Articles & News

Selected references
  • Bachtarzi H and Farries T. Therapeutic epigenome editing: safety and quality considerations of a new class of gene-targeted medicines. Cell & Gene Therapy Insights 2024; 10 (9): 1257–1272.
    insights.bio/cell-and-gene-therapy-insights/journal/article/3331/Therapeutic-epigenome-editing-safety-and-quality-considerations-of-a-new-class-o
  • Bachtarzi H. The Double-edge Sword of Innovative Therapies – Evolving CMC Challenges and Expectations for Gene and Cell Therapy Development, 3rd Gene and Cell Therapies: CMC, CGT & Vector Manufacturing, Vienna, Austria, 20-21 June 2023.
  • Bachtarzi H. Genome Editing: Moving Toward a New Era of Innovation, Development, and Approval. Hum Gene Ther. Pathways 2023; 34 (5-6): 171-176.
    https://pubmed.ncbi.nlm.nih.gov/36772799/
  • Bachtarzi H. Convergence or Divergence – Next Frontiers Towards Globalisation of Current- and Next-Generation Cell and Gene Therapies. Regen Med 2022; 17 (5): 313-326.
    https://pubmed.ncbi.nlm.nih.gov/35287491/
  • Bachtarzi H. Navigating the Challenges and Safety Considerations for Next-Generation Cell Therapies, Next-Generation CAR-TCR, London, UK, 22-24 February 2022.
  • Bachtarzi H. Expedited Development Strategies for Advanced Therapies: Ongoing Challenges and Technical Considerations for Current and Next Generation Gene and Cell Therapies, 3rd Gene and Cell Therapy: Quality Developments to Commercialization Summit, 6-7 October 2021, Online.
  • Bachtarzi H. Gene and Cell Therapies – Integrating Science and Regulatory CMC Demands towards a Global Development Strategy, Gene and Cell Therapy Quality Development to Commercialization Summit, 26-27 October 2020, Online.
  • Bachtarzi H. Reflection on a Decade of Innovation and Approval in Advanced Therapies – Considerations for the Development of the Next Generation Cell and Gene Therapies, Cell & Gene Therapy Innovation Leaders Summit, Berlin, Germany, 5-6 February 2020.
  • Bachtarzi H. New Gene and Cell Therapy Technologies Meet New Regulatory Challenges – Science-based Considerations Remain the Reconciling Factor, Cell & Gene Therapy Innovation Leaders Summit, Berlin, Germany, 6-7 February 2019.
  • Going Global Module 6 – Europe – Workshop: Navigating Cell and Gene Therapies through Global Regulatory Pathways. BioMelbourne Network, Melbourne, Australia, 14 August 2019.
  • Bachtarzi H and Farries T. The Genetically Modified Organism Medicinal Framework in Europe, United States, and Japan: Underlying Scientific Principles and Considerations Toward the Development of Gene Therapy and Genetically Modified Cell-Based Products. Hum Gene Ther Clin Dev 2019; 30 (3): 114-128.
    https://pubmed.ncbi.nlm.nih.gov/31111736/
  • H. Bachtarzi, editor. In vivo and Ex vivo Gene Therapy for Inherited and Non-inherited Disorders, London: IntechOpen, 2019 (ISBN 978-1-78985-718-4/ Print ISBN: 978-1-78985-717-7).
    http://www.intechopen.com/books/in-vivo-and-ex-vivo-gene-therapy-for-inherited-and-non-inherited-disorders
  • Bachtarzi H. How Genetically Modified Organisms (GMO) Regulations Impact on the Development of Genetically Modified Cell-based Therapies in Europe, the US and Japan. 24 th Annual Meeting of the International Society for Cellular Therapy (ISCT), Montréal, Canada, 2-5 May 2018.
  • CMC Considerations for Gene Therapies for Rapid Translation into the Clinic, delivered under a workshop titled “Pathways to Pre-clinical Development Success – Focus on ATMPs”, UCL Translational Research Office, UCL, London, UK, 27 November 2018.
  • Bachtarzi H. Ex Vivo and In Vivo Genome Editing: A Regulatory Scientific Framework from Early Development to Clinical Implementation, Regen Med 2017; 12 (8): 1015-1030.
    https://pubmed.ncbi.nlm.nih.gov/29243558/
  • Bachtarzi H. Regulatory and Bio-Quality Aspects of Gene and Cell Therapies. Cell & Gene Therapy Manufacturing Conference, London, UK, 11-13 September 2017.
  • Malerba A, Klein P, Bachtarzi H, Jarmin SA, Cordova G, Ferry A, Strings V, Polay Espinoza M, Mamchaoui K, Blumen SC, St Guily JL, Mouly V, Graham M, Butler-Browne G, Suhy DA, Trollet C and Dickson G. PABPN1 gene therapy for oculopharyngeal muscular dystrophy, Nat Commun 2017; 8: 14848.
    https://pubmed.ncbi.nlm.nih.gov/28361972/
  • Bachtarzi H. Stem Cell Therapies: A Regulatory Scientific Approach for Successful Translation into the Clinic. Moving Forward with Stem Cell Therapy, EuroSciCon, 6-8 September 2016, Online.
  • Bachtarzi H and Farries T. 2016. Emerging Gene Correction Strategies for Muscular Dystrophies: Scientific Progress and Regulatory Impact. In: Kormann, M. ed. Gene Correction Technology: Intech open science.
    https://www.intechopen.com/chapters/50164
  • Harish P, Malerba A, Dickson G and Bachtarzi H. Progress on Gene Therapy, Cell Therapy and Pharmacological Strategies Toward the Treatment of Oculopharyngeal Muscular Dystrophy. Hum Gene Ther 2015; 26 (5): 286-92.
    https://pubmed.ncbi.nlm.nih.gov/25860803/
  • Bachtarzi H. Gene Therapy for Cancer and Muscular Dystrophy. Brighton Musculoskeletal Research Centre’s Annual Research Day, Brighton and Sussex Medical School, Brighton, UK, June 2014.
  • Bachtarzi H, Stevenson M and Fisher K. Cancer Gene Therapy with Targeted Adenoviruses. Expert Opin Drug Deliv 2008; 5 (11): 1231-1240.
    https://pubmed.ncbi.nlm.nih.gov/18976133/