About me
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals Working Party (BWP) at EMA and regulatory chair the ICH Quality Discussion Group. He has helped draft several guidelines such as the EMA toolbox guidance for PRIME products, the EMA reflection paper on a tailored clinical development of biosimilars, and the EMA-FDA Q&A on regulatory flexibilities. As a member of the ICMRA collaborative assessment group, Sean helped establish the first pilot programme for multi-agency assessment of post-approval CMC changes.
