Experience

Adaptimmune

• United Kingdom
• Biotechnology Research
• 300 - 400 Employee

• Senior Director, Regulatory Affairs CMC

  • Jul 2023 - Present

  • Currently leading the regulatory affairs CMC team. • Regulatory CMC lead for the afamitresgene autoleucel BLA submission including coordinating authoring of CMC related content (m2.3, m3), lead CMC communication with FDA (i.e., IRs, pre-BLA meeting, type B), effectively communicating BLA progress, risks, and mitigation strategies to wider team and senior leadership. • Support team members representing regulatory CMC on matrix teams for other genetically modified autologous TCR products… Show more • Currently leading the regulatory affairs CMC team. • Regulatory CMC lead for the afamitresgene autoleucel BLA submission including coordinating authoring of CMC related content (m2.3, m3), lead CMC communication with FDA (i.e., IRs, pre-BLA meeting, type B), effectively communicating BLA progress, risks, and mitigation strategies to wider team and senior leadership. • Support team members representing regulatory CMC on matrix teams for other genetically modified autologous TCR products and iPSC derived allogeneic T-cell products at various stages of development. • Coordinate or directly author CMC content for global regulatory dossiers including INDs (m2.3, m3), clinical trial applications (CTAs), INN/USAN applications, responses to CMC questions, pre-licensing activities (INTERACT, pre-IND, pre-BLA, national scientific advice), and GMO applications. • Providing strategic guidance and input related to current regulatory requirements and expectations for cell-based gene therapy products, e.g., strategy for product comparability, analytical development, etc. • Maintaining a good knowledge of GMP requirements and interacting frequently with QA and QC teams. • Regulatory assessment of change controls.

• Director, Regulatory Affairs CMC

  • Nov 2022 - Jul 2023

• Associate Director, Regulatory Affairs CMC

  • Jan 2022 - Nov 2022



BioMarin Pharmaceutical Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, Gene Therapy Regulatory CMC

  • Nov 2020 - Jan 2022

  London, United Kingdom • Regulatory CMC portfolio lead for early stage AAV5 and AAV9 based gene therapy products and oligonucleotides. • Provided CMC regulatory advice and guidance related to current regulatory requirements and expectations for AAV products and oligonucleotides. • Coordinated or directly authored CMC content for global regulatory dossiers including IMPD/IND m2.3 and m3, responses to CMC questions, pre-licensing activities (INTERACT, pre-IND, Type B facilities, Type C, national scientific… Show more • Regulatory CMC portfolio lead for early stage AAV5 and AAV9 based gene therapy products and oligonucleotides. • Provided CMC regulatory advice and guidance related to current regulatory requirements and expectations for AAV products and oligonucleotides. • Coordinated or directly authored CMC content for global regulatory dossiers including IMPD/IND m2.3 and m3, responses to CMC questions, pre-licensing activities (INTERACT, pre-IND, Type B facilities, Type C, national scientific advice), and GMO applications. • Ensured maintenance of ongoing CMC dossiers in line with regulatory requirements, including assessment of change controls and amendments where required. Show less



Cell and Gene Therapy Catapult

• United Kingdom
• Biotechnology Research
• 200 - 300 Employee

• Senior Regulatory Affairs Manager - CMC Specialist

  • Oct 2018 - Oct 2020

  London, United Kingdom Additional responsibilities: • Deputising for the Head of Regulatory Affairs when required (e.g. leading Catapult advice clinics, business development meetings, etc.). • Line management of two team members and mentoring of wider team for regulatory CMC. • Leading the preparation, compilation and submission of EU CTAs and US INDs. • Leading Health Authority meetings (national scientific advice, INTERACT, pre-IND). • Helped development of the wider cell and gene therapy… Show more Additional responsibilities: • Deputising for the Head of Regulatory Affairs when required (e.g. leading Catapult advice clinics, business development meetings, etc.). • Line management of two team members and mentoring of wider team for regulatory CMC. • Leading the preparation, compilation and submission of EU CTAs and US INDs. • Leading Health Authority meetings (national scientific advice, INTERACT, pre-IND). • Helped development of the wider cell and gene therapy manufacturing and regulatory landscape as a member of the British Society of Gene and Cell Therapy (BSGCT) Clinical Transitional and Regulatory Affairs sub-committee. • Involved with A-Gene project and CMC Regulatory Task Force with the Alliance for Regenerative Medicine (ARM).

• Regulatory Affairs Manager - CMC Specialist

  • Jul 2017 - Oct 2018

  London, United Kingdom • Regulatory CMC consultancy for external companies (pharma and biotech) and academic groups for all types of ATMPs (viral vectors, allogeneic, autologous, gene therapy, cell therapy, tissue engineered products, etc.). • Support included CMC regulatory gap analyses, strategic review of development programs, and authoring of regulatory documents for all types of ATMPs including ATMP classifications, scientific advice briefing documents, core CMC documents (IMPD/IND m2.3 and m3) to meet… Show more • Regulatory CMC consultancy for external companies (pharma and biotech) and academic groups for all types of ATMPs (viral vectors, allogeneic, autologous, gene therapy, cell therapy, tissue engineered products, etc.). • Support included CMC regulatory gap analyses, strategic review of development programs, and authoring of regulatory documents for all types of ATMPs including ATMP classifications, scientific advice briefing documents, core CMC documents (IMPD/IND m2.3 and m3) to meet business needs and agreed time, cost and quality standards. • Authored a type II biologics master file for an iPSC line and worked to get independent technical assessment by FDA so the line could be used as a starting material for manufacture of drug products. • Agency point of contact for scientific advice meetings, CTA submissions, Pre-IND and IND submissions, and follow-up (i.e., information requests, informal communication, etc.) where required. • Maintain up to date knowledge of development in regulations, Quality, CMC, and GMP requirements for ATMPs. • Ensured appropriate regulatory due diligence was carried out on incoming propositions and external facing proposals.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CMC Regulatory Project Manager

  • Jan 2017 - Jul 2017

  Ware, United Kingdom • Represented CMC regulatory for ATMP and therapeutic antibody assets. • Provided regulatory advice and guidance to produce appropriate CMC components for global regulatory dossiers (IMPD, IND m2.3 and m3, MAA/BLA m3, scientific advice).

