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WETFEET RESOURCES
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| Pharma and Biotech Lingo Every industry has its own argot; pharma and biotech is no exception. The definitions that follow are designed merely to get you started; we don’t pretend that they’re comprehensive. Bioinformatics: The management and analysis of biological research data using advanced computing techniques. Particularly important in genomics research because of the large amount of complex data generated. Breakthrough drug: A drug that offers a dramatic step forward in terms of efficacy, side effects, dosing, and/or price—Claritin and Viagra are recent examples. Breakthrough drugs often get coverage on the evening news or talk shows. Clinical trial: Four phases of rigorous tests establish a drug’s safety and efficacy for humans. Phase I tests a tiny group of healthy people to determine the safe dosage range and track how the drug is metabolized by the body. Phase II tests a midsize group of patients who actually have the condition targeted by the prospective drug. Phase III increases the test group to more than a thousand patients and uses a double-blind, placebo-controlled protocol. If a drug is clearly more effective than a placebo and causes no serious adverse events, the manufacturer submits a new drug application (see below). Phase IV is a post-marketing study done after drug approval. Contract research organization: A CRO oversees the clinical trials required for FDA approval of a drug. Contract sales organization: A CSO helps sell and market drugs for companies that lack the resources to do it themselves. Detail: Usually a verb in pharmaceutical sales. To detail is to provide a doctor with information about a product, particularly with the help of a company-produced visual aid. Direct-to-consumer (DTC) marketing: Prescription-drug advertising that targets laypeople rather than physicians. This is the hottest segment of industry marketing. Ethical pharmaceuticals: Products, including biological and medicinal chemicals, used to treat disease in humans or animals, promoted mainly to health-care professionals. This category may include both over-the-counter and prescription drugs. Formulary: A managed care company’s list of reimbursable drugs. When a patented drug goes off-patent, it is usually kicked off the formulary in favor of a cheaper generic. Generic (or off-patent) drug: Once the patent on a drug expires, anyone can manufacture and sell it. An entire generic drug industry does precisely that, and since generic drug companies have no R&D costs to cover, they can sell any off-patent drug at a 50 percent to 90 percent discount. Genomics: The study of genes and their functions. Genomic research is revolutionizing our understanding of the mechanisms of disease and revealing thousands of new biological targets for drug development. Good manufacturing practices: GMPs are manufacturing regulations established by the U.S. Food and Drug Administration (FDA) that require companies extensively to document their ongoing manufacturing efforts. If you work in quality assurance or quality control, GMPs will exert a large influence over your life. Investigational new drug application: When a company is ready to begin testing a drug on humans, it submits an IND application to the FDA, which then has 30 days to accept or reject it. If the application is accepted, the company proceeds with Phase I through Phase III clinical trials. New drug application: A company’s final FDA application to sell a prescription drug. It is not uncommon for an NDA to be 50,000 pages long; FDA review typically takes between one and two years unless the drug treats a life-threatening illness or one that has no effective pharmacological treatments. In such cases, the FDA often gives the application a priority review, sometimes cutting the review time in half. Over-the-counter drug: A drug that can be sold directly to consumers, without a prescription. Most new OTC drugs started out as prescription drugs. Patented drug: A drug that is under patent to a pharmaceutical company. A patent on a drug lasts for 20 years. When it runs out, competitors can produce and sell the drug as a generic. Pipeline: A company’s collection of drugs in development. Since drugs are patented for only 20 years—and it can take a decade or longer to bring a drug to market—pipeline strength is a key predictor of a company’s success. Quality control/quality assurance: The folks who work in this area make sure that drugs are manufactured in accordance with FDA regulations Note to scientists: Don’t limit yourselves to R&D—opportunities abound in QA/QC. Recombinant DNA: Think of it as DNA that has been combined with other DNA and then replicated. It is made by putting foreign DNA, such as bacteria or yeast, into the DNA of an organism so that the foreign DNA is replicated along with the host DNA. |
