Her other challenge is to move products to market as expeditiously as possible. From the time of discovery to ultimate FDA
clearance, the agency's process is measured in years — decades in some cases.
"When a pharmaceutical company takes a molecule through the approval process, it takes many years. There are different times
of where these compounds are in the pipeline. You may have a year when many drugs just happen to come all the way through
and you see a higher rate of approvals."
While she hopes the same holds true for 2008, she stopped short of predicting the level of FDA approvals for the veterinary
"We have seen a wonderful benefit that truly has happened from the user-fee program that allowed us to try to do a catch up
on the backlog."
CVM brought on new reviewers to help improve the system. She believes the efforts will streamline the process long term.
And she remains bullish on the prospects for animal health driven by increasing consumer expectations and demands.
The greater the love consumers express toward their pets, the greater the opportunity for veterinarians and the animal-health
market, Dunham adds.
"We are seeing a huge change with the public and what they expect. They want the best treatements and new therapies for their
pets. It gives veterinarians an exciting challenge to deliver on owner expectations."
New drug modalities emerging from biotechnology and pharmacogenomics will help veterinarians hone therapeutic options, Dunham
says. Improved screening diagnostics could offer new ways to stave off adverse drug events. An example? P-glycoproteins. There
is a mutation that enables certain breeds (Collies) to react to avermectins. A screening test developed to predict hypersensitivities
to the compound prior to administration would help. Thanks to the decoding of the canine genome, advanced screening tests
are closer to reality.
"It is going to happen more and more as we begin to learn more and more about the genetics behind some of these problems."
Nanotechnology and novel cancer therapies will all play an important role in animal health.
"We are seeing new medications coming through where pharmaceutical companies are seeking approval." And that's good medicine
for the entire market.