Karin Hoelzer, DVM, PhD

Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). In this role, Karin provides strategic direction to advance NORDs federal policy and regulatory priorities. She works closely with key rare disease partners across the pharmaceutical and biological space to ensure the policy landscape supports innovative approaches and new treatments to help rare disease patients, and adequately incorporates patient preferences and perspectives in therapy development. Her role also involves extensive legislative and communication engagements to advance rare disease policy priorities.

Dr. Hoelzer is a health policy, risk analysis, and biomedical research expert, with extensive intellectual property and regulatory expertise across most FDA-regulated products. Most recently, she worked at Maximus, Inc. where she established and led a new health data analytics division to provide more timely data and better insights to government clients in support of the public health response to the COVID-19 pandemic.

Prior to working at Maximus, Inc., Dr. Hoelzer served as Senior Officer for Health Programs at The Pew Charitable Trusts where she led policy and regulatory efforts to improve the federal oversight of a variety of FDA-regulated products. Dr. Hoelzer joined Pew from the Food and Drug Administration (FDA), where she served as Risk Analyst. In this role, she assessed and quantified the expected impact of changes to FDA policy and regulatory practice.

Prior to joining FDA in 2010, Dr. Hoelzer worked as Biomedical Researcher for Cornell University. She received a PhD in comparative biomedical sciences from Cornell University and a Doctor of Veterinary Medicine degree from the University of Veterinary Medicine in Hannover (Germany). Since 2014, she is also a registered patent agent with the U.S. Patent and Trademark Office, and remains active in the biomedical research space. This includes serving as Editor in Chief for a major peer-reviewed international biomedical research journal and as the Executive Director for the professional association representing veterinarians in DC.
Speaking In
9:45 AM - 10:30 AM
Monday, October 23
Rare disease patients are facing more challenging access issues than ever before, and implications…
Independence Ballroom