Veterinary Biologics Regulatory Consultant
Consultants for Veterinary Biologics, LLC
From March 2008
Provide expert advice regarding licensure and permitting of veterinary biologics (vaccines, diagnostic test kits, immunomodulators, antibody products, allergenic extracts, etc.).
* Provide expert advice in regulatory jurisdiction issues (FDA vs. USDA)
* Evaluate potential regulatory issues for new biotechnology-derived veterinary biologics.
* Resolve issues that arise for veterinary biologics firms with regard to regulatory problems. Discuss issues with CVB to understand source of problem and resolve root cause.
* Individualize advice for each firm to ensure their licensure/regulatory issues are resolved as efficiently as possible with the best outcome possible.
o Served as Staff Officer (Reviewer)
June 1997 - March 2008
and Laboratory, Veterinary Services, Animal and Plant Health Inspection Service, Ames, Iowa
* 2/1998 to 3/2008: Chief/Section Leader of Biotechnology, Immunology, and Diagnostics
o Responsible for establishing, interpreting, implementing and overseeing licensing/permitting of: diagnostic test kits, immunomodulators, antibody products, antigenic extracts, and all veterinary biologics based on new and molecular technologies. Supervised section. Approved all responses to firms for products in BID responsibility.
o Provided leadership on jurisdiction resolution with FDA/CVM (primarily immunomodulators and cancer products). Initiated development of CVM/CVB Regulatory Jurisdiction Committee.
o Provided leadership in establishing policies for veterinary biologics products based on new technologies. Initiated policy development on new technologies including nucleic acid vaccines, cancer biologics, and plant-based biologics.
• Initiated and established working group with FDA to establish regulatory policies for plant-based biologic. Recommended licensure of first plant-based biologic in the world (veterinary or human). Co-authored Guidance on Biologics and Protein Drugs Derived from Bioengineered Plants for Use in Humans and Animals developed as collaborative guidance with the Food and Drug Administration. Received FDA Commissioner's Special Citation for outstanding cooperation and achievement in developing a joint agency policy.
o Developed guidelines for definition and licensure of immunomodulators.
o Provided leadership in development of Validation Standards and biotechnology policies.
o Provided leadership on designing Quality Assurance standards for veterinary laboratories.
* 6/1997 to 2/1998: Staff Microbiologist
o Served as Staff Officer (Reviewer): Reviewed applications for licenses and permits from firms to evaluate the safety, purity, potency, and efficacy of proposed and licensed biologics for agents intended for prevention, treatment, or diagnosis of...
National Veterinary Services Laboratories
May 1988 - June 1997
, Veterinary Services, Animal and Plant Health Inspection Service, Ames, Iowa
* Laboratory microbiologist for Veterinary Biologics Laboratory in Small Animal Virology (2 years), Bacteriology (5 years), and Mammalian Virology (2 years).
* Tested and evaluated the safety, purity, potency, and efficacy of proposed and licensed biologics for agents intended for prevention, treatment, or diagnosis of animal diseases.
* Designed, developed, and evaluated new procedures emphasizing molecular biology techniques. Developed and validated in vitro testing methods to replace host animal or lab animal tests. Developed and validated hybridomas.
* Served on Recombinant DNA Committee (1988 1997 and In Vitro Committee (1990-2008).
* Designed development of an ELISA for the detection of antibodies to Brucella canis.
* Developed Erysipelas rhusiopathiae ELISA and monoclonal antibodies.
* Demonstrated recombination of vaccine strains of pseudorabies virus in swine.
ISU Veterinary Diagnostic Laboratory, Bacteriology, Lead Technician
Iowa State University
September 1982 - May 1988
, Ames, IA
* Researched the development of a gene deleted or subunit Brucella abortus vaccine (2 years).
* ISU Veterinary Diagnostic Laboratory, Bacteriology, Lead Technician (4 years). Performed all aspects of diagnostic testing and identification of pathogens. Assisted in training of veterinary students and visiting scientists in bacteriology.
Previous: Mercy Medical Center and Iowa Lutheran Hospital, Des Moines, IA
* Medical Technologist in Microbiology. Educational coordinator. QA Technologist.
Academic Experience: Instructor, Microbiology for Health Professionals, DMACC
Patent: Hybridoma ERHU1 B60 91 producing monoclonal antibodies to a protective immunogen of Erysipelothrix rhusiopathiae.
Qualifications & Certifications
Iowa State University
Mercy School of Medical Technology
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