Professional Profile
Dr. Daniele Wikoff is ToxStrategies’ Chief Scientific Officer, as well as Senior Vice President of the firm’s Health Sciences practice. She specializes in using evidence-based methods to support hazard and risk assessment applications. Dr. Wikoff has led the firm’s initiatives to integrate evidence-based methods as part of safety assessments for a broad spectrum of substances, including food ingredients, cosmetic ingredients, dietary supplements and botanicals, industrial chemicals, environmental contaminants, and pharmaceuticals. She has successfully implemented a turn-key process for conducting systematic assessments involving an experienced multidisciplinary team and systematic review software, including AI-facilitation tools. She has experience applying these methods to different types of data (epidemiological, experimental animal, mechanistic) and to a variety of health outcomes for causation and risk assessment purposes. Dr. Wikoff routinely engages with risk communication efforts regarding hazard and risk assessment topics with diverse audiences, including international regulators and non-technical audiences.
Dr. Wikoff has experience applying systematic mapping (scoping reviews) and systematic reviews to develop health-based benchmarks and pathway-based analyses. She regularly employs both qualitative (e.g., AOP-based integration, biological plausibility) and quantitative integration techniques (e.g., meta-analyses, Bayesian/meta-regression) to characterize hazards, causal relationships, points of departure, estimates of relative potency, and dose-response relationships. Her expertise extends to topic-specific application of various organizational concepts for mechanistic data, including key characteristics, adverse outcome pathways, and modes of action. Dr. Wikoff has a particular interest in methods development related to defining and evaluating data quality, and how elements of internal, construct, and external validity can be used to transparently inform conclusions and provide critical information to decision makers. Her expertise also includes performing qualitative and quantitative assessments of confidence and uncertainty to characterize hazard and dose-response relationships with both toxicological and epidemiological data.
Dr. Wikoff is active in the scientific community, highlighted by her service to academic journals in the toxicology field. She currently serves as Co-Editor-in-Chief of the peer-review journal Regulatory Toxicology and Pharmacology, as Associate Editor at Toxicological Sciences, and on the editorial boards of Food and Chemical Toxicology and Current Opinion in Toxicology. She has also served as an appointed member of the Society of Toxicology’s Scientific Program Committee, and has held elected positions with the Risk Assessment Specialty Section and Food Safety Specialty Section.
In addition, Dr. Wikoff is involved in multiple global collaborations to advance evidence-based toxicology. She is both a member of the Board of Trustees and Chair of the Science Advisory Council for the Evidence-Based Toxicology Collaboration (EBTC), as well as a member of National Academy of Sciences committees, and co-author on the World Health Organization’s systematic review framework. She has been an invited speaker and panel participant at the National Academics of Sciences, the European Food Safety Authority, and the U.S. Environmental Protection Agency. She has also taught multiple continuing education courses on systematic review and risk assessment, and has authored numerous guidance documents and book chapters.