Florence Houn, M.D. Strategic Consultant to Industry and to International Health Authorities Dr. Florence Houn is owner-manager of Florence Houn MD MPH LLC, providing consultation to industry and health authorities regarding drug development programs and regulatory capacity building. She was previously the VP for Global Regulatory Science at Bristol-Myers Squibb/Celgene from 2016-2020 and VP, Global Regulatory Policy, Intelligence and Strategy at Celgene from 2008-2015. Prior to this, she served 15 years in the US Food and Drug Administration (US FDA) as Division Director of Mammography Quality, Deputy Office Director for the Office of Vaccines Research and Review and Office Director for Drug Evaluation III. In recognition of her contributions to public health, Dr. Houn received the US Department of Health and Human Services’ (DHHS) Secretary’s Award for Distinguished Service in 1998 and DHHS Career Achievement Award in January 2009. In 2014, she received the FDA Distinguished Alumni Award from Commissioner Margaret Hamburg for contributions to global regulatory capacity building. Prior to joining government, she served four years in the National Health Service Corps in a manpower health shortage area in Baltimore.
Dr. Houn was the founding co-chair of the FDA Alumni Association’s (FDAAA) International Network (FDAAAIN) and was a member of the FDAAA Board of Directors 2012-2018. She is a member of the Centers for Medicare and Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), January 2017 to now. She served on the PDUFA V negotiating team representing the Biotechnology Industry Organization (BIO) with FDA in 2010-2011. She serves on the Asia Pacific Economic Cooperation (APEC) Harmonization Center’s Advisory Board (2013 to now), Pharmaceutical Education and Research Institute, Inc. curriculum committee (PERI) (2019-now) and is on the Board of Directors for the International Partnership for Microbicides (IPMglobal.org) (2016-now).
Dr. Houn received her Bachelor of Arts degree, with honors, from Harvard University and her medical degree from the Albert Einstein College of Medicine. She completed her Cancer Prevention and Control Fellowship at the National Cancer Institute and obtained her MPH from the Johns Hopkins School of Hygiene and Public Health. She attended the Johns Hopkins Breast and Ovarian Surveillance Service as an Instructor in Oncology.