Dr. Isabel Lea is a Senior Scientist with ToxStrategies, based in Research Triangle Park, NC. Dr. Lea has more than 20 years of experience in the toxicology field, focusing on evaluating and assessing data for environmental chemicals with the potential to cause health effects. Dr. Lea has broad experience, ranging from conducting primary research and performing systematic literature reviews to translating of large bodies of evidence in scientific databases. Having conducted more than 50 literature reviews, Dr. Lea routinely develops search strategies and inclusion/exclusion criteria, extracts evidence from heterogeneous study types, conducts critical appraisals for study quality, and synthesizes evidence to develop qualitative conclusions. Dr. Lea has used this expertise in the development of documents regarding risk-based toxicity assessment for regulatory agencies. She was involved in the preparation of OSRI (Other Significantly Relevant Information) reports identified for Endocrine Disruptor Screening Program Tier 1 screening, for use in their weight-of-evidence assessments for assessment of Tier 2 testing.
Dr. Lea has specific expertise in performing literature reviews to collect and synthesize data describing genetic alterations associated with the development of cancerous lesions, highlighted by a review of point mutations, insertions, deletions, and loss of heterozygosity, which documented the acquisition of alterations in tumor suppressor genes and oncogenes that could induce or promote the development of malignancy. This work was then used as the basis to design an SQL database and a public website platform (Genetic Alterations in Cancer knowledge system) that allowed users to query, search, and download data. Dr. Lea’s role covered all aspects of the project—in addition to conducting the literature reviews, she also led an evaluation team and developed project-specific instructions, data dictionaries, and quality control criteria that led to the development of a genetic alterations database and website. In addition, Dr. Lea has significant experience evaluating in vivo data in vitro data, such as genetic toxicology (Comet, micronucleus, and Ames assays), toxicogenomics, and high-throughput screening (Tox21) and high-content screening. This work was conducted in support of toxicology projects for the National Toxicology Program (NTP) and the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).
Dr. Lea has extensive experience with toxicology data management for the Chemical Effects in Biological Systems (CEBS) and Integrated Chemical Environment (ICE) platforms. For CEBS, she played key roles, as lead data scientist and Program Manager. The CEBS database contains data from the NTP Toxicology Testing Program. In this capacity, Dr. Lea developed standard processes for data input to the CEBS system, created verification and validation processes to ensure that public data accurately represented the data delivered to the system. She was instrumental in promoting standard terminology in CEBS and oversaw the addition of CEBS terms to the Ontology for Biomedical Investigation. Promoting the FAIR guiding principles, she also was instrumental in making CEBS data available through Healthdata.gov. Regarding her role with ICE, which provides curated data sets and tools designed to facilitate the safety assessment of chemicals, Dr. Lea played a significant role in updating data sets to include cancer endpoints.
Dr. Lea has published academic and professional work in peer reviewed journals, has reviewed for scientific journals, and regularly attends and presents at professional conferences and colloquia. Dr. Lea is a Program Manager Professional (PMP), which has provided the knowledge, expertise, and skill needed to lead a large team of scientists and manage simultaneous projects while delivering on time, within budget, and with excellent client satisfaction ratings.