thoracic Society 2011 International Conference

Published May 2011 by Prof Alan Boyd

Regenerative medicine, resource and regulation: lessons learned from the remedi project

Regenerative Medicine

Published March 2011 by Dr Patrick Ginty

Achieving reimbursement for regenerative medicine products in the USA

Regenerative Medicine

Published May 2010 by Dr Patrick Ginty