WASHINGTON--(BUSINESS WIRE)--Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA or agency) regulatory consulting firm, today announces that Karen Midthun, M.D., has joined the firm as Principal, Drug and Biological Products.
Dr. Midthun joins fellow principals Drs. John Jenkins and Bob Meyer to co-lead the firm’s Drug and Biological Products Team. In this role, Dr. Midthun will contribute specialized insight — informed by her regulatory, research, and clinical experience — to the strategic and technical guidance that Greenleaf provides to FDA-regulated entities developing improved products to prevent the spread of infectious diseases, addressing ongoing public health needs for biologics, and advancing growing fields such as regenerative medicine.
About Dr. Midthun
Dr. Midthun joins Greenleaf following a distinguished 28-year career in public service, of which 22 years were dedicated to the FDA. An infectious disease physician by training, Dr. Midthun most recently served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER). Prior to her role as Center Director, Dr. Midthun served as the Deputy Director of CBER and the Director of the Office of Vaccines Research and Review within CBER.
During her FDA tenure, Dr. Midthun played a critical role in facilitating policy and technology development in the areas of blood products, vaccines, and cell, tissue, and gene therapies. Under her leadership, the FDA approved several vaccines that have had a significant public health impact, including vaccines for pneumococcal disease, meningococcal disease, and human papilloma virus. Dr. Midthun received praise for her work responding to the 2009 influenza pandemic; developing a framework for the regulation of human cell and tissue products; and, in collaboration with the Center for Drug Evaluation and Research (CDER), developing a policy for the regulation of biosimilar products.
Before joining the FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital.
Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology (MIT) and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases (NIAID). She is a fellow of the Infectious Diseases Society of America and a member of the American College of Physicians.
About Greenleaf’s Drug and Biological Products Team
Greenleaf’s Drug and Biological Products Team delivers a variety of services, including: monitoring and assessing the regulatory environment for emerging trends; analyzing the impact of agency actions on current development programs; and reviewing the competitive landscape for specific therapeutic areas.
Greenleaf experts specialize in clinical trial design, FDA submissions and the review process, and postmarket requirements, including safety monitoring. The team’s approach, firmly grounded in established principles of public health practices, is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.
About Greenleaf Health
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts has more than 225 years of combined FDA experience, and as such, provides a wealth of regulatory knowledge that is unmatched.
Dr. Midthun joins several former FDA officials at Greenleaf, including Patrick Ronan, former FDA Chief of Staff; John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. John Jenkins, former Director of the Office of New Drugs for FDA’s Center for Drug Evaluation and Research (CDER); Dr. Daniel Schultz, former Director of FDA’s Center for Devices and Radiological Health (CDRH); Dr. Bob Meyer, former Director of the Office of Drug Evaluation II within CDER; and Michael Chappell, former Associate Commissioner for Regulatory Affairs. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.
For more information on Dr. Midthun and Greenleaf Health, visit greenleafhealth.com.