Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Nikolett Biel, PhD
Senior Biologist
Division of Hematology Oncology Toxicology (DHOT)
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Nikolett Biel is a Senior Biologist and Acting Team Lead in the Division of Hematology Oncology Toxicology supporting the Office of Oncologic Diseases in the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. She received her PhD in Physiology and Pharmacology from the University of Florida College of Medicine in 2013 and joined the FDA in May 2020. Nikolett has experience reviewing pharmacology and toxicology studies in support of oncologic drug applications at the pre-IND, first-in-human IND, and late phase IND stages as well as reviewed several marketing applications and supported drug labeling for both small molecule and biologic drug products.
Abstract
Nikolett Biel, a non-clinical reviewer in the FDA’s Office of Oncology Drugs, provides an insightful overview of non-clinical information contained within the Investigator’s Brochure (IB) and its critical relevance to drug development. She outlines the key types of non-clinical data, starting with pharmacology, which establishes the drug’s mechanism of action, activity (in vitro and in vivo), primary and secondary pharmacology, and guides species selection for toxicology studies. The presentation then covers safety pharmacology, which assesses a drug’s potential adverse effects on vital physiological functions, specifically the cardiovascular, central nervous, and respiratory systems. Biel details pharmacokinetics (PK) and ADME (absorption, distribution, metabolism, and excretion), explaining how drugs move through and are processed by the body, alongside toxicokinetics (TK), which informs dose proportionality and potential drug accumulation. Furthermore, she elaborates on toxicology studies, encompassing general toxicology for determining a safe first-in-human clinical dose, genetic toxicology as a surrogate for carcinogenicity, and reproductive toxicology to prevent fetal malformations. Biel underscores that the amount of data varies with the drug type, indication, and development stage, emphasizing the continuous evolution of data and the importance of adhering to ICH and FDA guidance documents to assure drug quality, safety, and efficacy throughout its lifecycle.