Stacey A. Ayres, PhD, has more than 20 years in the pharmaceutical Industry, 15 years of which has been at Premier Consulting specializing in the 505(b)(2) drug approval process.
As Vice President, Regulatory Strategy, Dr. Ayres has participated in more than 60 regulatory meetings at the FDA, including pre-IND Application (PIND), End-of-Phase II (EOP2), and pre-New Drug Application (NDA) meetings, encompassing a broad range of therapeutic areas including cardiovascular, endocrinology, urology, dermatology, neurology, oncology, ophthalmology, and others. She has also been part of Investigational New Drug Application (IND), NDA and Abbreviated New Drug Application (ANDA) preparations/submissions, including electronic submissions. and has been responsible for the preparation of regulatory/scientific documents including feasibility reports, PIND meeting packages, EOP2 and Pre-NDA meeting packages for submission to regulatory agencies. Dr. Ayres has provided successful strategic regulatory approaches to Orphan Drug Designations Requests (including plausible hypothesis of clinical superiority, major contribution to patient care, and orphan subsets), Qualified Infectious Disease Product Designations and FDA’s expedited programs for serious conditions (eg, fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation). She has authored rare pediatric disease designation requests, rare pediatric priority review voucher requests, Citizen Petitions, and Suitability Petitions.
Dr. Ayres has transitioned in the past 6 years to leading Product Selection Projects and preparing Feasibility (Product Portfolio) Reports identifying commercially viable products via the 505(b)(2) regulatory pathway, as well as time- and cost-effective product-development strategies, ranging from product concept (identification) and development (nonclinical and clinical testing; chemistry, manufacturing, and controls; regulatory) to marketing approval and commercialization. The Feasibility/Product Portfolio Reports entail a disciplined/integrated approach of evaluating the scientific viability, medical viability, regulatory viability and commercial viability to meet the client’s identified product selection criteria/business strategy. The years of experience and frequent regulatory interaction affords Dr. Ayres an opportunity for creative, outside the box thinking leading to alternative acceptable regulatory strategies that benefits the Sponsor from a time-/cost-effective standpoint and/or commercial differentiation standpoint.
Prior to Premier Consulting, Dr. Ayres was at Duramed Pharmaceuticals (now Teva Pharmaceutical Industries LTD) where she was Research Associate, Clinical/Medical Affairs. In this role, she was responsible for diverse assignments in clinical and medical affairs, with responsibilities for managing and conducting research projects from Phases I–IV (including regulatory submissions, annual reports, and post-marketing materials). Dr. Ayres also provided scientific and clinical input into sales and marketing materials and developed medical education training materials for sales representatives, and prepared medical response letters for physician and consumer contacts hotlines.
Dr. Ayres received her B.A. in Exercise Physiology from Northern Kentucky University, a M.S. in Exercise Physiology from Ohio University and her Ph.D. in Interdisciplinary Studies (Physiology) from the University of Cincinnati, focusing on the role of 17β-estradiol in lipid peroxidation and DNA damage. Dr. Ayres was a Research Scientist at the Department of Veteran Affairs, Dayton VA Medical Center, and an Adjunct Professor, Physiology at Andrews University, Dayton, Ohio. Dr. Ayres has authored/co-authored numerous peer-reviewed publications, review articles, and presentations at scientific meetings and has been the recipient of both federal and private research grant support.
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