BACKGROUND
FOCUS AREAS
More than two decades of experience in nonclinical studies and 7+ years providing regulatory consultation support.
Supporting clients to ensure scientific rigor and regulatory adherence of nonclinical data
As a principal nonclinical consultant, Margery provides robust technical, regulatory and scientific support for nonclinical submissions, and leading face-to-face meetings with FDA officials.
Margery leads the nonclinical biologic team, offering comprehensive oversight and detailed preparation of nonclinical sections of regulatory dossiers, ensuring adherence to regulatory guidelines and scientific rigor. She offers expert guidance on study design, data analysis, and interpretation for nonclinical pharmacodynamics (PD), pharmacokinetics (PK), and toxicity studies, facilitating successful regulatory submissions. Her extensive experience with FDA regulations (in the areas of biologic drug products, mRNA vaccines and small molecules for various disease indications) and hands-on involvement in regulatory meetings further strengthens the quality and compliance of nonclinical submissions, ensuring they meet all necessary regulatory standards.
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EDUCATION:
Ph.D. in Immunology and Molecular Pathogenesis – Emory University
Bachelor of Science in Biology – Purdue University
Bachelor of Science in Medical Technology Purdue UniversityAFFILIATIONS:
Medical Technologist, MT (ASCP)
Member, American Association of Immunologist (AAI)
Member, American Association for the Advancement of Science (AAAS) -
PROFESSIONAL EXPERIENCE:
Eliquent Life SciencesBiologic group lead, principal consultant
DataRevive LLC Biologic group lead, principal consultant
Pfizer Senior Principal Scientist, Group Lead, Ph.D. Mentor Principal Scientist, Group Lead, Project LeadAREAS OF EXPERTISE:
Extensive experience with FDA regulations on biologic drug products, mRNA, small molecules in various disease indications
In vitro / in vivo assay development
PD, PK, and toxicology study design, protocol review and data evaluation
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