Veterinary Pharmaceutical
Consultants
Animal health consultants with industry, start-up, academic, and private practice experience.
providing expertise in veterinary clinical studies, veterinary regulations, business development, and development and
commercialization of veterinary pharmaceuticals, biologics, devices, and diagnostics
Since 2007, our veterinary consultants have assisted dozens of veterinary companies, human pharmaceutical firms and laboratories enter the veterinary market and animal health sector. Our seasoned animal health consultants can assist with veterinary clinical studies, business development and licensing transactions, and commercializing products for the veterinary market and animal health industry.
Our veterinary consultants also provide guidance on navigating the veterinary regulations and the various agencies involved in the oversight of various veterinary drugs, medicated feeds, biologics, parasiticides, cell-based therapies, devices, diagnostics, foods, and nutraceuticals (supplements).
Veterinary Consulting Services: Veterinary Products
Veterinary products in the United States are regulated by the FDA-Center for Veterinary Medicine, USDA-Center for Veterinary Biologics, or the Environmental Protection Agency. A veterinary product’s mode of action and its intended use are key factors in determining which agency will have regulatory oversight of the veterinary product.
Veterinary Vaccines and Veterinary Biologics: Veterinary biologics achieve their primary effect through immune modulation or stimulation.
Veterinary Pharmaceuticals: Veterinary drugs achieve their effect through chemical reaction or metabolism in the body.
Veterinary Diagnostics: Veterinary diagnostics used to diagnose pathogens or a patient’s immune status are regulated as biologics by the United States Department of Agriculture’s Center for Veterinary Biologics.
Veterinary Nutraceuticals: Veterinary nutraceuticals and veterinary supplements.
Business Development & Regulatory
Our veterinary consulting team provides a range of animal health consulting services to accelerate the development and commercialization of veterinary products, generally categorized as follows:
Technology and Market Analysis: we routinely assist small to large biomedical companies with assessing their technology or assets for applications in veterinary medicine. We can assist in establishing target disease applications, and conduct market research in connection with product attribute mapping, price elasticity analysis, and market forecasting.
Business Development: we have decades of experience in licensing transactions and can assist clients in licensing strategies, negotiations, due diligence, contract guidance, and financial modeling.
Regulatory Guidance: Our veterinary consulting team can assist clients in navigating the complex veterinary regulatory landscape and provide guidance for veterinary biologics, vaccinces, drugs, devices, nutritionals, and diagnostics.
Veterinary Clinical Studies
Our team has over 20 years experience in designing and implementing veterinary clinical studies as well as serving as investigators on human (Phase II-IV) and companion animal studies. Our veterinary consultants have experience in designing and implementing veterinary studies in the fields of cardiology, infectious disease, orthopedics, ophthalmology, neurology, and a range of other veterinary study areas.
Our veterinary clinical research focuses on proof of concept veterinary clinical studies to help de-risk assets prior to entering larger veterinary studies. In this capacity, our veterinary pharmaceutical consultants will work with sponsors to understand the project objectives, develop the study design and documentation, and then can implement and manage veterinary studies within our veterinary clinical study network.
Some papers may reference veterinary clinical studies or veterinary trials as Phase I, Phase II, and so on. This is incorrect, as so such Phases exist in veterinary medicine or by the veterinary regulatory authorities. Instead, we refer to studies as falling into safety or effectiveness (or efficacy). The terms substantial evidence also applies to technical sections regarding veterinary drug studies.
Veterinary Research: a translational research bridge
Existing Challenges in Translation Research: Pre-clinical research is routinely performed in fabricated settings (e.g., tightly controlled labs) using laboratory animal models with artificial diseases. Although these studies may provide insight into mechanisms of action or fundamentals of disease mechanisms, existing pre-clinical research is miles apart from recapitulating the complexities of human disease, comorbidities, and patient disease heterogeneity. Unfortunately, pre-clinical research using laboratory animal models rarely translates into predicting human clinical outcomes. In fact, on average more than 90% of all new drugs fail during human clinical trials. The failures of pre-clinical research questions if these studies should even be called translational.
Veterinary Comparative Medicine’s Role in Translational Research: Veterinary medicine is a highly sophisticated profession providing near equivalent surgical and therpeutic interventions to human medicine. Notably, veterinary patients naturally develop a range of diseases with molecular, cellular, physiological and clinical homology to humans, similarities which have increased the importance for veterinary clinical studies. Veterinary clinical studies allow veterinary patients access to new therapeutics and diagnostics and can be used to acquire valuable information for advancing human and veterinary pharmaceuticals in parallel. Link to Science Translational Medicine’s article: Companion animals: Translational scientist’s new best friends
Additional Resources
Information on the Veterinary Market: Animal Health Institute
Veterinary Companies: KC Animal Health
Veterinary Distributors: United Veterinary Services Association