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.
Quality Assurance Services
Jason directs the staff of the Quality Assurance Services department and is an active auditor. He coordinates auditor activities and schedules, negotiates and prepares budgets, interprets regulations and tracks regulatory initiatives, and develops and reviews departmental Standard Operating Procedures (SOPs). Jason joined the Quality Assurance Services staff as an Auditor in 2008 and became a Senior Quality Assurance Auditor in 2012. He performs GCP and GLP audits of raw data and reports and GLP/GCP facility inspections. He also audits bioanalytical data and reports and performs audits of GLP histopathology reports. He holds a B.S. in Biochemistry and has over 10 years of hands-on, research laboratory experience, working in molecular biology, genotyping, and immunology. Jason also has extensive training and experience with Biacore instrumentation and is co-author of research articles published in various peer-reviewed, scientific journals, such as the Journal of Biological Chemistry. Jason became a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) in November 2011.
, Senior Quality Assurance Auditor
Barbara, an employee of BSI since 1987, co-founded the Quality Assurance Services department in 1992. In her career as an auditor, she has assessed procedures and processes; developed SOPs, data collection forms, and policies; audited vendors and CROs; inspected laboratories, toxicology facilities, clinical investigator sites conducting GLP- and GCP-regulated studies, and clinical monitoring and database CROs; and audited all types of data and reports. She provides quality assurance and quality control services for research discovery studies, safety studies, animal clinical trials, bioanalytical method validations and analyses, and human clinical trials. Barbara has presented training sessions at national meetings of the Society of Quality Assurance (SQA) and the College of American Toxicologists (ACT). She has served in various offices for the Pacific Regional Chapter of SQA and on the SQA Education Committee, the Council on Professional Registration, and the RQAP(GLP) Exam Committee. Additionally, Barbara has developed and presented customized GLP and GCP training for clients conducting research in various fields. Prior to joining BSI, she worked as a registered clinical laboratory technologist in immunohematology, hematology, cytogenetics, radioimmunoassay, and chemistry laboratories. Barbara holds an MBA and an undergraduate degree in genetics and is both a registered quality assurance professional (RQAP-GLP) and a registered medical technologist (MT(ASCP)).
, Senior Quality Assurance Auditor
Sherry is a Senior Auditor with BSI Quality Assurance Services, who began in May 2011, and in May 2013, she acquired her professional registration as a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP). She performs GLP and GCP data and report audits in areas such as: bioanalytical, method validation, bioequivalence, biosimilar, toxicology, pathology and veterinary, and conducts GLP inspections. Sherry obtained her Master of Science in Biology degree with extensive field and laboratory research in plant physiological, ecological, and botanical studies. She brings experience in dairy farming, as a college biological laboratory instructor, and as a science teacher in Secondary Education, where Sherry instructed individual/student research projects, Advanced Placement Biology, Ecology and Microbiology. Sherry is a published researcher with scientific articles in peer-reviewed biological/environmental journals such as the American Midland Naturalist.
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.
Phyllis Rathman Nader, Science Writer/Editor
Phyllis joined BSI in 1990 and is currently a Writer-Editor of the National Toxicology Program Technical Reports. Phyllis has also worked for the Quality Assurance Services department providing quality assurance audits of other contract research organizations and data audits for human and veterinary clinical trials. Phyllis also has experience in SOP development and systems validation. She holds a B.S.E. degree in Biology with masters-level education in biology and toxicology.