Dr. Gad has more than 46 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology. A past president of the American College of Toxicology and the Roundtable of Toxicology Consultants and the recipient of the 2008 ACT Lifetime Achievement Award, Dr. Gad has authored or edited 53 books, 75 independent chapters, and more than 387 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (139 successfully filed to date), NDA, BLA, ANDA, 510(k), IDE, CTD, dietary supplement, and PMA preparation. Dr. Gad is fully experienced with the design, conduct, analysis, and reporting of preclinical and clinical safety and pharmacokinetic studies for drugs, devices combination products, and dietary supplements, and with regulatory submissions associated with them.

Gad Consulting Services holds SAS, DEREK, and Leadscope licenses and capabilities and continues to successfully provided computational analysis of PK/TK data and qualify impurities, intermediates, residual solvents, and excipient levels in existing and under development drugs for many of its clients, as well as leachables and extractables for device clients. GCS has established and current experience in CAPA safety assessments preparing F-value classifications, OEL determinations, and providing both GLP and GMP audits (nationally and internationally).

Additional associated staff specializes in food and cosmetic safety and regulation, quality assurance, data management, analytical, medical writing, environmental, and information services support. Referrals are gladly provided for work outside our areas of expertise.

Samantha is the Senior Director of Biocompatability at Gad Consulting Services, where she has supported clients with risk assessments of both drugs and medical devices for the last 13 years.

She holds a degree in chemical engineering from the University of Cincinnati, a background which led to her strong interest in the use of QSAR methods and material chemical characterization for the evaluation biological risk. Sam has a broad knowledge of Leachable and Extractable testing for both pharmaceuticals and medical devices, from study design through risk assessment. She frequently consults with companies to ensure device biocompatibility evaluation, testing, and risk assessment methods meet current regulatory expectations.

Samantha has a strong drive to learn and loves to share her knowledge and experience at every opportunity. She is a member of both ACT, where she currently serves on the Podcast Subcommittee, and SOT, and enjoys attending the Extractable & Leachables USA Conference annually.

Prior to her current position, Sam had a career advising production teams in a GMP manufacturing setting. Heavily involved in training and process documentation, and able to efficiently troubleshoot formulation and equipment issues, she soon fulfilled her goal of working on a team to startup a new production facility. Since transitioning to consulting, Samantha still performs the occasional cGMP facility audits of CMOs.

Dr. Jerry Bettis is a proven regulatory consultant with expertise in toxicological assessments from strategy through to implementation, for products regulated by the Food and Drug Administration (FDA), Heath Canada (HC), European Union (EU), and other regulatory agencies. Under the guidance of Dr. Shayne C Gad, he has also been trained to provide Quality Assurance (QA) and Quality Control (QC) audits in accordance with Good Laboratory Practices (GLPs).

Jerry is proficient in chemical drawing and Quantitative Structure-Activity Relationship (QSAR) software (e.g., DEREK, Leadscope, and OECD Toolbox). He specializes in the following types of assessments: toxicological, risk, mutagenicity, biocompatibility, impurity, and QSAR.

Jerry holds both a PhD and B.S in Chemistry from North Carolina State University, NC.

Dr. Rogers received her Ph.D. in Pharmacology and Toxicology from the University of Louisville in 2011, and has 13 years of experience in planning, leading, interpreting, and conducting multi-disciplinary scientific studies in chemical-induced cancer and genetic epidemiology, human health risk assessment, pharmacology, toxicology, and environmental health science. She is adept at developing and recommending new methods for given research findings, and a proficient communicator with the ability to review and evaluate results by preparing comprehensive written and oral summaries on major toxicological studies. Since joining Gad Consulting Services in 2017, Dr. Rogers has added an invaluable level of expertise to our team.

Kandice has accumulated over 11 years of analytical chemistry experience in the pharmaceutical, environmental, and human exposure research fields. She earned her Master’s degree in Public Health with a specialization in epidemiology from The Ohio State University in 2018 while working as a research associate in the environmental and human exposure sciences.

In January of 2019, Kandice joined Gad Consulting Services as a Risk Assessment and Regulatory Affairs scientist, bringing her literature research and chemistry background to conduct risk assessments of impurities, leachables and extractables, residual solvents, and excipients. She is proficient in gathering research data used to calculate Permissible Daily Exposure (PDE), Tolerable Intake (TI), Tolerable Exposure (TE), and F-value unit dose packaging values that are in line with regulatory guidelines, and generates detailed, high-quality reports that contribute to NDA, ANDA, and 510(k) filings. Kandice utilizes tools such as Quantitative Structure Activity Relationship (QSAR) to assess novel compounds.

Ms. Westich joined Gad Consulting Services in 2023 as a Risk Assessment Scientist III. She completed her Bachelor of Science in Wildlife Biology at the California University of Pennsylvania before proceeding to receive a Master of Science in Entomology and Applied Ecology at the University of Delaware.

Leslie works as a Senior Regulatory Affairs Specialist I and Project Manager III (from June 2024 and January 2023, respectively) at Gad Consulting Services, after beginning her work at the company in an Administrative role over 9 years ago. She studied Political Science and International Relations at American University in Washington DC and worked in the nonprofit sector as well as various customer facing positions before joining Gad Consulting Services in January 2015.

Since joining the team at GCS, Leslie has received training in Drug Development, eCTD Submissions, The GLPs, and Regulatory Writing. She is proficient in project support where she ensures all parts of new and existing client projects are processed, and organized within a predetermined timeline. She performs new hire orientation, planning, and executing staff training, and ensuring optimal operations by maintaining inventories, coordinating service calls and vendors as needed. She assists our team with her critical thinking and problem-solving skills to effectively identify and improve deliverables for our valued clients.

After working hours are over, Leslie spends most of her time with her pack of 4 dogs (Rabbit, Honeydew, Butterbean, and Duckie) and 3 cats (Ladyboy, Lipa, and BamBam), gardening both indoors and out, playing Dungeons and Dragons, and reading.