Karen Midthun, M.D., Joins Greenleaf Health

Firm Announces Dr. Midthun as Principal, Drug and Biological Products

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.

Contacts

Taryn Walpole
[email protected]