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Career Opportunities in the Life Sciences Industry


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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 of drug is validated and “scaled up’ to produce large quantities of the “drug”
    • Detection 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 Testing
    • IND is approved by FDA and drug is tested in human clinical trials
    • Phase I trials are conducted to assess drug safety; typically tested in healthy human subjects
    • Phase II trials are 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 trials are conducted to assess overall therapeutic effect of “drug” in large numbers of ill patients
  • 7. Clinical Testing (cont’d)
    • 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