LOUISE M. HENDERSON, Ph.D.

 

Residence:                               6873 Moccasin Ct. NW, Rochester, MN 55901

Telephone:                               515.292.7169

E‑mail:                                     lmhenderson@consultantsforveterinarybiologics.com

 

EDUCATION   

 

Doctor of Philosophy in Molecular, Cellular and Developmental Biology (MCDB), 1993.  Iowa State University, Ames, Ia.  (Safety and efficacy testing of veterinary vaccines).

Registered Microbiologist, American Society for Microbiology

· Specialties in Pathogenic Bacteriology; Immunology and Serology

Medical Technologist, American Society for Clinical Pathology (MT,ASCP).

 

EMPLOYMENT HISTORY   

 

3/2008 to present:  Co-President, Consultants for Veterinary Biologics, LLC.

§ 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)

§ Developed policy document for CVB and continue discussing potential policy with CVB.

 

6/1997 to 3/2008:  Center for Veterinary Biologics; Policy, Evaluation, 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 Policy and supervisory authority over:  diagnostic test kits, immunomodulators, antibody products, antigenic extracts, and all veterinary biologics based on new technologies.

o Acting Director of Policy, Evaluation and Licensing periodically.  Acting Director, Center for Veterinary Biologics periodically.

o Developed, interpreted and implemented policy and recommended licensure for products under authority.  Approved all responses to firms for products under authority.  Determined appropriate licensure requirements and adapted established policies to ensure intent of regulations was met with products not fitting established methods.

o Developed and established policies for veterinary biologics products based on new technologies including DNA vaccines, cancer biologics, and plant-based biologics.

· Initiated contact and established working group with FDA to establish policies regulatory considerations 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 Supervised section and approved all testing on all products under supervisory authority.

o Developed guidelines and policies for definition and licensure of immunomodulators.

o Initiated development of policies for cancer immunotherapeutics.  Held Public Meeting for veterinary cancer biologics.

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 development of Validation Standards and biotechnology policies.

o Provided leadership and wrote detailed guidance on designing Quality Assurance standards for veterinary laboratories.

o Served on USDA Grant Board, evaluating and recommending funding of USDA grants.

 

§ 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 animal diseases.

 

5/1988 to 6/1997:  National Veterinary Services Laboratories, 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 the use of current and emerging 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.

§ 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.

 

9/1982 to 5/1988:  Iowa State University, Ames, IA

§ Participated in research focused on 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 

Patent:  Hybridoma ERHU1‑B60‑91 producing monoclonal antibodies to a protective immunogen of Erysipelothrix rhusiopathiae.