Catarina Edfjäll

Dr. Catarina Edfjäll is passionate about the development of people and treatments for serious diseases. She is an expert in drug development across the entire product lifecycle, including orphan drug development, approval and launch. In more than 25 years Dr. Edfjäll has gained an in-depth knowledge of the global biotech & pharma industry. She is currently active as a member of various boards of directors, independent consultant and mentor, and, previously was a global leader in Regulatory Affairs.

Dr. Edfjäll is a longstanding Board Member of ICORD since 2008. Dr Edfjäll is also a member of the board of directors for the Cancer Drug Development Forum (CDDF) that facilitates collaboration and exchange between stakeholders in cancer drug development. Furthermore, she is a member of the Director Advisory Board to the I-ORD (Indian Organization for Rare Diseases).

Since many years, Dr Edfjäll is driven by a strong interest in bringing new treatments to patients with rare and/or life-threatening diseases. Over the past 20 years she has been involved in several multi-stakeholder organizations with a focus on rare diseases and orphan drugs and was an industry representative on the European Medicines Agency´s (EMA’s) Committee for Orphan Medicinal Products (COMP) Working Group with Interested Parties for its entire duration (2001-2008).

Dr. Edfjäll was responsible for the successful regulatory approval of 20 innovative medicinal products and new indications in more than 50 countries. The approved medicines include biotech, low-molecular and plasma derived products, as well as products for various rare diseases. In her most recent leadership role, she was the global head of regulatory affairs at the Australian company CSL Behring. Prior to that, she held leadership positions in regulatory affairs at both start-up and mid-size biotech and pharma companies (formerly known as Actelion, Celgene and Shire), she started her career in regulatory affairs at F. Hoffmann-La Roche.

Dr. Edfjäll holds a master’s degree in biotechnology engineering from the Ecole Supérieure de Biotechnologie de Strasbourg, France, and, a Ph.D. in biochemistry from the University of Basel, Switzerland.

Catarina Edfjäll, PhD