Preclinical Research Services

Depressed laboratory rats may enable pre-clinical research service providers to develop safer and more effective antidepressants for humans

Pre-clinical researchers in biological psychiatry, neuroscience and neuroendocrinology are studying rats in order to isolate the biochemicals in the brain responsible for a common depression subtype called “stress-induced depression” (STRID). Once these biochemicals are identified, the bench-to-bedside process of developing targeted antidepressants can begin.

Laboratory rats are “overfed, unfit and obese,” according to Mark Mattson, chief of the laboratory of neurosciences at the U.S. National Institute on Aging Intramural Research Program. They may also be depressed. Humans who suffer from major depression (MD) have an altered level of the L1-cell adhesion molecule in the prefrontal and parieto-occipital cortex of their brains. In an ongoing effort to determine the biochemicals responsible for MD, researchers at the University of Parma discovered that juvenile stress in rats produces the same biochemical response. This finding may enable researchers to develop a targeted drug for depression, which to date has not been possible.

Cooperation between preclinical and clinical scientists might be the magic formula for finding a better way to treat depression, which ranks fifth among leading causes of the global disease burden on health systems. Interestingly, the Italian researchers were able to prove that environmental enrichment reversed the stress-induced alterations in the biochemistry of the rat brains.

Best-in-Class Pre-clinical Research Service Providers:

• Offer special cell lines such as mouse, human or spontaneous transgenic/mutant tumors.
• Develop definitive and demonstrative Proof of Principle experiments.
• Follow all regulatory protocols.

Top Considerations Before Selecting Pre-clinical Research Service Provider:

Many clinical research organizations (CRO), who also offer pre-clinical services, are located in China and India. The strengths of these two countries’ CROs are different. For example, reviewers report that Chinese CROs possess better pre-clinical research service capabilities than Indian CROs, while the Indian companies provide better service during clinical trials. In addition, although China’s industry infrastructure is better, Indian companies align better with Western business operating style and philosophy, are more familiar with Western regulations and have a greater global presence.

Key Producers:

1. Rules-Based Medicine, Inc. (RBM), founded in 1998, is the world's leading laboratory testing biomarkers. RBM reports that “Our multiplexed immunoassay biomarker testing services are ideal for preclinical research, due to our ability to measure more than a hundred biomarkers cost-effectively using a small volume of sample.”  RBM's tests, which have been validated to meet or exceed clinical laboratory standards,  allow extension of the reproducible biomarker pattern discoveries made in the pre-clinical stage forward into human clinical trial stage. Corporate headquarters and CLIA-certified biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and its wholly owned subsidiary EDI GmbH is in Reutlingen, Germany.

2. The Jackson Laboratory is an NCI-designated Cancer Center that uses mouse genomics to discover ways to prevent cancer as well as to treat conditions including: cancer, diabetes, Alzheimer’ and cardiovascular disease. Its extensive experience with experimental genetics enhances the services it offers pre-clinical trial researchers. The Jackson Laboratory offers academic programs for teachers and students, as well as student internships and educational campus events. In addition to conducting genetic research, this independent nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. Its more than 1,400 employees work in offices in Bar Harbor, Maine and Sacramento, California.

3. TGA Sciences, Inc. offers researchers involved in pre-clinical studies a complete package of testing systems, which are all in compliance with the FDA’s cGLP and cGMP requirements, focusing on “the development and validation of immunoassay systems for the detection of target molecules, antibody responses and quantification.”  In vivo animal studies designed to optimize vaccine immunization schedules are also available from this Medford, Massachusetts-based company.

4. Aptuit, founded in 2004, offers drug development solutions, including critical expertise, technologies, facilities, ideas and services to companies engaged in pre-clinical trials. Headquartered in Greenwich CT, Aptuit has facilities in three other US states, England, Scotland, Wales, Italy, India and Singapore,  consulting services in the US and Scotland, and informatics in the US and India. What sets this company apart is its world-wide network of drug depots that results in secure storage of drugs at their optimum condition, reduced transit times and more efficient returns management programs.

Pre-clinical Research Services
Definition: The performance of all the research involved in gaining the knowledge required to develop new therapeutic treatments that lead up to clinical trials, which involve the evaluation of the safety and capabilities of these treatments.