Career Opportunities in the Life Sciences Industry

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    17-May-2015

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  • 1. Career Opportunities in the Drug Development Process www.biocrowd.com

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 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 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

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