Resolution Expands its CMC Capabilities with Key Hires
Preparing for first program to enter the clinic with appointments across Quality, Process and Analytical Development, Project Management and Regulatory
London, 30 March 2023 – Resolution Therapeutics Limited (“Resolution”), a biopharmaceutical company developing macrophage cell therapies to treat advanced liver disease, today announced that it has made key additions to the Company’s team by appointing experienced unit heads across the various CMC functions. They are, Damian Marshall – VP Analytical Development, Adeyemi Afuwape – Head CMC Regulatory Affairs, Anna-Kaisa Lehtivarjo – Head of Quality, Sarah McCrory – Head of Project Management and Steven Howe – VP Process Development.
“The Company is grounded in strong scientific research and macrophage manufacturing know-how, said Amol Ketkar, Chief Development Officer of Resolution. “These new hires are testament to our commitment to developing high quality cell therapies and are key as we rapidly progress our lead program, an engineered macrophage cell therapy to treat liver cirrhosis, into the clinic.”
Damian Marshall serves as VP Analytical Development at Resolution. He brings over 20 years’ experience in the cell and gene therapy field leading analytical innovation teams supporting CMC activities for early and late-stage clinical products. Prior to joining Resolution Damian held various leadership positions including VP – Manufacturing Science and Technology at Achilles Therapeutics, Director of New Technologies at the Cell and Gene Therapy Catapult and Head of Cell Biology R&D at LGC Limited. Damian holds a PhD in developmental biology and a BSc (hons) in biology from the University of Manchester.
Adeyemi Afuwape serves as Head of CMC Regulatory Affairs at Resolution. He brings over 17 years’ industrial experience as an immunological expert in medical devices and biologics with a strong focus on cell and gene therapies. Prior to joining Resolution, he served as Group Head, Regulatory Sciences – ATMP at ProPharma Group where he led a team advising clients on early to late-stage development of their advanced therapy products. Previously he held CMC regulatory consulting positions at ERA Consulting (now BioPharma Excellence), Diamond Pharma and PharmaLex. He gained his ATMP experience as Lead Process Development Scientist – Immunotherapy at the Cell and Gene Therapy Catapult in London. He also has over 8 years’ postdoctoral experience in in vivo disease models of rheumatoid arthritis (Imperial College London) and inflammatory conditions (King’s College London, Royal Free Hospital, UCL). Yemi holds both a BSc Pharmacology from King’s College London, an MPhil in Pharmacology from the University of Sheffield and a PhD in Immunology from University College London.
Anna-Kaisa Lehtivarjo serves as Head of Quality at Resolution. She brings over 15 years’ experience in ATMP quality and CMC regulatory management. Throughout her career she has worked in several GMP quality assurance positions, including as a Qualified Person releasing drug products for clinical trial use. Previously Anna-Kaisa held the position of Quality Director at FinVector, a CDMO manufacturing sterile ATMPs where she was responsible for Quality Assurance, Quality Systems and Compliance, Quality Control and Process Microbiology functions, and overall GMP compliance of the company. In addition, she has worked as a quality consultant, supporting clinical phase companies working with ATMP products in quality system development and quality management activities. Anna-Kaisa holds a MSc in Biotechnology and Molecular Biology from the University of Kuopio.
Sarah McCrory serves as Head of Project Management. She brings over 20 years’ of varied human health and pharma/biotech experience gained from roles within industry, the public sector and academia with experience of managing R&D, drug development, CMC programmes and CTA filings. Previous roles include Head of R&D Programme Management at the start up biotech, Macrophage Pharma Ltd, up to global scale organisations with roles as Senior Scientist in Molecular Biology and Customer Proposal Management in the Clinical Development and Licensing division of Lonza Biologics. She holds a BSc in Biological Sciences from University College London and a PhD in Molecular Virology undertaken at Public Health England in collaboration with the University of Reading.
Steven Howe serves as VP Process Development. He brings 25 years’ experience of working in cell and gene therapy including postdoctoral positions at the UCL Great Ormond Street Institute of Child Health, London, before joining GlaxoSmithKline in 2015 as Senior Director of Product Development leading a team in developing manufacturing processes for advanced therapies. During his career Steven has led groups researching a wide range of gene therapy areas including viral vectorology, stem cell biology and cell processing. His recent positions have focused on Process Development of manufacturing platforms for translation of advanced therapies, for disease areas including immunodeficiencies and cancer, into the clinic. Steven holds a BSc (hons) in Biology from Bristol University and a PhD from Imperial College, London.
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Notes for Editors:
Resolution Therapeutics is a biotechnology company developing macrophage cell therapies to treat advanced liver disease. The Company is built upon more than a decade of work in the Founders’ laboratories characterising the role of macrophages in organ repair, including the liver, both in the pre-clinical and clinical settings. Resolution will discover, develop, and take to market macrophage cell therapies based on its proprietary platform of macrophage biology, cell engineering and manufacturing processes. www.resolution-tx.com