Pets Vs. Pen Animals

Biotechnology Boom Molecular biologists find niche as new technologies are adapted to the animal health market. While the biotech boom resounds in human health research, the technology has made less of a roar in the animal health field. Uncertainty over product costs and regulatory approval has left some animal health companies hesitant to embrace biotechnology. But this situation could be changing. A growing number of vaccines for cats, dogs, and fish are based on recombinant DNA techniques. New diagnostic tests for these animals also rely on biotechnology. These emerging products offer molecular biologists-traditionally the mavens of human health research-a new niche. "Biotech is now having as profound an impact on animal health as human health," contends Timothy Cronin, senior vice president of animal health research at New York-based Pfizer Inc. "The real opportunities today are in companion animals [dogs and cats]." Cronin says the knowledge needed to enter this line of research are the same needed in human health-for example, molecular biology, biochemistry, and genetics. As of last February, the United States Department of Agriculture (USDA) had approved at least 38 biotech-based diagnostic tests and 24 vaccines for animals. More than half of these products were approved within the past six years. Today, 37 new biotech-based products-including 19 recombinant vaccines-are under review at USDA. "In particular, we're seeing more applications for [live] vector vaccines," reports David Espeseth, deputy director of veterinary biologics at USDA's Animal and Plant Health Inspection Service in Riverdale, Md., which regulates animal vaccines. Hot in human research, live vector vaccines pack immunity-stimulating genes inside a disarmed virus or bacterium that infects an animal. A handful of companies, including Pfizer; Rhone Merieux Inc. of Athens, Ga.; and Mallinckrodt Veterinary Inc. in Mundelein, Ill., have begun to fund biotech programs. Last year, Pfizer acquired Philadelphia-based SmithKline Beecham's animal health unit and contracted with publicly owned Cantab Pharmaceuticals plc of England to develop biotech veterinary vaccines. Mallinckrodt bought Lenexa, Kan.-based SyntroVet Inc., a private company that has developed biotech vaccines against diseases in swine and cattle. "We see biotechnology as the way of the future," comments Edwin Andrews, senior vice president of science and technology at Mallinckrodt Veterinary. "For us, it's an investment." Investment analysts predict biotechnology will make slow, steady strides into the animal health market. "I think we will definitely see advances [in animal-health biotech]," says James McCamant, editor of the Berkeley, Calif.-based AgBiotechnology Stock Letter. "Companies will find niches to fill with biotechnology." PCR FOR PETS: Vet biotech is a "field biologists should consider." suggests Rhone Merieux's Judy Jarekci-Black. Some molecular biologists give little thought to a career in animal-health research. That was the case with Judy Jarecki-Black. But at a party six years ago, she listened intently as another guest described difficulty in diagnosing Newcastle disease, a virus that affects chickens. Knowing that Newcastle is an RNA virus, Jarecki-Black interrupted the guest's lament with an idea for a diagnostic test. The conversation led Jarecki-Black to a postdoctoral position at USDA, where she did in fact create a test for Newcastle disease (J.C. Jarecki-Black, Avian Diseases, 36:134-8, 1992). Soon after, Rhone Merieux hired her to work on a new wave of recombinant DNA vaccines for dogs. Today, Jarecki-Black is manager of the companion animal bacteriology lab and handles intellectual property rights at Rhone. One of her major projects, a canine recombinant vaccine for Lyme disease, hit the market this spring. "[Launching a career] wouldn't have happened so easily in human health, where there are so many big names and it's difficult to break in," she says. "This is a field biologists should consider." Until recently, biotechnology has been too new and costly for most animal health companies to endorse, according to Kenneth Cohen, CEO of San Diego-based Synbiotics Corp., a public company that develops animal health products. "The biggest difference between [drugs for] an animal and a human is that you have to be able to get the costs low in animal health," explains Cohen, who has worked in human gene therapy. "People put a dollar value on the life of an animal, unlike a human's," he adds. "[Biotech-based] diagnostics haven't been simple and cheap enough to justify in an animal lab. And it's the same with recombinant technology in vaccines." As time goes by, however, technologies tend to grow cheaper. Cohen and others say biotechnology is now making its first big splash in the companion animal market. This fall, Synbiotics plans to introduce a new line of diagnostic tests that rely on polymerase chain reaction (PCR) technology to sift through a pet's DNA for signs of disease. "The business is definitely growing," he observes. "There's an opportunity for people who can watch the [biotech] science develop and figure out cost-effective and lower-risk ways it can be applied in animal health." One of Synbiotics' competitors, publicly owned IDEXX Laboratories Inc. of Westbrook, Maine, has produced at least 23 biotech-based tests for pet diseases. "There has been a dramatic growth in the kinds of things we can do," notes Bob Suva, director of R&D for veterinary products at IDEXX. "We have better monoclonal antibodies, for example. We can use a virus to get recombinant viral proteins. We can make tests easier to reproduce. We can do different kinds of tests within the same assay." Pfizer's Cronin explains that new animal vaccines and drugs naturally follow human disease discoveries. "Pets have similar diseases as humans, so the human research acts as a jump-off point." At Pfizer, he says, human health researchers share findings with animal divisions. Cronin says he expects biotech advances for humans-and molecular biology in general-to make inroads in treating arthritis and allergies in pets. While companies developing cat and dog products may lap up the new technology, firms that focus on farm animals still hesitate. For them, the cost of launching biotech programs may be prohibitive. "Right now, in feed animals, you generally can't recoup the costs of manufacturing biotech products," says Russ Cairns, associate director of biological research at Fort Dodge Laboratories Inc., a Fort Dodge, Iowa-based veterinary division of American Home Products Corp. "Different animal species will have different amounts of money the owner will pay. It's certainly not [cost-effective] for, say, swine." REALITY CHECK: Incorporating biotech into farm animal health will take time, says Boehringer