Bonnie M. Coyle
email: bonniecoyle@cvbllcusa.com
Summary of Qualifications
Bonnie Coyle retired in October 2022 from the Center for Veterinary Biologics (CVB) as the Program Information Management and Security (PIMS) Section Leader with over 33 years of experience in veterinary biologics. She spent 13 years as the CVB PIMS Section Leader assisting with development of program databases and applications to facilitate electronic submissions to the CVB, processing Freedom of Information Act requests, developing records policy, and supervising the records management staff to maintain compliance with federal records requirements. Bonnie served as a Program System Administrator regarding program information and functions on CVB computer systems, applications and services used (including LSRTIS, NCAH Portal access and use, and the User Management System).
Bonnie has experience with international and domestic facilities inspection, market release, regulatory compliance, with a focus on export certification. She has accompanied foreign regulatory agencies during inspections of US manufacturing facilities to identify the regulations that support the manufacturing processes and similarities to GMP.
She spent 2 years as the National Animal Health Laboratory Network, Associate Coordinator. Assisting with developing harmonized policies between agencies to facilitate coordination during an animal health emergency or outbreak situation.
Additionally, she has over 10 years of industry experience as a project leader in research and development of swine veterinary biologics and veterinary pharmaceuticals. She developed animal models and high-throughput in vitro compound screens to evaluate novel antimicrobial agents for use in cattle, swine, and poultry.
Employment History:
Center for Veterinary Biologics - Assistant Director's Office
Program Information Management & Security (PIMS) Section Leader
August 2009 - October 2022
- Advised and provided policy to the CVB Directors in matters involving administration, resources, security, strategic planning & program initiatives from a records (electronic and paper) and data management perspective.
- Served as a liaison between Information Technology staff, CVB staff, and veterinary biologics manufacturers to coordinate acquisition, implementation, maintenance, enhancement, and deployment of existing, acquired or newly developed technology used for the management and security of data from licensed manufacturing establishments and the CVB.
- Coordinated with the Information Management Staff to manage and secure both paper and electronic program information.
- Supervision of PIMS staff.
- Ensured program documentation is in compliance with APHIS regulations and directives for security, integrity, authenticity, and management/archival of documents related to the enforcement of the Virus-Serum-Toxin Act (VSTA).
- Acted as the subject matter expert for the maintenance and development of computerized systems, services and applications used by the CVB for the implementation and enforcement of the VSTA.
- Responsible for determining the effect of new technologies of data management and implementation of appropriate technologies on the veterinary biologics program, its stakeholders, and customers.
- Served as a Program System Administrator regarding program information and functions on computer systems, applications and services used (including LSRTIS, NCAH Portal, and the User Management System) ensuring all applications were properly certified and accredited for operation.
- Reviewed and processed Freedom of Information Act (FOIA) requests submitted for CVB program records.
- Served as a resource and providing support to Inspection & Compliance, Policy, Evaluation & Licensing (PEL), Diagnostics & Biologics (D&B), Veterinary Services (VS), APHIS, USDA, and other government programs in relation to the information issues necessary for operation of the biologics program.
National Veterinary Services Laboratory (NVSL) - National Animal Health Laboratory Network (NAHLN)
NAHLN Associate Coordinator
February 2008 - August 2009
- Communicated and represented USDA, APHIS, Veterinary Services regulations, and program perspectives, as well as NVSL, and standard operating procedures to NAHLN member laboratories and partners.
- Created and reviewed NAHLN documents, reports, and communications.
- Presented updates on NAHLN documents, reports, and communications.
- Presented updates on NAHLN activities and represented NAHLN interests at meetings with NVSL, partner laboratories, professional organizations, and other state and federal agencies.
- Represented NAHLN interests at meetings, training sessions, and conferences.
- Participated in the Integrated Consortium of Laboratory Networks (ICLN) activities as they relate to the NAHLN. ICLN is a consortium of federal laboratory networks that are developing harmonized policies between agencies to facilitate coordination during an emergency or outbreak situation.
USDA Secret Security Clearance
2004 - October 2022 (retired)
- Select Agents and Toxins
- US Customs and Border Protection
- Other
Center for Veterinary Biologics - Inspection & Compliance
Export Manager / Senior Biologics Specialist
July 2002 - February 2008
- Reviewed and certified Certificates of Licensing and Inspection (APHIS Forms 2046 & 2047) and Official Export Certificates for Animal Biological Products (APHIS Form 2017) submitted by licensed manufactures and distributors. These biologics certificates were used to facilitate trade with other countries by either using them in the dossier or registration package to license the product in that country or as an export certificate for a particular shipment of product.
