Area of Expertise:
Nicole Lay, MS, DABT
Nicole is a board-certified toxicologist and general regulatory affairs professional with more than 15 years of experience in the pharmaceutical industry. She provides leadership oversight and manages a team of nonclinical professionals. Nicole specializes in the nonclinical safety evaluation of drugs, biologics, and combination products. She offers strategic nonclinical development services to Sponsors and has worked on products for a variety of indications, including but not limited to, cardio-renal, dermatology, neuromuscular disease, oncology, pain management, and opioid addiction. Nicole has experience with novel pharmaceutical development of small and large molecule products. She also has expertise in navigating the 505(b)(2) regulatory pathway as well as effectively and efficiently contributing to cross-functional project teams to develop scientific and regulatory strategies to support all stages of development. Nicole started her career at a nonclinical CRO and has extensive experience in nonclinical program management, outsourcing support, and study monitoring. Her experience includes working with products delivered by standard and nontraditional routes of administration including inhalation and intravesical instillation as well as various models of bone healing. Nicole provides nonclinical regulatory support through authorship and scientific review of nonclinical regulatory submissions including briefing packages to support FDA meetings, INDs, and NDAs/BLAs, as well as preparation and participation in meetings with regulatory agencies. She also provides expertise in nonclinical safety assessments for product impurities, contaminants, and extractables/leachables. Nicole has a B.S. in Biology from Central Michigan University, an M.S. in Pharmacology & Toxicology from Michigan State University, and she is a certified Diplomate of the American Board of Toxicology (DABT).