Stephen Flore
Director, Regulatory Cmc, @Acadia Pharmaceuticals
San Diego, CA, US
EMAILS
MOBILE NUMBERS
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WORK HISTORY
Jun 2022 — Present
Director, Regulatory Cmc, @Acadia Pharmaceuticals
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San Diego, CA, US
Responsible for CMC content of regulatory submissions
EDUCATION
1989 — 1991
University of Detroit Mercy
Master's degree, Polymer Chemistry
SKILLS
Analytical ChemistryDrug DevelopmentBiopharmaceuticalsClinical DevelopmentHplcPharmaceutical IndustryFdaValidationTechnology TransferRegulatory SubmissionsGmpBiotechnology
ABOUT STEPHEN FLORE
Managed CMC team responsible for regulatory strategy for BYETTA® and BYDUREON®, including interface with FDA reviewers as CMC representative at End of Phase 2 and Pre-NDA meetings. Wrote CMC CTD sections of INDs, CTAs, MAAs and NDAs to support regulatory submissions, including responses to regulators during review.
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