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
About Animal Health Consultants
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 provide decades of experience in 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 and Regulations
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. Our veterinary consulting team can assist clients in navigating the complex veterinary regulatory landscape and provide guidance for veterinary biologics, veterinary vaccines, drugs, devices, nutritionals, and veterinary diagnostics.
Regulatory oversight of veterinary products are based on their mode of action and intended use, and agency purview is generally described as follows:
Food and Drug Administration – Center for Veterinary Medicine (FDA-CVM)
- Veterinary Pharmaceuticals: Veterinary drugs achieve their effect through chemical reaction on or within the body of an animal.
- Veterinary Nutraceuticals: Veterinary nutraceuticals and veterinary supplements.
- Veterinary Medical Devices
USDA-Center for Veterinary Biologics (USDA-CVB)
- Veterinary Vaccines and Veterinary Biologics: Veterinary biologics achieve their primary effect through immune modulation or stimulation.
- Veterinary Diagnostics: Veterinary diagnostics used to detect pathogens or a patient’s immune status are regulated by the United States Department of Agriculture’s Center for Veterinary Biologics.
Animal Health Business Development
Our veterinary consulting team provides a range of animal health consulting services to accelerate the development and commercialization of veterinary products.
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.
Veterinary Clinical Studies
Our veterinary clinical research 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 cardiology, dermatology, 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 implement and manage veterinary studies within our veterinary clinical study network.
Types of Veterinary Clinical Trials: Some papers may reference veterinary clinical studies or veterinary trials as Phase I, II, or III. This terminology is incorrect as such Phases do not exist in veterinary medicine or by the veterinary regulatory authorities.
Instead, veterinary clinical studies and trials are categorized into target animal safety or target animal efficacy / effectiveness. The term “substantial evidence” is used to describe the target animal effectiveness section for veterinary drug studies (FDA-CVM).
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