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.  He retired from CVB in 2016 as a Senior Staff Microbiologist. 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 was the primary or co-author of the following policy/guidance documents during his 16+ years at CVB.

Veterinary Services Memoranda

  1. 1.800.112 Guidelines for Validation of In Vitro Potency Assays (April 10, 2015) 

  2. 2.800.115 Potency Testing by Unlicensed Facilities (June 21, 2013) 

  3. 3.800.117 Guidance for Inactivation Studies (August 12, 2013) 

  4. 4.800.118 Live Master References (December 12, 2013) 

  5. 5.800.203 General Licensing Considerations: Compatibility of Components (January 16, 2007) 

  6. 6.800.209 Bovine Corona Virus and Rotavirus Master Reference Qualification by Colostral Antibody Titers (December 8, 2010) 

  7. 7.800.211 Guidelines for Master Reference Qualification and Requalification (June 28, 2011) 

  8. 8.800.213 Licensing Guidelines for Production Platform-Based, Non-Replicating, Nonviable Products (April 29, 2015) 

  9. 9.Draft VSM Doc 567 Individualized Therapeutic Biologics (autologous cancer treatments) (in process). 

CVB Notices

  1. 1.09-04 Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts 

Reviewers manual

 

1. 4.1.2 Potency Testing of Biological Products

2. 4.1.3 Considerations to Requests for Changes to Outlines of Production for Bacterial Products

3. 4.4.3 Master Reference Qualification and Requalification and Understanding VSM 800.211

4. 4.6 Guidelines for Review Staff Re: Reviewing potency assay proposals and validation reports

5. 4.6.1 Reference terminology

6. 4.10.3 Guidance for Evaluation of Studies Submitted for Confirmation of Expiration Dating of Product as Required by 9CFR 114.13.