Katie McCarthy | SVP & Practice Lead, Clinical & Regulatory
Lumanity

Katie McCarthy, SVP & Practice Lead, Clinical & Regulatory, Lumanity

Katie is the Senior Vice President and Practice Lead of Clinical and Regulatory Services at Lumanity. In this role, Katie drives the strategic direction and operational excellence of the Clinical and Regulatory practice, ensuring alignment with Lumanity’s vision and growth objectives. She leads a high-performing team, expands the service portfolio, enhances capabilities, and fosters growth while maintaining a relentless focus on delivering impactful solutions that improve patient outcomes and promote client success.  Katie’s leadership skills and asset development expertise have been honed through decades of industry experience, spanning academic, biotech, and consulting roles. Before joining Lumanity, she served as Chief Innovation Officer at Halloran Consulting Group, where she played a key role in shaping the company’s growth vision. Before this, she spent many years guiding biopharma companies, building and leading Halloran’s consulting business and practices, and providing expert guidance on strategic planning, clinical development portfolios, and complex drug development challenges. Katie’s career began at Massachusetts General Hospital, where she worked as a Clinical Research Coordinator in the Memory & Movement Disorders unit. She later joined Biogen, where she held multiple leadership roles in Program and Alliance Management, Medical Research, Organizational Effectiveness, Clinical Development, and Clinical Operations.  Beyond her professional achievements, Katie is committed to community service and mentorship. She serves on the Life Science Cares Board of Advisors and their Grant Committees and actively supports the Massachusetts Life Sciences Center MassNextGen Program as an advisor and coach.  

Appearances:



Day 2 - World Orphan Drug Congress USA 2025 @ 11:00

Panel: The future of drug development in Rare and Orphan Diseases: Navigating regulatory Challenges and clinical innovation

Sponsored by Lumanity.

last published: 24/Apr/25 11:35 GMT

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