Non-Animal Technologies

Thanks to advances in non-animal research methods, human diseases can increasingly be studied in human volunteers and in human tissue. These technologies not only save animal lives, they also allow scientists to study superior disease models with increased efficacy and reduced costs. Additionally, these technologies act in synergy with epidemiological and clinical studies by providing detailed physiological data on study participants. Take a look at a few of the many technologies that make animal testing obsolete.

Featured Technologies

• Microdosing
• Genetic Mapping
• 3-D In Vitro Models

A Sampling of Other Technologies

• Stem Cell Tissue and Culture Models
• Computer Modeling
• Patient Simulators
• Functional Magnetic Resonance Imaging (fMRI)
• Positron Emission Tomography (PET) Scanning
• Computerized Tomography (CT) Scan
• Electroencephalography (EEG)
• Electrocardiogram (ECG or EKG)
• Ultrasound Imaging

Microdosing

The biggest problem in preclinical drug development is that neither cell cultures nor animal tests can predict how a chemical will be absorbed, metabolized, and eliminated by the human body. Only human studies can supply the key pharmacokinetic data that weed out ineffective or dangerous drugs. As a result, 92 percent of the drug candidates that pass preclinical animal testing fail in clinical trials.¹ This high failure rate is the problem behind the slow pace and enormous cost of drug development.

Microdosing (also known as “Phase 0 testing”) promises to revolutionize drug development by replacing preclinical animal testing with preclinical human studies. In microdosing, human volunteers are given drug doses that are less than 1/100 of the amount believed to cause a pharmacological reaction—so there is no danger of drug toxicity or side effects for the volunteers.² Even at these extremely low levels, people still absorb, metabolize, and excrete the drug, thus providing the necessary pharmacological data. Researchers need only analyze blood samples from the volunteers to determine exactly how a drug behaves in the human body. In the journal Drug Discovery Today, Dr. Ian Wilding and Dr. Angus Bell report that “microdosing helps to move the focus of early drug development away from laboratory animals to safe and ethical studies in humans via a reduced preclinical safety package for low-dose clinical studies.”³

Fears that microdoses are too small to model full doses have been laid to rest by the Consortium for Resourcing and Evaluating AMS Microdosing (CREAM) trial, which proved that the pharmacokinetics of microdoses are largely predictive of the pharmacokinetics of regular doses.⁴ These findings validate the theory that microdosing offers the most accurate preclinical data. In response to CREAM and other microdosing trials, U.S. and European Union regulatory agencies are reevaluating their drug testing guidelines. The European Medicines Agency Committee for Medicinal Products for Human Use has written a position paper strongly supporting the adoption of microdosing for preclinical regulatory testing.⁵ Likewise, the U.S. Food and Drug Administration has drafted guidance that advises industry to adopt microdosing technology in place of inadequate animal testing.⁶ Drug companies and regulatory agencies are finally realizing that replacing archaic animal tests is good for business and good for patient safety.

Genetic Mapping

With the completion of the Human Genome Project, researchers now have a powerful tool that opens up new possibilities in the field of epidemiology. Scientists now know which DNA markers are linked to which specific genes, and so they can tell with a simple DNA test which genes an individual has. Epidemiologists have traditionally looked for common lifestyle factors in disease populations, but now they can also look for common genes. 

Researchers use a two-step process to track down the genes that put individuals at risk of developing a disease. First, they conduct linkage studies of families in which the disease is common. By comparing the DNA of family members who do and who do not have the illness, researchers narrow down which genetic code could be linked to the disease. Because family members share so many genes, it’s relatively easy to spot patterns that are found only in the ill members. Next, researchers conduct association studies, which test the genes singled out by the linkage studies against the DNA of unrelated individuals who have the target disease. Because these people have only the illness in common, any shared genes must be connected to that illness.

Once specific genes are identified as risk factors for a disease, new prevention and treatment options become available, such as gene therapy, prenatal screening, and preemptive lifestyle changes.

Three-Dimensional (3-D) In Vitro Tissue Culture Models

The field of cancer research—particularly breast cancer research—is currently being revolutionized by a new type of in vitro technology—3D tissue culture modeling. Unlike traditional cell cultures grown on flat surfaces, 3-D cultures grow in the same geometrical forms and structures as actual tumors. Scientists can now experiment on exact models of tumors in well-defined and controlled environments. The development of 3-D in vitro modeling leaves animal models increasingly archaic and obsolete in comparison.

In their seminal review of this emerging technology, cancer researchers Jong Kim, Robert Stein, and Mike O’Hare detail the many advantages of using this technology. They explain that 3-D cultures allow scientists to study cancer formation, growth, and suppression as it actually happens in the human body while, at the same time, having  unparalleled control over every facet of the experiment design. Additionally, 3-D cultures can directly replace the main role traditionally played by animals—testing therapeutic agents on whole cancers. What’s more, Kim et al. explain that 3-D cultures are far superior to animal models for testing therapeutic agents because “they provide a well defined environment for cancer research in contrast to the complex host environment of an [animal] model.”⁷ Three-dimensional cultures provide all the advantages of animal testing with none of the drawbacks.