Meet the Gad Consulting Team

Our Practice

Gad Consulting Services is an internationally recognized toxicology consulting practice serving primarily the pharmaceutical, and medical device industries in the areas of preclinical and early clinical evaluation, safety assessment and risk assessment. The practice is primarily focused on technical and regulatory support of new product development and the technical support of existing products. We provide the full range of services in our areas of expertise in an effective, flexible, reliable and timely manner.

Shayne C. Gad, Ph.D., DABT

Shayne C. Gad, Ph.D., DABT

Principal

Dr. Gad has more than 38 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 47 books, 58 independent chapters and more than 350 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (109 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 has successfully provided computational analysis of PK/TK data and qualified impurities, intermediates, residual solvent, 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, and providing both GLP and GMP audits.

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 E. Gad-McDonald, B.S.ChE

Samantha E. Gad-McDonald, B.S.ChE

Senior Consultant & Partner

Samantha received her B.S. in Chemical Engineering from University of Cincinnati in 2004.

She began her career as a production leader in GMP manufacturing facilities. During this time she helped design processing systems, develop operating procedures, troubleshoot formulations issues, validate equipment and start up a new GMP processing plant.

Samantha joined Gad Consulting Services (GCS) permanently in 2009. She brings to the company experience in CAPA investigations, analytical testing methods, GMP auditing (domestically and internationally), and expertise in material science. Trained in areas such as: six sigma/quality by design, regulatory affairs, formulation, CMC, toxicology, and pharmacokinetics.

Samantha’s current work includes risk assessments, safety of drug formulation, CAPA investigations and HHE’s, determination of biocompatibility of medical device materials, setting acceptance criteria for degradants, impurities and residual solvents in drugs, pesticides, and e-cig formula and material evaluation. Experienced in QSAR evaluations using knowledge based (DEREK) and statistical based programs (Leadscope, TOPKAT, EPA TEST). Also the preparation, filing and upkeep of Investigational New Drug Applications (INDs), drug master file (DMFs) and other regulatory filings (FDA & international regulatory agencies). Highly skilled in the design, interpretation and evaluation of leachable and extractables for drugs and devices. Samantha also has several publications and is a skilled instructor and auditor.

Dexter W. Sullivan Jr., M.S., DABT

Dexter W. Sullivan Jr., M.S., DABT

Senior Toxicologist

Mr. Sullivan has over ten years of professional experience as a toxicologist. He is currently a regulatory affairs toxicologist at Gad Consulting Services where he serves as a project manager and technical specialist of Gad Consulting Services projects for pharmaceutical, medical device, and pesticide companies. Mr. Sullivan’s current work includes safety evaluations for drug formulations and materials for pharmaceuticals and medical devices including development of 510(k) Premarket Notifications, Informational Brochures (IBs), and Investigational New Drug (IND) applications; qualification works including calculations for Permissible Daily Exposure (PDE), Tolerable Exposure (TE), Tolerable Intake (TI); and F-value assessments to determine unit packaging for pharmaceuticals. Mr. Sullivan also utilizes Quantitative Structure Activity Relationship (QSAR) programs including DEREK, METEOR, EPA TEST, and Leadscope to predict toxic responses and metabolic fates of chemicals. In addition, he has technical experience in performing quantitative safety assessments of pesticide impurities for qualification under FAO guidelines.

Prior to being employed at GCS, Mr. Sullivan prepared and assisted in the development of hundreds of human health risk assessments for private companies and regulatory agencies. He has extensive experience in performing hazard identifications, as well as non-cancer and cancer dose-response assessments including risk assessments in support of EPA IRIS, PPRTVs, and Health Effects Support Documents for the EPA Office of Water.

Jerry L Bettis, Jr., Ph.D.

Jerry L Bettis, Jr., Ph.D.

Regulatory Consultant

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

Amy Mihalchik-Burhans, Ph.D.

Toxicologist

Amy Mihalchik-Burhans received her Ph.D. in Pharmaceutical and Pharmacological Sciences from West Virginia University in 2016.  Amy primarily focused on assessing the occupational risk and toxicity associated with engineered nanomaterials to complete her degree requirements through a partnership between WVU and the National Institute for Occupational Safety and Health.

Upon completion of her degree, she joined Gad Consulting Services as a regulatory toxicologist specializing in occupational risk assessments and toxicological assessments of a variety of pharmaceutical products and medical devices.  She is proficient in calculating Permissible Daily Exposure (PDE), Tolerable Intake (TI), Tolerable Exposure (TE), and F-value unit dose packaging values, and is committed to crafting high-quality literature assessments to support product safety.  Amy is also well-versed in assessing (Q)SAR results generated from DEREK and Leadscope software packages to predict potential genotoxicity and target organ toxicities associated with a compound of interest.

Quyen T. Pham, M.S.

Quyen T. Pham, M.S.

Biochemist & Toxicologist

Ms. Pham has over eight years of toxicology research experience working at Gad Consulting Services (GCS). She started as an intern in 2008 and gained a permanent offer as toxicology research specialist upon receiving her B.S. in Biochemistry and Biological Sciences from North Carolina State University in 2010. She has also recently graduated with her Masters in Toxicology and Pharmacology from Michigan State University. As a Biochemist, she is knowledgeable in identifying chemical substances and physical properties of biochemical products and performs risk evaluation assessment on both drug formulations, and medical device materials. At GCS she also carries out extensive and thorough searches of pharmacodynamic, pharmacokinetic, and toxicity literature, using proprietary and public databases such as: The Merck Index, STN, RTECS, eChem Portal, Pubmed, USP, Martindale’s Drug, and Leadscope Enterprise.

Ms. Pham’s current work includes: qualification assessment calculations for Tolerable Exposure (TE), Tolerable Intake (TI), and Permissible Daily Exposure (PDE) using ICH (Q3A, Q3B) guidances for impurities, excipients, degradants, and residual solvents; gauging relevance of pesticide impurities under FAO guidelines, F-Value assessment for pharmaceutical unit packaging; leachables and extractables under ISO 10993 guidance, and ICH guidelines. She is highly trained in using chemical drawing software and use of Quantitative Structure-Activity Relationship (QSAR) such as: knowledge based DEREK, statistics based EPA TEST, and Leadscope Model Applier to predict toxic responses. Additionally, she has been trained for and provides Quality Assurance (QA) and Quality Control (QC) for Good Laboratory Practices (GLPs) in clinical reports, medical records, Case Report Files (CFRs), and FWD.

Erica N. Rogers, Ph.D.

Toxicologist

Coming soon!

Corey M Ballou, B.S.

Corey M Ballou, B.S.

Toxicology Consultant

Mr. Ballou graduated in 2009 from North Carolina State University with a B.S. in Animal Sciences. Through a combination of undergraduate research, laboratory technician and management, and medical device development, he has a combined 6 years of experience in animal research.

During his employment, his acquired skills in planning and coordination have aided him greatly across many large projects at Gad Consulting. With a focus on business, Mr. Ballou excels in project management, business development, and communication to all clients.

Since entering Gad Consulting in 2013, Mr. Ballou’s responsibilities include calculations of Tolerable Exposure (TE), Tolerable Intake (TI), Permissible Daily Exposure (PDE), and F-values, with a special focus on Health Hazard Evaluations (HHE) and pesticide impurity evaluations. He is trained in using chemical drawing software and Quantitative Structure-Activity Relationship (QSAR) systems including DEREK, Leadscope, and TEST.

Mr. Ballou also performs IT services for the office and is capable of reviewing and editing large documents.

Sean Eagle

Coming soon!

Leslie Eagle

Administrative Assistant