Ingelhiem Animal Health Inc.'s Steve Bell. Steve Bell, a virologist at Boehringer Ingelheim Animal Health Inc. in St. Joseph, Mo., agrees that the biotech industry may be over-optimistic when looking at product potential in the farm-animal market. "At this stage, I believe it's too early to imagine that we can incorporate modern biotechnology into a highly cost-conscious farm animal health arena," he says. "Further, I expect it might take another five to 10 years before biotechnology costs will decrease to anywhere near the affordable price range." McCamant counters that animal biotech's time has already arrived. But he agrees that farmers may be reluctant to choose high-tech products. "One thing that makes the sector difficult is that, in most cases, you're talking about changes in an existing market," McCamant says. In other words, companies must convince farmers to switch from current drugs or vaccines to new biotech varieties, which may be more expensive-at least at the outset. In some cases, biotech alternatives arise out of dire necessity. That's what happened with a PCR-based test for whirling disease, which affects fish. Trout and salmon catch whirling disease-named for the frantic tail-chasing it induces-by ingesting a parasite, Myxobolus cerebralis, which is carried in worms. Whirling disease is untreatable and has devastated trout populations in Montana, Colorado, and Utah. "In one Montana outbreak, the disease reduced the rainbow trout population from 3,000 per mile down to 300," says Tom Baldwin, a veterinary pathologist at Washington State University in Pullman. Health officials try to squelch a whirling disease outbreak by keeping infected fish away from others. But to determine infection, researchers must painstakingly cut open a fish and search for bits of diseased tissue. "You may have to look at 100 sections from one fish to make a diagnosis," Baldwin explains. FISH TALES: UC-Davis fish disease specialist Ronald Hedrick and colleagues deveopled a PCR test for whirling disease in trout and salmon. Surely, researchers thought, there must be a better way. Maybe there is. In an unrelated project, Ronald Hedrick, a fish infectious disease specialist at the University of California, Davis, isolated DNA from M. cerebralis and characterized one of the genes. With that information in hand, Hedrick decided to devise a PCR test to screen for the parasite in whirling disease victims. "In this case, biotechnology made quite a bit of difference because there really weren't other [viable] approaches to this type of detection," says Hedrick, who is patenting the whirling disease test and discussing its commercialization with several companies. In addition to diagnostics, biotechnology intrigues researchers working in fish vaccination. The $30 billion worldwide aquaculture industry loses an estimated $3 billion annually to fish disease, according to the University of Maryland Biotechnology Institute in College Park. But many fish are not deemed financially worthy of injected vaccines. Biotechnology might offer cheap alternatives. THE NET RESULT: Biotechnology may offer alternatives to injected vaccines for fish, says Louisiana State's Ron Thune. "When you're growing salmon, you've got a fish that, when full grown, is worth $70 to $80," explains Ron Thune, a professor of aquatic animal health at Louisiana State University (LSU) in Baton Rouge. "So it's cost-effective to inject a vaccine into this population. But if you're talking about a catfish, it's worth only a couple of dollars. So it's a different story." One biotech-based vaccination idea is to immerse fish in a solution containing E. coli or other bacteria that have been engineered with genes spurring immunity to a given disease. Another biotech idea is to use so-called DNA vaccines, a headline-winning type of vaccine borrowed from human medicine. DNA vaccines are simply plasmids, or chemical envelopes, that carry immunizing DNA. For example, Jo-Ann Leong, a microbiologist at Oregon State University, has injected trout with a plasmid containing genes that code for infectious hematopoietic necrosis virus (IHNV) proteins. This DNA vaccine appears to protect fish from IHNV infection (E.D. Anderson et al., Molecular Marine Biology and Biotechnology, 5[2]:105-22, 1996). But because biotech solutions are new, these vaccine approaches must undergo intense regulatory scrutiny. "I would say [new recombinant products] raise more questions than conventionally derived materials because they haven't been in nature previously," comments USDA's Espeseth. While USDA rules on animal vaccines, the Food and Drug Administration (FDA) handles drugs and therapeutic agents. In particular, the vision of genetically engineered animals living near their wild brethren concerns FDA, according to Richard Teske, associate director for policy at the agency's Center for Veterinary Medicine. "We have concerns about the genetic engineering of salmon to create fish resistant to certain disease," Teske says. "The salmon, as a part of their life cycle, are released and go downstream out to sea, coming back at a later time. They can breed with wild fish and perhaps change the genetics of those wild fish." One solution, he notes, might be to sterilize engineered salmon, ensuring that the fish don't breed. From fish to fowl, safety questions like this dominate discussion of biotech products. Next to cost, regulatory tangles are the single biggest deterrent to animal biotech, researchers note. "The regulatory process for biotech vaccines is definitely difficult," states Jarecki-Black. "It's a new technology, and there's a lot of concern out there. But I think it will get better as more products are released." Cronin agrees, noting that time spent developing and testing animal biotech products pales by comparison to that needed in human health. "We can test products more quickly," he says. "And that's a real turn-on for scientists." McCamant estimates that animal biotech products travel the regulatory pipeline in six to eight years, much less than the 15 years it usually takes for human drugs to be approved. The shorter pipeline means animal health researchers may be involved with a product from conception to market, which isn't always the case in human medicine. In the end, it could be this kind of perk that attracts more biologists, biochemists, and other scientists to animal research, predicts LSU's Thune. "Animal health is a small world," he says, noting that some vet companies and university departments are unable to match salaries in human research. Still, opportunities exist. And, like Jarecki-Black, many researchers may find they love being a big fish in a little pond. Kathryn S. Brown is a freelance science writer based in Columbia, Mo.

Pets Vs. Pen Animals

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