Stephen Flore Email & Phone Number

San Diego, California, US

New York, New York, US

Responsible for CMC content of regulatory submissions

San Diego, CA, US

· Responsible for CMC content of regulatory submissions

Samumed conducts drug development of small molecule Wnt pathway modulators, for oncology, regenerative medicine and degenerative diseases.·Wrote CMC technical reports and drug product sections of CTDs for multiple IND submissions.·Managed drug product manufacturing at multiple CMOs for tablets, suspensions, topicals, and parenterals.·Managed.

Lawrence Township, NJ, US

Responsible for manufacturing and submission activities for extended release parenteral peptide products.

San Diego, CA, US

·Led activities for CMC technical reports and sections of BYDUREON® Common Technical Document (CTD) for regulatory submissions, including representing CMC technical activities at regulatory interactions with FDA and EMA, at End of Phase 2, pre-NDA, and Scientific Advice Working Party meetings.·Managed clinical supplies manufacturing for all trials from.

·Validated analytical methods related to drug substance, drug product, and excipients for blood substitute and ultrasound agent and for cleaning agent residue in manufacturing equipment.·Responsible for preparation of analytical sections of IND, NDA, and MAA submissions for IMAGENT®, and integration of project into cross functional teams. ·Optimized.

Silver Spring, MD, US

·Inspected pharmaceutical firms’ quality control labs and manufacturing sites for compliance with CFR and GMPs.· Performed analytical chemistry method validation on NDA pharmaceutical products as supplied by applicants in support of the approval process. Analyzed pharmaceutical products for compliance with federal criteria and quality. Extensive use of.