Animal & Veterinary
Need for Veterinarians in Biomedical Research
FDA Veterinarian Newsletter 2007 Volume XXII, No IV
The Food and Drug Administration’s “Critical Path” Initiative is reinvigorating the field of biomedical research, making it more productive and efficient, and creating opportunities for veterinarians to become involved in scientific research in academia, the private sector, or government, according to Dr. Stephen F. Sundlof, Director of FDA’s Center for Veterinary Medicine.
In a speech he presented to the Association of American Veterinary Medical Colleges (AAVMC) in August, Dr. Sundlof said that veterinarians are ideally suited to take advantage of those research opportunities, because, as veterinarians, they acquire a broad range of biomedical disciplines that go from working at the molecular level to encompassing entire ecosystems.
FDA launched its Critical Path Initiative in 2004 to address the problem of medical product development bottlenecks. In its report published that year, FDA said the problem was that “the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences.” In other words, many medical innovations developed by companies or in academia were not reaching patients as new, effective, affordable, and safe medical products.
FDA began the Critical Path Initiative to create a new “product development toolkit” that would include better ways to assess a product’s safety, medical utility, and potential for manufacturing, Dr. Sundlof said.
The 2004 report said, “Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness (the measure of medical product performance) of new products can be demonstrated in faster timeframes with more certainty and at lower costs.” The report added that product sponsors in some cases have had to use last century’s tools to assess potential new products. With older tools, companies may not be able to detect failures early. The sooner a sponsor can detect products likely to fail, the fewer resources will be wasted on those products.
Using resources to develop products that ultimately do not work means fewer resources for products that do work, a situation that could potentially delay or even prevent products from getting to patients.
And, without better tools to determine safety and effectiveness early, some products can get to market before the problems are uncovered, Dr. Sundlof said.
FDA is the only organization that could be expected to implement a program such as Critical Path, because it has a unique position in biomedical research, Dr. Sundlof said. FDA oversees the evaluation of all U.S. medical products. Therefore, FDA is in a position to identify key product development hurdles that commonly delay companies trying to bring products to market.
Also, FDA is the only organization that can set the scientific standards for product development, so it is the only organization that can ensure that new Critical Path tools become the standards for proving efficacy, assessing safety, and ensuring the safety of medical products, Dr. Sundlof said.
Although FDA is implementing Critical Path, the initiative was never designed to apply only to FDA. The Critical Path Initiative uses applied science and is meant to work in partnership with the discovery science carried out by industry, academia, and other health-related organizations, he said.
“The expected outcome of Critical Path, in fact the outcome we have already seen, is an increase in the movement of new products down the pipeline from discovery to patients,” Dr. Sundlof said.
FDA issued a report, “Critical Path Opportunities Initiated During 2006,” that listed more than 40 initiatives begun by industry and academia, so the program has had a strong beginning.
The report pointed out that not all of the projects identified in the Opportunities List are for human medicine. Several are in veterinary medicine, Dr. Sundlof said.
For example, he said, scientific advances under Critical Path can improve the tools FDA uses to evaluate safety and effectiveness of veterinary and human products. The advances can help FDA determine the safety of food ingredients, through new rapid tests for biological and chemical contamination of animal-derived foods. Improved analysis technologies can be used for assessing safety and nutritive value of foods, food ingredients, and feeds. Sophisticated cross-disciplinary scientific review is necessary to appropriately assess the issues of genetic engineering and animal cloning.
In animal production, FDA sees a need for new technologies to reduce various pathogens and will need to be ready to evaluate them as they are developed. An example is the therapeutic intervention for the reduction of E. coli O157:H7 in cattle immediately prior to slaughter, which could lower human exposure to the pathogen through food.
Role of veterinarians in Critical Path projects
“We believe that, whether working for a government agency, for industry, or in academia, veterinarians can offer a great deal of scientific know-how to advance Critical Path goals,” Dr. Sundlof told the AAVMC audience.
“We believe that veterinarians are uniquely trained to succeed in research. They have a broad range of biomedical training, and they often are involved in one of a large number of specialties,” he added.
- Veterinary specialties include:
- Laboratory animal medicine
- Clinical pharmacology
- Internal medicine
- Animal nutrition
- Preventive medicine
And, while veterinarians often have in depth knowledge in one area, they also have an awareness of the bigger picture through their training, a fact acknowledged in a report, the Pew Health Professions Commission in Health America: Practitioners for 2005, Dr. Sundlof said. In its report, Pew said: “Veterinarians are more knowledgeable about the impact of animals and diseases on human health and the role and use of animals in the improvement of health and well-being than any other health professional in most communities. Thus veterinarians should be more directly available to human health providers for consultation on these subjects.”
In addition to all that, “Veterinarians must become resourceful and creative in problem solving, simply due to the nature of their work,” Dr. Sundlof said.
FDA employs more than 100 veterinarians. They have scientific skills that allow them to do many jobs, Dr. Sundlof said. They direct science-based programs, are involved in epidemiology, drug review, risk assessment, food safety, biosecurity, and international trade.
CVM employs approximately 90 of the FDA veterinarians. At CVM, the veterinarians are involved in scientific research in areas such as:
- Animal drug safety and efficacy;
- Microbiology, including DNA fingerprinting, determining antimicrobial resistance mechanisms, and gathering data from the National Antimicrobial Resistance Monitoring Program;
- Toxicology (for instance, veterinarians helped significantly in resolving the incident concerning melamine and cyanuric acid contamination of pet food);
- Metabolism, pharmacokinetics, and residue depletion;
- Residue chemistry, detecting drug residues in animal products;
- Method trials and validation;
- Aquaculture research, such as developing model species and infections for testing drug efficacy, providing data for non-sponsored drugs, developing pharmacokinetic/marker residue data in different species; and
- Developing techniques, such as state-of-the-art polymerase chain reaction techniques and immunochemical-based methods to detect prohibited materials in feed, to allow FDA to enforce the BSE rule.
Pre-market evaluation of medical products must change from the current passive, empirical (trial-and-error) system that uses patient-exposure as a basis for assessing adverse events to become a predictive evaluation, based on a “robust body of prior knowledge about the molecular or the physical mechanisms of a product,” FDA said in its “Critical Path Opportunities Report” released in March 2006.
Moving in that direction of predictive evaluation will require developing expertise in the new sciences, particularly:
- Genomics and proteomics, and related disciplines;
- Bioinformatics; and
- Even “in silico testing,” which is computer simulation, rather than laboratory or animal testing.
A significant benefit to the individual veterinarian involved in biomedical research is that the experience can serve as a stepping stone to more significant, more influential positions, such as overseeing public health programs or protecting food safety, Dr. Sundlof said. Those types of positions can be filled only by someone who has broad experience beyond just the practice of veterinary medicine, he said, adding that research positions will provide that necessary experience.
Critical Path is making it possible for companies to more efficiently, effectively move products from biomedical innovation stage to the products that help to keep humans and animals healthy.
As the Critical Path Initiative picks up momentum, the opportunities for those interested in biomedical research are increasing, Dr. Sundlof added.
Veterinarians, because of their in-depth knowledge of certain biomedical specialties, combined with their broad understand of biomedical science, are uniquely suited to do biomedical research. In return, meeting the challenges of biomedical research prepares veterinarians for leadership roles in government or industry in research, public health, program management, and many other areas. And many of those roles are open because of FDA’s Critical Path Initiative.
The time has never been better for a veterinarian to seek a position in research, and the experience can help them in their careers. Dr. Sundlof said. At the same time, a veterinarian might find that time spent doing research could be very rewarding personally, because it is an effort that ultimately will benefit a large number of humans and animals, he added.