Daniele Wikoff, Ph.D.
Principal, Practice Director, Health Sciences


Phone(828) 348-6833
LocationAsheville, NC
Address31 College Place
Suite B118
Asheville, NC 28801



Professional Profile

Dr. Daniele Wikoff is the Director of ToxStrategies’ Health Sciences Practice and is based in Asheville, North Carolina. She specializes in the use of evidence-based methods in support of hazard and risk assessment applications. Dr. Wikoff has led the firm’s initiatives to integrate evidence-based methods as part of safety assessments for food ingredients and contaminants, industrial chemicals, cosmetic ingredients, OTCs, and consumer products. She has successfully implemented a turn-key process for conducting systematic assessments at ToxStrategies, with a workflow facilitated by the combination of an experienced multidisciplinary team and use of systematic review software and tools. She has experience applying these methods to a wide range of agents (e.g., caffeine, TCE, TCDD, low-calorie sweeteners, sunscreen actives), across evidence streams (human, experimental animal, mechanistic), to heterogeneous data sets (e.g., epidemiological data and high-throughput data), for a variety of outcomes (e.g., endocrine disruption, carcinogenicity). Dr. Wikoff is well versed in frameworks and guidance from authorities around the world, including NTP-OHAT, EPA-TSCA and EPA-IRIS, EFSA/ECHA, IOM, WHO, GRADE, Cochrane, and others—as well as tools and software—that are used to manage and facilitate the systematic review process.

Dr. Wikoff’s experience as a practitioner of both risk assessment and systematic review allows for a unique area of expertise in the evolving field of evidence-based toxicology. Dr. Wikoff has diverse experience in applying systematic mapping (scoping reviews) and systematic reviews as platforms for facilitating risk assessment, including development of health-based benchmarks and pathway-based analyses. She also routinely uses computational approaches to identify and evaluate evidence, integrating data from databases such as ToxRefDB and ToxCast/Tox21. Dr. Wikoff regularly employs both qualitative (e.g., AOP-based integration) and quantitative integration techniques (e.g., meta-analyses, Bayesian/meta-regression) to characterize hazards, points of departure, estimates of relative potency, and dose-response relationships. Her expertise extends to the topic-specific application of various organizational concepts for mechanistic data, including key characteristics, adverse outcome pathways, and mode of action. Dr. Wikoff has particular interest in methods development related to the definition and evaluation of 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.

Dr. Wikoff is involved in a number of global collaborations to advance the practice of evidence-based toxicology, highlighted by her membership on the Board of Trustees and role as the Chair of the Science Advisory Council for the Evidence-Based Toxicology Collaboration (EBTC), membership on a National Academy of Sciences committee in the capacity of systematic review, co-authorship on the World Health Organization’s systematic review framework, and service as an Associate Editor for Toxicological Sciences in the area of systematic review. She has been an invited speaker and participant at systematic-review workshops hosted by the National Academics of Sciences, the European Food Safety Authority, and the U.S. Environmental Protection Agency. She also co-taught a Continuing Education course on systematic review for the Society of Toxicology, as well as in an advanced course on systematic review at EUROTOX in 2021. Dr. Wikoff has presented on systematic review topics in a variety of scientific forums, including the Toxicology Forum and the Society of Risk Assessment. She is on the International Editorial Board of the journal Food and Chemical Toxicology, and she serves on the Editorial Board of Current Opinion in Toxicology. She is also an Associate Editor for Regulatory Toxicology and Pharmacology. For the Society of Toxicology, Dr. Wikoff is an elected Councilor to the Food Safety Specialty Section and serves as the Vice-President of the Risk Assessment Specialty Section,