Area of Expertise:
Nicole Lay, MS, DABT
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 cardiorenal, dermatology, neuromuscular disease, gene therapy, oncology, and opioid addiction. Nicole provides nonclinical regulatory support through authorship and scientific review of nonclinical regulatory submissions including briefing packages to support FDA meetings, INDs, and NDAs, and participation in meetings with regulatory agencies. Nicole has extensive experience in nonclinical program management, outsourcing support, and study monitoring. Prior to joining SciLucent, Nicole was employed by a contract research organization where she participated in the design, conduct, and reporting of toxicology studies to support drug development programs. Nicole has a B.S. in Biology from Central Michigan University, an M.S. in Toxicology from Michigan State University, is an active member of the American College of Toxicology and Society of Toxicology, and continues her education and training through regular participation in toxicology workshops, classes, and meetings.