Shaun Stapleton

Shaun Stapleton is an independent consultant providing regulatory strategy advice and support to biopharma clients globally.

Shaun held positions of increasing responsibility in regulatory affairs at Sterling Winthrop, Eli Lilly, Boehringer Ingelheim and Ipsen, where he managed regulatory input into development programmes globally, securing new product approvals in the neurology, endocrinology and oncology therapeutic areas.

More recently, Shaun spent 8 years in regulatory consultancy at RRG (a Voisin Consulting Life Sciences Company) where he was a Director and Vice President of Regulatory Science working with global clients on a wide range of regulatory projects. From VCLS he moved to ReNeuron Ltd where he led regulatory, pharmacovigilance and latterly quality aspects of cell therapy and exosome development programmes.

Shaun has extensive experience in orphan drug development from first in man clinical trials through to commercialisation globally. He has been involved in discussions with regulators relating to specific orphan exclusivity issues and chaired the Alliance for Regenerative Medicine working group on “sameness” in the context of market exclusivity for orphan ATMPs (cell therapy). Most recently he was VP and Head of Global Regulatory Affairs at Amryt Pharma, a company specialising in the development and commercialisation of orphan medicines globally, where he contributed to the approval and life cycle management of several orphan drugs in areas of high unmet medical need.