Steven Linberg, PhD

Principal Steven Linberg has over 35 years in the regulatory industry with emphasis on drug and biologics development, clinical trial design, and interactions with the FDA. Steven began his career in academia but has since founded Airway Therapeutics, focusing on pulmonary research programs, and held numerous pharmaceutical research positions in various senior leadership functions at Chiesi Pharmaceuticals Inc and Cato Research Limited. He has also worked as an independent consultant. He is the principal editor and contributing author of the text “Expediting Drug and Biologics Development,” currently in its 3rd Edition. He continues to teach graduate courses at John Hopkins University in Drug and Biologics Development, Clinical Trial Design, and Clinical Trial Operations. Steven earned both his Ph.D. and M.S in Physiology from Pennsylvania State University.