Lisa brings almost 20 years of experience in regulatory strategy, clinical program development and operations, and medical writing for scores of FDA and EMA regulated drugs and biologics—from early-stage development through post marketing.

Approach

Data tells a story, and Lisa leverages her clinical and regulatory experience across all stages of development and product types to create briefing documents that highlight key scientific messages. She understands how regulators think and process information, and crafts scientific narratives that are engaging and persuasive. Lisa tailors each communication to the specific needs of the audience, situation, and milestone—so clients achieve the best outcome.

Background

Lisa earned a PhD in Genetics from North Carolina State University, where she researched genetic underpinnings of embryonic development. Before coming to 3D, Lisa worked as a medical writer, clinical strategist, and regulatory scientist for a clinical research organization. She supported the development of more than 100 therapeutic products, with a focus on rare diseases and oncology. Lisa was the lead clinical author and strategist for seven successful US and EU product approvals over the past 10 years. She obtained her Regulatory Affairs Certification with the Regulatory Affairs Professionals Society in 2006.

Special Interests

Lisa is an avid supporter of the Samaritan’s Purse and The Methodist Home for Children in Raleigh, NC. Outside of 3D, Lisa cherishes time with her family, working in her garden, and riding her horses.