Marlene Haffner
Biochemistry
Denovamed Inc.
Canada
Biography
Dr. Haffner is the CEO of Haffner Associates, LLC a firm dedicated to the strategy, development and policy of drug development with a special emphasis on rare diseases and the products that treatment them. For 20 years, Dr. Haffner served as Director of the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA). As OOPD Director she was responsible for the leadership and management of the FDA orphan products development program, the first Orphan Products program in the world. In addition to her FDA responsibilities, Dr. Haffner assisted in the development of Orphan Drug programs in the EU, Japan, Australia and beyond. She is well known as an expert in orphan drug development and is a sought after speaker and consultant in that area of regulatory science.
Research Interest
Biochemistry
