Speakers

Mustafa Ünlü is an experienced attorney with expertise in complex legal and scientific issues in public health, federal regulation, enforcement, and administrative law. He also has had a prior career as a proteomics researcher in academia and the private sector. Currently, Mustafa is the Policy Staff Director at the FDA’s Office of Therapeutic Biologics and Biosimilars where he leads the group responsible for biosimilar and interchangeable product regulatory policy development. His field of experience reaches across several FDA practice areas, including Hatch-Waxman and the Biologics Price Competition and Innovation Act, exclusivity, generic and biosimilar approval standards, orphan drugs, product classification, combination products, labeling, preemption, debarments, as well as general matters of administrative law, among others. He has also been involved as the lead litigator in several litigation matters, including those that involved complex questions of exclusivity.

Mustafa Ünlü has a PhD in biochemistry from Carnegie Mellon University.  In 1998, he started a postdoctoral fellowship at Aberdeen University in Aberdeen, Scotland. He joined Millennium Pharmaceuticals in 2001 as a researcher. In 2004, he joined MIT’s Center for Computational and Systems Biology as a research scientist.

Mustafa obtained his JD in 2009 from the University of Michigan Law School.  After graduating law school, Mustafa spent the summer as a legal intern in the Office of Chief Counsel at FDA, then clerked at the D.C. Court of Appeals for a year. After finishing his clerkship, Mustafa joined OCC in 2011. Since then, in addition to his FDA duties, he has served on AAAS’s judicial fellowship selection committee and as an adjunct professor of law at the University of Maryland law school, and has taught various courses at FDA.