Shayne
Cox Gad, Ph.D., D.A.B.T., ATS
Phone: (919)233-2926
Fax:(919)233-2927
QUALIFICATIONS SUMMARY
Over 30 years experience as a toxicologist, statistical consultant, manager and consultant on research and development in the biotechnology, medical device, pharmaceutical, chemical, consumer product, and contract testing industries. Experienced in development program (both preclinical and clinical) and study design, conduct and reporting; in recruiting; in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies, commercial concerns, and contract research organizations; in identifying, developing and putting into everyday use new technology; in writing reports, position papers, Material Safety Data Sheets, MAA/PLA/IND/NDA toxicology summaries and package inserts; in developing and managing operations and capital budgets; and in designing experiments, designing and executing surveys, in the statistical analysis of both experimental and clinical data and risk assessment and in providing litigation support.
PROFESSIONAL POSITIONS
Principal, Gad Consulting Services,1994-present
Director of Toxicology, Synergen, 1993 - 1994
Director of Medical Affairs Product Support Services, Becton Dickinson, 1991-1993
Senior Director of Product Safety and Metabolism, G.D. Searle, 1989 1991
Director of Toxicology, G.D. Searle, 1986 1989
Manager, Mammalian Toxicology, Allied Corporation, 1980 1986
Supervisor of Inhalation and Neurotoxicology, Shell Research, 1979 1980
Fellow/Group Leader for Inhalation and Neurotox, Chemical Hygiene Fellowship, 1977 1979EDUCATION
Ph.D., Pharmacology/Toxicology, University of Texas at Austin, 1977.
B.S., Chemistry and Biology (two majors), Whittier College, 1970.KEY ACCOMPLISHMENTS
• Directed the design, conduct, writing and successful filing of 75 complete INDs plus 2 PLA, 2 MAA, 4 NADA and 8 NDA safety packages on antiinfectives, antiviral, cardiovascular, gastrointestinal, anti-inflammatory, central nervous system, and immune modulatory products derived from both biotechnology and traditional synthetic organic processes for US and foreign filings. Also 21 510(k)s, 12 IDEs, and 3 PMAs plus OTC petitions and sterilant approvals for medical devices.
• Developed and implemented programs to clarify and solve problems/issues around the preclinical, clinical, and manufacturing safety of pharmaceutical products and medical devices, keeping development, production and marketing of drugs on or near plan.
• Oversaw completion, identified and solved quality problems, and completed reports on clinical trials. Designed minority subject recruitment plans for NIH intramural studies.
• Product project team member for eight potential drug products through the course of preclinical and clinical development. Provided safety oversight and counsel for clinical development of drugs.
• Directed positive regulatory interactions with domestic and foreign regulatory agencies, allowing product approval/registration, and initiation and continuation of clinical trials.
• Performed risk assessments and prepared reports on them for pharmaceutical, industrial, agricultural and environmental agents.
• Created and directed programs to provide highly interactive safety assessment support to drug discovery groups, allowing more rapid, efficient and effective identifications of lead compounds and product candidates.
• Reviewed and provided recommendations on 97 potential in‑license packages. Key member of small negotiating team for five foreign and domestic compounds.
• As study director, responsible for the design, conduct and reporting of over 900 studies of all types: primate, canine, acute, subchronic, chronic, carcinogenicity, reproductive and developmental toxicity, inhalation, neurotoxicity, immunotoxicity, in vitro toxicity, and environmental toxicity.
• Directed the conduct of over 9000 device safety assessment studies a year, upgraded all laboratory operations and changed the focus of a 20-person group from a contract testing lab to a full range, product support organization. Prepared group to successfully complete their first FDA GLP inspection in 10 years.
• Initiated and managed occupational toxicology program at Searle, identifying needs, developing data and generating Material Safety Data Sheets for all compounds and process intermediates, making them available world‑wide by an electronic system. Generated airborne control objectives for all production materials, allowing cost effective engineering of safe facilities, compliance with domestic and international regulations, and flexible management of synthesis and manufacturing operations.
• Initiated and directed the development of a computerized indexing and retrieval system of thirty years of data on biocompatibility and safety of medical devices and their components and constituent materials.
• Developed, validated, put into use and got acceptance of new test methods and techniques (functional observational battery [FOB]; mouse ear swelling test [MEST]; in vitro screens for hepatotoxicity and cardiotoxicity; reduced animal use designs) which are faster, more effective, and use fewer animals and less test compound. The FOB is the starting point for EPA's and FDA’s neurotoxicity evaluations. The MEST is now accepted by international regulatory agencies.
PUBLICATIONS
31 Books
48 Chapters
More than 300 papers and abstractsGAD CONSULTING SERVICES - Principal
Providing regulatory, statistical, preclinical and clinical study support services for the pharmaceutical, biotechnology, medical device and animal health industries. Also marketing, technical consulting, statistical analysis and report writing for contract research organizations (both preclinical and clinical). Expert witness support to defendant pharmaceutical and device companies.
LITIGATION SUPPORT
Research, evaluation, depositions and expert witness testimony provided in areas of professional expertise. Recent litigation support experience in the areas of pharmaceuticals, medical devices, and occupational toxicology.
NEUROTOXICOLOGY
Dr. Gad was the originator of the functional observational battery, and has extensive experience in the areas of behavioral and neurotoxicology, with current GCS experience in study design and conduct, hands-on testing, SOP , protocol and technique development and evaluation, and data analysis. Animal model experience (and publications) in the field of neurotoxicology includes rats, mice, ferrets, primates, and guinea pigs.
STATISTICAL ANALYSIS AND DESIGN
Experienced in preclinical, clinical and survey study design and analysis. Work is supported by numerous publications in the field, and GCS can offer a unique perspective of experience in both statistical analysis/modeling and experimental toxicology.
TRAINING COURSES AND SEMINARS
Dr Gad teaches courses on the Development and Biocompatibility Evaluation of Medical Devices, Pharmaceutical Safety Evaluation, Statistical Design and Analysis for Preclinical Toxicology, Development of Combination Products, and Safety Assessment of Biologics. He can teach a modified form of these courses, offering tailored "in plant" courses or seminars at reasonable rates. Such courses include full syllabi for all participants.