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Founded and directed Milestone. In her new role as president of Aclairo®, Dr. Sheevers will continue to provide scientific and regulatory advice in preclinical development, FDA interactions, due diligence and strategic planning for drug development. Dr. Sheevers was a preclinical team leader in Pulmonary Drug Products, and a reviewer in the Division of Dermatologic and Ophthalmic Drug Products. In the past 5 years as a consultant, she provided complete toxicology plans, study monitoring planning and support, regulatory support including data interpretation and presentation, as well as preparation of IND, NDA, CTD, and pre-IND submissions for the FDA. She also provided expertise in the strategy and development of varied molecules, including inhalation, dermal, ophthalmic, neuropharmaceutical, endocrine, oncology, reproductive, GI, anti-infective, and intra-nasal drug products. Dr. Sheevers also specializes in developing unique strategies for carcinogenicity testing, reproductive and developmental toxicity testing, route of administration switches, excipient and impurities development, and out-of-the-ordinary problem solving. She is often called to serve on expert panels on issues related to carcinogenicity, reproductive and developmental toxicity, non-monitorable toxicity, inhalation drug development, and unusual preclinical issues. |
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