• Investigator, Process Development, Cell and Gene Therapy Platform

  • Dec 2012 - Jan 2017

  Stevenage, United Kingdom • Worked within the GSK-TIGET alliance on late stage development of ex vivo gene therapies for rare genetic disorders including ADA-SCID (Strimvelis), MLD (Libmeldy), and WAS. • Key member of the CMC team for Strimvelis ensuring manufacture of the retroviral vector, drug substance (gene modified haematopoietic stem cells), and drug product were sufficiently robust for commercial supply • Helped define the strategy for process validation and product comparability following manufacturing… Show more • Worked within the GSK-TIGET alliance on late stage development of ex vivo gene therapies for rare genetic disorders including ADA-SCID (Strimvelis), MLD (Libmeldy), and WAS. • Key member of the CMC team for Strimvelis ensuring manufacture of the retroviral vector, drug substance (gene modified haematopoietic stem cells), and drug product were sufficiently robust for commercial supply • Helped define the strategy for process validation and product comparability following manufacturing process changes made to both vector and drug substance/drug product manufacture. • Lead author for ten sections of the Strimvelis MAA module 3. • From October 2015 to January 2017 was CMC technical lead for MLD; a matrix team leadership role with accountability for the delivery of CMC activities to support product commercialisation. • For MLD this included both the lentiviral vector and cell manufacturing process development, process comparability, process validation, defining the product control strategy, and authoring of CMC components of regulatory dossiers (scientific advice, IMPD, MAA/BLA Module 3).



UCL

• United Kingdom
• Research Services
• 700 & Above Employee

• Postdoctoral Research Associate

  • Apr 2011 - Dec 2012

  London, United Kingdom • Part of the Gene Transfer Technology Group led by Prof. Simon Waddington developing and analysing novel gene therapy vectors (LV and AAV) for inherited diseases of coagulation. • Researched transduction of murine amniotic fluid (AF) stem cells with a FVII expressing viral vector and subsequent reintroduction of cells into recipient haemophilia mice. • Regular lab based duties included production and analysis of viral vectors in vitro and in vivo, coagulation assays, tissue culture… Show more • Part of the Gene Transfer Technology Group led by Prof. Simon Waddington developing and analysing novel gene therapy vectors (LV and AAV) for inherited diseases of coagulation. • Researched transduction of murine amniotic fluid (AF) stem cells with a FVII expressing viral vector and subsequent reintroduction of cells into recipient haemophilia mice. • Regular lab based duties included production and analysis of viral vectors in vitro and in vivo, coagulation assays, tissue culture, isolation and selection of AF stem cells (lin- / CD117+), and molecular biology. • Held a personal home office license and helped maintain the FVII, FVIII, and FIX mouse colonies. Show less



McGill University

• Canada
• Higher Education
• 700 & Above Employee

• Postdoctoral Research Associate

  • Oct 2010 - Mar 2011

  Montreal, Canada Area • Maternity cover post in the lab of Dr. Anne Gatignol at the Lady Davis Institute for Medical Research investigating the RNA interference (RNAi) pathway, specifically assembly of RNA-Induced Silencing Complex (RISC), in relation to infection of host cells by the Human Immunodeficiency Virus (HIV). • Regular lab based techniques included Western blotting, PCR, qPCR, RT-PCR, tissue culture, and manipulation of infectious HIV in a level 3 biological facility. • Completed a basic French… Show more • Maternity cover post in the lab of Dr. Anne Gatignol at the Lady Davis Institute for Medical Research investigating the RNA interference (RNAi) pathway, specifically assembly of RNA-Induced Silencing Complex (RISC), in relation to infection of host cells by the Human Immunodeficiency Virus (HIV). • Regular lab based techniques included Western blotting, PCR, qPCR, RT-PCR, tissue culture, and manipulation of infectious HIV in a level 3 biological facility. • Completed a basic French language course at McGill. Show less



UCL

• United Kingdom
• Research Services
• 700 & Above Employee

• Postdoctoral Research Associate

  • Mar 2010 - Oct 2010

  London, United Kingdom • Continued my PhD work at the Institute of Child Health evaluating expression of factor VIII from a novel lentiviral vector and expanded the project by studying immune responses in vivo. • Additionally began a new project analysing gene targeting by novel meganuclease proteins based on I-SceI for gene therapy of Wiskott Aldrich Syndrome (WAS). • We aimed to express a specific meganuclease protein from integration deficient lentiviral vectors to correct mutations in the WASp gene in… Show more • Continued my PhD work at the Institute of Child Health evaluating expression of factor VIII from a novel lentiviral vector and expanded the project by studying immune responses in vivo. • Additionally began a new project analysing gene targeting by novel meganuclease proteins based on I-SceI for gene therapy of Wiskott Aldrich Syndrome (WAS). • We aimed to express a specific meganuclease protein from integration deficient lentiviral vectors to correct mutations in the WASp gene in CD34+ HSCs. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist

  • Jun 2005 - Jun 2006

  Sandwich, UK • Returned to Pfizer after completing my BSc in 2005. • Worked as part of a team responsible for the development and execution of high throughput assays to identify novel anthelmintic small molecules.