Biotechnology Glossary

What is “Bird Flu”?
Avian influenza (also known as bird flu, avian flu, H5N1, influenzavirus A flu, type A flu, or genus A flu) is an extremely virulent form of flu that originated in Asia and has since spread to other areas around the world. It is endemic to bird populations but can spread to other species, including humans. Thus far the virus has been contracted mostly through human-avian contact, but health officials around the world fear a virus strain that could be easily transmitted from human to human and result in a worldwide pandemic.

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Clinical trials are carefully controlled research studies conducted in humans to test the effectiveness and safety of new drugs, medical products, or treatments. Before a company can initiate clinical trials (i.e. testing in humans), it must conduct extensive experiments in animal and human cells, and in live animals. If this stage of testing is successful, the company files an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to request permission to conduct clinical trials. All drugs in the United States undergo three phases of clinical trials

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FierceBiotech examines the FDA’s new drug development process critical to Biotech and Pharma companies. From drug discovery and drug development technology to clinical testing and the FDA approval process, FierceBiotech’s newsletters bring you the information you need to stay on top of emerging and well as mature companies.

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A CRO, or contract research organization, is a company that is contracted to perform all or part of a sponsor's clinical trials-related tasks. This might include the design, monitoring, and... Read more...

The FDA Drug and Biologic Approval Process: A hot topic

The high cost of prescription drugs is a hotly debated issue and poses a significant burden to individuals, families, and the federal government. Drug costs have led to Medicare Part D, a federally subsidized program meant to defray the costs of prescription drugs, particularly to the elderly. Though there are many contributing factors drug prices, their expense is due in part to the cost involved in completing the FDA approval process.

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Genomics is the study of genes and their function. It typically involves high-speed sequencing of a large numbers of genes, which helps researchers to identify specific genes responsible for specific proteins with specific functions in an organism.

Genomics is stimulating the discovery of breakthrough medical treatments by revealing thousands of new biological targets for the development of drugs, and by giving scientists innovative ways to design new drugs, vaccines and DNA diagnostics. Genomics-based therapeutics include "traditional" small chemical drugs, protein drugs, and potentially gene therapy.

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In order to ensure the safety and efficacy of pharmaceutical products, the FDA mandates that manufacturers follow a set of methodologies and procedures known as Good Manufacturing Practices, or GMP. These guidelines are the FDA’s way of regulating production processes that are constantly changing as new technology enters the scene. Specific regulations governing pharmaceutical production are often not feasible when dealing with novel technologies. GMP guidelines establish best practices as they evolve and also provide for extensive record...

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An institutional review board, or IRB, is an independent body charged with the protecting the safety and well-being of human subjects who participate in clinical trials. An IRB is sometimes called an independent ethics committee or a committee for the protection of human subjects. This group, which is composed of medical, scientific, and non-scientific members, oversees a trial's protocols to ensure that it is conducted in an ethical manner. A key function of IRBs is to obtain and document informed consent from the trial subjects. In addition to protecting human subjects, IRBs also review the use of data culled from human subjects' medical records, tissue samples, and fluid specimens.

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FierceBiotech covers the life science industry like no other daily publication. The life science article list covering molecular and cellular biology, biotechnology, genomics, proteomics, physiology, and life science company news is emailed to 20,000 life science professionals and investors every weekday. FierceBiotech also focuses on the bioinformatics companies providing the technological resources to advance the life sciences field with the final outcome being the discovery and development of new treatments.

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Nanotechnology researchers work at the atomic, molecular or macromolecular levels in the 1 - 100 nanometer range to create and use devices, systems, and structures that can be controlled or manipulated on the atomic scale. Although nanotechnology is still in its nascent stages, products such as cosmetics, paints, and protective coatings for eyeglasses are already on the market. Often, nanomaterials are combined with other materials to improve the functionality of products such as ink and car bumpers.

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There is nothing novel in the insight that individuals react differently to medicines. When we take pain killers, asthma drugs, antidepressants, or even cold medicines, we are taking a 'one size fits all' treatment that cannot account for the differences in our genetic makeups. The problem facing doctors is how to determine which individuals will benefit from a prescription and which ones will experience negative side effects or even death. This is the question that personalized medicine proposes to answer.

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FierceBiotech brings the pharmaceutical industry to your desktop. The pharmaceutical company news delivered by FierceBiotech enables you to keep up with the pharmaceutical industry quickly and efficiently. The daily pharmaceutical newsletter includes general pharmaceutical company news, drug discovery information, clinical trial data, financing reports, and pharmaceutical M&A scoops.

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FierceBiotech, our free daily email newsletter, covers proteomics and proteomics research, along with other key biotech industry topics.

Proteomics is the study of proteins that are expressed in a cell. The field attempts to catalog and characterize proteins derived from genetic code, compare variations in their expression levels under different conditions, study their interactions, and identify their functional role. Understanding of these proteins will enable scientist to make even more medical breakthroughs.

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Recombinant DNA (rDNA) technology is a field of molecular biology in which scientists "edit" DNA to form new synthetic molecules, which are often referred to as "chimeras". The practice of cutting, pasting, and copying DNA dates back to Arthur Kornberg's successful replication of viral DNA in a breakthrough that served as a proof-of-concept for cloning. This was followed by the Swiss biochemist Werner Arber's discovery of restriction enzymes in bacteria that degrade foreign viral DNA molecules while sparing their own DNA. Arber effectively showed geneticists how to "cut" DNA molecules; soon to follow was the understanding that ligase could be used to "glue" them together. These two achievements launched rDNA technology research, allowing...

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Stem cells are immature cells that mature into differentiated cell types. They are abundant in embryos, bone marrow, and umbilical chords, and can be harvested for transplant.

Stem cells differ from other kinds of cells in the body in three ways:

• Stem cells are capable of dividing and renewing themselves for long periods
• Stem cells are unspecialized
• Stem cells can give rise to specialized cell types

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In 1987, the FDA enacted regulations that provide increased access to experimental drugs for patients with life-threatening or seriously-debilitating diseases when no alternative treatment exists. These guidelines, commonly called Treatment IND (Investigational New Drug), provide for rapid review of new therapies even when clinical trials results proving efficacy have not yet been established. Once a drug's safety has been determined in human trials, it may be prescribed to patients that are terminally ill or suffering from diseases such as HIV/AIDS, herpes simplex encephalitis, or subarachnoid hemorrhage under the Treatment IND protocol...

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