Agnes V. Klein MD, DPH


Health Canada


Agnes V. Klein MD, DPH, is currently the Director, Centre for the Evaluation of Radiopahrmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate.


After receiving her medical degree from the University of Toronto, Dr. Klein trained in Endocrinology, Medical Biochemistry and Public and Community Health. After joining Health Canada, she has occupied many and varied positions, scientific and managerial. Amongst relevant accomplishments, Dr. Klein represented Health Canada on NCBHR, as founding member and NCEHR as well as chairing the Committee on Clinical Trials of the Council.

In 2000, Dr. Klein moved to Biologics where she actively participated in the inception of the new Directorate and its processes.


Dr. Klein was an active participant in the CIOMS document on Pharmacogenetics and Pharmacoeconomics as well as in the ICH process drafting of guidelines (ICH E15 and E16 on pharmacogenomics). In addition to her special interest in biomarkers, surrogate endpoints and the appropriate design of clinical trials, especially the issues related to small studies, Dr. Klein is also interested in the regulatory and clinical issues regarding subsequent entry biologics (SEBs). This interest has included authorship and co-authorship of several articles on biosimilars.


Dr. Klein has made numerous presentations to professional and regulatory groups on issues surrounding the ethics of clinical trials and the integrity of clinical trial data. Dr. Klein has also presented on a wide-variety of new regulatory endeavours. As such, Dr. Klein has been involved actively with the various meetings organized through the Drug Information Association.


Dr. Klein is an active supporter for excellence in the development of medicines.