Career Opportunities in the Life Sciences Industry

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Post on 17-May-2015




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1. Career Opportunities in the Drug Development Process 2. Bioscience Industry Statistics There are over 1,500 bioscience companies in the U.S. today Bioscience companies employ approximately 191,000 people The market capitalization (total market value of publicly-traded U.S. bioscience companies) was $206 billion as of April 2003 There are currently more than 370 bioscience drug products in various stages of clinical development in the U.S. 3. Drug Development Process Discovery Development Clinical Testing Licensure Marketing & Sales Manufacturing 4. Drug Discovery Target identification and validation Production and/or synthesis of drugs Interaction between drugs and targets characterized and validated: tested for efficacy in vitro and in animal models of disease Personnel involved:chemists, molecular biologists, animal handlers, bioinformatics, biochemists, protein chemists, etc. Degree requirements:bachelors through Ph.D. 5. Drug Development Process of production/synthesis ofdrug is validated and scaled up to produce large quantities of the drugDetection and analytical methods for the drug are created and validated Toxicology and ADME experiments performed in animals Investigational New Drug Application (IND) is prepared and submitted to the Food and Drug Administration (FDA) Personnel required:process chemists, analytical chemists, pharmacologists, toxicologists, regulatory affairs, drug safety, animal handlers, veterinarians, quality control, quality assurance, etc. Degree requirements:associate through Ph.D./M.D./DVM 6. Clinical TestingIND is approved by FDAanddrug is tested in human clinical trials Phase I trialsare conducted to assess drug safety; typically tested in healthy human subjects Phase II trialsare conducted to assess drug efficacy in patients suffering from the target disease; dosing is determined and numbers of patients in the trials are typically small Phase III trialsare conducted to assess overall therapeutic effect of drug in large numbers of ill patients 7. Clinical Testing (contd) Personnel required:clinical research associates (CRA), nurses, physicians, statisticians, clinical operations, data management, safety monitors, etc. Degree requirement:nursing/bachelors through M.D. 8. Licensure Data from Phase I-III clinical trials tabulated and analyzed for overall safety and therapeutic efficacy A New Drug Application (NDA) is prepared and submitted to the FDA for review Personnel required:regulatory affairs specialists, drug safety personnel, pharmacologists, physicians, statisticians, marketing, etc. Degree requirements:bachelors through M.D./Ph.D. 9. Manufacturing NDA is approved by the FDA; drug must be manufactured in large quantities to meet therapeutic demand Drug is manufactured in a pharmaceutical plant or protein production facility Personnel required:pharmaceutical operators, analytical chemists, quality control, quality assurance, regulatory affairs, sterile fill operators, formulations, drug safety, marketing, engineers, etc. Degree requirement:associate through bachelors 10. Sales & Marketing Drug must be advertised,marketed, and sold by manufacturer to the public Distribution channels must be developed and a sales force must be trained to sell the drug Personnel required:advertising, marketing, accounting, administrative support, sales, etc. Degree requirements:associate through bachelors