Judith C. McDowall, President
As founder, president, and regulatory affairs manager of BSI, Judith brings over 25 years of industry experience to BSI's clients. Judith's responsibilities include ensuring that quality systems are in place and functional, that personnel and other resources are available, and that staff understand the functions they are to perform. She monitors the quality, timeliness, and cost of project deliverables and is available to advise clients and staff. As Regulatory Affairs Manager, Judith is responsible for submitting and maintaining regulatory documents, managing regulatory submissions and correspondence, and interpreting regulations and policies of interest to BSI and its clients.
Judith's experience in the pharmaceutical industry has included medical writing, new product development and registration, and regulatory compliance. She began her career at American Cyanamid Company as a Research Scientist in Toxicology Research and later became Department Head, Toxicology Information Systems. At Cyanamid she was directly responsible for the preparation of numerous pharmacology, pharmacokinetics, and toxicology summary documents for submission to American, Canadian, and European regulatory agencies. She defined toxicology testing requirements and participated in the development of project plans and regulatory strategy for the registration of drug products and implantable medical devices.
Judith was an essential member of the project team responsible for implementing automated systems for collection, analysis, and reporting of toxicology laboratory data. When GLP regulations emerged, Judith developed and supported procedures for compliance, including facility and in-process inspections; data audits; protocol, report, and SOP preparation; archive administration; and toxicology software validation. She also provided GLP training for toxicology staff.
Other notable assignments included proposing exposure limits for medical products and preparing supporting monographs, conducting a study in workers to assess systemic exposure to an anticancer drug, and conducting studies in volunteers to assess efficacy of surgical scrub sponges.
Subsequent relocation and requests for contract services led Judith to organize BSI. After her experience at a large pharmaceutical company, Judith is well acquainted with industry standards and client expectations of a CRO.
Judith holds a B.A. in chemistry from Tufts University and a M.S. in biochemistry from MIT. She is a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP).
Michele Leyes, Director of Finance and Administration
Michele, Director of Finance and Administration, has been with BSI since 1987. Along with the administrative day-to-day operations at BSI, she oversees all accounting and financial procedures including payroll generation, quarterly payroll tax reporting and annual reconciliations. Michele works with other department directors to make sure project costs are tracked accurately and stay within contracted budgets. She performs client billing monthly or as milestones are reached and provides quarterly and annual statements. Michele writes business proposals in response to government requests for proposal and indirect cost agreements for government contracts. Michele also manages vendor services and contracts.
Medical and Scientific Writing Services
Susan R. Gunnels, Director
Susan has been the Director of Medical and Scientific Writing since 1997 and manages all of its personnel and activities and sets the departmental budget. Susan has 20 years of experience writing and editing scientific, environmental, and technical documents and has spent much of that time in supervisory positions. She has been the Principal Investigator for the National Toxicology Program's Technical Reports Preparation Support Services Contract since 1996 and has managed NTP Report production since 1993. She has also managed projects for BSI's pharmaceutical, environmental, and engineering clients. Before joining BSI in 1992, Susan was an environmental projects manager for a consulting firm and a Project Officer for the Environmental Protection Agency. Her responsibilities included managing personnel and writing environmental audit reports, standard operating procedures, quality assurance project plans, and sampling plans. Susan holds a M.A. in political economy with an emphasis in environmental policy.
Del C. Serbus, Senior Science Writer
Del has extensive experience with a wide variety of animal experimentation related to toxicology testing, and he is thoroughly familiar with the conduct of laboratory research studies and animal bioassays. Since joining BSI in 1994, Del has written, edited, and reviewed toxicology documents for submission to government agencies and incorporation into medical/scientific monographs for scientific content, accuracy, and internal consistency. He has written and edited preclinical pharmacotoxicologic summary documents for pharmaceuticals for United States and international regulatory submissions, and he has performed quality assurance audits for accuracy and consistency in regulatory documents for veterinary and human pharmaceuticals and agricultural chemicals. In his position as Senior Science Writer, he draws upon his expertise in the areas of chemistry, biochemistry, pharmacology, physiology, pathology, statistics, and toxicology. Prior to joining BSI, Del conducted biochemical and neurotoxicological research at the University of Arkansas for Medical Sciences and the National Center for Toxicological Research. Del holds a doctorate in interdisciplinary toxicology and an undergraduate degree in chemistry.
Lynn M. Harper, Production Manager
Lynn has been involved in all aspects of preparing National Toxicology Program Technical Reports including writing and editing, quality assurance, project scheduling and coordination, and staff development since joining BSI in 1991. She has reviewed portions of Food and Drug Administration (FDA) submissions for editorial consistency and readability. She has over 25 years of experience writing and editing scientific and engineering documents, standard operating procedures, Federal Register notices, technical art, procedure and style manuals, and proposals for contractors employed by the Departments of Defense, Energy, and Health and Human Services. Lynn holds a B.S. in solar engineering technology.
Perry Gideon, Science Writer/Editor
Perry has been employed with BSI since 2000 and has prepared over 40 NTP technical reports and toxicology studies. He has collaborated with other writers and science professionals in the writing, editing, and quality assurance of many more. Those reports and other documentation was created using Microsoft Word, Adobe Acrobat, and Quark Express software. Perry's other responsibilities at BSI include maintaining Microsoft Word and Quark Express templates and supporting other users of Word. He currently holds a B.A. in Professional and Technical Writing from the University of Arkansas at Little Rock (UALR) with an M.A. in Professional and Technical Writing from UALR expected in May 2019.
Karen Coker, Science Writer/Editor
Karen joined BSI in 1998 as a statistician and programmer. She performed statistical analysis on clinical and nonclinical studies, developed data analysis plans, and validated statistical results according to standard operating procedures and Food and Drug Administration regulations. She has provided technical assistance in statistical analyses, computer graphics, and computer programming for the production of NTP reports; written macro programs designed to format electronic study data into final tables; and contributed her writing, editing, and auditing skills to the production of several NTP reports. Prior to joining BSI, Karen was a programmer analyst for the Arkansas Department of Health and an assistant professor of political science and public administration at the University of North Dakota. She has also been an associate director of the Survey Research Center and an assistant professor at the University of Arkansas at Little Rock, an assistant professor at the Clinton School of Public Service, and a research associate at the University of Arkansas for Medical Sciences.