I continue to think about the number of innovative products necessary to meet the expected growth of the animal health market over the next 10 years, especially given the generic parasiticides we expect to see on the market for dogs. When taken in the context of the ongoing discussion about reducing the necessity for animal testing in the FDA approval process, how will this impact future development plans?
Some of the expected benefits of less animal testing include:
- Reduced timeline and cost of approval, with some suggesting it could reduce time and/or cost by 20% or more
- Ethics and animal welfare resulting in fewer animals being needed for terminal studies
- Use of computational models and microphysiological systems to facilitate studies
- Overall expedited approval to support market growth
- Facilitate development and investment in medications that might not reach blockbuster status
Each of these comes with the challenge of how to manage any transition:
- Initial investment in technology
- Ensuring the necessary regulatory endpoints can be met from non-animal studies
- Having proven, reliable and consistent processes that are validated
- Accurate alternative methods that correctly quantify riskChaos of living through a change
There is no clear guidance for the animal health industry and most suspect this will be dealt with on the human side first. It is impossible to eliminate all animal studies for veterinary products. I think we can agree that adoption of new methods that can decrease the approval timelines and costs while ensuring the continued safety and efficacy of the medications will be good for future innovation.
Chuck Johnson
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