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David’s is as a Subject Matter Expert (SME) on the CMC of Biological Medicinal Products and Regulatory Affairs and his role at Parexel involves guiding and advising clients on these aspects at the pre- and post-authorization stages of Clinical Trial and Marketing Authorization procedures. David also routinely interacts with the regulatory agencies on these projects.
Prior to joining Parexel, David worked for 6 years as a Pharmaceutical (CMC/Quality) Assessor of Biological Medicinal Products at the Health Products Regulatory Authority (HPRA) in Ireland. This involved the evaluation of CMC for human biological medicinal products for national and EU procedures. David was a quality assessor as Rapporteur / Co-Rapporteur on new EMA centralized marketing applications and post-authorization variations as well as a coordinator on EMA scientific advice procedures related to the quality aspects for various types of biological products including recombinant proteins, vaccines, monoclonal antibodies, biosimilars and low molecular weight heparin products. During this time, David was the Irish delegate at numerous EMA CHMP Biologics Working Party (BWP) meetings, at the annual CHMP influenza update meeting and a member of BWP vaccine core group. David was also a member of the Irish delegation to the Ph. Eur. Commission. David was a member of the drafting group for the EMA guideline on the quality of water for pharmaceutical use. David frequently delivered lectures to students on these aspects (University of Copenhagen, University College Cork, Trinity College Dublin, Royal College of Surgeons in Ireland) and at conferences as an invited speaker.
Prior to joining the HRPA, David developed a strong biomedical research career authoring / co-authoring 40 scientific publications covering a range of biomedical areas including tumour cell biology.
PhD in Cancer Molecular and Cell Biology. Dublin City University (DCU), Dublin, Ireland. BSc (Hons) in Analytical Science, DCU, Dublin, Ireland.
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