An Industry Statistician in Animal Health
Daniel H. Mowrey, Eli Lilly and Company
Statisticians have found productive, challenging, and rewarding careers in many industries. In particular, the animal health industry is one in which statisticians have been involved for many years. Statisticians usually work in one of the following two components:
- Companion animal - Animals such as dogs, cats, or horses with the main focus on their care and well-being
- Livestock - Animals such as swine, beef and dairy cattle, chickens, turkeys, lambs, and goats with the main focus on making food healthy, safe, and efficient to produce
The livestock animal health statistician works with a diverse group of people with degrees in areas such as biochemistry, biology, virology, analytical chemistry, organic chemistry, physical chemistry, physiology, veterinary science, animal nutrition, meat science, computer science, business, marketing, and sales. Some colleagues have nominal or moderate formal statistical training, but many have none.
The animal health statistician must become familiar with the area in which he or she is working in order to give guidance and direction for the problem being investigated and assist in writing reports and formal papers and giving presentations.
The problems an animal health statistician encounters are diverse and challenging. In general, the statistician works with a team of colleagues to discover, develop, and market a compound. Rigorous tests and processes must be conducted to receive government approval and market the compound properly. The tests and processes occur in four phases of a company's research. The phases animal health statisticians are involved in depend on the company for which they work.
Phase One: The discovery phase involves the search for a compound or class of compounds. The objective is to identify a compound (stimulus) that produces a specific, desired biological response. A challenge for statisticians working in the discovery phase is that there usually is only a tiny amount of compound available to test, so there is little opportunity for assay replication. Therefore, innovative and reliable testing needs to be developed.
Phase Two: The compound starts to undergo toxicology testing to make sure the product is safe. In most cases, the statistician working in the livestock component is not involved with testing in the toxicology division. However, as the compound is undergoing toxicology tests, it also is being tested outside the target specie in what are called in vitro (laboratory or artificial environment) tests, as well as in the target specie in what are called in vivo (living organism or natural environment) tests. The statistician in testing both in and out of the target specie provides guidance designing appropriate studies, collecting data in proper format, performing proper statistical analyses, and writing reports to evaluate the effectiveness of the compound.
Phase Three: This most expensive and time-consuming phase involves more safety testing and a much more rigorous efficacy evaluation. The statistician is called upon to provide input on all aspects of this phase to ensure government approval to market the compound. For instance, statisticians assist in validating some of the assay methods in the analytical chemistry area. In the formulation development area, statisticians assist in evaluating the homogeneity and stability of the compound. In pharmacology, they collaborate on what is called a target animal safety study. The purpose of the study is to determine an acceptable margin of safety for the target specie.
Efficacy is evaluated using clinical trials designed and conducted at several sites across the nation. Statisticians in most companies have a large role in the clinical trial process. They assist in defining the objective(s) and primary variables for the trials; determine the number of sites needed to detect a specific power for the primary variable(s); determine the number of pens at each site and the number of animals per pen; and assist in feed-mixing studies, randomization schemes, data validation and analyses, and writing the final pooled report.
From discovery to submission, most compounds take an average of eight to 10 years for the first three phases of testing.
Phase Four: After completing the three phases of testing, a submission is made to the Center of Veterinary Medicine, a branch of the Food and Drug Administration. If approved, the compound moves to the fourth phase: marketing. As the compound enters the marketing phase, new indications may need to be added or certain restrictions removed. The statistician is called upon to provide expertise in solving a new set of problems and the challenges continue.
The job of a statistician in the animal health world is challenging and interesting. In a real sense, you become part of the effort to find new ways of improving life in our civilization.