Brian Malkin

Brian Malkin is an Instructor in the M.S. in Biotechnology Management and Entrepreneurship program at Yeshiva University's Katz School of Science and Health. He concurrently serves as a Partner at McDermott, Will & Emery in Washington, D.C., specializing in FDA regulatory law and intellectual property litigation for pharmaceutical, biotechnology, and medical device clients. His expertise spans FDA-regulated products (drugs, biologics, medical devices, cannabis, cosmetics), patent lifecycle management, and compliance strategies.

Education: Holds a J.D. from George Washington University Law School (1991), B.A. in Economics (1988), and B.S. in Biochemistry (2004) from George Washington University.

Research focuses on FDA regulatory challenges in biotechnology, orphan drugs, biosimilars, and cannabis. He frequently speaks at industry conferences and publishes on topics such as REMS compliance, off-label promotion, and patent litigation strategies. Teaching includes the course 'Intellectual Property, Regulation and Compliance for Biotechnology Companies.'

Professional activities include moderating panels at FDLI, ACI, and NYSBA events, advising on FDA pre-market approval processes, and navigating patent disputes in life sciences. His work bridges legal, scientific, and regulatory domains to support innovation while ensuring compliance.