Dr. Caster will help to establish WuXi AppTec’s one-stop service for US submissions, and she will act as a subject matter expert for US regulatory affairs.
With thirty years of experience in drug development, Dr. Donna Caster will be the FDA representative on behalf of IND clients for pre-IND meetings, dossier preparation and submission. She will work together with the Shanghai regulatory team as well.
Dr. Caster received her PhD in Chemistry from Washington State University in Pullman. Her experience includes analytical R&D, coordination and delivery of global regulatory CMC documentation to support all phases of clinical development, delivery of a wide range of regulatory filings, and associated regulatory activities supportive of clinical, registration and post-marketing phases.
Previously, she worked as a Regulatory Product Lead in the newly formed AstraZeneca Pharmaceuticals Antibiotics Business Unit, as Regulatory Affairs Manager, as a Senior CMC Documentation Coordinator, and as a method development chemist/group leader/team manager, at AstraZeneca Pharmaceuticals (legacy Zeneca, ICI Pharmaceuticals) in Wilmington.
Please contact your account manager or email Dr. Caster to learn more about how WuXi AppTec’s can work with you for all your US submissions.