Business: Veterinary market analysis, financial modeling and licensing strategies
Regulatory: Investigational New Animal Drug Applications (INAD), Veterinary Master Files (VMF), Outlines of Production
Clinical: Protocol development and veterinary clinical study documentation for veterinary drugs, biologics, diagnostics, and devices
About our Veterinary Consultants
Our Clients
Since 2007, our veterinary consultants have assisted dozens of human and animal health companies develop products for the animal health market. Our veterinary consultants bring decades of industry, academic and private practice experience with expertise in veterinary regulations (FDA, USDA), veterinary clinical studies, veterinary product development, technology licensing, and veterinary distribution strategies. We have also started multiple veterinary companies with our own money, and can provide real-world, hands-on advice to our clients.
Our animal health consultants have worked with an array of clients including biomedical companies, veterinary companies, veterinary laboratories, medical device companies, veterinary contract research organizations, and animal health investors evaluate and enter the animal health sector. Unlike many firms, we DO NOT disclose the list of our clients.
In addition, our veterinary clinical research services can acquire real-world data in comparative diseases to de-risk technologies before advancing into larger studies.
Our Veterinary Consulting Services
Our animal health consulting team of veterinarians and professional have experience in starting veterinary companies and taking products from concept to commercialization.
01Veterinary Business Development
-veterinary market analysis
-forecasting & financial modeling
-research & development plans
-commercialization strategy
-technology licensing & negotiations
-veterinary company formation
-interim management
02Veterinary Clinical Studies
-veterinary clinical trials
-protocols and study documentation
-data analysis
-veterinary drugs & biologics
-veterinary diagnostics & devices
03Veterinary Regulatory Guidance
-guidance on veterinary regulations
-veterinary regulatory submissions
-FDA-CVM and USDA-CVB
-product development plans
-veterinary development budgets
Principal Veterinary Consultant
Craig Woods DVM, MS, MBA formed Woods Consulting, LLC (d/b/a Animal Health Consulting) in 2007. Craig is a licensed veterinarian and holds an appointment as Director of Infectious Disease and Biosecurity Projects at Arizona State University’s Complex Adaptive Systems Initiative. His recent academic projects involve biosurveillance for highly pathogenic avian influenza, next generation bioweapons risk analysis and biomarker detection of human cardiac amyloidosis (joint ASU-Mayo Clinic). Craig has served as investigator on human clinical studies, complimenting his 20+ years experience as an investigator on veterinary clinical studies to develop antivenoms, immunotherapeutics, orthopedic implants, cancer therapeutics, and intraocular implants. Craig’s One Medicine philosophy and comparative medical research has facilitated the commercialization of human medical devices and numerous veterinary products. Prior to academia, Craig spent >15 years in the pharmaceutical industry holding clinical, regulatory and business development positions.
Veterinary Clinical Studies
veterinary clinical research (e.g., veterinary clinical trials, veterinary clinical studies) and the field of comparative medicine is the epitome of translational research, and can accelerate the development of biomedical innovations for human and animals in parallel.
Existing Challenges in Drug Development: The majority of in vivo pre-clinical research is performed in artificial environments using laboratory animal models with low phenotypic diversity and induced disease states. Although these models can provide insight into disease mechanisms, they consistently fail in predicting human safety and efficacy and has prompted the US Food and Drug Administration’s to explore solutions (see “Advancing New Alternative Methodologies at FDA“).
Comparative Medicine (One Medicine): Comparative medicine evaluates similarities among animal species to enhance the understanding of mechanisms of human and animal disease and facilitates the translation of basic science knowledge into clinical applications. Our veterinary consultants focus on comparative medicine and veterinary clinical studies to leverage the sophistication of veterinary medicine and naturally occurring veterinary diseases which share molecular, cellular, physiological and clinical disease homology to humans. Veterinary clinical studies provide our companion pets access to novel therapeutics and diagnostics that may be otherwise unavailable, while gathering valuable information to advance human and veterinary pharmaceuticals.
additional information from our veterinary consultants
veterinary market – animal health market
The following are recent estimates of the animal health market
Sales: global ex-manufacturer sales of animal health products: ~$40B USD
Region: 33% US and 30% Europe
Products: 60% pharmaceuticals, 30% biologics, 10% medicated feeds.
Species: 60% livestock, 40% companion animal
Veterinary Company Types: Veterinary manufacturers, veterinary distributors, veterinary reference laboratories, and veterinary corporate hospitals.
Other Animal Health Links
veterinary regulations – updates and links
Animal health products in the US fall under the oversight of the FDA Center for Veterinary Medicine, USDA Center for Veterinary Biologics or the Environmental Protection Agency. Animal health product purview largely depends on its intended use and mechanism of action, and each agency has different requirements for research and development of animal health products.
FDA-Center for Veterinary Medicine Updates
USDA-Center for Veterinary Biologics (CVB)
animal health events
Animal Health Annual Summit (Aug. 26-27, 2024.): An ideal summit to learn about emerging veterinary companies and learn from experts in the animal health industry. Attendees include representatives from veterinary distributors, start-up and mature animal health companies, animal health investors, veterinary contract research organizations and others. LINK
Comparative Medicine Symposium (Nov. 30, 2023; Scottsdale, AZ.): Dr. Woods organized the first ASU Comparative Medicine Symposium to discuss veterinary medicine’s role in transforming translational research. Speakers from ASU, NAU, UA, TGen North, industry and private practice discussed contemporary animal health topics including innovations in veterinary oncology, cardiology, infectious disease, canine aging and veterinary clinical research to over 130 veterinarians, physicians, and researchers from across the State of Arizona. Speakers: Bridget Barker PhD; Emily Bray PhD; Evan MacLean PhD; Matthew Miller DVM, MS, DACVIM (cardiology); George Poste DVM, PhD, DSc; Noah Snyder-Mackler PhD; Rachel Venable DVM, MS, DACVIM (oncology); Craig Woods DVM, MS, MBA; and Hayley Yaglom MS, MPH.
