Consultants for Veterinary Biologics, LLC (CVBLLC), was founded in 2008 by Dr. AdaMae Lewis and Dr. Louise Henderson, both former Section Leaders at the Center for Veterinary Biologics (CVB), Veterinary Services/Animal and Plant Health Inspection Services/USDA. CVBLLC is focused on providing expert guidance in veterinary biologics regulation to firms developing and producing veterinary biologics. We strive to provide guidance that ensures an efficient pathway to licensing and permitting veterinary biologics (veterinary vaccines, antiserums, antitoxins, immunomodulators, and diagnostic test kits). As we have expanded, we have added Dr. David Dusek, Dr. Larry Ludemann, Dr. Beverly Schmitt, and Dr. Debbie Champ. Together we have expertise in all aspects of veterinary biologics regulatory issues and provide complete guidance tailored to your specific needs for licensing, permitting, post-license regulatory issues, facilities review, mock inspections and compliance post-licensing. In addition, we work with both new and established firms to provide training, develop compliance plans, and resolve complex regulatory issues.
We customize our services to meet each firm's specific needs and manage integration of our services so that the process is seamless for our clients. We invite you to find out how we might help you efficiently comply with all USDA regulations on veterinary biologics.
Please contact us by e-mail at email@example.com.
AdaMae Lewis, Ph.D., retired from the CVB, Inspections and Compliance as a manager in CVB Inspections and Compliance in 1994 and has since been a consultant in veterinary biologics. She has extensive experience and expertise in facilities inspection and requirements for licensing and permitting of veterinary biologics. She facilitated the Institute for International Cooperation in Animal Biologics (IICAB) Training from 1996-2014.
Louise Henderson, Ph.D. retired from the CVB, Policy, Evaluation, and Licensing, in 2008. She served as Section Leader of Biotechnology, Immunology, and Diagnostics. She was responsible for overseeing policy, laboratory testing, and review and approval of licensing submissions for all biotechnology, immunology, and diagnostic products. She also has expertise in regulatory jurisdiction issues for those products that may be either a veterinary biologic regulated by the USDA or a veterinary drug regulated by the FDA and initiated the forming of the FDA/USDA Jurisdiction Committee for resolution of regulatory jurisdiction decisions.
David Dusek, Ph.D. gained research and development experience working in the veterinary biologics industry for seven years in the development of vaccines prior to joining the Center for Veterinary Biologics (CVB) as a reviewer in 2000. He retired from CVB in 2016 as a Senior Staff Microbiologist. Dr, Dusek developed expertise and provided leadership in development and implementation of policy as well as authoring guidance documents in a wide range of topics, including potency testing (in vitro and in vivo), reference qualification, biotechnology products, cancer products, regulatory jurisdiction, inactivation kinetics, contract testing, and production platform-based products. Dr. Dusek served as CVB’s expert in detailed review of company submissions on these topics. His interest in the 3R’s contributed to his chairing the organizational committee for the 3R’s meeting in 2004 launching CVB’s policy of shifting the emphasis of potency testing from in vivo to in vitro.
Larry Ludemann, DVM, retired in December 2020 from the Center for Veterinary Biologics-Policy, Evaluation, and Licensing (CVB-PEL) as the Bacteriology Section Leader with over 32 years of experience regulating veterinary biologics in the U.S. He spent 13 years in the CVB laboratory intimately involved in testing and analyzing veterinary diagnostic test kits and virology vaccines, 12 years as a Reviewer with a focus on licensing and permitting test kits, and 7 years as Section Leader. Dr. Ludemann has extensive experience developing policy related to licensing and permitting veterinary vaccines and diagnostic test kits over the years. He has presented nationally and internationally on USDA policy on veterinary vaccines and test kits. He has experience in eradicating Foot and Mouth Disease from the United Kingdom, Virulent Newcastle disease from California, and Avian Influenza from the live bird market in New York city. He served as the CVB Institutional Animal Care and Use Committee chair for 10 years.
Kevin Ruby, Ph.D., retired July 31, 2021 from the Center for Veterinary Biologics-Policy, Evaluation, and Licensing (CVB-PEL) as a Senior Staff Reviewer with 34+ years of experience regulating veterinary biologics in the U.S. He spent 11 years in the CVB Bacteriology laboratory and 23+ years as a Senior Staff Reviewer. While in the laboratory, Dr. Ruby was responsible for testing and analyzing veterinary diagnostic test kits and bacterial vaccines, development and validation of reference bacterins and reagents of aerobic bacteriological origin, and development of hybridomas secreting serovar-specific protective monoclonal antibodies against Leptospira interrogans serovars canicola, grippotyphosa, icterohaemorrhagiae, and pomona. He subsequently developed and validated in vitro assays (ELISAs) that are currently used by the biologics industry to potency test leptospiral fractions of biologics containing these serovars as an alternative to the codified hamster potency assay. Dr. Ruby has extensive experience reviewing protocols, reports, Outlines of Production, and other associated required documents for licensure/permitting of all regulated biologics intended for use as prophylactic or as a diagnostic. For the past 18-20 years, Dr. Ruby has been the reviewer of all antivenin and allergenic products and has been instrumental in the policy regarding these products as well as diagnostic products. He was responsible for publication of the Single Tier and recent labeling and packaging Final Rules in the Code of Federal Regulations in 2015. In a novel approach to bovine respiratory disease, Dr. Ruby has demonstrated a role of immediate hypersensitivity in cattle in response to vaccination with modified live viral vaccines and Haemophilus somnus bacterins. This research may explain the fatal pneumonias in calves/cattle and that vaccination may exacerbate development of pneumonias and is likely a contributor to the bovine respiratory disease complex (BRDC). Dr. Ruby brings a wealth of regulatory expertise in all aspects of licensure/permitting of all product types and he has a solid background interacting with international regulators.
Beverly Schmitt, DVM, MS, retired in 2017 as Director of the National Veterinary Services Laboratories (NVSL). She has almost 30 years of experience in veterinary diagnostics. Dr. Schmitt also served as President of the Biological Standards Commission of the Office des Epizooties (OIE) which is an international commission dedicated to the analysis and implementation of testing standards for the purpose of facilitating trade between member countries.
Debbie Champ, DVM, is a lead veterinary epidemiologist with proven record of achievement in developing effective study designs and data analysis procedures which have consistently been applied effectively in attaining numerous U.S. and E.U. registrations of veterinary biologics. Strong experience and skills in developing biostatistical methods which have been essential to product license defense efforts such as vaccine efficacy challenge studies, potency assay reference requalification, potency assay validation, bioequivalence demonstrations, statistical modeling and product stability studies and formulation optimization.