Biotech Startup May Change Veterinary Drug Approval Landscape

Big pharma generally works backward: Determine what a chemical compound does to a body, then see where it can be applied in medicine. To bring a drug to market, a four-stage trial has to take place; it then takes about 10 years and $100 million to navigate the FDA approval process. DVM 360 reports that only about 14 percent of drugs developed actually make it to market.

Generally, if a drug doesn’t do well on the human side, it’s then offered to the animal-medicine side, said Dr. David Bruyette, chief medical officer at Anivive Lifesciences. The trial process then begins again. Because of this onerous process, nearly 85 percent of diseases vets face either have no treatment or the treatment involves using human drugs off-label, Bruyette says.

Bruyette is hoping his company can change that: the company looks for an unmet need, like canine lymphoma, then thinks about what vets would prefer for an administration modality, like an oral treatment. Once the need has been identified, Anivive uses software to determine if compounds to treat the disease exist.

The software hunts for an initial set of compounds that could work and researchers determine if the compounds interact with a target that is known to be present in the disease. The team also determines if any of the compounds are patented and picks out the most promising compounds; the company then approaches the groups working with the drugs.

If Anivive feels the compound is promising, they will take the product through the regulatory process. These strategic partnerships streamline both cost and time to approval. Bruyette thinks it will take only between three and five years to bring a drug to market this way since the required studies on safety and toxicity will have already been performed.

Read more at DVM360.

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