Michelle Rose

Dr. Michelle Rose established Michelle Rose, Inc. after 20 years of working in the pharmaceutical and biotech industry as both in-house Regulatory support for Sponsor companies and as a consultant in all phases of the drug development process from discovery through clinical research to licensing. She endeavors to serve as a trusted, experienced partner when bringing strategic regulatory advice to clients. Dr. Rose has extensive experience with Orphan Drug and Rare Disease Development Programs as well as FDA’s Expedited Programs for Serious Diseases and Conditions including Fast Track Designation, Accelerated Approval, Breakthrough Therapy Designations, and Priority Review. She also has extensive experience with other unique regulatory pathways, such as NDA Approval under the Animal Efficacy Rule. She has worked with FDA on Expanded Access programs, including Emergency INDs and Intermediate Size Expanded Access Programs and has led and participated in FDA Advisory Committees.

Prior to becoming a consultant, Dr. Rose served as Vice President of Regulatory Affairs for Chimerix, Inc, an antiviral focused drug development company, where she built the Regulatory Affairs and Operations functions. Over the course of 8 years, her department of one overseeing a single FIH clinical program grew to encompass both US and EU based employees conducting global Phase 3 clinical trials and preparing for simultaneous NDA and MAA submissions. Prior to her time with Chimerix, Dr. Rose served as a Regulatory Authority Liaison at Biolex Therapeutics and EMD Pharmaceuticals, where she was the regulatory lead for global development projects in antiviral and oncology therapeutic areas and led US submissions for small molecule NCEs for treatment of Type 2 diabetes and for one of the first products approved by the FDA under the Animal Efficacy Rule.

Dr. Rose earned a BS in biochemistry from Case Western Reserve University and PhD in toxicology from the University of North Carolina at Chapel Hill.