David Dusek, PhD

SUMMARY OF QUALIFICATIONS

Senior consultant for Consultants for Veterinary Biologics, LLC. Retired from Center for Veterinary Biologics (CVB) USDA as Senior Staff Microbiologist (Reviewer); previously project scientist for Boehringer Ingelheim Vetmedica, Inc., and Heska/Diamond Animal Health. Lead by fostering and promoting missions and goals within organizations; working closely with Federal regulatory agencies, state officials, and industry groups. Experienced at regulating a wide variety of veterinary vaccines and diagnostics.

    ☐ A broad understanding of federal regulations for veterinary biologics, able to avoid pitfalls in attaining product licenses and permits through expertise in regulating and review, and time management skills.
    ☐ Developed guidance documents for testing, biotech and cancer products used in the veterinary environment.
    ☐ Experienced in regulatory jurisdictional issues.

CAREER HIGHLIGHTS

2016-present, Consultants for Veterinary Biologics, LLC, Ames, IA
Senior Consultant
Provide guidance, resources to new and established firms to facilitate the USDA licensing process.

2000-2016, USDA CVB, Ames, IA
Senior Staff Microbiologist in the Center for Veterinary Biologics Policy, Evaluation, and Licensing Development (CVB-PEL) section of the Veterinary Services arm of USDA/APHIS. As a Senior Staff reviewer my responsibilities included development of policy, jurisdictional issues, evaluation of protocols, license submissions, risk analysis, and safety and efficacy submissions from veterinary biologics firms. In this capacity I was required to have a thorough understanding of the Virus Serum Toxin Act and the provisions covering it in the Title 9 Code of Federal Regulations, Veterinary Services Memorandum and Notices. Other duties as assigned include organizing scientific and policy meetings of national and international importance, development of policy/guidance documents and technical advice to the Center for Veterinary Biologics Laboratory, serving on coordinated review teams and representing CVB-PEL at national and international scientific and regulatory meetings as speaker/presenter. Primary or co-author of numerous regulatory guidance documents related potency testing, test validation, inactivation studies, production platform guidance, and autologous therapeutics.

1998-2000, Boehringer-Ingelheim Vetmedica, Inc., St. Joseph, MO
Staff Scientist/Project Leader in the Bovine Business unit at Boehringer-Ingelheim Vetmedica, Inc. (BIVI) with responsibility for development of bacterial vaccines for use in cattle. Responsible for management of projects, protocol development, contract administration and monitoring of studies leading to licensure of bacterial vaccines for cattle in the U.S., Europe, and Canada. These duties include but were not limited to design and implementation of host and laboratory animal studies, assay development, optimization of fermentations and downstream processes in compliance with USDA, EU, and Canadian regulations. I developed strategy for upgrading old products and evaluating new technology for application to these products and their potential replacements. Additionally, I supervised one MS level scientist directly and as many as a dozen indirectly according to project demands. This position required considerable interaction with the internal regulatory affairs, QA, Marketing, QC, Research Farm and manufacturing departments, as well as coordination of external studies offsite. At BIVI I was responsible for the licensing of a Clostridial vaccine and was project leader on two major projects and in addition had responsibility for major portions of several minor projects involving conventional and genetically modified microorganisms. I regularly presented progress reports to senior management, these took the form of monthly presentations and semi-annual updates to the combined US and European animal health groups. Trained in cGMP, GCP and GLP and has a state-of-the-art GMP manufacturing facility in St. Joseph.

1993-1998, Heska/Diamond Animal Health, Inc. Des Moines, IA
Senior scientist managing the Bacterin development/assay development/protein core/fermentation group at Diamond Animal Health, a subsidiary of Heska Corporation, Department of Research and Development, Des Moines, Iowa. Responsible for the management of all bovine and companion animal bacterial activities associated with vaccine development, diagnostics development, and process transfer. Gained experience in designing and implementing studies fulfilling USDA-APHIS licensing requirements. Considerable experience in designing and implementing in-process and potency tests leading to licensing of products. Regular interactions with academic institutions, other biologics firms and the parent company (in Ft. Collins, CO). Direct report to Manager/Director of Research and Development and direct supervisor of five BS level scientists and indirectly of up to three BS/MS level scientists. Various duties included protocol development, project administration, assay development, chairing the Institutional Biosafety Committee (IBC) and departmental compliance with GLP/cGMP. With respect to the IBC and GLP/GMP training I coordinated formation of the IBC and laid the foundation for the institutional review of projects. In addition, I conducted introductory training to GLP and cGMP in the R&D department. I regularly provided oral and written presentations to senior management and staff on technical issues and projects. Versed in 9CFR and testing requirements.

Supervisor of Sterility Laboratory and Microbial Identification at Diamond Animal Health, Department of Quality Control, Des Moines, Iowa. Developed, implemented, and reviewed SOP's, departmental practices and served as temporary manager of Quality Control. Responsible for verification of tests, authorization of APHIS Form 2008 submitted to CVB-IC for product release and day-to-day operation of the department. Gained experience in troubleshooting, animal testing, environmental monitoring, and investigation of contamination problems.

1989-1993, Department of Oral Biology, University of Florida
Post-doctoral fellow in the Department of Oral Biology, College of Dentistry, University of Florida. Investigated the mucosal and systemic immune response of mice to a surface protein (hemagglutinin) of Porphyromonas gingivalis as expressed in recombinant, avirulent, vaccine strains of Salmonella typhimurium.

EDUCATION

University of Florida, Gainesville, Florida; Department of Microbiology and Cell Science. Dissertation title: Isolation and characterization of amatoxin resistant lines of Chlamydomonas reinhardtii having an altered RNA polymerase II. Ph.D. in Microbiology, 1990.

Cleveland State University, Cleveland, Ohio. BS, Biology, 1973, minor, chemistry.