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Aoife Duffy
Production Manager, Regulatory Affairs and Training Manager at Centre for Cell Manufacturing Ireland (CCMI)

Profile

Aoife graduated with a BSc in Biochemistry and then completed an MSc in Molecular Medicine from Trinity College Dublin and a postgraduate Higher Diploma in Quality Assurance from NUIGalway. Aoife has over 18 years’ experience in stem cell biology, ATMPs, GMP manufacturing of ATMPs, Quality Control and regulatory affairs. Aoife has been Production Manager at CCMI since 2010. In 2013, Aoife played an essential role in getting the regulatory license for the first approved stem cell manufacturing facility in Ireland to produce clinical grade ATMPs. Since then Aoife has successfully led technical transfer, process development and clinical trial approvals for 4 clinical trials in Ireland and across Europe (one of which went through the VHP submission process) for various different ATMPs for different disease indications (critical limb Ischemia, Osteroarthritis, diabetic Kidney Disease), with over 20 patients treated. In addition, she is currently developing a newly funded product for a novel immune cell based therapy for oncology and is developing the production and clinical trial strategy for first in human trials of this product in Ireland.

Agenda Sessions

  • Evaluation, implementation and validation of an in-house rapid mycoplasma method to support the manufacture of advanced therapeutic medicinal products (ATMPs).

    11:35am