Consultant

Ewa Budzynski, PhD, DABT

Dr. Hilary Sheevers is an established toxicology and regulatory strategy consultant to the pharmaceutical industry. She provides guidance on nonclinical safety, strategic planning for drug development, gap analysis, and due diligence for in- and out-licensing assets. Hilary received her PhD in Pharmacology and Toxicology from the University of Arizona. She is a former regulator at the FDA (CDER), the founder and president of Aclairo Pharmaceutical Development Group, and a former Worldwide Director at Janssen Pharmaceuticals.

At Akkeri, Hilary continues to provide global nonclinical safety strategy, study planning recommendations, position papers, and regulatory documentation and interaction support. She is a recognized expert in regulatory communications with health authorities, handling both conventional regulatory filings and complex position papers that involve sophisticated scientific and regulatory discussions. Hilary’s experience spans virtually all therapeutic areas for both biologics and small molecules.

She is an active member of the American College of Toxicology (ACT) and the Society of Toxicology (SOT) and serves on the National Advisory Board for the College of Pharmacy at the University of Arizona.