Shannon Holmes

Shannon is a Sr. Director of Regulatory CMC at Ultragenyx. She leads a Regulatory CMC team responsible for early and late phase gene therapy programs as well as a commercial small molecule program and a late phase anti-sense oligonucleotide program. Prior to this role, Shannon was Sr. Director and Head of Global Product Development Quality at Biogen, where she led a global Quality Product Lead (QPL) team responsible for quality oversight and strategy of all products and devices in clinical development as well as lifecycle management of commercial programs. While at Biogen, Shannon was also a member of the Regulatory Affairs CMC team and led a global team responsible for early phase and commercial biological products as well as change management/compliance activities. Prior to Biogen, Shannon worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting small molecules, biosimilars, and medical devices. Shannon is an active member of the BIO Regenerative Medicine Committee, the BIO Cell and Gene Therapy Discussion Group, BioPhorum’s Cell and Gene Therapy Regulatory group, the ARM Regulatory CMC Advisory Group, and CASSS. Shannon received her PhD in Chemistry from the University of North Carolina and a BS degree in Chemistry from Davidson College.