Walker Downey & Associates, Inc.
Proof of Concept Testing
Proof of Concept (POC) testing is the initial stage of product commercialization. The development in this stage involves taking an idea and conducting enough research to prove that the idea is feasible and can work. Walker Downey & Associates prides itself in being able to offer POC testing in the domestic pig (sp. Sus scrofa) using our dedicated animal isolation facility. For all POC testing, animals of the client’s desired age/weight are carefully selected from our reputable supplier, physically examined for good health by our veterinarian, and monitored round-the-clock by our dedicated animal caretaker. The facility meets USDA-APHIS standards.
Walker Downey & Associates will collaborate with you early in product development to provide critical proof-of-concept data. We can serve as an incubator for successful biotechnology companies and support fundraising efforts by generating proof-of-concept data, assisting with presentations to investors and serving as a subcontractor on grant proposals.
Experts in large animal studies, we can quickly set up studies to test medical device functionality and safety, drug and biologics safety, or obtain pharmacokinetic profiles or metabolism. We will assist you in selecting the best model for your scientific end-point. Data are presented to you in a written report. We will define and defend our findings in applications for 510(k), IND and NDA before the FDA.
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Our Peterson Isolation Facility (PIF) is environmentally controlled to USDA standards and contains four (4) separate stalls that can hold animals of various ages/sizes. Typically a single stall will hold ~15 young animals (6-12 weeks of age). Larger older animals are grouped in smaller numbers, as required by guidelines. We will conduct testing on a single animal and up to our PIF animal number limitation. Please contact us for additional discussion. |
Walker Downey & Associates can assist you in designing your protocol and support power calculations for the number of animals needed for proof-of-concept based on pilot experiments performed by us or based on our historical experience. Each experimental design not only yields positive results and strong proof-of-concept but is performed in a scientifically sound and rigorous manner with significant cost and time savings to our clients.
Swine have been used rather extensively in dermal studies and in cardiology, but they have more recently been proposed for vaginal studies because their estrus cycle is similar to a woman's menstrual cycle. This is in contrast to rabbits (a more traditional model) which cycle after stimulation, and the vaginal lining of a dog is rather thin until estrus, which occurs after several months. Walker Downey & Associates have already, quickly and cost-effectively, developed wound healing and vaccine animal models with Sus scrofa. For other disease models please inquire. We can help you to identify the most useful animal model to meet your needs. Walker Downey & Associates is comprised of experienced veterinarians, pathologists, toxicologists, statisticians, quality assurance auditors and other doctoral level scientists who are highly skilled and have a strong academic network.