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Daniela Verthelyi, MD,PhD (she/her/hers)

Consultant
Thimmus LLC
Potomac, Maryland

Daniela Verthelyi has over 25 years of experience in applying bench science to regulation at FDA to facilitate the development of safe and effective therapeutics and continues to be a key contributor to innovative policies in immunogenicity risk assessments. As a Division Director in the Office of Pharmaceutical Quality Research oversaw multiple research and assessor teams aiming to improve the assessment of product quality and immunogenicity risk as well as reviewing INDs, NDA, ANDA and BLA submissions. Her own team of research-reviewers focused on understanding innate immunity and inflammation and applying the information to address regulatory problems. The group developed new methods, models, and strategies to understand the role of product and process related impurities on product immunogenicity, as well as animal models to assess the safety and efficacy of innate immune response modulators and other therapeutics to respond to infectious diseases. She has authored over 130 peer-reviewed articles, is an inventor in 11 patents, and contributed to over 20 FDA Guidance for Industry documents. In January 2026 Daniela left the FDA to work as a consultant on issues of immunogenicity risk assessment, mitigation, and policy as well as on approaches that use immune modulators in disease prevention and treatment.

Disclosure information not submitted.

Presentation(s):