KEVIN RUBY, M.S., PhD

Consultants for Veterinary Biologics, LLC

Biologics Consultant

• 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.

 

Center for Veterinary Biologics; Policy, Evaluation, and Laboratory, Veterinary Services, Animal and Plant Health Inspection Service, Ames, IA

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 hypersensitivity 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 Intra-agency 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, Senecavirus, 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.

 

National Veterinary Services Laboratories, Veterinary Services, Animal and Plant Health Inspection Service, Ames, IA

Microbiologist

• 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)

 

Department of Biochemistry and Biophysics, Iowa State University, Ames, IA

Researcher

• 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.

 

Paramedic, Marshall County Ambulance Service