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Shaun Stapleton
VP Regulatory Affairs and Pharmacovigilance at ReNeuron


Shaun is currently VP of Regulatory Affairs and Pharmacovigilance at ReNeuron Ltd, a UK- based biotech company developing stem cell therapeutics in neurology and ophthalmology indications.

Shaun has 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.

Before joining ReNeuron, 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.

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 most recently has chaired the Alliance for Regenerative Medicine working group on “sameness” in the context of market exclusivity for orphan ATMPs.

Agenda Sessions

  • Think Tank: Sameness/Similarity for Orphan ATMP Products