Kevin Ruby Email & Phone Number

Canoga Park, Los Angeles, California, United States

Navigating U.S. Federal regulations and processes can be daunting. VBPS, LLC, believes there are high quality biological products manufactured in foreign (non-U.S.) countries that could be marketed in the U.S. A biological product is defined as a vaccine, bacterin, immunotherapeutic, diagnostic products, antibody products, antivenoms, and allergenics. At VBPS, LLC, we provide expert guidance for U.S. licensing (permitting) of global veterinary biological products. We represent your company to the U.S. regulatory authorities. With your input, we will draft and submit all required regulatory documents to the regulatory authorities, maintain a quarantine facility for your product, assist and/or design clinical study (efficacy/safety) protocols and final reports and identify resources for conduct of these studies, interact with U.S. regulatory authorities, provide marketing and distribution of your product within the U.S. if needed, and address any and all post-licensing (permitting) requirements once your product is licensed (permitted). Finally, we can assist in licensing/marketing your U.S. licensed (permitted) product into other foreign markets if needed. If you are a non-U.S. (foreign) manufacturer of veterinary biologicals and would like to pursue licensure (permitting) of your product in the U.S., please email us at info@vbpsllc.com or kruby@vbpsllc.com for further information.

08/2021 to present: Consultant, Consultants for Veterinary Biologics, LLC.Licensure/permitting of a product can be complex, incomprehensible, and stressful. As a consultant with nearly 34 years experience as a Senior Staff Reviewer, I assist new and established firms to obtain licensure/permits for ALL product types by providing expertise in regulatory jurisdiction issues (FDA vs. USDA) and licensing/permitting of all product types. Expertise include all phases/studies related to licensure/permitting of veterinary biologicals including but not limited to Outlines of Production, writing protocols/final reports, Master Seed/Master Cell, vaccination-challenge models, efficacy, safety, Supplemental Information Formats (recombinant and importation), and potency assay development/validation.

Licensed/permitted hundreds of products: review all documents, protocols, reports/data, etc. for new/ established products. Some products (e.g., new technologies) didn't conform to existing policies/guidelines. Wrote/published (2014) Single Tier Final Rule in Title 9 of the Code of Federal Regulations to amend how label claim info is presented/provide more meaningful info to end-users. Wrote/published (2015) Final Rule on labeling/packaging to reflect current policies.Wrote new firm informational packets for antivenin, Cancer/Immunomodulatory products, live/inactivated products (including recombinants), and diagnostic test kits. Consultant to American Academy of Veterinary Consultants (AAVC) et al regarding role of immediate type I hypersensitivity in cattle post-vaccination. Guest speaker at: 1) AAVC, 2019; overview of licensure and role of H. somnus bacterins and vaccines in BRD; 2) International Symposium on Alternatives to Animal Challenge Tests in the Batch Control of Leptospiral Vaccines for Veterinary Use, (1999), European Department for the Quality of Medicines, Council of Europe, Strasbourg, France; 3) International Leptospiral Vaccine Workshop, Ames, Iowa, 2012; 4) Commonwealth Serum Laboratory, Melbourne, Australia; transfer of leptospiral ELISAs and participate in symposium on pain, analgesia, and the immune response.Directors Science Advisory Taskforce (1992-998). Chair of the Institutional Animal Care and Use Committee (1994-1997); oversight of National Veterinary Services Labs accreditation by the American Laboratory Animal Care (ALAC).Developed serovar-specific/protective monoclonal antibodies (MAbs) and ELISAs against leptospiral serovars canicola, gripppotyphosa, icterohaemorrhagiae, and pomona used by industry for potency testing of leptospiral bacterins. Developed neutralizing/protective MAbs against dermonecrotic toxin Type D of Bordetella bronchiseptica. President, American Leptospirosis Research Conference, (1993-1996)

Ames, Iowa, United States

Ames, Iowa

Research included 1) identification, sequencing, and cloning of the ped gene in mice that regulates pre-embryonic development and its involvement in the aging process of mice and mammals; 2) structure and function of the major histocompatibility complex (MHC) in mice, pigs, and chickens and their function in cellular interactions and 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.

Marshalltown, Iowa