Kevin W. Ruby, MS, Ph.D.
Residence: P.O. Box 148, Roland, IA 50236
Telephone: 515.290.5979
E mail: kevinruby@cvbllcusa.com
EDUCATION, STRENGTHS, & INTERESTS:
B.S., M.S., Ph.D.: Iowa State University, Ames, Iowa.
Immunology, Microbiology, Preventive Medicine, physiology,
pharmacology, pathology
STRENGTHS:
Creating a calming and step-by-step approach toward the
licensure process for all product types;
Vaccine Potency Assay Development/validation with emphasis on in
vitro assays;
Vaccination-challenge models to demonstrate efficacy and
evaluate safety;
Antivenin, Diagnostic, and Allergenic products;
Hypersensitivities in all species;
Cancer immunology and signal transduction mechanisms;
One-Health Initiative
INTERESTS:
Hypersensitivities in cattle, dogs, people in response to
vaccination with modified live and killed vaccines/Bacterin
combinations;
Diminishing/mitigating adverse immune responses to vaccination;
Role of prostaglandins, leukotrienes, thromboxanes, and typtase
in development of pneumonia and hypersensitivities in cattle,
dogs, cats, people;
Physiologic and pharmacologic role of atrial natriuretic factor
(peptide) in regulation of blood pressure, heart failure, and
other cardiomyopathies;
Preventive medicine (veterinary and human);
Novel cancer products;
Emerging Infectious Diseases;
Medical nanotechnology
EMPLOYMENT HISTORY
08/2021 to present: Biologics Consultant, 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)
- Assist new firms navigating the complex
licensure/permitting process for new products.
- Assist firms (new and established) with:
vaccination-challenge models to demonstrate efficacy/safety,
potency test development and validation, basic/applied
research to address current issues with vaccinology,
immunologic disease, or various complex disease situations
(e.g., Bovine Respiratory Disease).
- Provide training regarding the regulatory requirements for
licensure/permitting of new products.
12/1998 to 08/2021: Senior Staff Reviewer
- Reviewed applications for licenses and permits from firms
to evaluate the efficacy, safety, purity, and potency of
proposed and/or licensed biologics intended for prevention,
treatment, or diagnosis of animal diseases.
- Acting Section Leader of Bacteriology Section as needed.
Ensured policy consistency in CVB correspondence from all
reviewers regarding bacteriology, diagnostic products,
allergenics, and other related products.
Assumed primary contact for guidelines and policies for
diagnostic products.
- Responsible for review of all anti-venin and allergenic
products for the past 18 years (~2003-July 2021).
- Assisted with special projects as assigned by Directors of
the Center for Veterinary Biologics or the Policy,
Evaluation, and Licensing Director as requested.
- Single Tier (2009) Rules. Discussions with American
Veterinary Medical Association and industry groups
(Animal Health Institute, American Veterinary Biologics
Companies) to amend how label claim information is
presented and to provide more meaningful information to
practitioners and other end-users. Held public meeting
in Ames, Iowa in 2011 to gather input. Two components to
Single Tier Rule: 1) label claim changes and reference
to the CVB website and 2) publication of efficacy and
safety data summaries used to license the product.
Proposed Rule published April 21, 2024, with Final Rule
published in Title 9 of the Code of Federal Regulations
on July 10, 2015.
- Significant revision of labeling and packaging Final
Rules (9 CFR 112) to reflect current policies.
- Instrumental in the development of new firm
informational packets for antivenin products, Cancer
products/Immunomodulatory products, diagnostic test
kits, and live/inactivated vaccines including
recombinant vaccine
- Consultant and provided input to various research entities
(NADC/ARS, University of Mississippi, University of
California @ Davis) regarding research spawned from PhD
dissertation investigating the role of immediate type I
hypersentivity in cattle in response to vaccination with
modified live viral vaccines and Haemophilus somnus
bacterins to explain fatal pneumonias in calves/cattle.
