
Dismissing the role of independent, outside experts in FDA decision-making weakens the drug review process.
is senior vice president and practice lead for clinical and regulatory services at Lumanity, partnering with biopharma companies to shape clinical development and regulatory strategies from early development through approval and lifecycle management. With decades of experience spanning academia, biotech, and consulting, she has helped organizations navigate complex development and evidence-generation challenges, align stakeholders, and translate scientific innovation into clear development pathways.