Dr. Dusek gained research and development experience working in the veterinary biologics industry for seven years in the development of vaccines prior to joining the Center for Veterinary Biologics (CVB) as a reviewer in 2000. During his tenure at CVB he was involved in all aspects of the review process; specifically, he developed expertise and provided leadership in development and implementation of policy in a wide range of topics, including potency testing (in vitro and in vivo), reference qualification, biotechnology products, cancer products, regulatory jurisdiction, inactivation kinetics, contract testing, and production platform based products. Dr. Dusek served as CVB’s expert in detailed review of company submissions on these topics. His interest in the 3R’s contributed to his chairing the organizational committee for the 3R’s meeting in 2004 launching CVB’s policy of shifting the emphasis of potency testing from in vivo to in vitro.He is the primary or co-author of the following policy/guidance documents. Veterinary Services Memoranda1. 800.112 Guidelines for Validation of In Vitro Potency Assays (April 10, 2015)2. 800.115 Potency Testing by Unlicensed Facilities (June 21, 2013)3. 800.117 Guidance for Inactivation Studies (August 12, 2013)4. 800.118 Live Master References (December 12, 2013)5. 800.203 General Licensing Considerations: Compatibility of Components (January 16, 2007)6. 800.209 Bovine Corona Virus and Rotavirus Master Reference Qualification by Colostral Antibody Titers (December 8, 2010)7. 800.211 Guidelines for Master Reference Qualification and Requalification (June 28, 2011)8. 800.213 Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products (April 29, 2015)9. Draft VSM Doc 567 Individualized Therapeutic Biologics (autologous cancer treatments) (in process).CVB Notices1. 09-04 Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts

Project leader in Bovine Business unit 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. 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. Developed strategy for upgrading old products, and evaluating new technology for application to these products and their potential replacements. Supervised MS level scientist. 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. 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. Regularly presented progress reports to senior management, these took the form of monthly presentations and semiannual updates to the combined US and European animal health groups. Trained in cGMP, GCP and GLP .