- Guest speaker at the International Symposium on
Alternatives to Animal Challenge Tests in the Batch Control
of Leptospiral Vaccines for Veterinary Use (Mar 5, 1999,
European Department for the Quality of Medicines, Council of
Europe, Strasbourg, France). Purpose of this meeting was to
identify forward-looking approaches to reducing animal use
in potency testing and conveying United States policies
regarding veterinary biologics.
- Co-organizer and guest speaker at International
Leptospiral Vaccine Workshop held in Ames, Iowa, July 3,
2012. Federal agencies involved in co-organizing or
providing speakers included National Intragency Center for
the Evaluation of Alternative Toxicological Methods
(NICEATM), National Institute of Environmental Health
Sciences (NIEHS/NIH), Center for Disease Control
(CDC/OID/NCEZID), National Institute for Allergy and
Infectious Disease (NIH/NIAID), and various recognized
infectious disease experts from various domestic and
international universities. The purpose of the conference
was to identify current state of leptospiral vaccines,
epidemiology, current alternatives to animal use in
regulation of animal biologics, and approaches forward.
- Developed and proposed appropriate licensure requirements
and adapted established policies to ensure the intent of
regulations was met with products not fitting established
methods.
- Developed and proposed policies for veterinary biologics
products based on new technologies including antivenin,
allergenic, platform, cancer biologics, and diagnostic
products.
- Provided input on policy related to Equine
Parvovirus-Hepatitis Virus in antibody products of equine
origin and other emerging infectious diseases (Porcine
Epidemic Diarrhea Virus, Porcine Circovirus, Seneccavirus,
etc).
- Effectively interacted with Inspection and Compliance Unit
and Statistics Section to clarify issues and provide
accurate guidance to the regulated industry.
- Guest lecturer in pathogenic bacteriology, College of
Veterinary Medicine, Iowa State University, 1995-1998.
12/1987 to 12/1998: Microbiologist, National Veterinary
Services Laboratories (NVSL), Bacteriology Section, Veterinary
Services, Animal and plant Health Inspection Service, Ames,
Iowa
- 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.
- Responsible for development and validation of all
reference vaccines, challenge cultures, and other reagents
of aerobic bacteriology origin.
- Served on Directors Science Advisory Taskforce (1992 1998)
at the request of the NVSL Director.
- Developed career ladder guidelines for scientific
positions. Was forwarded to APHIS Management Team.
- Served as Chair of the Institutional Animal Care and Use
Committee (1994-1997). Responsible for oversight of the
process toward NVSL obtaining accreditation by the American
Laboratory Animal Care (ALAC).
- Responsible for testing of the first recombinant Rabies
Vaccine for use in wildlife.
- Developed hybridomas secreting neutralizing and protective
monoclonal antibodies against Leptospira interrogans
serovars canicola, gripppotyphosa, icterohaemorrhagiae, and
pomona. Developed and validated ELISAs for use as potency
tests as an alternative to the hamster potency assays
required by Title 9 of the Code of Federal Regulations.
These assays are currently being used by the regulated
industry for potency testing of bacterins containing these
leptospiral serovars.
- Developed neutralizing and protective monoclonal
antibodies against the dermonecrotic toxin Type D of
Bordetella bronchiseptica.
- President, American Leptospirosis Research Conference,
(1993-1996)
06/1984 to 9/1987: Researcher. Iowa State University, Ames,
IA, Department of Biochemistry and Biophysics, Iowa State
University, Ames, Iowa
- Participated in research focused on the role of the ped
gene in the aging process as well as characterization of the
Major Histocompatability Complex (MHC) antigens (types I and
II) in regulation of the immune response in mice, pigs, and
chickens and their function in cellular interactions related
to embryonic development of these animal species, and 3)
initial evaluation of the murine bcg gene in cattle in the
immune responses of cattle to tuberculosis. Applications to
human medicine.
Previous: 1974-1981: Paramedic, Marshall County Ambulance
Service.