Wendy Sanhai, Ph.D., M.B.A.

President, Innovative Strategic Solutions, LLC 

Dr. Sanhai’s extensive experience in biomedical research and regulatory science ranges from the basic research, to teaching, to technology and business development, to the design, implementation, and management of large-scale strategic collaborations at NIH, the Foundation for NIH (FNIH), and FDA and medical product development in industry. She has held key leadership roles in academia; at federal research and regulatory organizations; and, most recently, with regulated industry. Among her many strengths is her ability to identify critical clinical and scientific gaps and leverage resources to create innovative approaches in support of large-scale, strategic, scientific, and public health initiatives, all directed to patient benefit.

Dr. Sanhai’s dedication to the advancement of biomedical research and public health began in academia while serving first as clinical chemistry fellow, then scientific researcher, and finally Assistant Professor in the Departments of Pathology and Medical and Research Technology at the University of Maryland, School of Medicine. She left academia in 2001 to join the NIH, Office of Technology Transfer, as a Technology Licensing Specialist and Patent Advisor. There, she managed a license and intellectual property portfolio of more than 300 NIH invention families from across 27 Institutes and Centers of the NIH, with special emphasis on the National Cancer Institute. Dr. Sanhai worked extensively with industry, academia, and international organizations on behalf of NIH and FDA, conducting a full range of activities associated with business development, including intramural and extramural NIH research, securing appropriate intellectual property protection, and negotiating the transfer those patent rights to the private sector to promote the research, development, and commercialization of medical products that were patient-focused. Dr. Sanhai also served as Director of Public-Private Partnerships at FNIH. She created, implemented, managed, and evaluated all new and existing programs in clinical research, education, and training. Serving as Chief Scientific Liaison to the NIH, other federal agencies, academia, industry, and non-profit organizations, her program portfolio budget was to reach $113M, notwithstanding the FNIH’s $200M Grand Challenges in Global Health Initiative.

In 2004 Dr. Sanhai assumed the responsibilities of Senior Scientific Advisor, Office of the Commissioner, FDA, where she led until 2011 the development, implementation, and management of FDA’s Scientific Initiatives/ Strategic Alliances as part of FDA’s public health mission. Dr. Sanhai served as FDA’s Chief Scientific Liaison on a number of boards, clinical studies, consortia, and regulatory/scientific committees, leading the establishment of innovative models of scientific collaborations. Dr. Sanhai was recognized for her outstanding achievements at FDA, receiving the Commissioner’s.