Tacey E. K. White, PhD
Director of Operations & Senior Consultant
Aclairo Pharmaceutical Development Group
Dr. White is the Director of Operations and a Senior Consultant at Aclairo Pharmaceutical Development Group. She has been a consultant in the pharmaceutical industry since 2012. She advises pharmaceutical and biotech companies on nonclinical safety assessment strategies throughout the entire drug development process, including creating customized nonclinical strategies, placing and monitoring studies, developing human risk assessments for toxicology issues, addressing regulatory questions, and contributing to regulatory documents. Dr. White has deep regulatory and investigative expertise in developmental and reproductive toxicity (DART), and juvenile toxicity, and assists clients with FDA Pregnancy Labeling (PLLR) and pediatric development plans for EMA (PIP) and FDA (PSP).
Prior to her position at Aclairo, Dr. White spent 14 years as a DART study director at Sanofi; a safety assessment project team representative, DART study director, and DART investigative lead at GlaxoSmithKline; and Global Director of Small Animal DART at Covance, where she gained experience with many classes of therapeutics regulated by CDER and CBER. She has served as a toxicology project team member, as well as a strategic advisor on FDA interactions, for DART and general toxicity issues, mechanisms of action, and nonclinical study planning and management. Dr. White has extensive experience in all aspects of nonclinical toxicology and safety pharmacology assessments for small and large molecules, with particular emphasis on DART and juvenile toxicity.
Dr. White is the sitting Past President of the US Teratology Society (Vice President: 2014-2015, President: 2015-2016), and actively participates in the ILSI/HESI DART sub-team, including co-organization of the FDA Pregnancy and Lactation Label Rule workshop, and participation in the Neonatal Pediatric Therapeutics workgroup.
