Dr. Mark Rohrbaugh
Acierto Innovations Consulting; NIH (Retired)
Global Leader in Intellectual Property, Technology Transfer & Regulatory Strategy for Healthcare and Medical Technologies

Biography
Dr. Rohrbaugh brings deep expertise in structuring, licensing, and governing intellectual property arising from publicly funded biomedical research, with a particular focus on aligning IP strategy, regulatory pathways, and commercialization outcomes. His work has shaped how medical technologies, including drugs, biologics, diagnostics, and platform technologies, move from government laboratories into the marketplace while balancing incentives for innovation, access considerations, and regulatory requirements.
He served for more than twenty years at the U.S. National Institutes of Health (NIH), including over a decade as Director of the NIH Office of Technology Transfer (OTT). In this role, Dr. Rohrbaugh managed the patenting and licensing portfolio for inventions developed by scientists at the NIH, FDA, and CDC, overseeing more than 3,000 issued and pending U.S. patents, 1,400 active licenses, and a global licensee base that commercializes healthcare technologies. Under his leadership, NIH-licensed inventions resulted in 27 FDA-approved products, over 100 diagnostics, and annual product sales exceeding $7 billion.
In parallel, Dr. Rohrbaugh served as a senior advisor on technology transfer and innovation policy to NIH leadership, the U.S. Department of Health and Human Services, and the White House Office of Science and Technology Policy. His responsibilities spanned Bayh-Dole implementation, march-in considerations, public-private partnership design, regulatory-linked licensing terms, and data- and IP-sharing frameworks, particularly in areas such as stem cell technologies, pandemic preparedness, biomarkers, and global health innovation.
Dr. Rohrbaugh has also played a central role in international health technology access and global IP frameworks. He led NIH’s first patent-licensing contributions to WHO-supported Unitaid and the Medicines Patent Pool and later coordinated the licensing of COVID-related technologies to WHO’s COVID-19 Technology Access Pool (C-TAP). He served on the WHO Expert Working Group on R&D Financing and participated in U.S. negotiations supporting the WHO Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property, contributing to global approaches that link innovation, regulation, and access to medical technologies.
Earlier in his career, Dr. Rohrbaugh combined scientific, industrial, and regulatory experience, working as a senior scientist and founding employee at biotechnology startups developing monoclonal antibodies, recombinant biologics, and vaccines, and was responsible for GMP scale-up and manufacturing protocols. He later joined NIH’s National Institute of Allergy and Infectious Diseases (NIAID), where he served as Director of the Office of Technology Development and as a Scientific Review Administrator overseeing competitive biomedical research programs.
Dr. Rohrbaugh holds a Ph.D. in Biochemistry from The Pennsylvania State University and a J.D. with honors from The George Washington University Law School, where he served as Articles Editor of the AIPLA Quarterly Journal. He is licensed to practice law in the State of Maryland and before the U.S. Patent and Trademark Office.
At TIV, Dr. Rohrbaugh advises on healthcare and medical technology innovation systems, supporting clients on IP strategy, technology transfer models, regulatory-aware commercialization pathways, and the translation of complex life-science innovations into scalable, market-ready solutions.
