Craig Ostroff is Senior Director, Global Regulatory Affairs and Therapeutic Area Head for the CardioRenal, Dermatology, and Pulmonary areas for Otsuka Pharmaceuticals, Princeton NJ. He also serves in a
partial policy role via engagement with PhRMA on multiple scientific and policy committees. He
previously served as lead for the company’s steering committee for a challenging 2013 FDA advisory
committee for an orphan, fast track program, and has recently guided a global team through multiple
ICH region first-in-disease MAA approvals. Dr. Ostroff has twice worked within the US FDA in both a
review division role in the Office of New Drugs as well as being awarded an Oak Ridge Institute Research
Fellowship, being assigned in clinical review to the Office of Compliance. Over his career, Dr. Ostroff has
served in roles of increasing responsibility within global regulatory affairs at Aventis, sanofi-aventis,
Schering-Plough, Cephalon, and more recently at startup Archimedes Pharma US where he built out and
led the US regulatory organization. Dr. Ostroff is an active author and has previously taught regulatory
affairs courses at Johns Hopkins University Dr. Ostroff holds both undergraduate and graduate degrees
in Pharmacy from Rutgers University and is a licensed pharmacist-immunizer. Dr. Ostroff’s present
professional interests cover a broad span and include increasing patient voice in drug development and
review by helping to educate advocacy groups about the FDA and drug development process, clarifying
the increasingly gray area of device regulation and mobile medicine, understanding the intersection of
social media and Pharmacovigilance responsibilities, as well as sensitizing health authorities to the
unique needs of small business enterprises.