Hilde Williams

With over 30 years’ in the biotechnology/pharmaceutical industry, Hilde is an expert in strategic regulatory affairs and clinical development across multiple disease areas and compound classes. Hilde’s deep regulatory affairs expertise has focused on investigational pharmaceutical products, including Phase 1 through Phase IV development. Hilde served as Sr. Vice President, Regulatory Affairs and Development, Acadia Pharmaceuticals where she oversaw the only successful Phase 3 program in Parkinson’s Disease Psychosis. Hilde garnered FDA agreement for an NDA submission based on a single study, gained strategic Breakthrough Designation (first for FDA Psychiatry Division) and oversaw development of a high-quality NDA granted Priority Review by the FDA, and subsequent approval. During her career, Hilde has provided leadership on regulatory and development activities associated with the launch and conduct of five other development programs for CNS and psychiatric indications.