REGULATORY AFFAIRS, quality assurance
Innovations in ATMP: State of the industry in 2024
This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024:
- ATMPs are revolutionizing healthcare. Discover how new technologies are transforming treatment options for rare diseases and beyond.
- Learn about the latest breakthroughs in ATMPs such as CAR T-Cell therapy or Tumor Infiltrating Lymphocyte (TIL) therapy
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Author
Dr. Julian De Havilland (MBA PhD FIBMS FRSB)
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Julian trained as a transplant immunologist and earned his PhD from the University of London, focusing on innate mechanisms of organ transplant rejection. His post-doctoral work included developing recombinant cell-surface targeted complement inhibitors and novel organ perfusion fluids. In 2008, Julian began his role at the Royal Free Hospital in London, where he led the clinical isolation of autologous and allogeneic pancreatic islets of Langerhans in both adult and pediatric patients. Since 2012, Julian has held various positions, including Quality Manager, Production Supervisor, Facilities Manager, Associate Director, and Director of cell and gene therapy production units in Newcastle, London, and Cambridge.
Throughout these roles, Julian gained extensive experience in developing and delivering therapies for diabetes, bone fractures, stroke, blindness, arthritis, myocardial infarction, transplant rejection, viremia, hematological malignancies, and solid organ tumors. His work in cell and gene therapies has included CAR T cells, tumor-infiltrating cells, somatic cells, tissue-engineered products, and stem cell transplantation products, providing him with a comprehensive and technical understanding of advanced therapeutics.
As Director, Julian was responsible for regulatory compliance and inspections in JACIE-accredited and HTA/MHRA-licensed GMP facilities. In 2022, Julian completed a Level 7 Senior Leaders Apprenticeship in Advanced Therapeutics, during which he also earned his MBA. He is currently employed by QbD Group as an ATMP Expert, supporting the development of our clients’ ATMP development programs.