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 Prior to the formation of Aclairo® and her appointment as VP, Chief Operating Officer, Ms. Dunn served as Milestone's senior project manager and regulatory consultant. Ms. Dunn has over 13 years of consulting experience as an independent consultant and as the Director of Quality Assurance at SRA Sciences. Prior to her consulting experience, she worked at Covance and EPL, Inc. in management or project coordination roles. At Milestone, Ms. Dunn specialized in the overall management of toxicology programs for clients, including inhalation, dermal, and parentally administered products. Ms. Dunn was responsible for overall program management including the strategic design of pharmacology and toxicology programs, drug substance and drug product manufacturing considerations, clinical study designs, and strategic regulatory plans. Ms. Dunn has also continued to monitor nonclinical toxicology studies for compliance and scientific integrity. As a regulatory consultant, Ms. Dunn has served as an US Agent; has prepared and reviewed IND, NDA, and CTD packages, participated in FDA meetings, and provided strategic regulatory advice. |
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