(Gene Therapy)
Katie O'Keefe is a regulatory affairs consultant with more than 25 years of experience leading global regulatory strategy for rare disease, oncology, ophthalmology, chronic pain, and hematology drug and biologic products from early clinical development through post-marketing lifecycle management.
As the founder of KORE Strategy Solutions, Katie partners with biotechnology companies to develop and execute regulatory strategies that accelerate product development while maintaining compliance with global regulatory requirements. Her expertise spans regulatory strategy, health authority engagement, submission planning and execution, regulatory operations, and program management for emerging biotechnology companies.
Throughout her career, Katie has been recognized for building collaborative relationships with regulatory authorities, development partners, and cross-functional teams. She is known for translating complex regulatory requirements into practical development strategies, aligning diverse stakeholders around common objectives, and guiding organizations through critical development milestones with a thoughtful, risk-based approach.
Katie earned a Bachelor of Arts in Anthropology and Psychology from The Johns Hopkins University and a Master of Public Health in International Health from Boston University. She was also awarded a Fulbright Grant to work with the Soros Foundation to set up programs for at-risk-youth in Lithuania and has completed extensive post-graduate training in health and wellness coaching, positive psychology, neurolinguistic programming, and personal leadership development.
(Gene Therapy)
(Canavan Disease)