The federal money will be used over a 25 year period to fund a national children's study into children's health and development; it aims to recruit 100,000 children from before birth and track them to age 21.
The grant was awarded by the National Institute of Child Health and Human Development and will enable researchers to track children from birth to adulthood collecting data on a genetic makeup and a number of biological, chemical, environmental, physical and psychosocial factors.
Dr. Duane Alexander, director of the National Institute of Child Health and Human Development says the "National Children's study" is the largest and longest research study ever to look at the ways in which environment and genetics interact to influence child health and human development.
The 35 to 45 centers, in 105 locations, involved in the study will begin enrolling pregnant women within the next 9 to 10 months and important scientific information is expected to be available as early as 2011 and 2012, says study director Dr. Peter Scheidt.
The study will be conducted by Saint Louis University School of Public Health along with Saint Louis University School of Medicine, Southern Illinois University Edwardsville School of Nursing, Southern Illinois University School of Medicine in Springfield, Washington University School of Medicine in St. Louis and St. Louis Battelle Memorial Institute.
The study is a collaborative effort between the U.S. Department of Health and Human Services, including the National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences at the NIH, and the Centers for Disease Control and Prevention and the U.S. Environmental Protection Agency.
The next step is to find suitable agents. The scientists start off with more than 10,000 substances. Using automatic test systems, they filter out candidates that exhibit an effect on certain pathological processes. Researchers at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB use cell-based assays to identify agents that block validated targets. This is done by bringing several tens of thousands of substances in contact with a target-specific reporter assay in the presence of human cell cultures, explains Dr. Steffen Rupp. To test whether or not a substance has an effect, a fluorescent protein is selectively switched on or off, depending on the test set-up. The human cells employed in the process enable the researchers to simultaneously test whether or not the agent has a cytotoxic effect in general. This eventually leaves the researchers with about 100 substances. In order to rapidly determine suitable agents for drug development from among these candidates, they need to be able to assess the effect and toxicity of a new substance at an early stage. Researchers at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM use gene and protein expression analysis for this purpose. This enables them to test the effect of a substance on gene activity and subsequently to draw conclusions as to possible side-effects. First of all, the gene expression profiles of the potential agents are compared with those of substances whose harmful effects are already known. If a newly researched agent displays a similar signature to that of a drug that causes liver damage, for example, then this substance is likely to have the same side-effect. As for toxic properties, the most important indicators are provided by tests on cell and organ structures. But how will the new agent be absorbed, distributed and metabolized by the body? Will toxic degradation products emerge in the process, potentially leading to undesired side-effects? Tests on three-dimensional tissue systems developed by scientists at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB can provide the answers. These scientists have succeeded in producing human tissue belonging to different organs such as the skin, liver and intestines. The special feature of this artificial ™ tissue is that it actually has blood vessels to supply it. This allows conclusive tests to be carried out on the effects of different drugs. These tests complement the results of animal experiments, which show how the substances work in a complex organism and in what doses they start to become toxic.
Once a promising agent has been found, it has to be produced in small quantities for clinical tests according to Good Manufacturing Practice (GMP) guidelines. The Fraunhofer Institutes for Molecular Biology and Applied Ecology IME and for Cell Therapy and Immunology IZI are able to produce therapeutic, recombinant proteins under GMP conditions. The IZI also has the capacity for GMP-compliant manufacture of cell therapeutics and test systems. New technologies have been established to investigate therapeutics for treating cancer and other diseases. This model system makes it possible to systematically test how new types of agent are distributed inside the organism. The IGB can produce cell systems for organ replacement according to GMP guidelines.
Before a new drug is approved for the treatment of patients, it has to undergo clinical studies to demonstrate its effectiveness and safety. The ITEM carries out clinical studies according to internationally standardized Good Clinical Practice (GCP) guidelines in collaboration with the Hanover Medical School (MHH). The ITEM researchers specialize in clinical studies for the approval of drugs to treat respiratory diseases such as asthma, chronic bronchitis and hay fever. Agents are only approved for medical use once they have passed these clinical tests.
The route from a chemical molecule to a prescription drug is long and arduous. New research findings and technologies are helping to make it safer and shorter. The topic of accelerated drug development ™ will be presented by Fraunhofer researchers in Hall 9, Stand E29. We offer journalists individual guided tours of the Fraunhofer stand.
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