- Collaborated with the National Center for Import and Export and International Services on trade issues involving veterinary biologicals. Facilitated export to foreign countries.
- Developed a GMP-like statement that enabled veterinary biological export and facilitated the registration of their products.
- Performed international and domestic inspections to determine if the manufacturer was compliant with CVB policy, VSTA and the applicable requirements of Title 9 Code for Federal Regulations (9 CFR).
- Prepared and presented technical and general informational presentations on the biologics program activities to other governmental employees and the public.
- Performed regulatory oversight of international and domestic manufactures.
Center for Veterinary Biologics - Inspection & Compliance
Biologics Specialist
June 1999 - July 2002
- Served as the Biologics Specialist for several veterinary biologics manufacturers and importers. Performed biologics inspection and control activities required in the enforcement of the VSTA and the applicable rules and regulations, in 9 CFR.
- Scheduled, organized, and conducted in-plant inspections and audits of facilities, production methods, records, and testing procedures.
- Prepared written reports following in-plant inspections to document all observations and violations of the VSTA or regulations.
- Reviewed biologic facility construction plans and specifications involving new construction or modification of existing structures to determine that the construction, finished surfaces, space arrangement, and equipment were adequate and in compliance with the applicable regulations.
- Investigated alleged or suspected violations of the VSTA or other regulations.
- Established and maintained cooperative and effective working relationships with the CVB PEL reviewers and laboratory staff, and management officials and scientists representing the biologics establishments.
Boehringer Ingelheim Vetmedica, Inc.
Research Scientist III/Project Leader
July 1997 - June 1999
- Independent work on individual projects related to the development of APHIS/USDA licensed biologics products, specifically involved with assisting the licensing of a veterinary biologicals for Actinobacillus pleuropneumoniae and Mycoplasma hyopneumonia.
- Investigated and developed new scientific methods and techniques.
- Planned and conducted laboratory and animal models to achieve project objectives.
- Independently developed test methods (including in vitro and in vivo assays for efficacy and potency determination), prepared formulations, and performed assays and studies required to achieve work objectives.
- Technical consultant for other teams or projects.
- Independently planned and executed experiments to develop findings, draw conclusions, and make recommendations.
- Supervision and training of staff.
- Preparation of Standard Operating Procedures (SOPs), technical reports and presentations, and APHIS/USDA submissions.
- Use of pilot and industrial size fermentors.
- Tissue culture techniques and knowledge of several different cell lines.
- Isolation, passage, and identification of aerobic and anaerobic bacteria from clinical specimens.
Elanco Animal Health (Division of Eli Lilly)
Associate Microbiologist
April 1995 - July 1997
- Contributed to the discovery and evaluation of novel antimicrobial agents for use in cattle, swine, and poultry.
- Implemented studies to evaluate new compounds both in vitro and in vivo.
- Supervision of technicians and responsible for day-to-day activities of the laboratory.
- Designed, implemented, and monitored novel screens (in vitro and in vivo) for detection of new antimicrobial agents.
- Managed in vivo efficacy experiments, data acquisition, interpretation, and summarization.
- Developed new high-throughput in vitro compound screens by utilizing techniques and knowledge of bacterial physiology, cell culture, and immunology.
- Developed infectious disease and treatment models in large or small animals. Performed pathological necropsies including isolation and identification of disease.
Ambico, Inc.
Research Associate
September 1989 - April 1995
- Independent work on individual projects related to the development of an APH1S/USDA licensed biologics product.
- Preparation of manuscripts, SOPs, technical reports and presentations, and APHIS/USDA submissions.
- Designing, writing, and implementation of experimental protocols.
- Formulation and production of swine enteric, respiratory, and systemic vaccines.
- Pathological necropsy of small and large animals.
- Use of pilot and industrial size fermentors.
- Tissue culture techniques and knowledge of several different cell lines.
- Development of Enzyme Linked Immunosorbent Assays (ELISA).
- Supervised the Central Services and Media Preparation personnel in Research and Development.
Mercy Hospital - Microbiology Laboratory - Des Moines, IA
Medical Technologist
July 1987 - September 1989
- Logging-in and processing receipt of all clinical samples in the microbiology laboratory.
- Bacterial, fungal, and viral culturing.
- Isolation, identification, and antibiotic sensitivity testing of clinical samples.
- Medical support including fluorescent antibody assays, agglutination assays, and overall clinical specimen evaluation.
Education:
Mercy School of Medical Technology - Des Moines, IA
Graduated June 1987
University of Iowa - Iowa City, IA
Bachelor of Science Degree - December 1985
Major - General Science