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


Phone(980) 785-1093
LocationAsheville, NC
Address31 College Place
Suite B118
Asheville, NC 28801

Professional Profile

Dr. Daniele Wikoff is the Health Sciences Practice Director for ToxStrategies and the Center for 21st Century Toxicology, and is based in Asheville, North Carolina. She specializes in evaluating human health hazards and risks associated with exposures to a wide variety of consumer products, food ingredients and additives, pharmaceuticals, and industrial chemicals. Her current focus is on systematic reviews in support of risk assessment applications, including development of health-based toxicity values. Dr. Wikoff has led the firm’s initiatives to integrate evidence-based methods, and has been responsible for designing and implementing projects involving systematic review and systematic maps using a variety of frameworks, including IOM, OHAT, and PRISMA. Efforts include problem formulation and PECO questions, development of protocols (search strategies, inclusion and exclusion criteria), critical appraisal of individual studies for internal (i.e., risk of bias) and external validity, as well as qualitative and quantitative evidence integration. She has experience applying these methods to a wide range of agents (e.g., caffeine, TCE, TCDD), across evidence streams (human, experimental animal, mechanistic), to heterogeneous data sets (e.g., epidemiological data and high-throughput data from ToxCast/Tox21), for a variety of outcomes (e.g., endocrine disruption, carcinogenicity). Most recently, she has participated in projects exploring the utility of quantitative integration techniques (e.g., meta-analyses, meta-regression, Bayesian modeling) and tools to characterize confidence and/or uncertainty in hazard analyses, points of departure, estimates of relative potency, and dose-response relationships. Dr. Wikoff has particular interest in methods development related to the definition and evaluation of data quality, and how elements of internal and external validity can be used to transparently inform conclusions and provide critical information to decision makers.

Dr. Wikoff is active in the systematic review community. She currently serves as the Vice-Chair of the Science Advisory Council for the Evidence-Based Toxicology Collaboration (EBTC), based out of Johns Hopkins University; she also serves as the EBTC’s Education Workgroup Co-Chair and is a member of the Tox21 Workgroup. She was invited by the European Food Safety Authority to be an overall co-rapporteur of a colloquium on evidence integration in risk assessment, has presented at systematic review meetings held by both the National Toxicology Program and the U.S. Environmental Protection Agency, and has chaired sessions (or is scheduled to chair upcoming sessions) on systematic review at the Toxicology Forum, Society of Toxicology, and Society of Risk Assessment. Dr. Wikoff is currently working along with international experts on manuscripts related to problem formulation, evaluation of data quality (validity), and evidence integration; she is also a co-author on a chapter for the World Health Organization’s systematic review guidance on problem formulation. Dr. Wikoff serves on the editorial boards of Toxicological Sciences and Toxicology Reports, and actively serves as a peer reviewer for a number of other toxicology and risk journals. She is an author on over 20 peer-reviewed scientific papers and multiple book chapters, and has served on NIEHS and USDA grant review panels. She also regularly prepares reports for submission to public entities, as well as state, regional, and federal regulatory agencies.