Someday soon, Craig Woods hopes to measure the success of his fledgling venture against the ultimate corporate benchmark: profitability. But for now, a more modest goal drives him. “I’d like to be able to pay my employees,” says Woods, DVM, MS, MBA, chief executive officer of Imulan BioTherapeutics of Prescott, Ariz., a company seeking to develop immunotherapies for veterinary medicine. Welcome to the crucible that is today’s veterinary pharmaceutical and bioscience proving ground. The hurdles are many as potential breakthroughs progress from concept to product, enduring multiple phases of testing and myriad strains on resources. The promised land is marketability and the prospect of healthy and sustainable returns on investment. But getting there means clearing the ultimate barrier–regulatory approval. And that can be the most taxing test of all. Until that goal is reached, a small privately held company like Imulan exists largely on a diet of sweat equity and faith. “We started 4-1/2 years ago on a wing and a prayer,” Dr. Woods says. “My whole team has worked without compensation, giving up evenings and weekends to advance veterinary medicine. “It’s not just altruistic–our goal is to be profitable. But (going without pay) is a testament to how confident we are that our technology will deliver breakthroughs.” These days, Imulan has several bioscience irons in the fire, including at least one immunotherapy product targeting cancer that’s in the exploratory phase. Navigating the path to market would be easier if Imulan had a financial war chest, instead of operating on self-financing. However, in this economic climate, outside financing isn’t readily available anyway. Among the key challenges, Dr. Woods says, are to identify the most viable bioscience opportunities and then “finding the budget to succeed in this regulatory environment.” “You may have lots of good ideas but not a million dollars for each to go through the regulatory process. I would like to have seven cancer trials now on parallel tracks, but that’s just not possible.” Essentially, therapies developed for animals go through an approval process almost identical to the one for human drugs, says Ron Phillips, vice president of legislative and public affairs for the Animal Health Institute, an advocacy group representing drug companies and others with an interest in animal health. Data has to prove efficacy, safety, potency and purity. Pharmaceuticals are regulated by the Food and Drug Administration, biologics by the U.S. Department of Agriculture. “While we have the same rigorous process, at the end there is a totally different market than for a human drug,” Phillips says. “You’re talking about a drug that applies to one or two species at best, so the market and the margins are different. Companies have to be efficient.” On the animal side, drug companies do get help from the federal Minor Use and Minor Species Act, passed in 2004. The goal is to encourage development of new animal drugs for minor species and minor uses for major species. Companies get a chance to recoup some costs through early marketing as well as eligibility for grants and a period of marketing exclusivity. But for most companies, the product development process still starts with determining the pathway to regulatory approval. Manufacturing, timeline, data capture methods and other specifics of clinical trials all link back to conditions set by regulators. Those specifics can commit a company to a process anywhere from two to seven years in length, depending on the technology and the species, Woods says. “If you’re recruiting from a population that has advanced osteosarcoma and you need 100 patients, it may take 10 months just for enrollment,” he notes. When AB Science USA began the process of bringing to market its targeted molecular therapy for canine mast cell tumors, the company projected a three- to four-year timeline, says Albert Ahn, DVM, president of U.S. operations. “We view the FDA as a partner,” he says. “We knew we would need a robust data package, and we knew we would need to be prepared to invest a tremendous amount of money.” The ability to adapt even while taking a long view in process planning is critical to success, leaders at animal health companies say. An unshakable belief in your ideas and your organization doesn’t hurt, either. “It will be a good 2009, even with the recession, because we have built our company brick by brick,” Imulan’s Woods says. “We can weather anything.” RELATED ARTICLE: In With the New 2009 arrives loaded with the potential to define the future of cancer therapy. <HOME>
