Fred Holdbrook, PhD, is a statistician with expertise in rare diseases. He is currently the Director of Biostatistics at Amicus Therapeutics, Inc. Amicus is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases (such as Fabry, Pompe, Batten disease).
Fred earned his BSc in Computer Science from University of Ghana, and MSc in Statistics from University of Manitoba, Canada. He also earned his PhD in Statistics from Montana State University, Bozeman, MT in 2001. Prior to Amicus, Fred joined GSK in 2001 as a project biostatistician. He then worked at Abbott (on Humira, now a block-buster selling biologic), at Novartis (on Gilenya, the first oral medication for multiple sclerosis), and at Allergan.
Fred led Amicus Fabry program through successful NDA approvals of Migalastat in the US, and other countries. Most recently, he also led Amicus Pompe program to a successful granting of breakthrough therapy designation (BTD) by the FDA.
Fred continues his work on the Pompe program, focusing on the next steps, collaborating in research, development, and application of innovative statistical methodologies to influence clinical trial designs, analysis methods, and clinical and regulatory strategies in rare disease areas.